Online and in-person care fostered similar improvements in atopic dermatitis symptoms

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ALBUQUERQUE – Children and adults with atopic dermatitis had similar improvements in symptoms whether they received follow-up care through direct access to physicians online or in person, according to a 12-month randomized trial.

The mean decrease in scores on the patient-oriented eczema measure (POEM) was –5.1 for patients who received follow-up care from a dermatologist online, compared with –4.86 for those who received care in person, said Dr. April Armstrong.

"We’re looking at models that can essentially work for delivery of dermatology care anywhere, anytime," said Dr. Armstrong, vice chair of clinical research and associate professor of dermatology at the University of Colorado in Aurora. "From patients’ perspectives, they may be willing to pay out of pocket in return for expedited care without traveling, waiting, or missing work or school."

Dr. Armstrong presented the study findings at the annual meeting of the Society for Investigative Dermatology. Her interest in online care was sparked by patients’ lack of access to dermatologists and younger patients’ acceptance of and comfort with technology, she said.

She and her associates randomized 156 children (aged at least 4 years) and adults with atopic dermatitis to receive 12 months of follow-up care from dermatologists either in person or online. The online group took high-quality photographs of their skin lesions and sent the images and clinical data to dermatologists at the University of California, Davis, who provided asynchronous evaluations, made recommendations, and e-prescribed medications as needed. The second group received in-person care from the UC Davis dermatologists.

At 12 months, the difference in mean POEM scores between the two groups was 0.24, and the 95% confidence interval of –1.8-2.2 fell within the prespecified equivalence margin of 3, said Dr. Armstrong. Therefore, the results supported rejecting the null hypothesis that the care models had different effects, she said. The POEM assessment focuses primarily on symptom morbidity, and scores have been shown to correlate with the Eczema Area and Severity Index (EASI) and the SCORAD (scoring atopic dermatitis) Index, Dr. Armstrong said.

In addition, the researchers observed "clinically meaningful" improvements in both groups’ scores on the Dermatology Life Quality Index (DLQI) and the Children’s Dermatology Life Quality Index (CDLQI), with all mean improvements greater than 5, said Dr. Armstrong.

The groups did not differ significantly in terms of baseline characteristics, said Dr. Armstrong. There was a 10% dropout rate overall, with similar rates of loss to follow up between the two groups, she said. The groups also did not differ in terms of adverse effects from medications, she added.

The findings suggest that direct-access online follow-up care may be a reasonable option for children and adults with atopic dermatitis, Dr. Armstrong said. "The key questions are which diseases are suitable, which patients are suitable, and what the regulatory and consumer issues are," she added. "We want to tailor our delivery approach to our healthcare consumers."

The Agency for Healthcare Research and Quality funded the study. Dr. Armstrong reported no conflicts of interest.

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ALBUQUERQUE – Children and adults with atopic dermatitis had similar improvements in symptoms whether they received follow-up care through direct access to physicians online or in person, according to a 12-month randomized trial.

The mean decrease in scores on the patient-oriented eczema measure (POEM) was –5.1 for patients who received follow-up care from a dermatologist online, compared with –4.86 for those who received care in person, said Dr. April Armstrong.

"We’re looking at models that can essentially work for delivery of dermatology care anywhere, anytime," said Dr. Armstrong, vice chair of clinical research and associate professor of dermatology at the University of Colorado in Aurora. "From patients’ perspectives, they may be willing to pay out of pocket in return for expedited care without traveling, waiting, or missing work or school."

Dr. Armstrong presented the study findings at the annual meeting of the Society for Investigative Dermatology. Her interest in online care was sparked by patients’ lack of access to dermatologists and younger patients’ acceptance of and comfort with technology, she said.

She and her associates randomized 156 children (aged at least 4 years) and adults with atopic dermatitis to receive 12 months of follow-up care from dermatologists either in person or online. The online group took high-quality photographs of their skin lesions and sent the images and clinical data to dermatologists at the University of California, Davis, who provided asynchronous evaluations, made recommendations, and e-prescribed medications as needed. The second group received in-person care from the UC Davis dermatologists.

At 12 months, the difference in mean POEM scores between the two groups was 0.24, and the 95% confidence interval of –1.8-2.2 fell within the prespecified equivalence margin of 3, said Dr. Armstrong. Therefore, the results supported rejecting the null hypothesis that the care models had different effects, she said. The POEM assessment focuses primarily on symptom morbidity, and scores have been shown to correlate with the Eczema Area and Severity Index (EASI) and the SCORAD (scoring atopic dermatitis) Index, Dr. Armstrong said.

In addition, the researchers observed "clinically meaningful" improvements in both groups’ scores on the Dermatology Life Quality Index (DLQI) and the Children’s Dermatology Life Quality Index (CDLQI), with all mean improvements greater than 5, said Dr. Armstrong.

The groups did not differ significantly in terms of baseline characteristics, said Dr. Armstrong. There was a 10% dropout rate overall, with similar rates of loss to follow up between the two groups, she said. The groups also did not differ in terms of adverse effects from medications, she added.

The findings suggest that direct-access online follow-up care may be a reasonable option for children and adults with atopic dermatitis, Dr. Armstrong said. "The key questions are which diseases are suitable, which patients are suitable, and what the regulatory and consumer issues are," she added. "We want to tailor our delivery approach to our healthcare consumers."

The Agency for Healthcare Research and Quality funded the study. Dr. Armstrong reported no conflicts of interest.

ALBUQUERQUE – Children and adults with atopic dermatitis had similar improvements in symptoms whether they received follow-up care through direct access to physicians online or in person, according to a 12-month randomized trial.

The mean decrease in scores on the patient-oriented eczema measure (POEM) was –5.1 for patients who received follow-up care from a dermatologist online, compared with –4.86 for those who received care in person, said Dr. April Armstrong.

"We’re looking at models that can essentially work for delivery of dermatology care anywhere, anytime," said Dr. Armstrong, vice chair of clinical research and associate professor of dermatology at the University of Colorado in Aurora. "From patients’ perspectives, they may be willing to pay out of pocket in return for expedited care without traveling, waiting, or missing work or school."

Dr. Armstrong presented the study findings at the annual meeting of the Society for Investigative Dermatology. Her interest in online care was sparked by patients’ lack of access to dermatologists and younger patients’ acceptance of and comfort with technology, she said.

She and her associates randomized 156 children (aged at least 4 years) and adults with atopic dermatitis to receive 12 months of follow-up care from dermatologists either in person or online. The online group took high-quality photographs of their skin lesions and sent the images and clinical data to dermatologists at the University of California, Davis, who provided asynchronous evaluations, made recommendations, and e-prescribed medications as needed. The second group received in-person care from the UC Davis dermatologists.

At 12 months, the difference in mean POEM scores between the two groups was 0.24, and the 95% confidence interval of –1.8-2.2 fell within the prespecified equivalence margin of 3, said Dr. Armstrong. Therefore, the results supported rejecting the null hypothesis that the care models had different effects, she said. The POEM assessment focuses primarily on symptom morbidity, and scores have been shown to correlate with the Eczema Area and Severity Index (EASI) and the SCORAD (scoring atopic dermatitis) Index, Dr. Armstrong said.

In addition, the researchers observed "clinically meaningful" improvements in both groups’ scores on the Dermatology Life Quality Index (DLQI) and the Children’s Dermatology Life Quality Index (CDLQI), with all mean improvements greater than 5, said Dr. Armstrong.

The groups did not differ significantly in terms of baseline characteristics, said Dr. Armstrong. There was a 10% dropout rate overall, with similar rates of loss to follow up between the two groups, she said. The groups also did not differ in terms of adverse effects from medications, she added.

The findings suggest that direct-access online follow-up care may be a reasonable option for children and adults with atopic dermatitis, Dr. Armstrong said. "The key questions are which diseases are suitable, which patients are suitable, and what the regulatory and consumer issues are," she added. "We want to tailor our delivery approach to our healthcare consumers."

The Agency for Healthcare Research and Quality funded the study. Dr. Armstrong reported no conflicts of interest.

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Key clinical point: Patients may be willing to pay out of pocket in return for expedited and effective care without traveling, waiting, or missing work or school.

Major finding: In-person and direct-access online dermatologic care led to similar mean decreases in symptom severity on the patient-oriented eczema measure (POEM) (–4.86 vs. –5.1, respectively).

Data source: Randomized controlled equivalency trial of 156 children and adults with atopic dermatitis.

Disclosures: The Agency for Healthcare Research and Quality funded the study. Dr. Armstrong reported no conflicts of interest.

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Basal cell cancer incidence higher than previously reported

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ALBUQUERQUE – The incidence of basal cell carcinoma in northern California rose by about 13% during 1998 through 2012, according to an analysis of more than 147,000 insured patients.

The steepest rises occurred in whites, women, and adults aged 80 years and older, while rates remained relatively stable among individuals younger than 40, said Dr. Maryam Asgari, who conducted the analysis with colleagues at Kaiser Permanente Northern California in Oakland.

© Kelly Nelson/National Cancer Institute
Estimated rates of basal cell cancer have been increasing worldwide.

Estimated rates of basal cell carcinoma (BCC) have been increasing worldwide, Dr. Asgari noted. But the epidemiology of the disease in the United States "is tricky to study, because these are not reportable cancers, and they do not have unique ICD-9 identifiers," she said at the annual meeting of the Society for Investigational Dermatology

The investigators used a previously validated BCC registry of electronic pathology reports to estimate crude and standardized 15-year BCC incidence rates by age, sex, and race with year 2000 U.S. Census data, Dr. Asgari said. The registry included 147,093 patients from Kaiser Permanente Northern California, an integrated health care delivery system. Patients were included if they developed at least one incident BCC during the study period, but were not counted multiple times for developing additional BCCs in the same year, Dr. Asgari said. The researchers used Poisson regression to examine annual changes in incidence over time.

The overall incidence of BCC increased from 418 cases per 100,000 person-years in 1998 to 535 cases per 100,000 person-years in 2012, Dr. Asgari said. "The overall standardized incidence rate for BCCs in the U.S. population for 2012 was 448 per 100,000, much higher than previously reported estimates," she and her colleagues reported.

Patients with BCCs had a median age of 66 years, and most were aged 40-80 years, with a slight male predominance (55%) that was consistent with the literature, she said. Fully 92% of affected patients were non-Hispanic whites, she noted. Kaiser Permanente patients resembled the U.S. population in terms of age and sex, but were ethnically and racially more diverse, "so the fact that we’re seeing 92% of the cohort being non-Hispanic white means BCC is really a disease of non-Hispanic whites," she said.

In contrast, the incidence of BCC decreased slightly among Asians, African-Americans, and multiracial persons during the 15-year study period, Dr. Asgari added. Among Hispanics, the incidence increased slightly in males aged 65-80 years, but decreased overall in younger persons, she said.

Based on the data, "BCCs and their treatment pose an increasing burden to the health care system," Dr. Asgari and her associates concluded.

The National Institutes of Health funded the study. Dr. Asgari reported no conflicts of interest.

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ALBUQUERQUE – The incidence of basal cell carcinoma in northern California rose by about 13% during 1998 through 2012, according to an analysis of more than 147,000 insured patients.

The steepest rises occurred in whites, women, and adults aged 80 years and older, while rates remained relatively stable among individuals younger than 40, said Dr. Maryam Asgari, who conducted the analysis with colleagues at Kaiser Permanente Northern California in Oakland.

© Kelly Nelson/National Cancer Institute
Estimated rates of basal cell cancer have been increasing worldwide.

Estimated rates of basal cell carcinoma (BCC) have been increasing worldwide, Dr. Asgari noted. But the epidemiology of the disease in the United States "is tricky to study, because these are not reportable cancers, and they do not have unique ICD-9 identifiers," she said at the annual meeting of the Society for Investigational Dermatology

The investigators used a previously validated BCC registry of electronic pathology reports to estimate crude and standardized 15-year BCC incidence rates by age, sex, and race with year 2000 U.S. Census data, Dr. Asgari said. The registry included 147,093 patients from Kaiser Permanente Northern California, an integrated health care delivery system. Patients were included if they developed at least one incident BCC during the study period, but were not counted multiple times for developing additional BCCs in the same year, Dr. Asgari said. The researchers used Poisson regression to examine annual changes in incidence over time.

The overall incidence of BCC increased from 418 cases per 100,000 person-years in 1998 to 535 cases per 100,000 person-years in 2012, Dr. Asgari said. "The overall standardized incidence rate for BCCs in the U.S. population for 2012 was 448 per 100,000, much higher than previously reported estimates," she and her colleagues reported.

Patients with BCCs had a median age of 66 years, and most were aged 40-80 years, with a slight male predominance (55%) that was consistent with the literature, she said. Fully 92% of affected patients were non-Hispanic whites, she noted. Kaiser Permanente patients resembled the U.S. population in terms of age and sex, but were ethnically and racially more diverse, "so the fact that we’re seeing 92% of the cohort being non-Hispanic white means BCC is really a disease of non-Hispanic whites," she said.

In contrast, the incidence of BCC decreased slightly among Asians, African-Americans, and multiracial persons during the 15-year study period, Dr. Asgari added. Among Hispanics, the incidence increased slightly in males aged 65-80 years, but decreased overall in younger persons, she said.

Based on the data, "BCCs and their treatment pose an increasing burden to the health care system," Dr. Asgari and her associates concluded.

The National Institutes of Health funded the study. Dr. Asgari reported no conflicts of interest.

ALBUQUERQUE – The incidence of basal cell carcinoma in northern California rose by about 13% during 1998 through 2012, according to an analysis of more than 147,000 insured patients.

The steepest rises occurred in whites, women, and adults aged 80 years and older, while rates remained relatively stable among individuals younger than 40, said Dr. Maryam Asgari, who conducted the analysis with colleagues at Kaiser Permanente Northern California in Oakland.

© Kelly Nelson/National Cancer Institute
Estimated rates of basal cell cancer have been increasing worldwide.

Estimated rates of basal cell carcinoma (BCC) have been increasing worldwide, Dr. Asgari noted. But the epidemiology of the disease in the United States "is tricky to study, because these are not reportable cancers, and they do not have unique ICD-9 identifiers," she said at the annual meeting of the Society for Investigational Dermatology

The investigators used a previously validated BCC registry of electronic pathology reports to estimate crude and standardized 15-year BCC incidence rates by age, sex, and race with year 2000 U.S. Census data, Dr. Asgari said. The registry included 147,093 patients from Kaiser Permanente Northern California, an integrated health care delivery system. Patients were included if they developed at least one incident BCC during the study period, but were not counted multiple times for developing additional BCCs in the same year, Dr. Asgari said. The researchers used Poisson regression to examine annual changes in incidence over time.

The overall incidence of BCC increased from 418 cases per 100,000 person-years in 1998 to 535 cases per 100,000 person-years in 2012, Dr. Asgari said. "The overall standardized incidence rate for BCCs in the U.S. population for 2012 was 448 per 100,000, much higher than previously reported estimates," she and her colleagues reported.

Patients with BCCs had a median age of 66 years, and most were aged 40-80 years, with a slight male predominance (55%) that was consistent with the literature, she said. Fully 92% of affected patients were non-Hispanic whites, she noted. Kaiser Permanente patients resembled the U.S. population in terms of age and sex, but were ethnically and racially more diverse, "so the fact that we’re seeing 92% of the cohort being non-Hispanic white means BCC is really a disease of non-Hispanic whites," she said.

In contrast, the incidence of BCC decreased slightly among Asians, African-Americans, and multiracial persons during the 15-year study period, Dr. Asgari added. Among Hispanics, the incidence increased slightly in males aged 65-80 years, but decreased overall in younger persons, she said.

Based on the data, "BCCs and their treatment pose an increasing burden to the health care system," Dr. Asgari and her associates concluded.

The National Institutes of Health funded the study. Dr. Asgari reported no conflicts of interest.

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Major finding: The incidence of basal cell carcinoma in northern California rose by about 13% from 1998 through 2012.

Data source: Registry of electronic pathology reports of basal cell carcinomas during 1998-2012 among 147,093 patients from the Kaiser Permanente Northern California health care system.

Disclosures: The National Institutes of Health funded the study. Dr. Asgari reported no conflicts of interest.

Buccal acyclovir delays recurrence of herpes labialis

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ALBUQUERQUE – A single buccal application of acyclovir delayed recurrence of herpes labialis by an average of 100 days, compared with placebo, according to the results of a randomized, double-blind, phase III study.

The 50-mg buccal mucoadhesive tablet also reduced recurrence of herpes labialis by 9.4% during the 9-month follow-up period, Dr. Christopher Downing said at the annual meeting of the Society for Investigative Dermatology.

The tablet is designed to be applied to the gum above the canine incisor at the time of prodromal symptoms, said Dr. Downing of the Center for Clinical Studies in Webster, Texas. Patients hold the tablet in place for 30 seconds, and acyclovir is then absorbed into the labial mucosa for the next 6-8 hours, Dr. Downing said, adding that salivary and mucosal concentrations remain at high levels for at least 24 hours.

"We know that the replication of HSV-1 is highest before and during the first hours of prodromal symptoms," Dr. Downing added. "Therefore, rapid and high concentrations of antiviral drug are needed."

The researchers enrolled 775 immunocompetent patients who had experienced at least four recurrent episodes of herpes labialis in the past 12 months. Patients had to be able to identify their prodromal symptoms to be enrolled in the study. A total of 378 patients were randomized to receive the acyclovir buccal tablet, while 397 were randomized to placebo. In all, 537 patients were evaluated during the entire 9-month follow-up period, and 59 patients had missing data.

A total of 330 patients had recurrence of a primary vesicular lesion, but a significantly fewer 149 (64.2%) in the treatment group vs. 181 (73.6%) in the control group (P = 0.027). In a subanalysis of 415 patients who applied the tablet within the first hour after noticing prodromal symptoms, lesions recurred in 63.2% of the treatment group and in 71.6% of the placebo group, said Dr. Downing.

The time to the next recurrence in the treatment group was 304 days (standard deviation, 19.4 days), compared with 199 days for the placebo group (SD, 9.3 days; P = 0.042).

The tablet "may modify the clinical course of labial herpes," the investigators noted. "By having a high salivary concentration and a high mucosal concentration of acyclovir during the time of highest replication, we’re seeing a difference in time to recurrence," said Dr. Downing. "We’re not sure exactly what the mechanism of action is."

Senior author Dr. Pierre Attali is with BioAlliance Pharma in Paris, which manufactures acyclovir Lauriad, a mucoadhesive buccal tablet.

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ALBUQUERQUE – A single buccal application of acyclovir delayed recurrence of herpes labialis by an average of 100 days, compared with placebo, according to the results of a randomized, double-blind, phase III study.

The 50-mg buccal mucoadhesive tablet also reduced recurrence of herpes labialis by 9.4% during the 9-month follow-up period, Dr. Christopher Downing said at the annual meeting of the Society for Investigative Dermatology.

The tablet is designed to be applied to the gum above the canine incisor at the time of prodromal symptoms, said Dr. Downing of the Center for Clinical Studies in Webster, Texas. Patients hold the tablet in place for 30 seconds, and acyclovir is then absorbed into the labial mucosa for the next 6-8 hours, Dr. Downing said, adding that salivary and mucosal concentrations remain at high levels for at least 24 hours.

"We know that the replication of HSV-1 is highest before and during the first hours of prodromal symptoms," Dr. Downing added. "Therefore, rapid and high concentrations of antiviral drug are needed."

The researchers enrolled 775 immunocompetent patients who had experienced at least four recurrent episodes of herpes labialis in the past 12 months. Patients had to be able to identify their prodromal symptoms to be enrolled in the study. A total of 378 patients were randomized to receive the acyclovir buccal tablet, while 397 were randomized to placebo. In all, 537 patients were evaluated during the entire 9-month follow-up period, and 59 patients had missing data.

A total of 330 patients had recurrence of a primary vesicular lesion, but a significantly fewer 149 (64.2%) in the treatment group vs. 181 (73.6%) in the control group (P = 0.027). In a subanalysis of 415 patients who applied the tablet within the first hour after noticing prodromal symptoms, lesions recurred in 63.2% of the treatment group and in 71.6% of the placebo group, said Dr. Downing.

The time to the next recurrence in the treatment group was 304 days (standard deviation, 19.4 days), compared with 199 days for the placebo group (SD, 9.3 days; P = 0.042).

The tablet "may modify the clinical course of labial herpes," the investigators noted. "By having a high salivary concentration and a high mucosal concentration of acyclovir during the time of highest replication, we’re seeing a difference in time to recurrence," said Dr. Downing. "We’re not sure exactly what the mechanism of action is."

Senior author Dr. Pierre Attali is with BioAlliance Pharma in Paris, which manufactures acyclovir Lauriad, a mucoadhesive buccal tablet.

ALBUQUERQUE – A single buccal application of acyclovir delayed recurrence of herpes labialis by an average of 100 days, compared with placebo, according to the results of a randomized, double-blind, phase III study.

The 50-mg buccal mucoadhesive tablet also reduced recurrence of herpes labialis by 9.4% during the 9-month follow-up period, Dr. Christopher Downing said at the annual meeting of the Society for Investigative Dermatology.

The tablet is designed to be applied to the gum above the canine incisor at the time of prodromal symptoms, said Dr. Downing of the Center for Clinical Studies in Webster, Texas. Patients hold the tablet in place for 30 seconds, and acyclovir is then absorbed into the labial mucosa for the next 6-8 hours, Dr. Downing said, adding that salivary and mucosal concentrations remain at high levels for at least 24 hours.

"We know that the replication of HSV-1 is highest before and during the first hours of prodromal symptoms," Dr. Downing added. "Therefore, rapid and high concentrations of antiviral drug are needed."

The researchers enrolled 775 immunocompetent patients who had experienced at least four recurrent episodes of herpes labialis in the past 12 months. Patients had to be able to identify their prodromal symptoms to be enrolled in the study. A total of 378 patients were randomized to receive the acyclovir buccal tablet, while 397 were randomized to placebo. In all, 537 patients were evaluated during the entire 9-month follow-up period, and 59 patients had missing data.

A total of 330 patients had recurrence of a primary vesicular lesion, but a significantly fewer 149 (64.2%) in the treatment group vs. 181 (73.6%) in the control group (P = 0.027). In a subanalysis of 415 patients who applied the tablet within the first hour after noticing prodromal symptoms, lesions recurred in 63.2% of the treatment group and in 71.6% of the placebo group, said Dr. Downing.

The time to the next recurrence in the treatment group was 304 days (standard deviation, 19.4 days), compared with 199 days for the placebo group (SD, 9.3 days; P = 0.042).

The tablet "may modify the clinical course of labial herpes," the investigators noted. "By having a high salivary concentration and a high mucosal concentration of acyclovir during the time of highest replication, we’re seeing a difference in time to recurrence," said Dr. Downing. "We’re not sure exactly what the mechanism of action is."

Senior author Dr. Pierre Attali is with BioAlliance Pharma in Paris, which manufactures acyclovir Lauriad, a mucoadhesive buccal tablet.

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Nonmelanoma skin cancer linked to increased fracture risk in postmenopausal women

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ALBUQUERQUE – Postmenopausal women who reported a history of nonmelanoma skin cancer were almost 16% more likely to sustain a lower arm fracture than were women without a skin cancer history, according to a large, prospective, longitudinal study.

Women with prior nonmelanoma skin cancers (NMSCs) also were more likely to suffer a subsequent hip fracture, although the association did not reach statistical significance, said Eric Anderson of the dermatology department at Stanford (Calif.) University School of Medicine.

"These results suggest that prior history of NMSC is associated with an increased risk of subsequent bone fracture, contrary to our hypothesis," noted Mr. Anderson. He presented the findings at the annual meeting of the Society for Investigational Dermatology.

Nonmelanoma skin cancer has been correlated with decreased fracture risk in at least one small cohort study, Mr. Anderson said (Osteoporos. Int. 2007;18:687-92). However, patients with NMSC also have been shown to wear more sunscreen and limit their sun exposure after diagnosis, which might lower their vitamin D levels and increase their fracture risk, Mr. Anderson noted (Cancer Causes Control 2012;23:133-40).

To better clarify the relationship between NMSC and fracture risk, Mr. Anderson and his associates compared prospective data from 4,289 women with self-reported NMSC and 67,470 women who did not report a history of NMSC at baseline. The participants were from the Womens Health Initiative, a prospective longitudinal cohort study of postmenopausal women aged 50-79 years who were enrolled at 40 centers in the United States. Participants were followed for more than 10 years, and new spine, hip, and lower arm fractures were recorded, Mr. Anderson said.

In age-adjusted Cox proportional hazards models, women with a history of NMSC were 1.55 times more likely to sustain a hip fracture (95% confidence interval, 1.31-1.85; P < 0.0001), 1.29 times more likely to suffer a spine fracture (95% CI, 1.10-1.51; P = 0.0018), and 1.28 times more likely to sustain a lower arm fracture (95% CI, 1.13-1.45; P < 0.0001) than were women who did not report a history of NMSC at baseline, Mr. Anderson and his associates reported.

After adjusting for sun exposure, sunscreen use, vitamin D intake, physical activity, and other risk factors for fracture, only lower arm fracture remained statistically significant (hazard ratio, 1.16; 95% CI, 1.31-1.85; P = 0.02), although hip fracture was borderline significant (HR, 1.18; 95% CI, 0.99-1.41; P = 0.06), the investigators reported. Baseline hip bone marrow density was not associated with risk of NMSC in a subgroup analysis of 4,267 women with available data, Mr. Anderson said.

"We’re inclined to believe that this increased fracture risk may be due to sun exposure avoidance after NMSC diagnosis," said Mr. Anderson. He added that, in future studies, the investigators would compare serum vitamin D levels between participants with and without a history of NMSC, and explore temporal relationships between diagnosis of NMSC and fracture occurrence.

The National Institutes of Health and the Medical Scholars Research Program at Stanford University funded the research. Mr. Anderson reported no conflicts of interest.

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ALBUQUERQUE – Postmenopausal women who reported a history of nonmelanoma skin cancer were almost 16% more likely to sustain a lower arm fracture than were women without a skin cancer history, according to a large, prospective, longitudinal study.

Women with prior nonmelanoma skin cancers (NMSCs) also were more likely to suffer a subsequent hip fracture, although the association did not reach statistical significance, said Eric Anderson of the dermatology department at Stanford (Calif.) University School of Medicine.

"These results suggest that prior history of NMSC is associated with an increased risk of subsequent bone fracture, contrary to our hypothesis," noted Mr. Anderson. He presented the findings at the annual meeting of the Society for Investigational Dermatology.

Nonmelanoma skin cancer has been correlated with decreased fracture risk in at least one small cohort study, Mr. Anderson said (Osteoporos. Int. 2007;18:687-92). However, patients with NMSC also have been shown to wear more sunscreen and limit their sun exposure after diagnosis, which might lower their vitamin D levels and increase their fracture risk, Mr. Anderson noted (Cancer Causes Control 2012;23:133-40).

To better clarify the relationship between NMSC and fracture risk, Mr. Anderson and his associates compared prospective data from 4,289 women with self-reported NMSC and 67,470 women who did not report a history of NMSC at baseline. The participants were from the Womens Health Initiative, a prospective longitudinal cohort study of postmenopausal women aged 50-79 years who were enrolled at 40 centers in the United States. Participants were followed for more than 10 years, and new spine, hip, and lower arm fractures were recorded, Mr. Anderson said.

In age-adjusted Cox proportional hazards models, women with a history of NMSC were 1.55 times more likely to sustain a hip fracture (95% confidence interval, 1.31-1.85; P < 0.0001), 1.29 times more likely to suffer a spine fracture (95% CI, 1.10-1.51; P = 0.0018), and 1.28 times more likely to sustain a lower arm fracture (95% CI, 1.13-1.45; P < 0.0001) than were women who did not report a history of NMSC at baseline, Mr. Anderson and his associates reported.

After adjusting for sun exposure, sunscreen use, vitamin D intake, physical activity, and other risk factors for fracture, only lower arm fracture remained statistically significant (hazard ratio, 1.16; 95% CI, 1.31-1.85; P = 0.02), although hip fracture was borderline significant (HR, 1.18; 95% CI, 0.99-1.41; P = 0.06), the investigators reported. Baseline hip bone marrow density was not associated with risk of NMSC in a subgroup analysis of 4,267 women with available data, Mr. Anderson said.

"We’re inclined to believe that this increased fracture risk may be due to sun exposure avoidance after NMSC diagnosis," said Mr. Anderson. He added that, in future studies, the investigators would compare serum vitamin D levels between participants with and without a history of NMSC, and explore temporal relationships between diagnosis of NMSC and fracture occurrence.

The National Institutes of Health and the Medical Scholars Research Program at Stanford University funded the research. Mr. Anderson reported no conflicts of interest.

ALBUQUERQUE – Postmenopausal women who reported a history of nonmelanoma skin cancer were almost 16% more likely to sustain a lower arm fracture than were women without a skin cancer history, according to a large, prospective, longitudinal study.

Women with prior nonmelanoma skin cancers (NMSCs) also were more likely to suffer a subsequent hip fracture, although the association did not reach statistical significance, said Eric Anderson of the dermatology department at Stanford (Calif.) University School of Medicine.

"These results suggest that prior history of NMSC is associated with an increased risk of subsequent bone fracture, contrary to our hypothesis," noted Mr. Anderson. He presented the findings at the annual meeting of the Society for Investigational Dermatology.

Nonmelanoma skin cancer has been correlated with decreased fracture risk in at least one small cohort study, Mr. Anderson said (Osteoporos. Int. 2007;18:687-92). However, patients with NMSC also have been shown to wear more sunscreen and limit their sun exposure after diagnosis, which might lower their vitamin D levels and increase their fracture risk, Mr. Anderson noted (Cancer Causes Control 2012;23:133-40).

To better clarify the relationship between NMSC and fracture risk, Mr. Anderson and his associates compared prospective data from 4,289 women with self-reported NMSC and 67,470 women who did not report a history of NMSC at baseline. The participants were from the Womens Health Initiative, a prospective longitudinal cohort study of postmenopausal women aged 50-79 years who were enrolled at 40 centers in the United States. Participants were followed for more than 10 years, and new spine, hip, and lower arm fractures were recorded, Mr. Anderson said.

In age-adjusted Cox proportional hazards models, women with a history of NMSC were 1.55 times more likely to sustain a hip fracture (95% confidence interval, 1.31-1.85; P < 0.0001), 1.29 times more likely to suffer a spine fracture (95% CI, 1.10-1.51; P = 0.0018), and 1.28 times more likely to sustain a lower arm fracture (95% CI, 1.13-1.45; P < 0.0001) than were women who did not report a history of NMSC at baseline, Mr. Anderson and his associates reported.

After adjusting for sun exposure, sunscreen use, vitamin D intake, physical activity, and other risk factors for fracture, only lower arm fracture remained statistically significant (hazard ratio, 1.16; 95% CI, 1.31-1.85; P = 0.02), although hip fracture was borderline significant (HR, 1.18; 95% CI, 0.99-1.41; P = 0.06), the investigators reported. Baseline hip bone marrow density was not associated with risk of NMSC in a subgroup analysis of 4,267 women with available data, Mr. Anderson said.

"We’re inclined to believe that this increased fracture risk may be due to sun exposure avoidance after NMSC diagnosis," said Mr. Anderson. He added that, in future studies, the investigators would compare serum vitamin D levels between participants with and without a history of NMSC, and explore temporal relationships between diagnosis of NMSC and fracture occurrence.

The National Institutes of Health and the Medical Scholars Research Program at Stanford University funded the research. Mr. Anderson reported no conflicts of interest.

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Key clinical point: A history of nonmelanoma skin cancer may predispose patients to bone fractures.

Major finding: Incident lower arm fracture was significantly associated with a self-reported history of nonmelanoma skin cancer (hazard ratio, 1.16; P = 0.02).

Data source: Ten-year prospective cohort study of 4,289 women who self-reported a history of nonmelanoma skin cancer and 67,470 women who reported no history of NMSC.

Disclosures: The National Institutes of Health and the Medical Scholars Research Program at Stanford University funded the research. Mr. Anderson reported no conflicts of interest.

NSAID use linked to reduced risk for second nonmelanoma skin cancer

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ALBUQUERQUE – Postmenopausal women who had a history of nonmelanoma skin cancer and regularly used nonsteroidal anti-inflammatory drugs had an 18% lower risk of developing subsequent skin cancers, based on a large prospective longitudinal study.

The effect was evident regardless of NSAID type and in women who had used NSAIDs regularly for less than 5 years, said Dr. Mina Ally at the annual meeting of the Society for Investigative Dermatology.

Data on how NSAID use affects the risk of nonmelanoma skin cancer (NMSC) have been inconsistent, noted Dr. Ally, who is a postdoctoral research fellow in dermatology at Stanford University in Redwood City, Calif.

Previously, a double-blind, placebo-controlled trial found that NSAID use reduced the risk of NMSC in patients with a skin cancer history, Dr. Ally said (J. Natl. Cancer Inst. 2010;102:1835-44). In contrast, the Nurses Health Study found no association, but excluded women with a history of skin cancer (Cancer Causes Control 2012;23:1451-61).

In the current study, self-reported skin cancer was not confirmed by reviewing medical records, and data on NMSC subtype was not collected, Dr. Ally said.

Dr. Ally and her associates analyzed data from standardized medication questionnaires given at baseline and 3 years later to postmenopausal women aged 50-79 years. Respondents were from the Women\'s Health Initiative, which began in 1991 and includes more than 161,000 women enrolled at 40 centers in the United States.

The analysis was limited to participants who were white, immunocompetent, and had no missing data, yielding a final cohort of 54,728 women. NSAID users were defined as those who reported using the medications at least twice in the past 2 weeks in the baseline and year-3 questionnaires. The researchers collected data on the type, strength, and duration of NSAID use, and validated participants’ responses with data from pill bottle labels and prescription records, although they did not examine dose-response associations, Dr. Ally said.

The women were followed for a median of 6.9 years, during which there were 7,652 incident cases of NMSC, Dr. Ally said. After adjusting for skin type, sun exposure history, reason for using NSAIDs, and other potential confounders, women who regularly used any type of NSAID had no significant difference in risk of NMSC compared with women who did not use NSAIDs or used them inconsistently, she added.

But in the subgroup of 5,488 women who reported a prior history of skin cancer, the odds of incident NMSC were significantly lower with regular NSAID use, whether for less than 5 years (odds ratio, 0.82; 95% confidence interval, 0.70-0.95) or 5 years or longer (OR, 0.82; 95% CI, 0.69-0.98), the researchers reported.

Cyclooxygenase-2 enzymes are unregulated in several cancers, including NMSC, Dr. Ally noted. High levels of ultraviolet exposure increase epidermal COX-2 expression, which might explain why women with a prior history of skin cancer appear to be more responsive to chemoprevention with NSAID treatment, she said.

The National Institutes of Health funded the study. Dr. Ally reported no conflicts of interest.

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ALBUQUERQUE – Postmenopausal women who had a history of nonmelanoma skin cancer and regularly used nonsteroidal anti-inflammatory drugs had an 18% lower risk of developing subsequent skin cancers, based on a large prospective longitudinal study.

The effect was evident regardless of NSAID type and in women who had used NSAIDs regularly for less than 5 years, said Dr. Mina Ally at the annual meeting of the Society for Investigative Dermatology.

Data on how NSAID use affects the risk of nonmelanoma skin cancer (NMSC) have been inconsistent, noted Dr. Ally, who is a postdoctoral research fellow in dermatology at Stanford University in Redwood City, Calif.

Previously, a double-blind, placebo-controlled trial found that NSAID use reduced the risk of NMSC in patients with a skin cancer history, Dr. Ally said (J. Natl. Cancer Inst. 2010;102:1835-44). In contrast, the Nurses Health Study found no association, but excluded women with a history of skin cancer (Cancer Causes Control 2012;23:1451-61).

In the current study, self-reported skin cancer was not confirmed by reviewing medical records, and data on NMSC subtype was not collected, Dr. Ally said.

Dr. Ally and her associates analyzed data from standardized medication questionnaires given at baseline and 3 years later to postmenopausal women aged 50-79 years. Respondents were from the Women\'s Health Initiative, which began in 1991 and includes more than 161,000 women enrolled at 40 centers in the United States.

The analysis was limited to participants who were white, immunocompetent, and had no missing data, yielding a final cohort of 54,728 women. NSAID users were defined as those who reported using the medications at least twice in the past 2 weeks in the baseline and year-3 questionnaires. The researchers collected data on the type, strength, and duration of NSAID use, and validated participants’ responses with data from pill bottle labels and prescription records, although they did not examine dose-response associations, Dr. Ally said.

The women were followed for a median of 6.9 years, during which there were 7,652 incident cases of NMSC, Dr. Ally said. After adjusting for skin type, sun exposure history, reason for using NSAIDs, and other potential confounders, women who regularly used any type of NSAID had no significant difference in risk of NMSC compared with women who did not use NSAIDs or used them inconsistently, she added.

But in the subgroup of 5,488 women who reported a prior history of skin cancer, the odds of incident NMSC were significantly lower with regular NSAID use, whether for less than 5 years (odds ratio, 0.82; 95% confidence interval, 0.70-0.95) or 5 years or longer (OR, 0.82; 95% CI, 0.69-0.98), the researchers reported.

Cyclooxygenase-2 enzymes are unregulated in several cancers, including NMSC, Dr. Ally noted. High levels of ultraviolet exposure increase epidermal COX-2 expression, which might explain why women with a prior history of skin cancer appear to be more responsive to chemoprevention with NSAID treatment, she said.

The National Institutes of Health funded the study. Dr. Ally reported no conflicts of interest.

ALBUQUERQUE – Postmenopausal women who had a history of nonmelanoma skin cancer and regularly used nonsteroidal anti-inflammatory drugs had an 18% lower risk of developing subsequent skin cancers, based on a large prospective longitudinal study.

The effect was evident regardless of NSAID type and in women who had used NSAIDs regularly for less than 5 years, said Dr. Mina Ally at the annual meeting of the Society for Investigative Dermatology.

Data on how NSAID use affects the risk of nonmelanoma skin cancer (NMSC) have been inconsistent, noted Dr. Ally, who is a postdoctoral research fellow in dermatology at Stanford University in Redwood City, Calif.

Previously, a double-blind, placebo-controlled trial found that NSAID use reduced the risk of NMSC in patients with a skin cancer history, Dr. Ally said (J. Natl. Cancer Inst. 2010;102:1835-44). In contrast, the Nurses Health Study found no association, but excluded women with a history of skin cancer (Cancer Causes Control 2012;23:1451-61).

In the current study, self-reported skin cancer was not confirmed by reviewing medical records, and data on NMSC subtype was not collected, Dr. Ally said.

Dr. Ally and her associates analyzed data from standardized medication questionnaires given at baseline and 3 years later to postmenopausal women aged 50-79 years. Respondents were from the Women\'s Health Initiative, which began in 1991 and includes more than 161,000 women enrolled at 40 centers in the United States.

The analysis was limited to participants who were white, immunocompetent, and had no missing data, yielding a final cohort of 54,728 women. NSAID users were defined as those who reported using the medications at least twice in the past 2 weeks in the baseline and year-3 questionnaires. The researchers collected data on the type, strength, and duration of NSAID use, and validated participants’ responses with data from pill bottle labels and prescription records, although they did not examine dose-response associations, Dr. Ally said.

The women were followed for a median of 6.9 years, during which there were 7,652 incident cases of NMSC, Dr. Ally said. After adjusting for skin type, sun exposure history, reason for using NSAIDs, and other potential confounders, women who regularly used any type of NSAID had no significant difference in risk of NMSC compared with women who did not use NSAIDs or used them inconsistently, she added.

But in the subgroup of 5,488 women who reported a prior history of skin cancer, the odds of incident NMSC were significantly lower with regular NSAID use, whether for less than 5 years (odds ratio, 0.82; 95% confidence interval, 0.70-0.95) or 5 years or longer (OR, 0.82; 95% CI, 0.69-0.98), the researchers reported.

Cyclooxygenase-2 enzymes are unregulated in several cancers, including NMSC, Dr. Ally noted. High levels of ultraviolet exposure increase epidermal COX-2 expression, which might explain why women with a prior history of skin cancer appear to be more responsive to chemoprevention with NSAID treatment, she said.

The National Institutes of Health funded the study. Dr. Ally reported no conflicts of interest.

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Key clinical point: NSAID use is associated with a lower risk of a second nonmelanoma skin cancer in white women.

Major finding: In women with a history of skin cancer, the odds of incident non-melanoma skin cancer were significantly lower with regular use of NSAIDs, whether for less than 5 years (odds ratio, 0.82; 95% confidence interval, 0.70-0.95) or at least 5 years (OR 0.82; 95% CI, 0.69–0.98).

Data source: Subgroup analysis of 5,488 women from the Women’s Health Initiative who were aged 50-79 years had a history of skin cancer.

Disclosures: The National Institutes of Health funded the study. Dr. Ally reported no conflicts of interest.

Using cyclosporine A: Study sheds light on inflammatory mechanisms in atopic dermatitis

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ALBUQUERQUE – Symptoms decreased by 51% at 2 weeks and by 73% at 12 weeks in adults with atopic dermatitis who received cyclosporine A therapy in an open-label, single-arm study.

Clinical improvements correlated with suppression of epidermal hyperplasia and decreases in inflammatory biomarkers including S100A7, IL-13, and IL-22, reported Mariya Rozenblit of Mount Sinai Medical Center in New York and her associates. Ms. Rozenblit presented the results at the annual meeting of the Society for Investigative Dermatology, and the findings were published online in the Journal of Allergy and Clinical Immunology (J. Allergy Clin. Immunol. 2014 [doi:10.1016/j.jaci.2014.03.003]).

"This is the first study that establishes a link between Th2/Th22 cytokines and molecular epidermal alterations as well as correlations between clinical improvement and skin biomarkers" in atopic dermatitis, said Ms. Rozenblit and her associates.

To characterize these mechanisms and compare them with clinical outcomes in atopic dermatitis, the researchers treated 19 affected adults, aged 18-69 years, with 5 mg/kg/day of cyclosporine A. Patients were assessed at baseline, week 2, and week 12 using gene expression and immunohistochemistry studies, biopsies of lesional and nonlesional skin, and the Scoring of Atopic Dermatitis (SCORAD) measure.

"Patients had decreases in erythema and edema at week 2, with further reductions at week 12," said Ms. Rozenblit. By week 12, 17 of the 19 patients had SCORAD reductions of at least 50%, the threshold for therapeutic response, she said. The cohort’s SCORAD scores improved by an average of 51% (standard deviation, 23%) at week 2 and by 73% (SD, 18%) at week 12, she added. SCORAD results ranged from 44 to 98 (mean, 65; standard deviation, 16) at baseline, from 5.9 to 76 (mean, 33; SD, 20) at week 2, and from 0 to 59 (mean, 18; SD, 15) at week 12.

Clinical improvements correlated with significant genomic improvements as measured by gene arrays and reverse transcriptase polymerase chain reaction (PCR) testing. In particular, the researchers observed reductions of Th2, Th22, and some Th17-related molecules such as IL-13 and IL-22; modulation of epidermal hyperplasia and proliferation markers K16 and Ki67 also were noted. IL-13 as well as several S100 proteins and IL-22 were among the top genes that were decreased after treatment, said Ms. Rozenblit.

After 12 weeks of treatment, lesional skin biopsies also indicated that the granular layer had improved to the point that it resembled nonlesional skin, Ms. Rozenblit noted. "Baseline lesional skin had substantial inflammatory cell infiltrates, with decreases essentially to baseline nonlesional levels by week 12," she said. Nonlesional skin showed similar but less marked reversal of inflammatory and epidermal measures after cyclosporine A treatment.

As clinical trials investigate better-tolerated targeted agents for atopic dermatitis, understanding the biomarkers involved will provide a reference point for evaluating improvements in tissue inflammation.

Ms. Rozenblit reported no conflicts of interest. The National Institutes of Health, Rockefeller University, and a Dermatology Foundation Physician Scientist Career Development Award helped fund the research. Novartis provided cyclosporine A for U.S. patients.

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ALBUQUERQUE – Symptoms decreased by 51% at 2 weeks and by 73% at 12 weeks in adults with atopic dermatitis who received cyclosporine A therapy in an open-label, single-arm study.

Clinical improvements correlated with suppression of epidermal hyperplasia and decreases in inflammatory biomarkers including S100A7, IL-13, and IL-22, reported Mariya Rozenblit of Mount Sinai Medical Center in New York and her associates. Ms. Rozenblit presented the results at the annual meeting of the Society for Investigative Dermatology, and the findings were published online in the Journal of Allergy and Clinical Immunology (J. Allergy Clin. Immunol. 2014 [doi:10.1016/j.jaci.2014.03.003]).

"This is the first study that establishes a link between Th2/Th22 cytokines and molecular epidermal alterations as well as correlations between clinical improvement and skin biomarkers" in atopic dermatitis, said Ms. Rozenblit and her associates.

To characterize these mechanisms and compare them with clinical outcomes in atopic dermatitis, the researchers treated 19 affected adults, aged 18-69 years, with 5 mg/kg/day of cyclosporine A. Patients were assessed at baseline, week 2, and week 12 using gene expression and immunohistochemistry studies, biopsies of lesional and nonlesional skin, and the Scoring of Atopic Dermatitis (SCORAD) measure.

"Patients had decreases in erythema and edema at week 2, with further reductions at week 12," said Ms. Rozenblit. By week 12, 17 of the 19 patients had SCORAD reductions of at least 50%, the threshold for therapeutic response, she said. The cohort’s SCORAD scores improved by an average of 51% (standard deviation, 23%) at week 2 and by 73% (SD, 18%) at week 12, she added. SCORAD results ranged from 44 to 98 (mean, 65; standard deviation, 16) at baseline, from 5.9 to 76 (mean, 33; SD, 20) at week 2, and from 0 to 59 (mean, 18; SD, 15) at week 12.

Clinical improvements correlated with significant genomic improvements as measured by gene arrays and reverse transcriptase polymerase chain reaction (PCR) testing. In particular, the researchers observed reductions of Th2, Th22, and some Th17-related molecules such as IL-13 and IL-22; modulation of epidermal hyperplasia and proliferation markers K16 and Ki67 also were noted. IL-13 as well as several S100 proteins and IL-22 were among the top genes that were decreased after treatment, said Ms. Rozenblit.

After 12 weeks of treatment, lesional skin biopsies also indicated that the granular layer had improved to the point that it resembled nonlesional skin, Ms. Rozenblit noted. "Baseline lesional skin had substantial inflammatory cell infiltrates, with decreases essentially to baseline nonlesional levels by week 12," she said. Nonlesional skin showed similar but less marked reversal of inflammatory and epidermal measures after cyclosporine A treatment.

As clinical trials investigate better-tolerated targeted agents for atopic dermatitis, understanding the biomarkers involved will provide a reference point for evaluating improvements in tissue inflammation.

Ms. Rozenblit reported no conflicts of interest. The National Institutes of Health, Rockefeller University, and a Dermatology Foundation Physician Scientist Career Development Award helped fund the research. Novartis provided cyclosporine A for U.S. patients.

ALBUQUERQUE – Symptoms decreased by 51% at 2 weeks and by 73% at 12 weeks in adults with atopic dermatitis who received cyclosporine A therapy in an open-label, single-arm study.

Clinical improvements correlated with suppression of epidermal hyperplasia and decreases in inflammatory biomarkers including S100A7, IL-13, and IL-22, reported Mariya Rozenblit of Mount Sinai Medical Center in New York and her associates. Ms. Rozenblit presented the results at the annual meeting of the Society for Investigative Dermatology, and the findings were published online in the Journal of Allergy and Clinical Immunology (J. Allergy Clin. Immunol. 2014 [doi:10.1016/j.jaci.2014.03.003]).

"This is the first study that establishes a link between Th2/Th22 cytokines and molecular epidermal alterations as well as correlations between clinical improvement and skin biomarkers" in atopic dermatitis, said Ms. Rozenblit and her associates.

To characterize these mechanisms and compare them with clinical outcomes in atopic dermatitis, the researchers treated 19 affected adults, aged 18-69 years, with 5 mg/kg/day of cyclosporine A. Patients were assessed at baseline, week 2, and week 12 using gene expression and immunohistochemistry studies, biopsies of lesional and nonlesional skin, and the Scoring of Atopic Dermatitis (SCORAD) measure.

"Patients had decreases in erythema and edema at week 2, with further reductions at week 12," said Ms. Rozenblit. By week 12, 17 of the 19 patients had SCORAD reductions of at least 50%, the threshold for therapeutic response, she said. The cohort’s SCORAD scores improved by an average of 51% (standard deviation, 23%) at week 2 and by 73% (SD, 18%) at week 12, she added. SCORAD results ranged from 44 to 98 (mean, 65; standard deviation, 16) at baseline, from 5.9 to 76 (mean, 33; SD, 20) at week 2, and from 0 to 59 (mean, 18; SD, 15) at week 12.

Clinical improvements correlated with significant genomic improvements as measured by gene arrays and reverse transcriptase polymerase chain reaction (PCR) testing. In particular, the researchers observed reductions of Th2, Th22, and some Th17-related molecules such as IL-13 and IL-22; modulation of epidermal hyperplasia and proliferation markers K16 and Ki67 also were noted. IL-13 as well as several S100 proteins and IL-22 were among the top genes that were decreased after treatment, said Ms. Rozenblit.

After 12 weeks of treatment, lesional skin biopsies also indicated that the granular layer had improved to the point that it resembled nonlesional skin, Ms. Rozenblit noted. "Baseline lesional skin had substantial inflammatory cell infiltrates, with decreases essentially to baseline nonlesional levels by week 12," she said. Nonlesional skin showed similar but less marked reversal of inflammatory and epidermal measures after cyclosporine A treatment.

As clinical trials investigate better-tolerated targeted agents for atopic dermatitis, understanding the biomarkers involved will provide a reference point for evaluating improvements in tissue inflammation.

Ms. Rozenblit reported no conflicts of interest. The National Institutes of Health, Rockefeller University, and a Dermatology Foundation Physician Scientist Career Development Award helped fund the research. Novartis provided cyclosporine A for U.S. patients.

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Key clinical point: Clinical improvements in atopic dermatitis correlated with reductions in inflammatory markers.

Major finding: SCORAD scores decreased by 51% at week 2 and 73% at week 12 of treatment with 5 mg/kg cyclosporine A daily.

Data source: Single-arm cohort study of 19 adults with atopic dermatitis.

Disclosures: Ms. Rozenblit reported no conflicts of interest. The National Institutes of Health, Rockefeller University, and a Dermatology Foundation Physician Scientist Career Development Award helped fund the research. Novartis provided cyclosporine A for U.S. patients.

Topical tazarotene did not improve response to imiquimod 5% in lentigo maligna

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ALBUQUERQUE – Adding topical tazarotene did not improve response to 5% imiquimod in lentigo maligna, based on data from nearly 300 patients.

But patients with higher levels of inflammation in response to topical therapy had significantly smaller surgical defects, required fewer surgical stages, and had improved clearance rates, said Nicholas Blickenstaff, a third-year medical student at the University of Utah and a former researcher at the Huntsman Cancer Institute, both in Salt Lake City.

Surgical excision with negative margins is the standard treatment for lentigo maligna, but the cancer’s predilection for the head and neck can cause disfigurement, especially with large tumors. Patients sometimes elect nonsurgical treatment because of cosmetic concerns, comorbidities, or both, Mr. Blickenstaff said at the annual meeting of the Society for Investigative Dermatology.

A prior study found that adding the topical retinoid tazarotene to 5% imiquimod showed a trend toward improved clearance in lentigo maligna, but the association did not reach statistical significance (Arch. Dermatol. 2012;148:592-6).

Based on those data, "we looked at a larger treatment cohort to determine if adding tazarotene to topical imiquimod increased clearance rates of lentigo maligna, as defined by the presence or absence of residual tumor at the time of surgical removal," said Mr. Blickenstaff.

He and his associates at the Huntsman Cancer Institute and the University of Utah School of Medicine conducted a retrospective chart study of 282 patients with an average age of 68 years and biopsy-confirmed lentigo maligna.

A total of 188 patients with 194 lesions received imiquimod 5% cream 5 days a week for 1-3 months, depending on the amount of inflammation observed, said Mr. Blickenstaff. Another group of 94 patients with 98 lesions received the same treatment plus tazarotene 0.1% gel twice weekly. Patients then underwent conservative staged excisions using Melan-A immunostaining on frozen sections to confirm negative margins. The investigators followed patients for an average of 43 months.

Using chart data, the investigators graded patients’ inflammatory responses to topical therapy on a 0-3 scale, with 0 interpreted as no erythema, 1 as mild erythema, 2 as moderate erythema, and 3 as severe erythema with possible surface erosions, said Mr. Blickenstaff.

The researchers found no difference between the two topical regimens in terms of presurgical clearance (P = 0.97). However, patients with higher levels of inflammation (scores of 2 or 3) were significantly more likely to be free of tumor at surgery than were other patients (odds ratio, 2.8; P = 0.002). Patients with more inflammation also had decreased postsurgical defect sizes (P = 0.023), and needed fewer stages to achieve clear margins (P = 0.015), Mr. Blickenstaff and his associates reported.

Patients required an average of 1.5 stages and a maximum of five stages to achieve clearance, Mr. Blickenstaff added. A total of four patients (1.4%) had a recurrence of lentigo maligna, and there were no deaths related to treatment or lentigo maligna, he said.

Based on the findings, "studies should evaluate whether the quality of the inflammatory response with 5% imiquimod is unique and required for efficacy," said Mr. Blickenstaff.

He is now a research fellow at UCSF Medical Center in San Francisco. He reported no conflicts of interest. The Huntsman Cancer Institute funded the study.

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ALBUQUERQUE – Adding topical tazarotene did not improve response to 5% imiquimod in lentigo maligna, based on data from nearly 300 patients.

But patients with higher levels of inflammation in response to topical therapy had significantly smaller surgical defects, required fewer surgical stages, and had improved clearance rates, said Nicholas Blickenstaff, a third-year medical student at the University of Utah and a former researcher at the Huntsman Cancer Institute, both in Salt Lake City.

Surgical excision with negative margins is the standard treatment for lentigo maligna, but the cancer’s predilection for the head and neck can cause disfigurement, especially with large tumors. Patients sometimes elect nonsurgical treatment because of cosmetic concerns, comorbidities, or both, Mr. Blickenstaff said at the annual meeting of the Society for Investigative Dermatology.

A prior study found that adding the topical retinoid tazarotene to 5% imiquimod showed a trend toward improved clearance in lentigo maligna, but the association did not reach statistical significance (Arch. Dermatol. 2012;148:592-6).

Based on those data, "we looked at a larger treatment cohort to determine if adding tazarotene to topical imiquimod increased clearance rates of lentigo maligna, as defined by the presence or absence of residual tumor at the time of surgical removal," said Mr. Blickenstaff.

He and his associates at the Huntsman Cancer Institute and the University of Utah School of Medicine conducted a retrospective chart study of 282 patients with an average age of 68 years and biopsy-confirmed lentigo maligna.

A total of 188 patients with 194 lesions received imiquimod 5% cream 5 days a week for 1-3 months, depending on the amount of inflammation observed, said Mr. Blickenstaff. Another group of 94 patients with 98 lesions received the same treatment plus tazarotene 0.1% gel twice weekly. Patients then underwent conservative staged excisions using Melan-A immunostaining on frozen sections to confirm negative margins. The investigators followed patients for an average of 43 months.

Using chart data, the investigators graded patients’ inflammatory responses to topical therapy on a 0-3 scale, with 0 interpreted as no erythema, 1 as mild erythema, 2 as moderate erythema, and 3 as severe erythema with possible surface erosions, said Mr. Blickenstaff.

The researchers found no difference between the two topical regimens in terms of presurgical clearance (P = 0.97). However, patients with higher levels of inflammation (scores of 2 or 3) were significantly more likely to be free of tumor at surgery than were other patients (odds ratio, 2.8; P = 0.002). Patients with more inflammation also had decreased postsurgical defect sizes (P = 0.023), and needed fewer stages to achieve clear margins (P = 0.015), Mr. Blickenstaff and his associates reported.

Patients required an average of 1.5 stages and a maximum of five stages to achieve clearance, Mr. Blickenstaff added. A total of four patients (1.4%) had a recurrence of lentigo maligna, and there were no deaths related to treatment or lentigo maligna, he said.

Based on the findings, "studies should evaluate whether the quality of the inflammatory response with 5% imiquimod is unique and required for efficacy," said Mr. Blickenstaff.

He is now a research fellow at UCSF Medical Center in San Francisco. He reported no conflicts of interest. The Huntsman Cancer Institute funded the study.

ALBUQUERQUE – Adding topical tazarotene did not improve response to 5% imiquimod in lentigo maligna, based on data from nearly 300 patients.

But patients with higher levels of inflammation in response to topical therapy had significantly smaller surgical defects, required fewer surgical stages, and had improved clearance rates, said Nicholas Blickenstaff, a third-year medical student at the University of Utah and a former researcher at the Huntsman Cancer Institute, both in Salt Lake City.

Surgical excision with negative margins is the standard treatment for lentigo maligna, but the cancer’s predilection for the head and neck can cause disfigurement, especially with large tumors. Patients sometimes elect nonsurgical treatment because of cosmetic concerns, comorbidities, or both, Mr. Blickenstaff said at the annual meeting of the Society for Investigative Dermatology.

A prior study found that adding the topical retinoid tazarotene to 5% imiquimod showed a trend toward improved clearance in lentigo maligna, but the association did not reach statistical significance (Arch. Dermatol. 2012;148:592-6).

Based on those data, "we looked at a larger treatment cohort to determine if adding tazarotene to topical imiquimod increased clearance rates of lentigo maligna, as defined by the presence or absence of residual tumor at the time of surgical removal," said Mr. Blickenstaff.

He and his associates at the Huntsman Cancer Institute and the University of Utah School of Medicine conducted a retrospective chart study of 282 patients with an average age of 68 years and biopsy-confirmed lentigo maligna.

A total of 188 patients with 194 lesions received imiquimod 5% cream 5 days a week for 1-3 months, depending on the amount of inflammation observed, said Mr. Blickenstaff. Another group of 94 patients with 98 lesions received the same treatment plus tazarotene 0.1% gel twice weekly. Patients then underwent conservative staged excisions using Melan-A immunostaining on frozen sections to confirm negative margins. The investigators followed patients for an average of 43 months.

Using chart data, the investigators graded patients’ inflammatory responses to topical therapy on a 0-3 scale, with 0 interpreted as no erythema, 1 as mild erythema, 2 as moderate erythema, and 3 as severe erythema with possible surface erosions, said Mr. Blickenstaff.

The researchers found no difference between the two topical regimens in terms of presurgical clearance (P = 0.97). However, patients with higher levels of inflammation (scores of 2 or 3) were significantly more likely to be free of tumor at surgery than were other patients (odds ratio, 2.8; P = 0.002). Patients with more inflammation also had decreased postsurgical defect sizes (P = 0.023), and needed fewer stages to achieve clear margins (P = 0.015), Mr. Blickenstaff and his associates reported.

Patients required an average of 1.5 stages and a maximum of five stages to achieve clearance, Mr. Blickenstaff added. A total of four patients (1.4%) had a recurrence of lentigo maligna, and there were no deaths related to treatment or lentigo maligna, he said.

Based on the findings, "studies should evaluate whether the quality of the inflammatory response with 5% imiquimod is unique and required for efficacy," said Mr. Blickenstaff.

He is now a research fellow at UCSF Medical Center in San Francisco. He reported no conflicts of interest. The Huntsman Cancer Institute funded the study.

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Key clinical point: Patients with higher levels of inflammation in response to topical therapy were more likely not to have residual tumor at surgery than were other patients (odds ratio, 2.8).

Major finding: Adding topical tazarotene did not improve response to 5% imiquimod in lentigo maligna (P = 0.97).

Data source: A chart review of 188 patients with 194 lesions of lentigo maligna who received imiquimod 5% cream 5 days a week for 1-3 months, and 94 patients with 98 lesions who received the same treatment plus tazarotene 0.1% gel twice weekly.

Disclosures: The Huntsman Cancer Institute funded the study. Mr. Blickenstaff reported no conflicts of interest.

Infrared detector distinguished malignant and benign skin lesions

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Infrared detector distinguished malignant and benign skin lesions

ALBUQUERQUE – A long-wave infrared system distinguished malignant and benign skin lesions with a sensitivity of 96.97% and a specificity of 78.05%, with skin biopsies used as a benchmark, in a pilot study of 74 patients.

The results "suggest the technique is promising as a noninvasive screening tool" and merits continued research and development to improve sensitivity, specificity, and statistical confidence, reported Stephen Myers, Ph.D., of Skinfrared, and his associates.

Recent advances in infrared technology have led to the development of imaging devices that noninvasively detect tumors, based on differential thermal properties of malignant versus healthy tissue. The long-wave infrared detection device used in the pilot study was designed to identify thermal signatures of suspicious lesions and surrounding skin after the application of a temperature stimulus, Dr. Myers said at the annual conference of the Society for Investigative Dermatology.

In the United States skin cancers are diagnosed more often than all other cancers combined, noted Dr. Myers, but screening for them "requires the skill of a highly trained dermatologist," who must assess a range of morphologic characteristics. "This is a rather subjective approach that causes many biopsies to be performed on benign lesions," Dr. Myers added.

To test the device, investigators at the University of New Mexico, Albuquerque, Dermatology Clinic offered patients with suspicious skin lesions the option of being evaluated with the infrared device before undergoing biopsy.

The device has infrared and visible cameras, as well as a registration marker, a cold air source, and a computer and software to guide image acquisition and analysis, Dr. Myers said. Investigators placed the registration marker near the skin lesion of interest, captured a visible image of the lesion, and then took a 15-second baseline thermal image sequence. After cooling the lesions and surrounding skin to 10° C, they measured and compared 3-minute thermal recovery rates for the lesion and surrounding skin.

Participants averaged 55 years of age, and 53% were male. A total of 102 suspicious lesions were tested. Based on biopsy results, 55% were benign, 34% were basal cell carcinomas, 7% were squamous cell carcinomas, and 4% were melanomas, Dr. Myers reported. The receiver operating curve – calculated to assess the test’s ability to classify skin lesions – had an area under the curve of 95.3% (95% confidence interval, 90.0-99.0). Using biopsy results as a benchmark, the infrared device had a sensitivity of 96.97% and a specificity of 78.05%, Dr. Myers said.

The study was supported by the National Science Foundation and Skinfrared, which makes the device. Dr. Myers is an employee of Skinfrared.

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ALBUQUERQUE – A long-wave infrared system distinguished malignant and benign skin lesions with a sensitivity of 96.97% and a specificity of 78.05%, with skin biopsies used as a benchmark, in a pilot study of 74 patients.

The results "suggest the technique is promising as a noninvasive screening tool" and merits continued research and development to improve sensitivity, specificity, and statistical confidence, reported Stephen Myers, Ph.D., of Skinfrared, and his associates.

Recent advances in infrared technology have led to the development of imaging devices that noninvasively detect tumors, based on differential thermal properties of malignant versus healthy tissue. The long-wave infrared detection device used in the pilot study was designed to identify thermal signatures of suspicious lesions and surrounding skin after the application of a temperature stimulus, Dr. Myers said at the annual conference of the Society for Investigative Dermatology.

In the United States skin cancers are diagnosed more often than all other cancers combined, noted Dr. Myers, but screening for them "requires the skill of a highly trained dermatologist," who must assess a range of morphologic characteristics. "This is a rather subjective approach that causes many biopsies to be performed on benign lesions," Dr. Myers added.

To test the device, investigators at the University of New Mexico, Albuquerque, Dermatology Clinic offered patients with suspicious skin lesions the option of being evaluated with the infrared device before undergoing biopsy.

The device has infrared and visible cameras, as well as a registration marker, a cold air source, and a computer and software to guide image acquisition and analysis, Dr. Myers said. Investigators placed the registration marker near the skin lesion of interest, captured a visible image of the lesion, and then took a 15-second baseline thermal image sequence. After cooling the lesions and surrounding skin to 10° C, they measured and compared 3-minute thermal recovery rates for the lesion and surrounding skin.

Participants averaged 55 years of age, and 53% were male. A total of 102 suspicious lesions were tested. Based on biopsy results, 55% were benign, 34% were basal cell carcinomas, 7% were squamous cell carcinomas, and 4% were melanomas, Dr. Myers reported. The receiver operating curve – calculated to assess the test’s ability to classify skin lesions – had an area under the curve of 95.3% (95% confidence interval, 90.0-99.0). Using biopsy results as a benchmark, the infrared device had a sensitivity of 96.97% and a specificity of 78.05%, Dr. Myers said.

The study was supported by the National Science Foundation and Skinfrared, which makes the device. Dr. Myers is an employee of Skinfrared.

ALBUQUERQUE – A long-wave infrared system distinguished malignant and benign skin lesions with a sensitivity of 96.97% and a specificity of 78.05%, with skin biopsies used as a benchmark, in a pilot study of 74 patients.

The results "suggest the technique is promising as a noninvasive screening tool" and merits continued research and development to improve sensitivity, specificity, and statistical confidence, reported Stephen Myers, Ph.D., of Skinfrared, and his associates.

Recent advances in infrared technology have led to the development of imaging devices that noninvasively detect tumors, based on differential thermal properties of malignant versus healthy tissue. The long-wave infrared detection device used in the pilot study was designed to identify thermal signatures of suspicious lesions and surrounding skin after the application of a temperature stimulus, Dr. Myers said at the annual conference of the Society for Investigative Dermatology.

In the United States skin cancers are diagnosed more often than all other cancers combined, noted Dr. Myers, but screening for them "requires the skill of a highly trained dermatologist," who must assess a range of morphologic characteristics. "This is a rather subjective approach that causes many biopsies to be performed on benign lesions," Dr. Myers added.

To test the device, investigators at the University of New Mexico, Albuquerque, Dermatology Clinic offered patients with suspicious skin lesions the option of being evaluated with the infrared device before undergoing biopsy.

The device has infrared and visible cameras, as well as a registration marker, a cold air source, and a computer and software to guide image acquisition and analysis, Dr. Myers said. Investigators placed the registration marker near the skin lesion of interest, captured a visible image of the lesion, and then took a 15-second baseline thermal image sequence. After cooling the lesions and surrounding skin to 10° C, they measured and compared 3-minute thermal recovery rates for the lesion and surrounding skin.

Participants averaged 55 years of age, and 53% were male. A total of 102 suspicious lesions were tested. Based on biopsy results, 55% were benign, 34% were basal cell carcinomas, 7% were squamous cell carcinomas, and 4% were melanomas, Dr. Myers reported. The receiver operating curve – calculated to assess the test’s ability to classify skin lesions – had an area under the curve of 95.3% (95% confidence interval, 90.0-99.0). Using biopsy results as a benchmark, the infrared device had a sensitivity of 96.97% and a specificity of 78.05%, Dr. Myers said.

The study was supported by the National Science Foundation and Skinfrared, which makes the device. Dr. Myers is an employee of Skinfrared.

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Major finding: Malignant skin lesions (basal cell carcinomas, squamous cell carcinomas, and malignant melanomas) were distinguished from benign lesions with a sensitivity of 96.97% and a specificity of 78.05%.

Data source: Observational pilot study of 74 patients with 102 suspicious skin lesions who underwent infrared imaging followed by biopsy.

Disclosures: The study was supported by the National Science Foundation and Skinfrared, which makes the device. Dr. Myers is an employee of Skinfrared.

Single-fraction radiation therapy showed promise in metastatic Merkel cell carcinoma

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ALBUQUERQUE – Single-fraction radiotherapy of distant metastatic Merkel cell carcinomas led to complete response rates ranging from 52% to 81%, and caused no adverse effects except rare transient pain flares, according to a single-center, single-arm study of 26 patients.

The rate of initial response was 94%, and three-quarters of responders never progressed during the study period, Dr. Paul Nghiem said at the annual meeting of the Society for Investigative Dermatology.

Merkel cell carcinoma (MCC) creates a "terribly frustrating situation" when it metastasizes because although two-thirds of patients initially respond to chemotherapy, the effect is short-lived, with a median progression-free survival of only 94 days, said Dr. Nghiem, professor of dermatology at the University of Washington, Seattle.

Dr. Paul Nghiem

Radiation therapy is often used as an adjuvant or palliative treatment in MCC, but it is almost always fractionated, requiring multiple visits and potentially killing T cells that function in tumor immunity, Dr. Nghiem said. In light of evidence that single-fraction radiotherapy (SFRT) enhanced tumor immunity in mice, he and his colleagues at the University of Washington and the Fred Hutchinson Cancer Research Center in Seattle decided to "think outside the box and do something different."

Therefore, in 2010, the researchers began using 8-Gy SFRT on distant MCC metastases. In all, they targeted 93 tumors in 26 patients (median age, 68 years). Survivors were followed for a median of 252 days (range, 76-699 days). The median tumor size was 4 cm (range, 1-19 cm), and patients had 1-28 tumors, with an average of 3.5 tumors per patient.

The investigators classified half of patients (n = 13) as high risk because they were immunosuppressed and/or had prior chemotherapy. Other patients were categorized as low risk. High-risk patients had 60 tumors and a 3.5-month median interval from chemotherapy to start of SFRT. The low-risk group had 33 tumors.

A complete response was seen in 81% of tumors in low-risk patients and 52% of tumors in high-risk patients (P = .008), Dr. Nghiem reported. No tumor that completely responded ever recurred, regardless of risk, he said. In one case, a patient with a 5-cm metastasis compressing the trachea reported greater ease of breathing several days after SFRT, and subsequent imaging studies showed complete response with no recurrence at 20 months, he said, adding that the patient remained on an immunostimulant.

The rate of recurrence also was significantly lower in low-risk (9%) versus high-risk patients (30%; P = .02), Dr. Nghiem said. The P value "was statistically significant in this midsize trial, suggesting that the immune system really matters in controlling these lesions," he said, adding that Merkel cell carcinoma, "maybe more than most other cancers, is extremely linked to immune function. As we increase radiation dose, we see more cancer killing [activity], and more immune cell activation at lower doses."

The investigators did not perform post-treatment biopsies to quantify abscopal effects, Dr. Nghiem noted.

The National Cancer Institute, the American Cancer Society, and the National Institutes of Health funded the research. Dr. Nghiem reported no relevant conflicts of interest.

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ALBUQUERQUE – Single-fraction radiotherapy of distant metastatic Merkel cell carcinomas led to complete response rates ranging from 52% to 81%, and caused no adverse effects except rare transient pain flares, according to a single-center, single-arm study of 26 patients.

The rate of initial response was 94%, and three-quarters of responders never progressed during the study period, Dr. Paul Nghiem said at the annual meeting of the Society for Investigative Dermatology.

Merkel cell carcinoma (MCC) creates a "terribly frustrating situation" when it metastasizes because although two-thirds of patients initially respond to chemotherapy, the effect is short-lived, with a median progression-free survival of only 94 days, said Dr. Nghiem, professor of dermatology at the University of Washington, Seattle.

Dr. Paul Nghiem

Radiation therapy is often used as an adjuvant or palliative treatment in MCC, but it is almost always fractionated, requiring multiple visits and potentially killing T cells that function in tumor immunity, Dr. Nghiem said. In light of evidence that single-fraction radiotherapy (SFRT) enhanced tumor immunity in mice, he and his colleagues at the University of Washington and the Fred Hutchinson Cancer Research Center in Seattle decided to "think outside the box and do something different."

Therefore, in 2010, the researchers began using 8-Gy SFRT on distant MCC metastases. In all, they targeted 93 tumors in 26 patients (median age, 68 years). Survivors were followed for a median of 252 days (range, 76-699 days). The median tumor size was 4 cm (range, 1-19 cm), and patients had 1-28 tumors, with an average of 3.5 tumors per patient.

The investigators classified half of patients (n = 13) as high risk because they were immunosuppressed and/or had prior chemotherapy. Other patients were categorized as low risk. High-risk patients had 60 tumors and a 3.5-month median interval from chemotherapy to start of SFRT. The low-risk group had 33 tumors.

A complete response was seen in 81% of tumors in low-risk patients and 52% of tumors in high-risk patients (P = .008), Dr. Nghiem reported. No tumor that completely responded ever recurred, regardless of risk, he said. In one case, a patient with a 5-cm metastasis compressing the trachea reported greater ease of breathing several days after SFRT, and subsequent imaging studies showed complete response with no recurrence at 20 months, he said, adding that the patient remained on an immunostimulant.

The rate of recurrence also was significantly lower in low-risk (9%) versus high-risk patients (30%; P = .02), Dr. Nghiem said. The P value "was statistically significant in this midsize trial, suggesting that the immune system really matters in controlling these lesions," he said, adding that Merkel cell carcinoma, "maybe more than most other cancers, is extremely linked to immune function. As we increase radiation dose, we see more cancer killing [activity], and more immune cell activation at lower doses."

The investigators did not perform post-treatment biopsies to quantify abscopal effects, Dr. Nghiem noted.

The National Cancer Institute, the American Cancer Society, and the National Institutes of Health funded the research. Dr. Nghiem reported no relevant conflicts of interest.

ALBUQUERQUE – Single-fraction radiotherapy of distant metastatic Merkel cell carcinomas led to complete response rates ranging from 52% to 81%, and caused no adverse effects except rare transient pain flares, according to a single-center, single-arm study of 26 patients.

The rate of initial response was 94%, and three-quarters of responders never progressed during the study period, Dr. Paul Nghiem said at the annual meeting of the Society for Investigative Dermatology.

Merkel cell carcinoma (MCC) creates a "terribly frustrating situation" when it metastasizes because although two-thirds of patients initially respond to chemotherapy, the effect is short-lived, with a median progression-free survival of only 94 days, said Dr. Nghiem, professor of dermatology at the University of Washington, Seattle.

Dr. Paul Nghiem

Radiation therapy is often used as an adjuvant or palliative treatment in MCC, but it is almost always fractionated, requiring multiple visits and potentially killing T cells that function in tumor immunity, Dr. Nghiem said. In light of evidence that single-fraction radiotherapy (SFRT) enhanced tumor immunity in mice, he and his colleagues at the University of Washington and the Fred Hutchinson Cancer Research Center in Seattle decided to "think outside the box and do something different."

Therefore, in 2010, the researchers began using 8-Gy SFRT on distant MCC metastases. In all, they targeted 93 tumors in 26 patients (median age, 68 years). Survivors were followed for a median of 252 days (range, 76-699 days). The median tumor size was 4 cm (range, 1-19 cm), and patients had 1-28 tumors, with an average of 3.5 tumors per patient.

The investigators classified half of patients (n = 13) as high risk because they were immunosuppressed and/or had prior chemotherapy. Other patients were categorized as low risk. High-risk patients had 60 tumors and a 3.5-month median interval from chemotherapy to start of SFRT. The low-risk group had 33 tumors.

A complete response was seen in 81% of tumors in low-risk patients and 52% of tumors in high-risk patients (P = .008), Dr. Nghiem reported. No tumor that completely responded ever recurred, regardless of risk, he said. In one case, a patient with a 5-cm metastasis compressing the trachea reported greater ease of breathing several days after SFRT, and subsequent imaging studies showed complete response with no recurrence at 20 months, he said, adding that the patient remained on an immunostimulant.

The rate of recurrence also was significantly lower in low-risk (9%) versus high-risk patients (30%; P = .02), Dr. Nghiem said. The P value "was statistically significant in this midsize trial, suggesting that the immune system really matters in controlling these lesions," he said, adding that Merkel cell carcinoma, "maybe more than most other cancers, is extremely linked to immune function. As we increase radiation dose, we see more cancer killing [activity], and more immune cell activation at lower doses."

The investigators did not perform post-treatment biopsies to quantify abscopal effects, Dr. Nghiem noted.

The National Cancer Institute, the American Cancer Society, and the National Institutes of Health funded the research. Dr. Nghiem reported no relevant conflicts of interest.

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Major finding: Complete response was seen in 52% of tumors in high-risk patients and 81% of tumors in low-risk patients (P = .008). No adverse effects were observed except pain flares in two patients.

Data source: Single-arm study of 26 patients with distant metastases of Merkel cell carcinoma treated with 8-Gy single-fraction radiotherapy.

Disclosures: The National Cancer Institute, the American Cancer Society, and the National Institutes of Health funded the research. Dr. Nghiem reported no relevant conflicts of interest.