Susan London

SEATTLE – Efforts to promote vaccination of boys against human papillomavirus may be more successful if they de-emphasize infection-related outcomes that make parents uncomfortable because of their sexual associations, according to a study of 158 parents of boys.

Surveyed parents were less likely to intend to vaccinate their son if they ranked anal cancer or oropharyngeal cancer as the most severe possible outcome of human papillomavirus (HPV) infection, investigators reported at the annual meeting of the Society for Adolescent Health and Medicine.

Comments made in focus groups suggested that these cancers elicited negative emotions: stigma in the case of anal cancer because it was associated with anal sex and homosexuality, and anxiety in the case of oropharyngeal cancer because it was associated with oral sex.

"Parents seemed to dwell on the sexual transmission of HPV," commented lead investigator Abigail C. Lees, a research assistant in the pediatrics department at the University of North Carolina, Chapel Hill.

"HPV awareness campaigns should decrease emphasis on outcomes that elicited either stigma associated with anal cancer or increased anxiety associated with oral cancer, and instead focus on prevalence," she recommended. "Furthermore, the parental preoccupation with the sexual transmission of HPV could be entirely avoided by vaccinating children at younger ages, when parents are less likely to associate stigmas or anxiety with their child’s behavior and the vaccine."

A quarter of the HPV-associated cancers that occurred in 2009 were in males, according to Ms. Lees. The quadrivalent HPV vaccine is now licensed for prevention of genital warts and anal cancer in both males and females, as well as for prevention of cervical, vulvar, and vaginal cancer in females.

To assess parental knowledge about male HPV outcomes and attitudes about vaccinating sons, the investigators recruited to their study parents of boys aged 11-17 years from a pediatric clinic, university listservs, craigslist, and other venues.

They completed surveys asking about perceived susceptibility (at least a 40% chance) of their son experiencing HPV infection and its outcomes, and perceived severity of the outcomes. They also participated in single-sex focus groups, conducted separately in English and Spanish.

The majority of the parents, 72%, were the boy’s mother. By race/ethnicity, 54% were white, 23% were black, 15% were Hispanic, and the rest were other. About a third had a high school diploma or less education. Slightly more than half were currently married. And 61% also had a daughter.

"Overall, parents believed their sons to have a low susceptibility to HPV infection and its outcomes," Ms. Lees reported. Just 22% thought their son was susceptible to infection. And smaller proportions thought he was susceptible to genital warts (18%), oropharyngeal cancer (11%), anal cancer (9%), and penile cancer (9%).

However, 82% of parents believed the consequence of HPV infection in their son would be severe; of these, 31% ranked penile cancer as the most severe possible outcome, 30% oropharyngeal cancer, 23% anal cancer, and 16% genital warts.

Eighty-three percent of parents indicated that they intended to vaccinate their sons against HPV. In a multivariate analysis, parents were more likely to intend to do so if they were older (odds ratio 1.14) and believed that the consequences of HPV infection could be severe (OR 9.94).

On the other hand, they were less likely to intend to vaccinate if they were more educated (OR 0.62). And there were trends whereby they were less likely to intend to do so if they ranked anal cancer or oropharyngeal cancer as the most severe possible outcome (OR 0.25 and 0.67, respectively).

"The most striking finding from our focus groups was that parents had very limited knowledge of HPV infection in males, despite an awareness of HPV in females," commented Ms. Lees. For example, parents were often unaware that HPV infection pertained to boys.

Their comments also provided some insight into why high rankings of certain HPV-related outcomes might have been associated with lower odds of intending to vaccinate. "Parents responded to the sexual nature of transmission, in particular, in focus groups, which revealed parental stigmatization of anal cancer by association with homosexuality among males," she noted.

In addition, "parents expressed an anxiety associated with oral sex practices they perceived youth to be engaging in," Ms. Lees elaborated. "Parents alluded to the frequency of oral sex among youth" and expressed "concerns that youth believe oral sex can be used to avoid infidelity, is safer than intercourse, and preserves their virginity."

Taken together, the study’s findings should help to inform provider and public health efforts to increase uptake of the HPV vaccine among boys, she concluded.

Ms. Lees reported that the investigators received grant support from Merck to conduct the study.

SEATTLE – Efforts to promote vaccination of boys against human papillomavirus may be more successful if they de-emphasize infection-related outcomes that make parents uncomfortable because of their sexual associations, according to a study of 158 parents of boys.

Surveyed parents were less likely to intend to vaccinate their son if they ranked anal cancer or oropharyngeal cancer as the most severe possible outcome of human papillomavirus (HPV) infection, investigators reported at the annual meeting of the Society for Adolescent Health and Medicine.

Comments made in focus groups suggested that these cancers elicited negative emotions: stigma in the case of anal cancer because it was associated with anal sex and homosexuality, and anxiety in the case of oropharyngeal cancer because it was associated with oral sex.

"Parents seemed to dwell on the sexual transmission of HPV," commented lead investigator Abigail C. Lees, a research assistant in the pediatrics department at the University of North Carolina, Chapel Hill.

"HPV awareness campaigns should decrease emphasis on outcomes that elicited either stigma associated with anal cancer or increased anxiety associated with oral cancer, and instead focus on prevalence," she recommended. "Furthermore, the parental preoccupation with the sexual transmission of HPV could be entirely avoided by vaccinating children at younger ages, when parents are less likely to associate stigmas or anxiety with their child’s behavior and the vaccine."

A quarter of the HPV-associated cancers that occurred in 2009 were in males, according to Ms. Lees. The quadrivalent HPV vaccine is now licensed for prevention of genital warts and anal cancer in both males and females, as well as for prevention of cervical, vulvar, and vaginal cancer in females.

To assess parental knowledge about male HPV outcomes and attitudes about vaccinating sons, the investigators recruited to their study parents of boys aged 11-17 years from a pediatric clinic, university listservs, craigslist, and other venues.

They completed surveys asking about perceived susceptibility (at least a 40% chance) of their son experiencing HPV infection and its outcomes, and perceived severity of the outcomes. They also participated in single-sex focus groups, conducted separately in English and Spanish.

The majority of the parents, 72%, were the boy’s mother. By race/ethnicity, 54% were white, 23% were black, 15% were Hispanic, and the rest were other. About a third had a high school diploma or less education. Slightly more than half were currently married. And 61% also had a daughter.

"Overall, parents believed their sons to have a low susceptibility to HPV infection and its outcomes," Ms. Lees reported. Just 22% thought their son was susceptible to infection. And smaller proportions thought he was susceptible to genital warts (18%), oropharyngeal cancer (11%), anal cancer (9%), and penile cancer (9%).

However, 82% of parents believed the consequence of HPV infection in their son would be severe; of these, 31% ranked penile cancer as the most severe possible outcome, 30% oropharyngeal cancer, 23% anal cancer, and 16% genital warts.

Eighty-three percent of parents indicated that they intended to vaccinate their sons against HPV. In a multivariate analysis, parents were more likely to intend to do so if they were older (odds ratio 1.14) and believed that the consequences of HPV infection could be severe (OR 9.94).

On the other hand, they were less likely to intend to vaccinate if they were more educated (OR 0.62). And there were trends whereby they were less likely to intend to do so if they ranked anal cancer or oropharyngeal cancer as the most severe possible outcome (OR 0.25 and 0.67, respectively).

"The most striking finding from our focus groups was that parents had very limited knowledge of HPV infection in males, despite an awareness of HPV in females," commented Ms. Lees. For example, parents were often unaware that HPV infection pertained to boys.

Their comments also provided some insight into why high rankings of certain HPV-related outcomes might have been associated with lower odds of intending to vaccinate. "Parents responded to the sexual nature of transmission, in particular, in focus groups, which revealed parental stigmatization of anal cancer by association with homosexuality among males," she noted.

In addition, "parents expressed an anxiety associated with oral sex practices they perceived youth to be engaging in," Ms. Lees elaborated. "Parents alluded to the frequency of oral sex among youth" and expressed "concerns that youth believe oral sex can be used to avoid infidelity, is safer than intercourse, and preserves their virginity."

Taken together, the study’s findings should help to inform provider and public health efforts to increase uptake of the HPV vaccine among boys, she concluded.

Ms. Lees reported that the investigators received grant support from Merck to conduct the study.

SEATTLE – Efforts to promote vaccination of boys against human papillomavirus may be more successful if they de-emphasize infection-related outcomes that make parents uncomfortable because of their sexual associations, according to a study of 158 parents of boys.

Surveyed parents were less likely to intend to vaccinate their son if they ranked anal cancer or oropharyngeal cancer as the most severe possible outcome of human papillomavirus (HPV) infection, investigators reported at the annual meeting of the Society for Adolescent Health and Medicine.

Comments made in focus groups suggested that these cancers elicited negative emotions: stigma in the case of anal cancer because it was associated with anal sex and homosexuality, and anxiety in the case of oropharyngeal cancer because it was associated with oral sex.

"Parents seemed to dwell on the sexual transmission of HPV," commented lead investigator Abigail C. Lees, a research assistant in the pediatrics department at the University of North Carolina, Chapel Hill.

"HPV awareness campaigns should decrease emphasis on outcomes that elicited either stigma associated with anal cancer or increased anxiety associated with oral cancer, and instead focus on prevalence," she recommended. "Furthermore, the parental preoccupation with the sexual transmission of HPV could be entirely avoided by vaccinating children at younger ages, when parents are less likely to associate stigmas or anxiety with their child’s behavior and the vaccine."

A quarter of the HPV-associated cancers that occurred in 2009 were in males, according to Ms. Lees. The quadrivalent HPV vaccine is now licensed for prevention of genital warts and anal cancer in both males and females, as well as for prevention of cervical, vulvar, and vaginal cancer in females.

To assess parental knowledge about male HPV outcomes and attitudes about vaccinating sons, the investigators recruited to their study parents of boys aged 11-17 years from a pediatric clinic, university listservs, craigslist, and other venues.

They completed surveys asking about perceived susceptibility (at least a 40% chance) of their son experiencing HPV infection and its outcomes, and perceived severity of the outcomes. They also participated in single-sex focus groups, conducted separately in English and Spanish.

The majority of the parents, 72%, were the boy’s mother. By race/ethnicity, 54% were white, 23% were black, 15% were Hispanic, and the rest were other. About a third had a high school diploma or less education. Slightly more than half were currently married. And 61% also had a daughter.

"Overall, parents believed their sons to have a low susceptibility to HPV infection and its outcomes," Ms. Lees reported. Just 22% thought their son was susceptible to infection. And smaller proportions thought he was susceptible to genital warts (18%), oropharyngeal cancer (11%), anal cancer (9%), and penile cancer (9%).

However, 82% of parents believed the consequence of HPV infection in their son would be severe; of these, 31% ranked penile cancer as the most severe possible outcome, 30% oropharyngeal cancer, 23% anal cancer, and 16% genital warts.

Eighty-three percent of parents indicated that they intended to vaccinate their sons against HPV. In a multivariate analysis, parents were more likely to intend to do so if they were older (odds ratio 1.14) and believed that the consequences of HPV infection could be severe (OR 9.94).

On the other hand, they were less likely to intend to vaccinate if they were more educated (OR 0.62). And there were trends whereby they were less likely to intend to do so if they ranked anal cancer or oropharyngeal cancer as the most severe possible outcome (OR 0.25 and 0.67, respectively).

"The most striking finding from our focus groups was that parents had very limited knowledge of HPV infection in males, despite an awareness of HPV in females," commented Ms. Lees. For example, parents were often unaware that HPV infection pertained to boys.

Their comments also provided some insight into why high rankings of certain HPV-related outcomes might have been associated with lower odds of intending to vaccinate. "Parents responded to the sexual nature of transmission, in particular, in focus groups, which revealed parental stigmatization of anal cancer by association with homosexuality among males," she noted.

In addition, "parents expressed an anxiety associated with oral sex practices they perceived youth to be engaging in," Ms. Lees elaborated. "Parents alluded to the frequency of oral sex among youth" and expressed "concerns that youth believe oral sex can be used to avoid infidelity, is safer than intercourse, and preserves their virginity."

Taken together, the study’s findings should help to inform provider and public health efforts to increase uptake of the HPV vaccine among boys, she concluded.

Ms. Lees reported that the investigators received grant support from Merck to conduct the study.

SAN FRANCISCO – Endo­scopic resection may help man­agement of clinically node– negative superficial squamous cell carcinoma of the esophagus, new data from Japan suggest.

<[stk -1]>A retrospective study of 83 patients who had endoscopic re­section and subsequent treat­ment because of the depth of cancer invasion found a 5-year survival rate of 76% when fol­lowed by chemoradiation and 100% when followed by surgery.<[etk]>

<[stk -1]>The most common complica­tion of the endoscopic resection was stenosis, noted in 11% of cases overall, lead investigator Dr. Toshiro Iizuka, a gastroen­terologist at Toranomon Hospi­tal in Tokyo, reported at the meeting  on gastrointestinal can­cers sponsored by the American Society of Clinical Oncology.

“Endoscopic therapy plus ad­ditional treatment for M3 to SM2 superficial carcinoma of the esophagus did not entail the development of any serious complications. Thus, such com­bined treatment was safe and feasible,” Dr. Iizuka comment­ed. “The long-term follow-up results were fairly gratifying.”

“Surgical resection has been considered as a standard treat­ment in cases of superficial esophageal cancer with poten­tial lymph node metastasis,” but up to two-thirds of patients ex­perience serious complications.

<[stk -1]>“The frequency of lymph node metastases in superficial squamous cell carcinoma of the esophagus … depends on the depth of invasion,” said Dr. Iizu­ka. “Accordingly, a therapeutic strategy has become feasible whereby endoscopic submucos­al dissection aimed at local con­trol is undertaken first, followed by considering additional treat­ment based on the results of the histological examination.”<[etk]>

<[stk -1]>The patients all had T1 tu­mors and clinically node-nega­tive (cN0) status as determined by endoscopy, endoscopic ultra­sound, CT, and PET imaging. They had endoscopic resection, either endoscopic mucosal re­section (EMR) before March 2005 or endoscopic submucosal dissection (ESD) after.<[etk]>

<[stk -3]>Histologic evaluation of the endoscopically resected lesions showed that 140 patients had pathologic M3, SM1, or SM2 tu­mors, and they therefore received additional treatment. Patients found to have pathologic M1 or M2 tumors were followed.<[etk]>

Dr. Iizuka focused on results for 27 patients who underwent subsequent surgical resection and 56 who underwent subse­quent chemoradiation, with the choice between these two op­tions left to patients after dis­cussion of each in their case.

Overall, these patients had a mean age of about 63 years, and 87% were men. Tumors were roughly equally located in the upper, middle, and lower esophagus; the mean size was 42 mm in the surgery group and 26 mm in the chemoradia­tion group. The majority of en­doscopic resections were ESD.

In the surgery group, patients more often had a three-field lymph node dissection (59%) than a two-field one (41%). In the chemoradiation group, the majority of patients received 40-45 Gy of radiation (86%) and low-dose 5-fluorouracil and cis­platin chemotherapy (57%).

Results for all 140 patients who underwent endoscopic re­section showed a resection rate of 81% and an R0 resection rate of 72%. Overall, 15% of pa­tients had a complication from the procedure, with stenosis, at 11%, being the most common.

The main complications were anastomotic stenosis (15% of patients) and recurrent nerve palsy (7%). Also, 7% of patients were found to have residual can­cer and 4% were found to have lymph node metastases. The main serious complication of chemoradiation was grade 3 leukopenia (14%). There were no treatment-related deaths or grade 4 adverse events.

The median duration of fol­low-up was 42.5 months in the surgery group and 33 months in the chemoradiation group.

None of the patients had a lo­cal recurrence. The actuarial 5-year rates of relapse-free survival were 100% and 88%, re­spectively; the actuarial 5-year rates of overall survival were 100% and 76%, respectively.

Dr. Iizuka reported no rele­vant conflicts of interest.

SAN FRANCISCO – Endo­scopic resection may help man­agement of clinically node– negative superficial squamous cell carcinoma of the esophagus, new data from Japan suggest.

<[stk -1]>A retrospective study of 83 patients who had endoscopic re­section and subsequent treat­ment because of the depth of cancer invasion found a 5-year survival rate of 76% when fol­lowed by chemoradiation and 100% when followed by surgery.<[etk]>

<[stk -1]>The most common complica­tion of the endoscopic resection was stenosis, noted in 11% of cases overall, lead investigator Dr. Toshiro Iizuka, a gastroen­terologist at Toranomon Hospi­tal in Tokyo, reported at the meeting  on gastrointestinal can­cers sponsored by the American Society of Clinical Oncology.

“Endoscopic therapy plus ad­ditional treatment for M3 to SM2 superficial carcinoma of the esophagus did not entail the development of any serious complications. Thus, such com­bined treatment was safe and feasible,” Dr. Iizuka comment­ed. “The long-term follow-up results were fairly gratifying.”

“Surgical resection has been considered as a standard treat­ment in cases of superficial esophageal cancer with poten­tial lymph node metastasis,” but up to two-thirds of patients ex­perience serious complications.

<[stk -1]>“The frequency of lymph node metastases in superficial squamous cell carcinoma of the esophagus … depends on the depth of invasion,” said Dr. Iizu­ka. “Accordingly, a therapeutic strategy has become feasible whereby endoscopic submucos­al dissection aimed at local con­trol is undertaken first, followed by considering additional treat­ment based on the results of the histological examination.”<[etk]>

<[stk -1]>The patients all had T1 tu­mors and clinically node-nega­tive (cN0) status as determined by endoscopy, endoscopic ultra­sound, CT, and PET imaging. They had endoscopic resection, either endoscopic mucosal re­section (EMR) before March 2005 or endoscopic submucosal dissection (ESD) after.<[etk]>

<[stk -3]>Histologic evaluation of the endoscopically resected lesions showed that 140 patients had pathologic M3, SM1, or SM2 tu­mors, and they therefore received additional treatment. Patients found to have pathologic M1 or M2 tumors were followed.<[etk]>

Dr. Iizuka focused on results for 27 patients who underwent subsequent surgical resection and 56 who underwent subse­quent chemoradiation, with the choice between these two op­tions left to patients after dis­cussion of each in their case.

Overall, these patients had a mean age of about 63 years, and 87% were men. Tumors were roughly equally located in the upper, middle, and lower esophagus; the mean size was 42 mm in the surgery group and 26 mm in the chemoradia­tion group. The majority of en­doscopic resections were ESD.

In the surgery group, patients more often had a three-field lymph node dissection (59%) than a two-field one (41%). In the chemoradiation group, the majority of patients received 40-45 Gy of radiation (86%) and low-dose 5-fluorouracil and cis­platin chemotherapy (57%).

Results for all 140 patients who underwent endoscopic re­section showed a resection rate of 81% and an R0 resection rate of 72%. Overall, 15% of pa­tients had a complication from the procedure, with stenosis, at 11%, being the most common.

The main complications were anastomotic stenosis (15% of patients) and recurrent nerve palsy (7%). Also, 7% of patients were found to have residual can­cer and 4% were found to have lymph node metastases. The main serious complication of chemoradiation was grade 3 leukopenia (14%). There were no treatment-related deaths or grade 4 adverse events.

The median duration of fol­low-up was 42.5 months in the surgery group and 33 months in the chemoradiation group.

None of the patients had a lo­cal recurrence. The actuarial 5-year rates of relapse-free survival were 100% and 88%, re­spectively; the actuarial 5-year rates of overall survival were 100% and 76%, respectively.

Dr. Iizuka reported no rele­vant conflicts of interest.

SAN FRANCISCO – Endo­scopic resection may help man­agement of clinically node– negative superficial squamous cell carcinoma of the esophagus, new data from Japan suggest.

<[stk -1]>A retrospective study of 83 patients who had endoscopic re­section and subsequent treat­ment because of the depth of cancer invasion found a 5-year survival rate of 76% when fol­lowed by chemoradiation and 100% when followed by surgery.<[etk]>

<[stk -1]>The most common complica­tion of the endoscopic resection was stenosis, noted in 11% of cases overall, lead investigator Dr. Toshiro Iizuka, a gastroen­terologist at Toranomon Hospi­tal in Tokyo, reported at the meeting  on gastrointestinal can­cers sponsored by the American Society of Clinical Oncology.

“Endoscopic therapy plus ad­ditional treatment for M3 to SM2 superficial carcinoma of the esophagus did not entail the development of any serious complications. Thus, such com­bined treatment was safe and feasible,” Dr. Iizuka comment­ed. “The long-term follow-up results were fairly gratifying.”

“Surgical resection has been considered as a standard treat­ment in cases of superficial esophageal cancer with poten­tial lymph node metastasis,” but up to two-thirds of patients ex­perience serious complications.

<[stk -1]>“The frequency of lymph node metastases in superficial squamous cell carcinoma of the esophagus … depends on the depth of invasion,” said Dr. Iizu­ka. “Accordingly, a therapeutic strategy has become feasible whereby endoscopic submucos­al dissection aimed at local con­trol is undertaken first, followed by considering additional treat­ment based on the results of the histological examination.”<[etk]>

<[stk -1]>The patients all had T1 tu­mors and clinically node-nega­tive (cN0) status as determined by endoscopy, endoscopic ultra­sound, CT, and PET imaging. They had endoscopic resection, either endoscopic mucosal re­section (EMR) before March 2005 or endoscopic submucosal dissection (ESD) after.<[etk]>

<[stk -3]>Histologic evaluation of the endoscopically resected lesions showed that 140 patients had pathologic M3, SM1, or SM2 tu­mors, and they therefore received additional treatment. Patients found to have pathologic M1 or M2 tumors were followed.<[etk]>

Dr. Iizuka focused on results for 27 patients who underwent subsequent surgical resection and 56 who underwent subse­quent chemoradiation, with the choice between these two op­tions left to patients after dis­cussion of each in their case.

Overall, these patients had a mean age of about 63 years, and 87% were men. Tumors were roughly equally located in the upper, middle, and lower esophagus; the mean size was 42 mm in the surgery group and 26 mm in the chemoradia­tion group. The majority of en­doscopic resections were ESD.

In the surgery group, patients more often had a three-field lymph node dissection (59%) than a two-field one (41%). In the chemoradiation group, the majority of patients received 40-45 Gy of radiation (86%) and low-dose 5-fluorouracil and cis­platin chemotherapy (57%).

Results for all 140 patients who underwent endoscopic re­section showed a resection rate of 81% and an R0 resection rate of 72%. Overall, 15% of pa­tients had a complication from the procedure, with stenosis, at 11%, being the most common.

The main complications were anastomotic stenosis (15% of patients) and recurrent nerve palsy (7%). Also, 7% of patients were found to have residual can­cer and 4% were found to have lymph node metastases. The main serious complication of chemoradiation was grade 3 leukopenia (14%). There were no treatment-related deaths or grade 4 adverse events.

The median duration of fol­low-up was 42.5 months in the surgery group and 33 months in the chemoradiation group.

None of the patients had a lo­cal recurrence. The actuarial 5-year rates of relapse-free survival were 100% and 88%, re­spectively; the actuarial 5-year rates of overall survival were 100% and 76%, respectively.

Dr. Iizuka reported no rele­vant conflicts of interest.

SAN FRANCISCO – Endo­scopic resection may help man­agement of clinically node– negative superficial squamous cell carcinoma of the esophagus, new data from Japan suggest.

<[stk -1]>A retrospective study of 83 patients who had endoscopic re­section and subsequent treat­ment because of the depth of cancer invasion found a 5-year survival rate of 76% when fol­lowed by chemoradiation and 100% when followed by surgery.<[etk]>

<[stk -1]>The most common complica­tion of the endoscopic resection was stenosis, noted in 11% of cases overall, lead investigator Dr. Toshiro Iizuka, a gastroen­terologist at Toranomon Hospi­tal in Tokyo, reported at the meeting  on gastrointestinal can­cers sponsored by the American Society of Clinical Oncology.

“Endoscopic therapy plus ad­ditional treatment for M3 to SM2 superficial carcinoma of the esophagus did not entail the development of any serious complications. Thus, such com­bined treatment was safe and feasible,” Dr. Iizuka comment­ed. “The long-term follow-up results were fairly gratifying.”

“Surgical resection has been considered as a standard treat­ment in cases of superficial esophageal cancer with poten­tial lymph node metastasis,” but up to two-thirds of patients ex­perience serious complications.

<[stk -1]>“The frequency of lymph node metastases in superficial squamous cell carcinoma of the esophagus … depends on the depth of invasion,” said Dr. Iizu­ka. “Accordingly, a therapeutic strategy has become feasible whereby endoscopic submucos­al dissection aimed at local con­trol is undertaken first, followed by considering additional treat­ment based on the results of the histological examination.”<[etk]>

<[stk -1]>The patients all had T1 tu­mors and clinically node-nega­tive (cN0) status as determined by endoscopy, endoscopic ultra­sound, CT, and PET imaging. They had endoscopic resection, either endoscopic mucosal re­section (EMR) before March 2005 or endoscopic submucosal dissection (ESD) after.<[etk]>

<[stk -3]>Histologic evaluation of the endoscopically resected lesions showed that 140 patients had pathologic M3, SM1, or SM2 tu­mors, and they therefore received additional treatment. Patients found to have pathologic M1 or M2 tumors were followed.<[etk]>

Dr. Iizuka focused on results for 27 patients who underwent subsequent surgical resection and 56 who underwent subse­quent chemoradiation, with the choice between these two op­tions left to patients after dis­cussion of each in their case.

Overall, these patients had a mean age of about 63 years, and 87% were men. Tumors were roughly equally located in the upper, middle, and lower esophagus; the mean size was 42 mm in the surgery group and 26 mm in the chemoradia­tion group. The majority of en­doscopic resections were ESD.

In the surgery group, patients more often had a three-field lymph node dissection (59%) than a two-field one (41%). In the chemoradiation group, the majority of patients received 40-45 Gy of radiation (86%) and low-dose 5-fluorouracil and cis­platin chemotherapy (57%).

Results for all 140 patients who underwent endoscopic re­section showed a resection rate of 81% and an R0 resection rate of 72%. Overall, 15% of pa­tients had a complication from the procedure, with stenosis, at 11%, being the most common.

The main complications were anastomotic stenosis (15% of patients) and recurrent nerve palsy (7%). Also, 7% of patients were found to have residual can­cer and 4% were found to have lymph node metastases. The main serious complication of chemoradiation was grade 3 leukopenia (14%). There were no treatment-related deaths or grade 4 adverse events.

The median duration of fol­low-up was 42.5 months in the surgery group and 33 months in the chemoradiation group.

None of the patients had a lo­cal recurrence. The actuarial 5-year rates of relapse-free survival were 100% and 88%, re­spectively; the actuarial 5-year rates of overall survival were 100% and 76%, respectively.

Dr. Iizuka reported no rele­vant conflicts of interest.

SAN FRANCISCO – Endo­scopic resection may help man­agement of clinically node– negative superficial squamous cell carcinoma of the esophagus, new data from Japan suggest.

<[stk -1]>A retrospective study of 83 patients who had endoscopic re­section and subsequent treat­ment because of the depth of cancer invasion found a 5-year survival rate of 76% when fol­lowed by chemoradiation and 100% when followed by surgery.<[etk]>

<[stk -1]>The most common complica­tion of the endoscopic resection was stenosis, noted in 11% of cases overall, lead investigator Dr. Toshiro Iizuka, a gastroen­terologist at Toranomon Hospi­tal in Tokyo, reported at the meeting  on gastrointestinal can­cers sponsored by the American Society of Clinical Oncology.

“Endoscopic therapy plus ad­ditional treatment for M3 to SM2 superficial carcinoma of the esophagus did not entail the development of any serious complications. Thus, such com­bined treatment was safe and feasible,” Dr. Iizuka comment­ed. “The long-term follow-up results were fairly gratifying.”

“Surgical resection has been considered as a standard treat­ment in cases of superficial esophageal cancer with poten­tial lymph node metastasis,” but up to two-thirds of patients ex­perience serious complications.

<[stk -1]>“The frequency of lymph node metastases in superficial squamous cell carcinoma of the esophagus … depends on the depth of invasion,” said Dr. Iizu­ka. “Accordingly, a therapeutic strategy has become feasible whereby endoscopic submucos­al dissection aimed at local con­trol is undertaken first, followed by considering additional treat­ment based on the results of the histological examination.”<[etk]>

<[stk -1]>The patients all had T1 tu­mors and clinically node-nega­tive (cN0) status as determined by endoscopy, endoscopic ultra­sound, CT, and PET imaging. They had endoscopic resection, either endoscopic mucosal re­section (EMR) before March 2005 or endoscopic submucosal dissection (ESD) after.<[etk]>

<[stk -3]>Histologic evaluation of the endoscopically resected lesions showed that 140 patients had pathologic M3, SM1, or SM2 tu­mors, and they therefore received additional treatment. Patients found to have pathologic M1 or M2 tumors were followed.<[etk]>

Dr. Iizuka focused on results for 27 patients who underwent subsequent surgical resection and 56 who underwent subse­quent chemoradiation, with the choice between these two op­tions left to patients after dis­cussion of each in their case.

Overall, these patients had a mean age of about 63 years, and 87% were men. Tumors were roughly equally located in the upper, middle, and lower esophagus; the mean size was 42 mm in the surgery group and 26 mm in the chemoradia­tion group. The majority of en­doscopic resections were ESD.

In the surgery group, patients more often had a three-field lymph node dissection (59%) than a two-field one (41%). In the chemoradiation group, the majority of patients received 40-45 Gy of radiation (86%) and low-dose 5-fluorouracil and cis­platin chemotherapy (57%).

Results for all 140 patients who underwent endoscopic re­section showed a resection rate of 81% and an R0 resection rate of 72%. Overall, 15% of pa­tients had a complication from the procedure, with stenosis, at 11%, being the most common.

The main complications were anastomotic stenosis (15% of patients) and recurrent nerve palsy (7%). Also, 7% of patients were found to have residual can­cer and 4% were found to have lymph node metastases. The main serious complication of chemoradiation was grade 3 leukopenia (14%). There were no treatment-related deaths or grade 4 adverse events.

The median duration of fol­low-up was 42.5 months in the surgery group and 33 months in the chemoradiation group.

None of the patients had a lo­cal recurrence. The actuarial 5-year rates of relapse-free survival were 100% and 88%, re­spectively; the actuarial 5-year rates of overall survival were 100% and 76%, respectively.

Dr. Iizuka reported no rele­vant conflicts of interest.

SAN FRANCISCO – Endo­scopic resection may help man­agement of clinically node– negative superficial squamous cell carcinoma of the esophagus, new data from Japan suggest.

<[stk -1]>A retrospective study of 83 patients who had endoscopic re­section and subsequent treat­ment because of the depth of cancer invasion found a 5-year survival rate of 76% when fol­lowed by chemoradiation and 100% when followed by surgery.<[etk]>

<[stk -1]>The most common complica­tion of the endoscopic resection was stenosis, noted in 11% of cases overall, lead investigator Dr. Toshiro Iizuka, a gastroen­terologist at Toranomon Hospi­tal in Tokyo, reported at the meeting  on gastrointestinal can­cers sponsored by the American Society of Clinical Oncology.

“Endoscopic therapy plus ad­ditional treatment for M3 to SM2 superficial carcinoma of the esophagus did not entail the development of any serious complications. Thus, such com­bined treatment was safe and feasible,” Dr. Iizuka comment­ed. “The long-term follow-up results were fairly gratifying.”

“Surgical resection has been considered as a standard treat­ment in cases of superficial esophageal cancer with poten­tial lymph node metastasis,” but up to two-thirds of patients ex­perience serious complications.

<[stk -1]>“The frequency of lymph node metastases in superficial squamous cell carcinoma of the esophagus … depends on the depth of invasion,” said Dr. Iizu­ka. “Accordingly, a therapeutic strategy has become feasible whereby endoscopic submucos­al dissection aimed at local con­trol is undertaken first, followed by considering additional treat­ment based on the results of the histological examination.”<[etk]>

<[stk -1]>The patients all had T1 tu­mors and clinically node-nega­tive (cN0) status as determined by endoscopy, endoscopic ultra­sound, CT, and PET imaging. They had endoscopic resection, either endoscopic mucosal re­section (EMR) before March 2005 or endoscopic submucosal dissection (ESD) after.<[etk]>

<[stk -3]>Histologic evaluation of the endoscopically resected lesions showed that 140 patients had pathologic M3, SM1, or SM2 tu­mors, and they therefore received additional treatment. Patients found to have pathologic M1 or M2 tumors were followed.<[etk]>

Dr. Iizuka focused on results for 27 patients who underwent subsequent surgical resection and 56 who underwent subse­quent chemoradiation, with the choice between these two op­tions left to patients after dis­cussion of each in their case.

Overall, these patients had a mean age of about 63 years, and 87% were men. Tumors were roughly equally located in the upper, middle, and lower esophagus; the mean size was 42 mm in the surgery group and 26 mm in the chemoradia­tion group. The majority of en­doscopic resections were ESD.

In the surgery group, patients more often had a three-field lymph node dissection (59%) than a two-field one (41%). In the chemoradiation group, the majority of patients received 40-45 Gy of radiation (86%) and low-dose 5-fluorouracil and cis­platin chemotherapy (57%).

Results for all 140 patients who underwent endoscopic re­section showed a resection rate of 81% and an R0 resection rate of 72%. Overall, 15% of pa­tients had a complication from the procedure, with stenosis, at 11%, being the most common.

The main complications were anastomotic stenosis (15% of patients) and recurrent nerve palsy (7%). Also, 7% of patients were found to have residual can­cer and 4% were found to have lymph node metastases. The main serious complication of chemoradiation was grade 3 leukopenia (14%). There were no treatment-related deaths or grade 4 adverse events.

The median duration of fol­low-up was 42.5 months in the surgery group and 33 months in the chemoradiation group.

None of the patients had a lo­cal recurrence. The actuarial 5-year rates of relapse-free survival were 100% and 88%, re­spectively; the actuarial 5-year rates of overall survival were 100% and 76%, respectively.

Dr. Iizuka reported no rele­vant conflicts of interest.

SAN FRANCISCO – Endo­scopic resection may help man­agement of clinically node– negative superficial squamous cell carcinoma of the esophagus, new data from Japan suggest.

<[stk -1]>A retrospective study of 83 patients who had endoscopic re­section and subsequent treat­ment because of the depth of cancer invasion found a 5-year survival rate of 76% when fol­lowed by chemoradiation and 100% when followed by surgery.<[etk]>

<[stk -1]>The most common complica­tion of the endoscopic resection was stenosis, noted in 11% of cases overall, lead investigator Dr. Toshiro Iizuka, a gastroen­terologist at Toranomon Hospi­tal in Tokyo, reported at the meeting  on gastrointestinal can­cers sponsored by the American Society of Clinical Oncology.

“Endoscopic therapy plus ad­ditional treatment for M3 to SM2 superficial carcinoma of the esophagus did not entail the development of any serious complications. Thus, such com­bined treatment was safe and feasible,” Dr. Iizuka comment­ed. “The long-term follow-up results were fairly gratifying.”

“Surgical resection has been considered as a standard treat­ment in cases of superficial esophageal cancer with poten­tial lymph node metastasis,” but up to two-thirds of patients ex­perience serious complications.

<[stk -1]>“The frequency of lymph node metastases in superficial squamous cell carcinoma of the esophagus … depends on the depth of invasion,” said Dr. Iizu­ka. “Accordingly, a therapeutic strategy has become feasible whereby endoscopic submucos­al dissection aimed at local con­trol is undertaken first, followed by considering additional treat­ment based on the results of the histological examination.”<[etk]>

<[stk -1]>The patients all had T1 tu­mors and clinically node-nega­tive (cN0) status as determined by endoscopy, endoscopic ultra­sound, CT, and PET imaging. They had endoscopic resection, either endoscopic mucosal re­section (EMR) before March 2005 or endoscopic submucosal dissection (ESD) after.<[etk]>

<[stk -3]>Histologic evaluation of the endoscopically resected lesions showed that 140 patients had pathologic M3, SM1, or SM2 tu­mors, and they therefore received additional treatment. Patients found to have pathologic M1 or M2 tumors were followed.<[etk]>

Dr. Iizuka focused on results for 27 patients who underwent subsequent surgical resection and 56 who underwent subse­quent chemoradiation, with the choice between these two op­tions left to patients after dis­cussion of each in their case.

Overall, these patients had a mean age of about 63 years, and 87% were men. Tumors were roughly equally located in the upper, middle, and lower esophagus; the mean size was 42 mm in the surgery group and 26 mm in the chemoradia­tion group. The majority of en­doscopic resections were ESD.

In the surgery group, patients more often had a three-field lymph node dissection (59%) than a two-field one (41%). In the chemoradiation group, the majority of patients received 40-45 Gy of radiation (86%) and low-dose 5-fluorouracil and cis­platin chemotherapy (57%).

Results for all 140 patients who underwent endoscopic re­section showed a resection rate of 81% and an R0 resection rate of 72%. Overall, 15% of pa­tients had a complication from the procedure, with stenosis, at 11%, being the most common.

The main complications were anastomotic stenosis (15% of patients) and recurrent nerve palsy (7%). Also, 7% of patients were found to have residual can­cer and 4% were found to have lymph node metastases. The main serious complication of chemoradiation was grade 3 leukopenia (14%). There were no treatment-related deaths or grade 4 adverse events.

The median duration of fol­low-up was 42.5 months in the surgery group and 33 months in the chemoradiation group.

None of the patients had a lo­cal recurrence. The actuarial 5-year rates of relapse-free survival were 100% and 88%, re­spectively; the actuarial 5-year rates of overall survival were 100% and 76%, respectively.

Dr. Iizuka reported no rele­vant conflicts of interest.

SAN FRANCISCO – Endo­scopic resection may help man­agement of clinically node– negative superficial squamous cell carcinoma of the esophagus, new data from Japan suggest.

<[stk -1]>A retrospective study of 83 patients who had endoscopic re­section and subsequent treat­ment because of the depth of cancer invasion found a 5-year survival rate of 76% when fol­lowed by chemoradiation and 100% when followed by surgery.<[etk]>

<[stk -1]>The most common complica­tion of the endoscopic resection was stenosis, noted in 11% of cases overall, lead investigator Dr. Toshiro Iizuka, a gastroen­terologist at Toranomon Hospi­tal in Tokyo, reported at the meeting  on gastrointestinal can­cers sponsored by the American Society of Clinical Oncology.

“Endoscopic therapy plus ad­ditional treatment for M3 to SM2 superficial carcinoma of the esophagus did not entail the development of any serious complications. Thus, such com­bined treatment was safe and feasible,” Dr. Iizuka comment­ed. “The long-term follow-up results were fairly gratifying.”

“Surgical resection has been considered as a standard treat­ment in cases of superficial esophageal cancer with poten­tial lymph node metastasis,” but up to two-thirds of patients ex­perience serious complications.

<[stk -1]>“The frequency of lymph node metastases in superficial squamous cell carcinoma of the esophagus … depends on the depth of invasion,” said Dr. Iizu­ka. “Accordingly, a therapeutic strategy has become feasible whereby endoscopic submucos­al dissection aimed at local con­trol is undertaken first, followed by considering additional treat­ment based on the results of the histological examination.”<[etk]>

<[stk -1]>The patients all had T1 tu­mors and clinically node-nega­tive (cN0) status as determined by endoscopy, endoscopic ultra­sound, CT, and PET imaging. They had endoscopic resection, either endoscopic mucosal re­section (EMR) before March 2005 or endoscopic submucosal dissection (ESD) after.<[etk]>

<[stk -3]>Histologic evaluation of the endoscopically resected lesions showed that 140 patients had pathologic M3, SM1, or SM2 tu­mors, and they therefore received additional treatment. Patients found to have pathologic M1 or M2 tumors were followed.<[etk]>

Dr. Iizuka focused on results for 27 patients who underwent subsequent surgical resection and 56 who underwent subse­quent chemoradiation, with the choice between these two op­tions left to patients after dis­cussion of each in their case.

Overall, these patients had a mean age of about 63 years, and 87% were men. Tumors were roughly equally located in the upper, middle, and lower esophagus; the mean size was 42 mm in the surgery group and 26 mm in the chemoradia­tion group. The majority of en­doscopic resections were ESD.

In the surgery group, patients more often had a three-field lymph node dissection (59%) than a two-field one (41%). In the chemoradiation group, the majority of patients received 40-45 Gy of radiation (86%) and low-dose 5-fluorouracil and cis­platin chemotherapy (57%).

Results for all 140 patients who underwent endoscopic re­section showed a resection rate of 81% and an R0 resection rate of 72%. Overall, 15% of pa­tients had a complication from the procedure, with stenosis, at 11%, being the most common.

The main complications were anastomotic stenosis (15% of patients) and recurrent nerve palsy (7%). Also, 7% of patients were found to have residual can­cer and 4% were found to have lymph node metastases. The main serious complication of chemoradiation was grade 3 leukopenia (14%). There were no treatment-related deaths or grade 4 adverse events.

The median duration of fol­low-up was 42.5 months in the surgery group and 33 months in the chemoradiation group.

None of the patients had a lo­cal recurrence. The actuarial 5-year rates of relapse-free survival were 100% and 88%, re­spectively; the actuarial 5-year rates of overall survival were 100% and 76%, respectively.

Dr. Iizuka reported no rele­vant conflicts of interest.

SAN FRANCISCO – Endo­scopic resection may help man­agement of clinically node– negative superficial squamous cell carcinoma of the esophagus, new data from Japan suggest.

<[stk -1]>A retrospective study of 83 patients who had endoscopic re­section and subsequent treat­ment because of the depth of cancer invasion found a 5-year survival rate of 76% when fol­lowed by chemoradiation and 100% when followed by surgery.<[etk]>

<[stk -1]>The most common complica­tion of the endoscopic resection was stenosis, noted in 11% of cases overall, lead investigator Dr. Toshiro Iizuka, a gastroen­terologist at Toranomon Hospi­tal in Tokyo, reported at the meeting  on gastrointestinal can­cers sponsored by the American Society of Clinical Oncology.

“Endoscopic therapy plus ad­ditional treatment for M3 to SM2 superficial carcinoma of the esophagus did not entail the development of any serious complications. Thus, such com­bined treatment was safe and feasible,” Dr. Iizuka comment­ed. “The long-term follow-up results were fairly gratifying.”

“Surgical resection has been considered as a standard treat­ment in cases of superficial esophageal cancer with poten­tial lymph node metastasis,” but up to two-thirds of patients ex­perience serious complications.

<[stk -1]>“The frequency of lymph node metastases in superficial squamous cell carcinoma of the esophagus … depends on the depth of invasion,” said Dr. Iizu­ka. “Accordingly, a therapeutic strategy has become feasible whereby endoscopic submucos­al dissection aimed at local con­trol is undertaken first, followed by considering additional treat­ment based on the results of the histological examination.”<[etk]>

<[stk -1]>The patients all had T1 tu­mors and clinically node-nega­tive (cN0) status as determined by endoscopy, endoscopic ultra­sound, CT, and PET imaging. They had endoscopic resection, either endoscopic mucosal re­section (EMR) before March 2005 or endoscopic submucosal dissection (ESD) after.<[etk]>

<[stk -3]>Histologic evaluation of the endoscopically resected lesions showed that 140 patients had pathologic M3, SM1, or SM2 tu­mors, and they therefore received additional treatment. Patients found to have pathologic M1 or M2 tumors were followed.<[etk]>

Dr. Iizuka focused on results for 27 patients who underwent subsequent surgical resection and 56 who underwent subse­quent chemoradiation, with the choice between these two op­tions left to patients after dis­cussion of each in their case.

Overall, these patients had a mean age of about 63 years, and 87% were men. Tumors were roughly equally located in the upper, middle, and lower esophagus; the mean size was 42 mm in the surgery group and 26 mm in the chemoradia­tion group. The majority of en­doscopic resections were ESD.

In the surgery group, patients more often had a three-field lymph node dissection (59%) than a two-field one (41%). In the chemoradiation group, the majority of patients received 40-45 Gy of radiation (86%) and low-dose 5-fluorouracil and cis­platin chemotherapy (57%).

Results for all 140 patients who underwent endoscopic re­section showed a resection rate of 81% and an R0 resection rate of 72%. Overall, 15% of pa­tients had a complication from the procedure, with stenosis, at 11%, being the most common.

The main complications were anastomotic stenosis (15% of patients) and recurrent nerve palsy (7%). Also, 7% of patients were found to have residual can­cer and 4% were found to have lymph node metastases. The main serious complication of chemoradiation was grade 3 leukopenia (14%). There were no treatment-related deaths or grade 4 adverse events.

The median duration of fol­low-up was 42.5 months in the surgery group and 33 months in the chemoradiation group.

None of the patients had a lo­cal recurrence. The actuarial 5-year rates of relapse-free survival were 100% and 88%, re­spectively; the actuarial 5-year rates of overall survival were 100% and 76%, respectively.

Dr. Iizuka reported no rele­vant conflicts of interest.

SAN FRANCISCO – Pretreatment ex­pression of ERCC1 in localized esophageal and gastroesophageal ade­nocarcinomas is a marker for outcomes among patients given trimodality thera­py that includes oxaliplatin-based chemoradiation, investigators reported from a prospective study.

Fully 58% of the 55 patients studied from the Southwest Oncology Group (SWOG) S0356 trial had tumors ex­pressing a high level of mRNA for ERCC1, a key gene in the repair of plat­inum- and radiation-induced DNA dam­age.«http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=103&abstractID=71402»

Compared with their counterparts whose tumors had low expression, these patients were nearly three times more likely to experience progression and more than twice as likely to die, accord­ing to results reported at the meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology.

“ERCC1 mRNA level is a very promis­ing pretreatment biomarker in patients with localized esophageal and gastroe­sophageal adenocarcinoma treated with trimodality treatment,” asserted lead in­vestigator Dr. Pierre O. Bohanes. “Based on these and published data, the SWOG is planning a prospective biomarker-dri­ven clinical trial.”

“In contrast to the growing number of predictive biomarkers for anticancer agents, there are no established bio­markers to select patients who will ben­efit most from chemoradiation,” he noted. “Utilization of predictive bio­markers to select therapy should lead to higher cure rates.”

The phase II trial, which was largely community based, enrolled patients with clinical stage II or III esophageal or gas­troesophageal junction adenocarcinoma. They underwent tumor biopsy, then chemoradiation (oxaliplatin, 5-fluo­rouracil, and 45-Gy external beam radi­ation), then surgery, and finally more chemotherapy (oxaliplatin and 5-fluo­rouracil).

Response Genetics Inc., manufacturer of several biomarker assays, analyzed tumor ERCC1 mRNA expression for the 55 patients who had sufficient pretreatment tumor tissue. Laser-capture mi­crodissection was used to ensure that only tumor cells were analyzed.

“ERCC1 has been shown to be a crit­ical gene in DNA repair,” Dr. Bohanes explained. “ERCC1 is involved in the nucleotide excision repair pathway, which recognizes and removes platinum-induced DNA adducts.” Higher expres­
sion is associated with resistance to plat­inum compounds, including cisplatin, oxaliplatin, and carboplatin.

“Also more recently, ERCC1 has been shown to be involved in the double-strand break repair pathway, which re­pairs radiation-induced damage,” he further observed.

Tumors were classified as having a high or low level of ERCC1 expression using a cutoff mRNA level of greater than 1.7 for high expression, as estab­lished in previous studies.

The 55 patients studied had a median age of 64 years. Most were men (93%) and white (94%), and had esophageal tu­mors (62%). One-fourth of them were found to have a pathological complete response at the time of surgery.

The median duration of follow-up was 36.8 months, reported Dr. Bohanes, a re­search fellow in medical oncology at the University of Southern California in Los Angeles.

Results showed that patients having high vs. low tumor expression of ERCC1 had a nearly tripled risk of progression (hazard ratio, 2.97; P = .006).«change in ONCR rendition» The medi­an duration of progression-free survival was 14.8 months for the former but was not reached for the latter. Corresponding 2-year rates of progression-free survival were 17% and 67%.

Similarly, patients with tumors having high vs. low expression of ERCC1 had a more than doubling of the risk of death (HR, 2.32; P = .047). «change in ONCR rendition» The median dura­tion of overall survival was 22.4 months for the former but was not reached for the latter. Corresponding 2-year rates of overall survival were 37% and 72%.

Expression of ERCC1 was not associ­ated with pathological complete re­sponse. Also, expression of a host of other genes – XPD and RRM1 (associat­ed with DNA repair), GSTP1 (associated with platinum detoxification), and TS, TP, and DPD (associated with 5-fluo­rouracil metabolism) – was not associat­ed with any of the outcomes studied.

“Biomarker studies are feasible within cooperative groups,” commented Dr. Bohanes, but adequate tissue was avail­able for only 55 of 92 eligible patients. Hence, “future trials need to request ad­ditional endoscopic biopsies to allow for sufficient tumor tissue collection.”

A study shortcoming was an inability to determine whether ERCC1 expression correlates with disease stage, he ac­knowledged.

“The design of this study unfortu­nately did not require preoperative en­doscopic ultrasound because it was thought that it would have hampered the
recruitment of this trial,” he said. “And often, in the community setting, endoscopic ultrasound is not avail­able.”

Also, the study could not deter­mine whether ERCC1 expression is a prognostic marker. “We would need a control arm without platinum agent,” he noted.

<[stk 3]>“I think that the patients with high expression are not benefiting from this treatment” and should be treated with alternative treatments, commented Dr. Heinz-Josef Lenz, senior investigator and chair of the gastrointestinal oncology program at the University of Southern Cali­fornia. <[etk]>

“We have choices, and I think that would certainly be part of the new concept and design going forward, ” he added.

<[stk 3]>Dr. Lenz agreed with an attendee that recruiting patients with esophageal and gastroesophageal cancer to randomized trials has been difficult in the past and it might therefore take many years to obtain important biomarker data. But adaptive trial designs are ad­dressing this issue.<[etk]>

I have checked the following facts in my story: (Please initial each.)

Meeting: 3660-11

Drug names and dosages: SML jsm

Lab test values and their units: n/a na

Citation (e.g., JAMA 2008;299:785-92): n/a na

Investigators’ names and affiliations: SML jsm

All other proper names (e.g., clinical trials; geographic, company, and test names): SML jsm

Investigators’ conflicts of interest and sponsor of study: SML jsm

Please provide your best contact number and email for questions on this story: (206) 393-2459; slondon@speakeasy.net

Notes:

(1) Abstract 2; log in on main ASCO page first -- http://www.asco.org

username: gi_pressaccess

password: pre$$1

Go to Virtual Meeting. Note: search function for this meeting is not working well yet, so better to look by track.

(2) Either they did not show the conflicts of interest slides at the start of the session or they blew through them at lightspeed. I don’t have any photos of them and they are not up on the Web site. So Dr. Lenz’s conflicts come from a slide in Dr. Bohanes’ talk, where the nature of the conflicts was not given.

“I think we are incorporating now more technologies with the design, which may be more flexible to adapt new findings so that we are not stuck for the next 3 or 5 years to a trial be­cause of low accrual,” he said.

Dr. Bohanes reported that he had no relevant conflicts of interest.

Dr. Lenz reported having relation­ships with Response Genetics Inc. and with Sanofi-Aventis, manufac­turer of oxaliplatin (Eloxatin). 

SAN FRANCISCO – Pretreatment ex­pression of ERCC1 in localized esophageal and gastroesophageal ade­nocarcinomas is a marker for outcomes among patients given trimodality thera­py that includes oxaliplatin-based chemoradiation, investigators reported from a prospective study.

Fully 58% of the 55 patients studied from the Southwest Oncology Group (SWOG) S0356 trial had tumors ex­pressing a high level of mRNA for ERCC1, a key gene in the repair of plat­inum- and radiation-induced DNA dam­age.«http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=103&abstractID=71402»

Compared with their counterparts whose tumors had low expression, these patients were nearly three times more likely to experience progression and more than twice as likely to die, accord­ing to results reported at the meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology.

“ERCC1 mRNA level is a very promis­ing pretreatment biomarker in patients with localized esophageal and gastroe­sophageal adenocarcinoma treated with trimodality treatment,” asserted lead in­vestigator Dr. Pierre O. Bohanes. “Based on these and published data, the SWOG is planning a prospective biomarker-dri­ven clinical trial.”

“In contrast to the growing number of predictive biomarkers for anticancer agents, there are no established bio­markers to select patients who will ben­efit most from chemoradiation,” he noted. “Utilization of predictive bio­markers to select therapy should lead to higher cure rates.”

The phase II trial, which was largely community based, enrolled patients with clinical stage II or III esophageal or gas­troesophageal junction adenocarcinoma. They underwent tumor biopsy, then chemoradiation (oxaliplatin, 5-fluo­rouracil, and 45-Gy external beam radi­ation), then surgery, and finally more chemotherapy (oxaliplatin and 5-fluo­rouracil).

Response Genetics Inc., manufacturer of several biomarker assays, analyzed tumor ERCC1 mRNA expression for the 55 patients who had sufficient pretreatment tumor tissue. Laser-capture mi­crodissection was used to ensure that only tumor cells were analyzed.

“ERCC1 has been shown to be a crit­ical gene in DNA repair,” Dr. Bohanes explained. “ERCC1 is involved in the nucleotide excision repair pathway, which recognizes and removes platinum-induced DNA adducts.” Higher expres­
sion is associated with resistance to plat­inum compounds, including cisplatin, oxaliplatin, and carboplatin.

“Also more recently, ERCC1 has been shown to be involved in the double-strand break repair pathway, which re­pairs radiation-induced damage,” he further observed.

Tumors were classified as having a high or low level of ERCC1 expression using a cutoff mRNA level of greater than 1.7 for high expression, as estab­lished in previous studies.

The 55 patients studied had a median age of 64 years. Most were men (93%) and white (94%), and had esophageal tu­mors (62%). One-fourth of them were found to have a pathological complete response at the time of surgery.

The median duration of follow-up was 36.8 months, reported Dr. Bohanes, a re­search fellow in medical oncology at the University of Southern California in Los Angeles.

Results showed that patients having high vs. low tumor expression of ERCC1 had a nearly tripled risk of progression (hazard ratio, 2.97; P = .006).«change in ONCR rendition» The medi­an duration of progression-free survival was 14.8 months for the former but was not reached for the latter. Corresponding 2-year rates of progression-free survival were 17% and 67%.

Similarly, patients with tumors having high vs. low expression of ERCC1 had a more than doubling of the risk of death (HR, 2.32; P = .047). «change in ONCR rendition» The median dura­tion of overall survival was 22.4 months for the former but was not reached for the latter. Corresponding 2-year rates of overall survival were 37% and 72%.

Expression of ERCC1 was not associ­ated with pathological complete re­sponse. Also, expression of a host of other genes – XPD and RRM1 (associat­ed with DNA repair), GSTP1 (associated with platinum detoxification), and TS, TP, and DPD (associated with 5-fluo­rouracil metabolism) – was not associat­ed with any of the outcomes studied.

“Biomarker studies are feasible within cooperative groups,” commented Dr. Bohanes, but adequate tissue was avail­able for only 55 of 92 eligible patients. Hence, “future trials need to request ad­ditional endoscopic biopsies to allow for sufficient tumor tissue collection.”

A study shortcoming was an inability to determine whether ERCC1 expression correlates with disease stage, he ac­knowledged.

“The design of this study unfortu­nately did not require preoperative en­doscopic ultrasound because it was thought that it would have hampered the
recruitment of this trial,” he said. “And often, in the community setting, endoscopic ultrasound is not avail­able.”

Also, the study could not deter­mine whether ERCC1 expression is a prognostic marker. “We would need a control arm without platinum agent,” he noted.

<[stk 3]>“I think that the patients with high expression are not benefiting from this treatment” and should be treated with alternative treatments, commented Dr. Heinz-Josef Lenz, senior investigator and chair of the gastrointestinal oncology program at the University of Southern Cali­fornia. <[etk]>

“We have choices, and I think that would certainly be part of the new concept and design going forward, ” he added.

<[stk 3]>Dr. Lenz agreed with an attendee that recruiting patients with esophageal and gastroesophageal cancer to randomized trials has been difficult in the past and it might therefore take many years to obtain important biomarker data. But adaptive trial designs are ad­dressing this issue.<[etk]>

I have checked the following facts in my story: (Please initial each.)

Meeting: 3660-11

Drug names and dosages: SML jsm

Lab test values and their units: n/a na

Citation (e.g., JAMA 2008;299:785-92): n/a na

Investigators’ names and affiliations: SML jsm

All other proper names (e.g., clinical trials; geographic, company, and test names): SML jsm

Investigators’ conflicts of interest and sponsor of study: SML jsm

Please provide your best contact number and email for questions on this story: (206) 393-2459; slondon@speakeasy.net

Notes:

(1) Abstract 2; log in on main ASCO page first -- http://www.asco.org

username: gi_pressaccess

password: pre$$1

Go to Virtual Meeting. Note: search function for this meeting is not working well yet, so better to look by track.

(2) Either they did not show the conflicts of interest slides at the start of the session or they blew through them at lightspeed. I don’t have any photos of them and they are not up on the Web site. So Dr. Lenz’s conflicts come from a slide in Dr. Bohanes’ talk, where the nature of the conflicts was not given.

“I think we are incorporating now more technologies with the design, which may be more flexible to adapt new findings so that we are not stuck for the next 3 or 5 years to a trial be­cause of low accrual,” he said.

Dr. Bohanes reported that he had no relevant conflicts of interest.

Dr. Lenz reported having relation­ships with Response Genetics Inc. and with Sanofi-Aventis, manufac­turer of oxaliplatin (Eloxatin). 

SAN FRANCISCO – Pretreatment ex­pression of ERCC1 in localized esophageal and gastroesophageal ade­nocarcinomas is a marker for outcomes among patients given trimodality thera­py that includes oxaliplatin-based chemoradiation, investigators reported from a prospective study.

Fully 58% of the 55 patients studied from the Southwest Oncology Group (SWOG) S0356 trial had tumors ex­pressing a high level of mRNA for ERCC1, a key gene in the repair of plat­inum- and radiation-induced DNA dam­age.«http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=103&abstractID=71402»

Compared with their counterparts whose tumors had low expression, these patients were nearly three times more likely to experience progression and more than twice as likely to die, accord­ing to results reported at the meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology.

“ERCC1 mRNA level is a very promis­ing pretreatment biomarker in patients with localized esophageal and gastroe­sophageal adenocarcinoma treated with trimodality treatment,” asserted lead in­vestigator Dr. Pierre O. Bohanes. “Based on these and published data, the SWOG is planning a prospective biomarker-dri­ven clinical trial.”

“In contrast to the growing number of predictive biomarkers for anticancer agents, there are no established bio­markers to select patients who will ben­efit most from chemoradiation,” he noted. “Utilization of predictive bio­markers to select therapy should lead to higher cure rates.”

The phase II trial, which was largely community based, enrolled patients with clinical stage II or III esophageal or gas­troesophageal junction adenocarcinoma. They underwent tumor biopsy, then chemoradiation (oxaliplatin, 5-fluo­rouracil, and 45-Gy external beam radi­ation), then surgery, and finally more chemotherapy (oxaliplatin and 5-fluo­rouracil).

Response Genetics Inc., manufacturer of several biomarker assays, analyzed tumor ERCC1 mRNA expression for the 55 patients who had sufficient pretreatment tumor tissue. Laser-capture mi­crodissection was used to ensure that only tumor cells were analyzed.

“ERCC1 has been shown to be a crit­ical gene in DNA repair,” Dr. Bohanes explained. “ERCC1 is involved in the nucleotide excision repair pathway, which recognizes and removes platinum-induced DNA adducts.” Higher expres­
sion is associated with resistance to plat­inum compounds, including cisplatin, oxaliplatin, and carboplatin.

“Also more recently, ERCC1 has been shown to be involved in the double-strand break repair pathway, which re­pairs radiation-induced damage,” he further observed.

Tumors were classified as having a high or low level of ERCC1 expression using a cutoff mRNA level of greater than 1.7 for high expression, as estab­lished in previous studies.

The 55 patients studied had a median age of 64 years. Most were men (93%) and white (94%), and had esophageal tu­mors (62%). One-fourth of them were found to have a pathological complete response at the time of surgery.

The median duration of follow-up was 36.8 months, reported Dr. Bohanes, a re­search fellow in medical oncology at the University of Southern California in Los Angeles.

Results showed that patients having high vs. low tumor expression of ERCC1 had a nearly tripled risk of progression (hazard ratio, 2.97; P = .006).«change in ONCR rendition» The medi­an duration of progression-free survival was 14.8 months for the former but was not reached for the latter. Corresponding 2-year rates of progression-free survival were 17% and 67%.

Similarly, patients with tumors having high vs. low expression of ERCC1 had a more than doubling of the risk of death (HR, 2.32; P = .047). «change in ONCR rendition» The median dura­tion of overall survival was 22.4 months for the former but was not reached for the latter. Corresponding 2-year rates of overall survival were 37% and 72%.

Expression of ERCC1 was not associ­ated with pathological complete re­sponse. Also, expression of a host of other genes – XPD and RRM1 (associat­ed with DNA repair), GSTP1 (associated with platinum detoxification), and TS, TP, and DPD (associated with 5-fluo­rouracil metabolism) – was not associat­ed with any of the outcomes studied.

“Biomarker studies are feasible within cooperative groups,” commented Dr. Bohanes, but adequate tissue was avail­able for only 55 of 92 eligible patients. Hence, “future trials need to request ad­ditional endoscopic biopsies to allow for sufficient tumor tissue collection.”

A study shortcoming was an inability to determine whether ERCC1 expression correlates with disease stage, he ac­knowledged.

“The design of this study unfortu­nately did not require preoperative en­doscopic ultrasound because it was thought that it would have hampered the
recruitment of this trial,” he said. “And often, in the community setting, endoscopic ultrasound is not avail­able.”

Also, the study could not deter­mine whether ERCC1 expression is a prognostic marker. “We would need a control arm without platinum agent,” he noted.

<[stk 3]>“I think that the patients with high expression are not benefiting from this treatment” and should be treated with alternative treatments, commented Dr. Heinz-Josef Lenz, senior investigator and chair of the gastrointestinal oncology program at the University of Southern Cali­fornia. <[etk]>

“We have choices, and I think that would certainly be part of the new concept and design going forward, ” he added.

<[stk 3]>Dr. Lenz agreed with an attendee that recruiting patients with esophageal and gastroesophageal cancer to randomized trials has been difficult in the past and it might therefore take many years to obtain important biomarker data. But adaptive trial designs are ad­dressing this issue.<[etk]>

I have checked the following facts in my story: (Please initial each.)

Meeting: 3660-11

Drug names and dosages: SML jsm

Lab test values and their units: n/a na

Citation (e.g., JAMA 2008;299:785-92): n/a na

Investigators’ names and affiliations: SML jsm

All other proper names (e.g., clinical trials; geographic, company, and test names): SML jsm

Investigators’ conflicts of interest and sponsor of study: SML jsm

Please provide your best contact number and email for questions on this story: (206) 393-2459; slondon@speakeasy.net

Notes:

(1) Abstract 2; log in on main ASCO page first -- http://www.asco.org

username: gi_pressaccess

password: pre$$1

Go to Virtual Meeting. Note: search function for this meeting is not working well yet, so better to look by track.

(2) Either they did not show the conflicts of interest slides at the start of the session or they blew through them at lightspeed. I don’t have any photos of them and they are not up on the Web site. So Dr. Lenz’s conflicts come from a slide in Dr. Bohanes’ talk, where the nature of the conflicts was not given.

“I think we are incorporating now more technologies with the design, which may be more flexible to adapt new findings so that we are not stuck for the next 3 or 5 years to a trial be­cause of low accrual,” he said.

Dr. Bohanes reported that he had no relevant conflicts of interest.

Dr. Lenz reported having relation­ships with Response Genetics Inc. and with Sanofi-Aventis, manufac­turer of oxaliplatin (Eloxatin). 

Major Finding: The combination of 25-hydroxyvitamin D level and sFlt-1:PlGF ratio early in the second trimester had an area under the ROC curve of 0.834 for predicting severe preeclampsia.

Data Source: A nested, case-control study of 164 pregnant women, one-fourth of whom had developed severe preeclampsia.

Disclosures: Dr. Woodham did not report any relevant financial disclosures.

SAN FRANCISCO – Levels of serum markers measured early in the second trimester of pregnancy may help identify women who are likely to develop severe preeclampsia, the results of a nested case-control study indicated.

In the study, there was no association between the level of vitamin D and levels of two angiogenic factors that have been previously implicated in the development of preeclampsia, soluble FMS-like tyrosine kinase 1 (sFlt-1) and placental growth factor (PlGF). But both the level of vitamin D and the ratio of sFlt-1 to PlGF predicted the development of severe preeclampsia after other risk factors were taken into account. And in ROC (receiver operating characteristic) curve analysis, the combination outperformed either measure individually.

“These results suggest that 25-hydroxyvitamin D and angiogenic factors play independent roles in the pathogenesis of preeclampsia,” said Dr. Padmashree Chaudhury Woodham. “Our findings suggest that the combination of 25-hydroxy-vitamin D level and sFlt-1:PlGF ratio is a better predictor of preeclampsia in midgestation than either marker alone.”

A low 25-hydroxyvitamin D level has previously been shown to be a risk factor for severe preeclampsia, according to Dr. Woodham, who is a fellow in ob.gyn. at the University of North Carolina at Chapel Hill. But its association with angiogenic factors is unclear.

The investigators drew their study patients from a large cohort of pregnant women who gave blood for routine prenatal screening early in the second trimester (gestational age, 15–20 weeks). They restricted analyses to women with a singleton pregnancy who did not have chronic medical illnesses and whose fetuses did not have congenital abnormalities.

Each woman who developed severe preeclampsia (n = 41) was matched by race/ethnicity with three control women who had uncomplicated births at term (n = 123). Banked frozen serum samples were assayed to determine levels of vitamin D (total 25-hydroxyvitamin D) and the angiogenic markers sFlt-1, PlGF, and vascular endothelial growth factor (VEGF).

The severe preeclampsia and control groups were similar in terms of age, parity, and body mass index, Dr. Woodham reported. Overall, 39% were black, 29% were white, 27% were Hispanic, and 5% were Asian. The season and the median gestational age at the time blood was drawn were also similar. But the median gestational age at delivery was younger in the preeclampsia group (32.6 vs. 39.6 weeks; P less than .001).

Relative to their control counterparts, the women who developed preeclampsia had lower levels of vitamin D (P less than .001), VEGF (P less than .001), and PlGF (P = .03), and a higher ratio of sFlt-1 to PlGF (P = .02). Levels of vitamin D were not correlated with levels of any of the angiogenic factors or with the sFlt-1:PlGF ratio, contrary to the findings of in vitro and animal studies. However, in a multivariate model, each 1-nmol/L increase in total vitamin D level was associated with a 5% reduction in the odds of preeclampsia, whereas each 1-unit increase in the sFlt-1:PlGF ratio was associated with an 11% increase in the odds.

ROC curve analysis showed that for predicting preeclampsia, the area under the curve was 0.745 for vitamin D alone and 0.669 for the sFlt-1:PlGF ratio alone. But it was higher with their combination (0.834). There was also a small further improvement when VEGF level was added to the mix, with an area under the curve of 0.851.

Major Finding: The combination of 25-hydroxyvitamin D level and sFlt-1:PlGF ratio early in the second trimester had an area under the ROC curve of 0.834 for predicting severe preeclampsia.

Data Source: A nested, case-control study of 164 pregnant women, one-fourth of whom had developed severe preeclampsia.

Disclosures: Dr. Woodham did not report any relevant financial disclosures.

SAN FRANCISCO – Levels of serum markers measured early in the second trimester of pregnancy may help identify women who are likely to develop severe preeclampsia, the results of a nested case-control study indicated.

In the study, there was no association between the level of vitamin D and levels of two angiogenic factors that have been previously implicated in the development of preeclampsia, soluble FMS-like tyrosine kinase 1 (sFlt-1) and placental growth factor (PlGF). But both the level of vitamin D and the ratio of sFlt-1 to PlGF predicted the development of severe preeclampsia after other risk factors were taken into account. And in ROC (receiver operating characteristic) curve analysis, the combination outperformed either measure individually.

“These results suggest that 25-hydroxyvitamin D and angiogenic factors play independent roles in the pathogenesis of preeclampsia,” said Dr. Padmashree Chaudhury Woodham. “Our findings suggest that the combination of 25-hydroxy-vitamin D level and sFlt-1:PlGF ratio is a better predictor of preeclampsia in midgestation than either marker alone.”

A low 25-hydroxyvitamin D level has previously been shown to be a risk factor for severe preeclampsia, according to Dr. Woodham, who is a fellow in ob.gyn. at the University of North Carolina at Chapel Hill. But its association with angiogenic factors is unclear.

The investigators drew their study patients from a large cohort of pregnant women who gave blood for routine prenatal screening early in the second trimester (gestational age, 15–20 weeks). They restricted analyses to women with a singleton pregnancy who did not have chronic medical illnesses and whose fetuses did not have congenital abnormalities.

Each woman who developed severe preeclampsia (n = 41) was matched by race/ethnicity with three control women who had uncomplicated births at term (n = 123). Banked frozen serum samples were assayed to determine levels of vitamin D (total 25-hydroxyvitamin D) and the angiogenic markers sFlt-1, PlGF, and vascular endothelial growth factor (VEGF).

The severe preeclampsia and control groups were similar in terms of age, parity, and body mass index, Dr. Woodham reported. Overall, 39% were black, 29% were white, 27% were Hispanic, and 5% were Asian. The season and the median gestational age at the time blood was drawn were also similar. But the median gestational age at delivery was younger in the preeclampsia group (32.6 vs. 39.6 weeks; P less than .001).

Relative to their control counterparts, the women who developed preeclampsia had lower levels of vitamin D (P less than .001), VEGF (P less than .001), and PlGF (P = .03), and a higher ratio of sFlt-1 to PlGF (P = .02). Levels of vitamin D were not correlated with levels of any of the angiogenic factors or with the sFlt-1:PlGF ratio, contrary to the findings of in vitro and animal studies. However, in a multivariate model, each 1-nmol/L increase in total vitamin D level was associated with a 5% reduction in the odds of preeclampsia, whereas each 1-unit increase in the sFlt-1:PlGF ratio was associated with an 11% increase in the odds.

ROC curve analysis showed that for predicting preeclampsia, the area under the curve was 0.745 for vitamin D alone and 0.669 for the sFlt-1:PlGF ratio alone. But it was higher with their combination (0.834). There was also a small further improvement when VEGF level was added to the mix, with an area under the curve of 0.851.

Major Finding: The combination of 25-hydroxyvitamin D level and sFlt-1:PlGF ratio early in the second trimester had an area under the ROC curve of 0.834 for predicting severe preeclampsia.

Data Source: A nested, case-control study of 164 pregnant women, one-fourth of whom had developed severe preeclampsia.

Disclosures: Dr. Woodham did not report any relevant financial disclosures.

SAN FRANCISCO – Levels of serum markers measured early in the second trimester of pregnancy may help identify women who are likely to develop severe preeclampsia, the results of a nested case-control study indicated.

In the study, there was no association between the level of vitamin D and levels of two angiogenic factors that have been previously implicated in the development of preeclampsia, soluble FMS-like tyrosine kinase 1 (sFlt-1) and placental growth factor (PlGF). But both the level of vitamin D and the ratio of sFlt-1 to PlGF predicted the development of severe preeclampsia after other risk factors were taken into account. And in ROC (receiver operating characteristic) curve analysis, the combination outperformed either measure individually.

“These results suggest that 25-hydroxyvitamin D and angiogenic factors play independent roles in the pathogenesis of preeclampsia,” said Dr. Padmashree Chaudhury Woodham. “Our findings suggest that the combination of 25-hydroxy-vitamin D level and sFlt-1:PlGF ratio is a better predictor of preeclampsia in midgestation than either marker alone.”

A low 25-hydroxyvitamin D level has previously been shown to be a risk factor for severe preeclampsia, according to Dr. Woodham, who is a fellow in ob.gyn. at the University of North Carolina at Chapel Hill. But its association with angiogenic factors is unclear.

The investigators drew their study patients from a large cohort of pregnant women who gave blood for routine prenatal screening early in the second trimester (gestational age, 15–20 weeks). They restricted analyses to women with a singleton pregnancy who did not have chronic medical illnesses and whose fetuses did not have congenital abnormalities.

Each woman who developed severe preeclampsia (n = 41) was matched by race/ethnicity with three control women who had uncomplicated births at term (n = 123). Banked frozen serum samples were assayed to determine levels of vitamin D (total 25-hydroxyvitamin D) and the angiogenic markers sFlt-1, PlGF, and vascular endothelial growth factor (VEGF).

The severe preeclampsia and control groups were similar in terms of age, parity, and body mass index, Dr. Woodham reported. Overall, 39% were black, 29% were white, 27% were Hispanic, and 5% were Asian. The season and the median gestational age at the time blood was drawn were also similar. But the median gestational age at delivery was younger in the preeclampsia group (32.6 vs. 39.6 weeks; P less than .001).

Relative to their control counterparts, the women who developed preeclampsia had lower levels of vitamin D (P less than .001), VEGF (P less than .001), and PlGF (P = .03), and a higher ratio of sFlt-1 to PlGF (P = .02). Levels of vitamin D were not correlated with levels of any of the angiogenic factors or with the sFlt-1:PlGF ratio, contrary to the findings of in vitro and animal studies. However, in a multivariate model, each 1-nmol/L increase in total vitamin D level was associated with a 5% reduction in the odds of preeclampsia, whereas each 1-unit increase in the sFlt-1:PlGF ratio was associated with an 11% increase in the odds.

ROC curve analysis showed that for predicting preeclampsia, the area under the curve was 0.745 for vitamin D alone and 0.669 for the sFlt-1:PlGF ratio alone. But it was higher with their combination (0.834). There was also a small further improvement when VEGF level was added to the mix, with an area under the curve of 0.851.

Major Finding: Girls whose parents signed up for text message reminders were twice as likely to get their next dose of HPV vaccine within a month of the due date, compared with girls whose parents did not sign up.

Data Source: A comparative study among 124 girls whose parents signed up for text message reminders, 308 girls whose parents opted not to sign up, and 1,080 girls from the preintervention period

Disclosures: Dr. Kharbanda reported that Vaughn I. Rickert, Psy.D., one of the study coinvestigators, is a consultant to Sanofi Pasteur and receives research funding from and sits on the advisory board of Merck.

SEATTLE – Text message reminders improve timely receipt of the human papillomavirus vaccine, according to results of a study of more than 1,500 girls who had started the three-dose series.

In the study reported at the meeting, about a third of parents offered the reminders signed up for them. Girls whose parents signed up were twice as likely to receive their next dose of vaccine within a month of when it was due, compared with their counterparts whose parents did not sign up.

“We found that text messaging can increase on-time vaccination,” commented Dr. Elyse O. Kharbanda, a pediatrician who was with Columbia University Medical Center, New York, at the time of the study and is now with the Health Partners Research Foundation in Minneapolis.

“We recommend these findings should be replicated in a larger and more diverse sample,” she added. “And future studies should really explore what our main issue was: How to get more parents to sign up for this type of service.”

Although the Food and Drug Administration approved the quadrivalent human papillomavirus (HPV) vaccine (Gardasil, Merck) in 2006, the rate of receipt of all three doses among girls remains low, and receipt of doses on time is also problematic, according to Dr. Kharbanda. Several factors may explain this poor adherence.

“Unlike routine vaccines that we give to infants, this three-dose vaccine series is not aligned with routine adolescent health care visits,” she said. Financial barriers and provider factors also may explain some of the adherence problem.

“But what actually I think is the most important barrier is the parents and teens themselves,” Dr. Kharbanda commented. “It's not that [the parents] explicitly oppose the vaccine, it's just that they are busy – they have busy lives with competing priorities, and getting their child or their teen in for three visits to get a shot over a 6-month period is just not high on their To-Do list.”

There is good reason to believe that use of text messaging to send reminders could help solve this problem. “We thought cellular technology may provide an advantage because of its penetrance: Over 96% of U.S. adults now own a cell phone,” she explained. “And especially in low-income populations, cell phone numbers may be even more stable than land-line numbers.”

Additionally, “these reminders serve as cues to action,” she said. “So the idea is the parent would get a text message and it may sort of push getting that vaccine up on their priority list.”

The study, part of the Text4Health study exploring use of this technology among underserved, low-income populations, was conducted in nine clinical sites in New York. It was open to English- or Spanish-speaking parents with a cell phone who brought daughters aged 10–18 years in for the first or second dose of the quadrivalent HPV vaccine between January and June 2009. The parents were given a recruitment card with instructions in English and Spanish on how to sign-up for text message reminders for the next dose of vaccine. Signing-up required calling a dedicated number, selecting a language, confirming interest, and entering a personal identification number from the recruitment card, used to link the caller to the daughter's medical record. The parent's cell phone number was automatically captured.

Parents who signed up received up to three automated text messages reminding them that their daughter had an upcoming due date for her next HPV vaccine dose, Dr. Kharbanda said. The messages included the name and phone number of the clinic where their daughter received care, and an option to cancel future reminders (although none used this option).

In all, recruitment cards were given to the parents of 434 girls, 29% of whom signed up. The 124 who entered a valid personal identification number were sent text message reminders. The comparison groups consisted of 308 girls whose parents did not sign up for the reminders and 1,080 girls who had received a first or second dose of HPV vaccine in the same clinics in the 6 months before the intervention and served as historic controls.

The girls were 14 years old on average, and nearly three-quarters had Medicaid or SCHIP health insurance. Most (84%) received their care in an academic clinic, and a sizable minority (40%) spoke Spanish.

Study results showed that the percentage of girls who received their next HPV vaccine dose within 1 month of the due date, the primary end point, was 52% among those whose parents signed up for reminders, 35% among those whose parents did not sign up, and 38% among those who served as historic controls, a significant difference.

The percentages were better in all three groups when it came to receipt of the vaccine dose within 4 months of the due date. But the value was still higher among girls whose parents signed up for reminders, at 65%, than among those whose parents did not sign up, at 51%, and the historic controls, at 53%.

In logistic regression analyses that controlled for type of insurance and type of clinic used for care (which differed across groups), girls whose parents signed up for text reminders were 2.03 times more likely than were the girls whose parents did not sign up and 1.83 times more likely than the historic control girls were to receive their next HPV vaccine dose within 1 month of the due date, significant differences.

Results of the HPV study have recently been published in Vaccine (2011;29:2537–41).

Major Finding: Girls whose parents signed up for text message reminders were twice as likely to get their next dose of HPV vaccine within a month of the due date, compared with girls whose parents did not sign up.

Data Source: A comparative study among 124 girls whose parents signed up for text message reminders, 308 girls whose parents opted not to sign up, and 1,080 girls from the preintervention period

Disclosures: Dr. Kharbanda reported that Vaughn I. Rickert, Psy.D., one of the study coinvestigators, is a consultant to Sanofi Pasteur and receives research funding from and sits on the advisory board of Merck.

SEATTLE – Text message reminders improve timely receipt of the human papillomavirus vaccine, according to results of a study of more than 1,500 girls who had started the three-dose series.

In the study reported at the meeting, about a third of parents offered the reminders signed up for them. Girls whose parents signed up were twice as likely to receive their next dose of vaccine within a month of when it was due, compared with their counterparts whose parents did not sign up.

“We found that text messaging can increase on-time vaccination,” commented Dr. Elyse O. Kharbanda, a pediatrician who was with Columbia University Medical Center, New York, at the time of the study and is now with the Health Partners Research Foundation in Minneapolis.

“We recommend these findings should be replicated in a larger and more diverse sample,” she added. “And future studies should really explore what our main issue was: How to get more parents to sign up for this type of service.”

Although the Food and Drug Administration approved the quadrivalent human papillomavirus (HPV) vaccine (Gardasil, Merck) in 2006, the rate of receipt of all three doses among girls remains low, and receipt of doses on time is also problematic, according to Dr. Kharbanda. Several factors may explain this poor adherence.

“Unlike routine vaccines that we give to infants, this three-dose vaccine series is not aligned with routine adolescent health care visits,” she said. Financial barriers and provider factors also may explain some of the adherence problem.

“But what actually I think is the most important barrier is the parents and teens themselves,” Dr. Kharbanda commented. “It's not that [the parents] explicitly oppose the vaccine, it's just that they are busy – they have busy lives with competing priorities, and getting their child or their teen in for three visits to get a shot over a 6-month period is just not high on their To-Do list.”

There is good reason to believe that use of text messaging to send reminders could help solve this problem. “We thought cellular technology may provide an advantage because of its penetrance: Over 96% of U.S. adults now own a cell phone,” she explained. “And especially in low-income populations, cell phone numbers may be even more stable than land-line numbers.”

Additionally, “these reminders serve as cues to action,” she said. “So the idea is the parent would get a text message and it may sort of push getting that vaccine up on their priority list.”

The study, part of the Text4Health study exploring use of this technology among underserved, low-income populations, was conducted in nine clinical sites in New York. It was open to English- or Spanish-speaking parents with a cell phone who brought daughters aged 10–18 years in for the first or second dose of the quadrivalent HPV vaccine between January and June 2009. The parents were given a recruitment card with instructions in English and Spanish on how to sign-up for text message reminders for the next dose of vaccine. Signing-up required calling a dedicated number, selecting a language, confirming interest, and entering a personal identification number from the recruitment card, used to link the caller to the daughter's medical record. The parent's cell phone number was automatically captured.

Parents who signed up received up to three automated text messages reminding them that their daughter had an upcoming due date for her next HPV vaccine dose, Dr. Kharbanda said. The messages included the name and phone number of the clinic where their daughter received care, and an option to cancel future reminders (although none used this option).

In all, recruitment cards were given to the parents of 434 girls, 29% of whom signed up. The 124 who entered a valid personal identification number were sent text message reminders. The comparison groups consisted of 308 girls whose parents did not sign up for the reminders and 1,080 girls who had received a first or second dose of HPV vaccine in the same clinics in the 6 months before the intervention and served as historic controls.

The girls were 14 years old on average, and nearly three-quarters had Medicaid or SCHIP health insurance. Most (84%) received their care in an academic clinic, and a sizable minority (40%) spoke Spanish.

Study results showed that the percentage of girls who received their next HPV vaccine dose within 1 month of the due date, the primary end point, was 52% among those whose parents signed up for reminders, 35% among those whose parents did not sign up, and 38% among those who served as historic controls, a significant difference.

The percentages were better in all three groups when it came to receipt of the vaccine dose within 4 months of the due date. But the value was still higher among girls whose parents signed up for reminders, at 65%, than among those whose parents did not sign up, at 51%, and the historic controls, at 53%.

In logistic regression analyses that controlled for type of insurance and type of clinic used for care (which differed across groups), girls whose parents signed up for text reminders were 2.03 times more likely than were the girls whose parents did not sign up and 1.83 times more likely than the historic control girls were to receive their next HPV vaccine dose within 1 month of the due date, significant differences.

Results of the HPV study have recently been published in Vaccine (2011;29:2537–41).

Major Finding: Girls whose parents signed up for text message reminders were twice as likely to get their next dose of HPV vaccine within a month of the due date, compared with girls whose parents did not sign up.

Data Source: A comparative study among 124 girls whose parents signed up for text message reminders, 308 girls whose parents opted not to sign up, and 1,080 girls from the preintervention period

Disclosures: Dr. Kharbanda reported that Vaughn I. Rickert, Psy.D., one of the study coinvestigators, is a consultant to Sanofi Pasteur and receives research funding from and sits on the advisory board of Merck.

SEATTLE – Text message reminders improve timely receipt of the human papillomavirus vaccine, according to results of a study of more than 1,500 girls who had started the three-dose series.

In the study reported at the meeting, about a third of parents offered the reminders signed up for them. Girls whose parents signed up were twice as likely to receive their next dose of vaccine within a month of when it was due, compared with their counterparts whose parents did not sign up.

“We found that text messaging can increase on-time vaccination,” commented Dr. Elyse O. Kharbanda, a pediatrician who was with Columbia University Medical Center, New York, at the time of the study and is now with the Health Partners Research Foundation in Minneapolis.

“We recommend these findings should be replicated in a larger and more diverse sample,” she added. “And future studies should really explore what our main issue was: How to get more parents to sign up for this type of service.”

Although the Food and Drug Administration approved the quadrivalent human papillomavirus (HPV) vaccine (Gardasil, Merck) in 2006, the rate of receipt of all three doses among girls remains low, and receipt of doses on time is also problematic, according to Dr. Kharbanda. Several factors may explain this poor adherence.

“Unlike routine vaccines that we give to infants, this three-dose vaccine series is not aligned with routine adolescent health care visits,” she said. Financial barriers and provider factors also may explain some of the adherence problem.

“But what actually I think is the most important barrier is the parents and teens themselves,” Dr. Kharbanda commented. “It's not that [the parents] explicitly oppose the vaccine, it's just that they are busy – they have busy lives with competing priorities, and getting their child or their teen in for three visits to get a shot over a 6-month period is just not high on their To-Do list.”

There is good reason to believe that use of text messaging to send reminders could help solve this problem. “We thought cellular technology may provide an advantage because of its penetrance: Over 96% of U.S. adults now own a cell phone,” she explained. “And especially in low-income populations, cell phone numbers may be even more stable than land-line numbers.”

Additionally, “these reminders serve as cues to action,” she said. “So the idea is the parent would get a text message and it may sort of push getting that vaccine up on their priority list.”

The study, part of the Text4Health study exploring use of this technology among underserved, low-income populations, was conducted in nine clinical sites in New York. It was open to English- or Spanish-speaking parents with a cell phone who brought daughters aged 10–18 years in for the first or second dose of the quadrivalent HPV vaccine between January and June 2009. The parents were given a recruitment card with instructions in English and Spanish on how to sign-up for text message reminders for the next dose of vaccine. Signing-up required calling a dedicated number, selecting a language, confirming interest, and entering a personal identification number from the recruitment card, used to link the caller to the daughter's medical record. The parent's cell phone number was automatically captured.

Parents who signed up received up to three automated text messages reminding them that their daughter had an upcoming due date for her next HPV vaccine dose, Dr. Kharbanda said. The messages included the name and phone number of the clinic where their daughter received care, and an option to cancel future reminders (although none used this option).

In all, recruitment cards were given to the parents of 434 girls, 29% of whom signed up. The 124 who entered a valid personal identification number were sent text message reminders. The comparison groups consisted of 308 girls whose parents did not sign up for the reminders and 1,080 girls who had received a first or second dose of HPV vaccine in the same clinics in the 6 months before the intervention and served as historic controls.

The girls were 14 years old on average, and nearly three-quarters had Medicaid or SCHIP health insurance. Most (84%) received their care in an academic clinic, and a sizable minority (40%) spoke Spanish.

Study results showed that the percentage of girls who received their next HPV vaccine dose within 1 month of the due date, the primary end point, was 52% among those whose parents signed up for reminders, 35% among those whose parents did not sign up, and 38% among those who served as historic controls, a significant difference.

The percentages were better in all three groups when it came to receipt of the vaccine dose within 4 months of the due date. But the value was still higher among girls whose parents signed up for reminders, at 65%, than among those whose parents did not sign up, at 51%, and the historic controls, at 53%.

In logistic regression analyses that controlled for type of insurance and type of clinic used for care (which differed across groups), girls whose parents signed up for text reminders were 2.03 times more likely than were the girls whose parents did not sign up and 1.83 times more likely than the historic control girls were to receive their next HPV vaccine dose within 1 month of the due date, significant differences.

Results of the HPV study have recently been published in Vaccine (2011;29:2537–41).

SAN FRANCISCO – As women grow heavier, tailoring antibiotic dose to weight or body mass index may be critical for preventing surgical site infections after cesarean deliveries, a study has shown.

In the prospective cohort study, all 29 women undergoing a cesarean were given the same standard fixed dose of cefazolin before their surgery. Concentrations of the antibiotic in adipose tissue collected at the start of the surgery were one-third lower in obese women and one-half lower in extremely obese women than those in their lean counterparts. Perhaps most importantly, some of the heavier women had tissue concentrations below those believed to be necessary for preventing antibiotic resistance.

“Based on the current findings, a considerable proportion of obese women undergoing cesarean delivery do not have adequate antimicrobial protection for the duration of the procedure, following current guidelines,” said Dr. Leo Pevzner, an ob.gyn. at the University of California, Irvine.

The National Surgical Infection Prevention Project has endorsed tailoring antibiotic dose to weight or body mass index (BMI), but data on appropriate prophylactic doses in adults are limited, he noted. Hence, recommendations still call for an intravenous dose of 1–2 g for all adults, large or small.

“Current obesity trends, along with evolutionary changes in bacterial resistance, portend a questionable utility of existing prophylaxis regimens and have the potential to drastically increase the rates of surgical site infections if no attempts are made to address antimicrobial dosing based on patients' weight or BMI,” Dr. Pevzner commented.

The investigators enrolled in the study women with a singleton pregnancy who were scheduled for a cesarean delivery at term (greater than 37 weeks' gestation). Any who had received antibiotics in the previous week or who had chronic hypertension or pregestational diabetes were excluded.

On the basis of their BMI, the women were classified as lean (less than 30 kg/m

All were given 2 g of cefazolin 30–60 minutes before skin incision for the cesarean surgery. The investigators collected adipose tissue at the time of skin incision (initial) and again just before closure (final), as well as myometrial tissue after delivery and blood at the end of the procedure.

The concentration of cefazolin in all samples was assessed in a blinded manner with a microbiologic plate assay performed in triplicate, using plates seeded with Streptococcus sanguis. Zones of inhibition were measured in millimeters.

The study participants were 30 years old, on average. The mean BMI was 27, 34, and 45 kg/m

Regression analysis showed that the higher the women's BMI, the lower the concentration of the antibiotic in their initial adipose tissue sample (r = −0.67, P less than .001). None of the lean women had an adipose concentration of cefazolin below 4 mcg/g, the theoretic breakpoint for preventing resistance, according to Dr. Pevzner.

But eight women – four obese and four extremely obese – had an initial or a final adipose concentration below this breakpoint.

And three women – all extremely obese – had both initial and final adipose concentrations below this breakpoint.

The concentrations of cefazolin in the final adipose tissue, myometrial tissue, and serum also decreased with increasing BMI category, but these differences were not statistically significant, Dr. Pevzner reported.

Among the 25 women with follow-up, 2 developed surgical site infections requiring antibiotic therapy. Both were in the extremely obese group, and both had initial and final adipose cefazolin concentrations below the 4-mcg/g threshold.

The study was small, Dr. Pevzner acknowledged. “As such, there is not enough information to reach a conclusion regarding the weight or BMI above which a higher dose of antibiotics should be used,” he said.

Also, the impact of multiple gestations and maternal diseases, such as hypertension and diabetes, in this setting is unknown.

Dr. Pevzner did not report any relevant financial disclosures.

SAN FRANCISCO – As women grow heavier, tailoring antibiotic dose to weight or body mass index may be critical for preventing surgical site infections after cesarean deliveries, a study has shown.

In the prospective cohort study, all 29 women undergoing a cesarean were given the same standard fixed dose of cefazolin before their surgery. Concentrations of the antibiotic in adipose tissue collected at the start of the surgery were one-third lower in obese women and one-half lower in extremely obese women than those in their lean counterparts. Perhaps most importantly, some of the heavier women had tissue concentrations below those believed to be necessary for preventing antibiotic resistance.

“Based on the current findings, a considerable proportion of obese women undergoing cesarean delivery do not have adequate antimicrobial protection for the duration of the procedure, following current guidelines,” said Dr. Leo Pevzner, an ob.gyn. at the University of California, Irvine.

The National Surgical Infection Prevention Project has endorsed tailoring antibiotic dose to weight or body mass index (BMI), but data on appropriate prophylactic doses in adults are limited, he noted. Hence, recommendations still call for an intravenous dose of 1–2 g for all adults, large or small.

“Current obesity trends, along with evolutionary changes in bacterial resistance, portend a questionable utility of existing prophylaxis regimens and have the potential to drastically increase the rates of surgical site infections if no attempts are made to address antimicrobial dosing based on patients' weight or BMI,” Dr. Pevzner commented.

The investigators enrolled in the study women with a singleton pregnancy who were scheduled for a cesarean delivery at term (greater than 37 weeks' gestation). Any who had received antibiotics in the previous week or who had chronic hypertension or pregestational diabetes were excluded.

On the basis of their BMI, the women were classified as lean (less than 30 kg/m

All were given 2 g of cefazolin 30–60 minutes before skin incision for the cesarean surgery. The investigators collected adipose tissue at the time of skin incision (initial) and again just before closure (final), as well as myometrial tissue after delivery and blood at the end of the procedure.

The concentration of cefazolin in all samples was assessed in a blinded manner with a microbiologic plate assay performed in triplicate, using plates seeded with Streptococcus sanguis. Zones of inhibition were measured in millimeters.

The study participants were 30 years old, on average. The mean BMI was 27, 34, and 45 kg/m

Regression analysis showed that the higher the women's BMI, the lower the concentration of the antibiotic in their initial adipose tissue sample (r = −0.67, P less than .001). None of the lean women had an adipose concentration of cefazolin below 4 mcg/g, the theoretic breakpoint for preventing resistance, according to Dr. Pevzner.

But eight women – four obese and four extremely obese – had an initial or a final adipose concentration below this breakpoint.

And three women – all extremely obese – had both initial and final adipose concentrations below this breakpoint.

The concentrations of cefazolin in the final adipose tissue, myometrial tissue, and serum also decreased with increasing BMI category, but these differences were not statistically significant, Dr. Pevzner reported.

Among the 25 women with follow-up, 2 developed surgical site infections requiring antibiotic therapy. Both were in the extremely obese group, and both had initial and final adipose cefazolin concentrations below the 4-mcg/g threshold.

The study was small, Dr. Pevzner acknowledged. “As such, there is not enough information to reach a conclusion regarding the weight or BMI above which a higher dose of antibiotics should be used,” he said.

Also, the impact of multiple gestations and maternal diseases, such as hypertension and diabetes, in this setting is unknown.

Dr. Pevzner did not report any relevant financial disclosures.

SAN FRANCISCO – As women grow heavier, tailoring antibiotic dose to weight or body mass index may be critical for preventing surgical site infections after cesarean deliveries, a study has shown.

In the prospective cohort study, all 29 women undergoing a cesarean were given the same standard fixed dose of cefazolin before their surgery. Concentrations of the antibiotic in adipose tissue collected at the start of the surgery were one-third lower in obese women and one-half lower in extremely obese women than those in their lean counterparts. Perhaps most importantly, some of the heavier women had tissue concentrations below those believed to be necessary for preventing antibiotic resistance.

“Based on the current findings, a considerable proportion of obese women undergoing cesarean delivery do not have adequate antimicrobial protection for the duration of the procedure, following current guidelines,” said Dr. Leo Pevzner, an ob.gyn. at the University of California, Irvine.

The National Surgical Infection Prevention Project has endorsed tailoring antibiotic dose to weight or body mass index (BMI), but data on appropriate prophylactic doses in adults are limited, he noted. Hence, recommendations still call for an intravenous dose of 1–2 g for all adults, large or small.

“Current obesity trends, along with evolutionary changes in bacterial resistance, portend a questionable utility of existing prophylaxis regimens and have the potential to drastically increase the rates of surgical site infections if no attempts are made to address antimicrobial dosing based on patients' weight or BMI,” Dr. Pevzner commented.

The investigators enrolled in the study women with a singleton pregnancy who were scheduled for a cesarean delivery at term (greater than 37 weeks' gestation). Any who had received antibiotics in the previous week or who had chronic hypertension or pregestational diabetes were excluded.

On the basis of their BMI, the women were classified as lean (less than 30 kg/m

All were given 2 g of cefazolin 30–60 minutes before skin incision for the cesarean surgery. The investigators collected adipose tissue at the time of skin incision (initial) and again just before closure (final), as well as myometrial tissue after delivery and blood at the end of the procedure.

The concentration of cefazolin in all samples was assessed in a blinded manner with a microbiologic plate assay performed in triplicate, using plates seeded with Streptococcus sanguis. Zones of inhibition were measured in millimeters.

The study participants were 30 years old, on average. The mean BMI was 27, 34, and 45 kg/m

Regression analysis showed that the higher the women's BMI, the lower the concentration of the antibiotic in their initial adipose tissue sample (r = −0.67, P less than .001). None of the lean women had an adipose concentration of cefazolin below 4 mcg/g, the theoretic breakpoint for preventing resistance, according to Dr. Pevzner.

But eight women – four obese and four extremely obese – had an initial or a final adipose concentration below this breakpoint.

And three women – all extremely obese – had both initial and final adipose concentrations below this breakpoint.

The concentrations of cefazolin in the final adipose tissue, myometrial tissue, and serum also decreased with increasing BMI category, but these differences were not statistically significant, Dr. Pevzner reported.

Among the 25 women with follow-up, 2 developed surgical site infections requiring antibiotic therapy. Both were in the extremely obese group, and both had initial and final adipose cefazolin concentrations below the 4-mcg/g threshold.

The study was small, Dr. Pevzner acknowledged. “As such, there is not enough information to reach a conclusion regarding the weight or BMI above which a higher dose of antibiotics should be used,” he said.

Also, the impact of multiple gestations and maternal diseases, such as hypertension and diabetes, in this setting is unknown.

Dr. Pevzner did not report any relevant financial disclosures.

Major Finding: The combination of elevated second-trimester levels of inhibin A and MSAFP had a positive likelihood ratio of 15.77 for the prediction of stillbirth. The combination also had high specificity (99.6%). But its sensitivity (6.0%) and negative likelihood ratio (0.94) were lower than those considered clinically useful.

Data Source: A population-based, case-control study of 157 women with a stillbirth and 626 women with a live birth.

Disclosures: Dr. Saade did not report any relevant conflicts of interest.

SAN FRANCISCO – Levels of serum markers measured in the second trimester for aneuploidy screening also may improve prediction of stillbirth, according to results of a population-based, case-control study conducted by the Stillbirth Collaborative Research Network.

Of four markers studied, inhibin A was the only one associated with the risk of stillbirth after adjustment for the other markers and risk factors known before pregnancy. But elevated levels of this marker alone had a positive likelihood ratio of just 5.44.

On the other hand, elevated levels of both inhibin A and maternal serum alpha-fetoprotein (MSAFP) had a positive likelihood ratio of 15.77.

“The combination of elevated inhibin A with elevated MSAFP improves prediction of stillbirth,” Dr. George R. Saade commented at the meeting o “This association is strong and may prove useful in risk assessment.”

An attendee asked how the findings could be applied clinically and whether laboratories should start flagging this combination on test results, given that it might not necessarily be flagged for Down syndrome or neural tube defects.

“That's obviously the next step in all of this: What do we do with the result, and how do we manage these patients?” Dr. Saade acknowledged. “You cannot ignore a positive likelihood ratio of 15, but what do we do?”

Giving one possible scenario, he noted that growth restriction has been implicated in up to 40% of cases of stillbirth, so earlier delivery in pregnancies with elevation of both markers could potentially alter outcome in some cases.

But “we still don't know,” he cautioned. “What I would like to do is actually dig down deeper and develop a model, like a multiple-marker screen we do for Down syndrome, where the risk is individualized according to the patient.”

For the study, births were drawn from a parent population-based, case-control study involving 59 hospitals and more than 2,500 births. Stillbirths (cases) and a representative sample of live births (controls) were evaluated with maternal interviews, medical record reviews, and analysis of biospecimens.

In the substudy, the investigators included births from the parent study in which the mother had second-trimester serum screening for aneuploidy as part of routine prenatal care and delivered after 24 weeks' gestation.

Levels of four serum markers – inhibin A, MSAFP, HCG, and unconjugated estriol (uE3) – were analyzed alone and in selected combinations for their association with stillbirth.

In all, the substudy had 157 stillbirths and 626 live births. “This is the largest population-based study of stillbirth with an extensive evaluation of both cases and controls,” noted Dr. Saade, chief of the division of maternal-fetal medicine at the University of Texas, Galveston.

In a multivariate analysis adjusted for the other markers only, women had an elevated risk of stillbirth if they had above-normal levels (defined as greater than 2.0 multiples of the median) vs. normal levels of MSAFP (odds ratio, 3.91; P = .006) and inhibin A (OR, 5.68; P less than .0001).

After additional adjustment for a prepregnancy risk score for stillbirth, which included more than a dozen sociodemographic, medical, and reproductive factors, the only marker still associated with increased risk was inhibin A (OR, 4.49; P = .001).

For predicting stillbirth, the combination of elevated MSAFP and inhibin A levels had the highest positive likelihood ratio of any of the markers individually and in combination by far (15.77).

This value “is above the cutoff of 10, traditionally considered as clinically useful,” noted Dr. Saade.

In comparison, the positive likelihood ratio was 5.44 for elevated inhibin A alone and 2.58 for elevated MSAFP alone.

The combination also had high specificity (99.6%). But its sensitivity (6.0%) and negative likelihood ratio (0.94) were lower than those considered clinically useful, according to Dr. Saade.

The study's findings were essentially the same after exclusion of births involving multiple gestations, intrapartum stillbirth, and fetal anomalies.

To expand on the findings, the investigators plan to reanalyze the data, stratifying results according to the causes of the stillbirths, he said.

Dr. Saade agreed with an attendee that it will be important to verify that the markers are, in fact, predicting stillbirth and not growth restriction instead.

“The problem is, when do you count what was the timing of the stillbirth death … because whether it's growth restricted or not depends on when the death occurred and whether there was even a change in the weight after the death,” he said.

His team is therefore obtaining fetal measurements to better determine the timing of this event and the potential contribution of growth restriction.

Major Finding: The combination of elevated second-trimester levels of inhibin A and MSAFP had a positive likelihood ratio of 15.77 for the prediction of stillbirth. The combination also had high specificity (99.6%). But its sensitivity (6.0%) and negative likelihood ratio (0.94) were lower than those considered clinically useful.

Data Source: A population-based, case-control study of 157 women with a stillbirth and 626 women with a live birth.

Disclosures: Dr. Saade did not report any relevant conflicts of interest.

SAN FRANCISCO – Levels of serum markers measured in the second trimester for aneuploidy screening also may improve prediction of stillbirth, according to results of a population-based, case-control study conducted by the Stillbirth Collaborative Research Network.

Of four markers studied, inhibin A was the only one associated with the risk of stillbirth after adjustment for the other markers and risk factors known before pregnancy. But elevated levels of this marker alone had a positive likelihood ratio of just 5.44.

On the other hand, elevated levels of both inhibin A and maternal serum alpha-fetoprotein (MSAFP) had a positive likelihood ratio of 15.77.

“The combination of elevated inhibin A with elevated MSAFP improves prediction of stillbirth,” Dr. George R. Saade commented at the meeting o “This association is strong and may prove useful in risk assessment.”

An attendee asked how the findings could be applied clinically and whether laboratories should start flagging this combination on test results, given that it might not necessarily be flagged for Down syndrome or neural tube defects.

“That's obviously the next step in all of this: What do we do with the result, and how do we manage these patients?” Dr. Saade acknowledged. “You cannot ignore a positive likelihood ratio of 15, but what do we do?”

Giving one possible scenario, he noted that growth restriction has been implicated in up to 40% of cases of stillbirth, so earlier delivery in pregnancies with elevation of both markers could potentially alter outcome in some cases.

But “we still don't know,” he cautioned. “What I would like to do is actually dig down deeper and develop a model, like a multiple-marker screen we do for Down syndrome, where the risk is individualized according to the patient.”

For the study, births were drawn from a parent population-based, case-control study involving 59 hospitals and more than 2,500 births. Stillbirths (cases) and a representative sample of live births (controls) were evaluated with maternal interviews, medical record reviews, and analysis of biospecimens.

In the substudy, the investigators included births from the parent study in which the mother had second-trimester serum screening for aneuploidy as part of routine prenatal care and delivered after 24 weeks' gestation.

Levels of four serum markers – inhibin A, MSAFP, HCG, and unconjugated estriol (uE3) – were analyzed alone and in selected combinations for their association with stillbirth.

In all, the substudy had 157 stillbirths and 626 live births. “This is the largest population-based study of stillbirth with an extensive evaluation of both cases and controls,” noted Dr. Saade, chief of the division of maternal-fetal medicine at the University of Texas, Galveston.

In a multivariate analysis adjusted for the other markers only, women had an elevated risk of stillbirth if they had above-normal levels (defined as greater than 2.0 multiples of the median) vs. normal levels of MSAFP (odds ratio, 3.91; P = .006) and inhibin A (OR, 5.68; P less than .0001).

After additional adjustment for a prepregnancy risk score for stillbirth, which included more than a dozen sociodemographic, medical, and reproductive factors, the only marker still associated with increased risk was inhibin A (OR, 4.49; P = .001).

For predicting stillbirth, the combination of elevated MSAFP and inhibin A levels had the highest positive likelihood ratio of any of the markers individually and in combination by far (15.77).

This value “is above the cutoff of 10, traditionally considered as clinically useful,” noted Dr. Saade.

In comparison, the positive likelihood ratio was 5.44 for elevated inhibin A alone and 2.58 for elevated MSAFP alone.

The combination also had high specificity (99.6%). But its sensitivity (6.0%) and negative likelihood ratio (0.94) were lower than those considered clinically useful, according to Dr. Saade.

The study's findings were essentially the same after exclusion of births involving multiple gestations, intrapartum stillbirth, and fetal anomalies.

To expand on the findings, the investigators plan to reanalyze the data, stratifying results according to the causes of the stillbirths, he said.

Dr. Saade agreed with an attendee that it will be important to verify that the markers are, in fact, predicting stillbirth and not growth restriction instead.

“The problem is, when do you count what was the timing of the stillbirth death … because whether it's growth restricted or not depends on when the death occurred and whether there was even a change in the weight after the death,” he said.

His team is therefore obtaining fetal measurements to better determine the timing of this event and the potential contribution of growth restriction.

Major Finding: The combination of elevated second-trimester levels of inhibin A and MSAFP had a positive likelihood ratio of 15.77 for the prediction of stillbirth. The combination also had high specificity (99.6%). But its sensitivity (6.0%) and negative likelihood ratio (0.94) were lower than those considered clinically useful.

Data Source: A population-based, case-control study of 157 women with a stillbirth and 626 women with a live birth.

Disclosures: Dr. Saade did not report any relevant conflicts of interest.

SAN FRANCISCO – Levels of serum markers measured in the second trimester for aneuploidy screening also may improve prediction of stillbirth, according to results of a population-based, case-control study conducted by the Stillbirth Collaborative Research Network.

Of four markers studied, inhibin A was the only one associated with the risk of stillbirth after adjustment for the other markers and risk factors known before pregnancy. But elevated levels of this marker alone had a positive likelihood ratio of just 5.44.

On the other hand, elevated levels of both inhibin A and maternal serum alpha-fetoprotein (MSAFP) had a positive likelihood ratio of 15.77.

“The combination of elevated inhibin A with elevated MSAFP improves prediction of stillbirth,” Dr. George R. Saade commented at the meeting o “This association is strong and may prove useful in risk assessment.”

An attendee asked how the findings could be applied clinically and whether laboratories should start flagging this combination on test results, given that it might not necessarily be flagged for Down syndrome or neural tube defects.

“That's obviously the next step in all of this: What do we do with the result, and how do we manage these patients?” Dr. Saade acknowledged. “You cannot ignore a positive likelihood ratio of 15, but what do we do?”

Giving one possible scenario, he noted that growth restriction has been implicated in up to 40% of cases of stillbirth, so earlier delivery in pregnancies with elevation of both markers could potentially alter outcome in some cases.

But “we still don't know,” he cautioned. “What I would like to do is actually dig down deeper and develop a model, like a multiple-marker screen we do for Down syndrome, where the risk is individualized according to the patient.”

For the study, births were drawn from a parent population-based, case-control study involving 59 hospitals and more than 2,500 births. Stillbirths (cases) and a representative sample of live births (controls) were evaluated with maternal interviews, medical record reviews, and analysis of biospecimens.

In the substudy, the investigators included births from the parent study in which the mother had second-trimester serum screening for aneuploidy as part of routine prenatal care and delivered after 24 weeks' gestation.

Levels of four serum markers – inhibin A, MSAFP, HCG, and unconjugated estriol (uE3) – were analyzed alone and in selected combinations for their association with stillbirth.

In all, the substudy had 157 stillbirths and 626 live births. “This is the largest population-based study of stillbirth with an extensive evaluation of both cases and controls,” noted Dr. Saade, chief of the division of maternal-fetal medicine at the University of Texas, Galveston.

In a multivariate analysis adjusted for the other markers only, women had an elevated risk of stillbirth if they had above-normal levels (defined as greater than 2.0 multiples of the median) vs. normal levels of MSAFP (odds ratio, 3.91; P = .006) and inhibin A (OR, 5.68; P less than .0001).

After additional adjustment for a prepregnancy risk score for stillbirth, which included more than a dozen sociodemographic, medical, and reproductive factors, the only marker still associated with increased risk was inhibin A (OR, 4.49; P = .001).

For predicting stillbirth, the combination of elevated MSAFP and inhibin A levels had the highest positive likelihood ratio of any of the markers individually and in combination by far (15.77).

This value “is above the cutoff of 10, traditionally considered as clinically useful,” noted Dr. Saade.

In comparison, the positive likelihood ratio was 5.44 for elevated inhibin A alone and 2.58 for elevated MSAFP alone.

The combination also had high specificity (99.6%). But its sensitivity (6.0%) and negative likelihood ratio (0.94) were lower than those considered clinically useful, according to Dr. Saade.

The study's findings were essentially the same after exclusion of births involving multiple gestations, intrapartum stillbirth, and fetal anomalies.

To expand on the findings, the investigators plan to reanalyze the data, stratifying results according to the causes of the stillbirths, he said.

Dr. Saade agreed with an attendee that it will be important to verify that the markers are, in fact, predicting stillbirth and not growth restriction instead.

“The problem is, when do you count what was the timing of the stillbirth death … because whether it's growth restricted or not depends on when the death occurred and whether there was even a change in the weight after the death,” he said.

His team is therefore obtaining fetal measurements to better determine the timing of this event and the potential contribution of growth restriction.

SEATTLE – Text message reminders improve timely receipt of the human papillomavirus vaccine, according to results of a study of more than 1,500 girls who had started the three-dose series.

In the study reported at the annual meeting of the Society for Adolescent Health and Medicine, about a third of parents offered the reminders signed up for them. Girls whose parents signed up were twice as likely to receive their next dose of vaccine within a month of when it was due, compared with their counterparts whose parents did not sign up.

"We found that text messaging can increase on-time vaccination," commented first author Dr. Elyse O. Kharbanda, a pediatrician who was with Columbia University Medical Center, New York, at the time of the study and is now with the Health Partners Research Foundation in Minneapolis.

"We recommend these findings should be replicated in a larger and more diverse sample," she added. "And future studies should really explore what our main issue was: How to get more parents to sign up for this type of service."

Although the Food and Drug Administration approved the quadrivalent human papillomavirus (HPV) vaccine (Gardasil, Merck) in 2006, the rate of receipt of all three doses among girls remains low, and receipt of doses on time is also problematic, according to Dr. Kharbanda. Several factors may explain this poor adherence.

"Unlike routine vaccines that we give to infants, this three-dose vaccine series is not aligned with routine adolescent health care visits," she said. Financial barriers and provider factors also may explain some of the adherence problem.

"But what actually I think is the most important barrier is the parents and teens themselves," Dr. Kharbanda commented. "It’s not that [the parents] explicitly oppose the vaccine, it’s just that they are busy – they have busy lives with competing priorities, and getting their child or their teen in for three visits to get a shot over a 6-month period is just not high on their To-Do list."

There is good reason to believe that use of text messaging to send reminders could help solve this problem. "We thought cellular technology may provide an advantage because of its penetrance: Over 96% of U.S. adults now own a cell phone," she explained. "And especially in low-income populations, cell phone numbers may be even more stable than land-line numbers."

Additionally, "these reminders serve as cues to action," she said. "So the idea is the parent would get a text message and it may sort of push getting that vaccine up on their priority list."

The study, part of the Text4Health study exploring use of this technology among underserved, low-income populations, was conducted in nine clinical sites in New York. It was open to English- or Spanish-speaking parents with a cell phone who brought daughters aged 10-18 years in for the first or second dose of the quadrivalent HPV vaccine between January and June 2009.

The parents were given a recruitment card with instructions in English and Spanish on how to sign up for text message reminders for the next dose of vaccine. Signing up required calling a dedicated number, selecting a language, confirming interest, and entering a personal identification number from the recruitment card, used to link the caller to the daughter’s medical record. The parent’s cell phone number was automatically captured.

Parents who signed up received up to three automated text messages reminding them that their daughter had an upcoming due date for her next HPV vaccine dose, Dr. Kharbanda said. The messages included the name and phone number of the clinic where their daughter received care, and an option to cancel future reminders (although none used this option).

In all, recruitment cards were given to the parents of 434 girls, 29% of whom signed up. The 124 who entered a valid personal identification number were sent text message reminders.

The comparison groups consisted of 308 girls whose parents did not sign up for the reminders and 1,080 girls who had received a first or second dose of HPV vaccine in the same clinics in the 6 months before the intervention and served as historic controls.

The girls were 14 years old on average, and nearly three-quarters had Medicaid or SCHIP health insurance. Most (84%) received their care in an academic clinic, and a sizable minority (40%) spoke Spanish.

Study results showed that the percentage of girls who received their next HPV vaccine dose within 1 month of the due date, the primary end point, was 52% among those whose parents signed up for reminders, 35% among those whose parents did not sign up, and 38% among those who served as historic controls (P = .003).

The percentages were better in all three groups when it came to receipt of the vaccine dose within 4 months of the due date. But the value was still higher among girls whose parents signed up for reminders, at 65%, than among those whose parents did not sign up, at 51%, and the historic controls, at 53% (P = .01).

In logistic regression analyses that controlled for type of insurance and type of clinic used for care (which differed across groups), girls whose parents signed up for text reminders were 2.03 times more likely than were the girls whose parents didn’t sign up and 1.83 times more likely than the historic control girls were to receive their next HPV vaccine dose within 1 month of the due date (P = .003 and .002, respectively).

Dr. Kharbanda said that the program could potentially be sustained without any additional funding, but there are ongoing costs associated with the personnel needed for monitoring. "Any time you are sending out text messages, you want to have somebody available to respond if the parent writes back ‘Help!’ or something else," she explained.

The infrastructure developed for the study also can be adapted for other purposes, she noted. For example, the research team has since used the platform to promote uptake of the flu vaccine and to recall parents whose child had to temporarily skip a Haemophilus influenza type B vaccine because of the shortage.

Results of the HPV study have recently been published in Vaccine (2011;29:2537-41).

Dr. Kharbanda reported that Vaughn I. Rickert, Psy.D., one of the study’s coinvestigators, is a consultant to Sanofi Pasteur and receives research funding from and sits on the advisory board of Merck.

SEATTLE – Text message reminders improve timely receipt of the human papillomavirus vaccine, according to results of a study of more than 1,500 girls who had started the three-dose series.

In the study reported at the annual meeting of the Society for Adolescent Health and Medicine, about a third of parents offered the reminders signed up for them. Girls whose parents signed up were twice as likely to receive their next dose of vaccine within a month of when it was due, compared with their counterparts whose parents did not sign up.

"We found that text messaging can increase on-time vaccination," commented first author Dr. Elyse O. Kharbanda, a pediatrician who was with Columbia University Medical Center, New York, at the time of the study and is now with the Health Partners Research Foundation in Minneapolis.

"We recommend these findings should be replicated in a larger and more diverse sample," she added. "And future studies should really explore what our main issue was: How to get more parents to sign up for this type of service."

Although the Food and Drug Administration approved the quadrivalent human papillomavirus (HPV) vaccine (Gardasil, Merck) in 2006, the rate of receipt of all three doses among girls remains low, and receipt of doses on time is also problematic, according to Dr. Kharbanda. Several factors may explain this poor adherence.

"Unlike routine vaccines that we give to infants, this three-dose vaccine series is not aligned with routine adolescent health care visits," she said. Financial barriers and provider factors also may explain some of the adherence problem.

"But what actually I think is the most important barrier is the parents and teens themselves," Dr. Kharbanda commented. "It’s not that [the parents] explicitly oppose the vaccine, it’s just that they are busy – they have busy lives with competing priorities, and getting their child or their teen in for three visits to get a shot over a 6-month period is just not high on their To-Do list."

There is good reason to believe that use of text messaging to send reminders could help solve this problem. "We thought cellular technology may provide an advantage because of its penetrance: Over 96% of U.S. adults now own a cell phone," she explained. "And especially in low-income populations, cell phone numbers may be even more stable than land-line numbers."

Additionally, "these reminders serve as cues to action," she said. "So the idea is the parent would get a text message and it may sort of push getting that vaccine up on their priority list."

The study, part of the Text4Health study exploring use of this technology among underserved, low-income populations, was conducted in nine clinical sites in New York. It was open to English- or Spanish-speaking parents with a cell phone who brought daughters aged 10-18 years in for the first or second dose of the quadrivalent HPV vaccine between January and June 2009.

The parents were given a recruitment card with instructions in English and Spanish on how to sign up for text message reminders for the next dose of vaccine. Signing up required calling a dedicated number, selecting a language, confirming interest, and entering a personal identification number from the recruitment card, used to link the caller to the daughter’s medical record. The parent’s cell phone number was automatically captured.

Parents who signed up received up to three automated text messages reminding them that their daughter had an upcoming due date for her next HPV vaccine dose, Dr. Kharbanda said. The messages included the name and phone number of the clinic where their daughter received care, and an option to cancel future reminders (although none used this option).

In all, recruitment cards were given to the parents of 434 girls, 29% of whom signed up. The 124 who entered a valid personal identification number were sent text message reminders.

The comparison groups consisted of 308 girls whose parents did not sign up for the reminders and 1,080 girls who had received a first or second dose of HPV vaccine in the same clinics in the 6 months before the intervention and served as historic controls.

The girls were 14 years old on average, and nearly three-quarters had Medicaid or SCHIP health insurance. Most (84%) received their care in an academic clinic, and a sizable minority (40%) spoke Spanish.

Study results showed that the percentage of girls who received their next HPV vaccine dose within 1 month of the due date, the primary end point, was 52% among those whose parents signed up for reminders, 35% among those whose parents did not sign up, and 38% among those who served as historic controls (P = .003).

The percentages were better in all three groups when it came to receipt of the vaccine dose within 4 months of the due date. But the value was still higher among girls whose parents signed up for reminders, at 65%, than among those whose parents did not sign up, at 51%, and the historic controls, at 53% (P = .01).

In logistic regression analyses that controlled for type of insurance and type of clinic used for care (which differed across groups), girls whose parents signed up for text reminders were 2.03 times more likely than were the girls whose parents didn’t sign up and 1.83 times more likely than the historic control girls were to receive their next HPV vaccine dose within 1 month of the due date (P = .003 and .002, respectively).

Dr. Kharbanda said that the program could potentially be sustained without any additional funding, but there are ongoing costs associated with the personnel needed for monitoring. "Any time you are sending out text messages, you want to have somebody available to respond if the parent writes back ‘Help!’ or something else," she explained.

The infrastructure developed for the study also can be adapted for other purposes, she noted. For example, the research team has since used the platform to promote uptake of the flu vaccine and to recall parents whose child had to temporarily skip a Haemophilus influenza type B vaccine because of the shortage.

Results of the HPV study have recently been published in Vaccine (2011;29:2537-41).

Dr. Kharbanda reported that Vaughn I. Rickert, Psy.D., one of the study’s coinvestigators, is a consultant to Sanofi Pasteur and receives research funding from and sits on the advisory board of Merck.

SEATTLE – Text message reminders improve timely receipt of the human papillomavirus vaccine, according to results of a study of more than 1,500 girls who had started the three-dose series.

In the study reported at the annual meeting of the Society for Adolescent Health and Medicine, about a third of parents offered the reminders signed up for them. Girls whose parents signed up were twice as likely to receive their next dose of vaccine within a month of when it was due, compared with their counterparts whose parents did not sign up.

"We found that text messaging can increase on-time vaccination," commented first author Dr. Elyse O. Kharbanda, a pediatrician who was with Columbia University Medical Center, New York, at the time of the study and is now with the Health Partners Research Foundation in Minneapolis.

"We recommend these findings should be replicated in a larger and more diverse sample," she added. "And future studies should really explore what our main issue was: How to get more parents to sign up for this type of service."

Although the Food and Drug Administration approved the quadrivalent human papillomavirus (HPV) vaccine (Gardasil, Merck) in 2006, the rate of receipt of all three doses among girls remains low, and receipt of doses on time is also problematic, according to Dr. Kharbanda. Several factors may explain this poor adherence.

"Unlike routine vaccines that we give to infants, this three-dose vaccine series is not aligned with routine adolescent health care visits," she said. Financial barriers and provider factors also may explain some of the adherence problem.

"But what actually I think is the most important barrier is the parents and teens themselves," Dr. Kharbanda commented. "It’s not that [the parents] explicitly oppose the vaccine, it’s just that they are busy – they have busy lives with competing priorities, and getting their child or their teen in for three visits to get a shot over a 6-month period is just not high on their To-Do list."

There is good reason to believe that use of text messaging to send reminders could help solve this problem. "We thought cellular technology may provide an advantage because of its penetrance: Over 96% of U.S. adults now own a cell phone," she explained. "And especially in low-income populations, cell phone numbers may be even more stable than land-line numbers."

Additionally, "these reminders serve as cues to action," she said. "So the idea is the parent would get a text message and it may sort of push getting that vaccine up on their priority list."

The study, part of the Text4Health study exploring use of this technology among underserved, low-income populations, was conducted in nine clinical sites in New York. It was open to English- or Spanish-speaking parents with a cell phone who brought daughters aged 10-18 years in for the first or second dose of the quadrivalent HPV vaccine between January and June 2009.

The parents were given a recruitment card with instructions in English and Spanish on how to sign up for text message reminders for the next dose of vaccine. Signing up required calling a dedicated number, selecting a language, confirming interest, and entering a personal identification number from the recruitment card, used to link the caller to the daughter’s medical record. The parent’s cell phone number was automatically captured.

Parents who signed up received up to three automated text messages reminding them that their daughter had an upcoming due date for her next HPV vaccine dose, Dr. Kharbanda said. The messages included the name and phone number of the clinic where their daughter received care, and an option to cancel future reminders (although none used this option).

In all, recruitment cards were given to the parents of 434 girls, 29% of whom signed up. The 124 who entered a valid personal identification number were sent text message reminders.

The comparison groups consisted of 308 girls whose parents did not sign up for the reminders and 1,080 girls who had received a first or second dose of HPV vaccine in the same clinics in the 6 months before the intervention and served as historic controls.

The girls were 14 years old on average, and nearly three-quarters had Medicaid or SCHIP health insurance. Most (84%) received their care in an academic clinic, and a sizable minority (40%) spoke Spanish.

Study results showed that the percentage of girls who received their next HPV vaccine dose within 1 month of the due date, the primary end point, was 52% among those whose parents signed up for reminders, 35% among those whose parents did not sign up, and 38% among those who served as historic controls (P = .003).

The percentages were better in all three groups when it came to receipt of the vaccine dose within 4 months of the due date. But the value was still higher among girls whose parents signed up for reminders, at 65%, than among those whose parents did not sign up, at 51%, and the historic controls, at 53% (P = .01).

In logistic regression analyses that controlled for type of insurance and type of clinic used for care (which differed across groups), girls whose parents signed up for text reminders were 2.03 times more likely than were the girls whose parents didn’t sign up and 1.83 times more likely than the historic control girls were to receive their next HPV vaccine dose within 1 month of the due date (P = .003 and .002, respectively).

Dr. Kharbanda said that the program could potentially be sustained without any additional funding, but there are ongoing costs associated with the personnel needed for monitoring. "Any time you are sending out text messages, you want to have somebody available to respond if the parent writes back ‘Help!’ or something else," she explained.

The infrastructure developed for the study also can be adapted for other purposes, she noted. For example, the research team has since used the platform to promote uptake of the flu vaccine and to recall parents whose child had to temporarily skip a Haemophilus influenza type B vaccine because of the shortage.

Results of the HPV study have recently been published in Vaccine (2011;29:2537-41).

Dr. Kharbanda reported that Vaughn I. Rickert, Psy.D., one of the study’s coinvestigators, is a consultant to Sanofi Pasteur and receives research funding from and sits on the advisory board of Merck.