Susan London

VANCOUVER, B.C. – The media played a major role in determining the fate of uterine morcellation, suggested a study reported at a meeting sponsored by AAGL.

“How did we lose this battle of uterine morcellation? We lost it in the media,” asserted lead investigator Dr. Adrian C. Balica, director of the minimally invasive gynecologic surgery program at the Robert Wood Johnson Medical School in New Brunswick, N.J.

He and his colleagues used the Google Adwords Keyword Planner to collect Internet search data for a variety of relevant terms used in 2013 and in 2014 through August.

This interval spanned events that included the first report of the issue in the mainstream media (December 2013), the Food and Drug Administration’s initial statement discouraging use of power morcellation for uterine fibroids (April 2014), and the issuance of analyses and rebuttals by several medical professional associations (May 2104 and thereafter).

Subsequent to the AAGL meeting, the FDA issued a new warning on Nov. 24, 2014, not to use power morcellation in the majority of women undergoing hysterectomy or myomectomy for uterine fibroids because “there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma” that morcellation could spread. The agency estimated that about 1 in 350 fibroid patients actually have an occult sarcoma.

Results showed that the average monthly number of Google searches for the term “morcellation” held steady throughout most of 2013 at about 250 per month, reported Dr. Balica. There was, however, a sharp uptick in December 2013 to more than 2,000 per month, and the number continued to rise to a peak of about 18,000 per month in July 2014. A similar pattern was seen for the terms “morcellator,” “fibroids in uterus,” and “morcellation of uterine fibroid.”

Additionally, there were virtually no searches for “power morcellation” in 2013, but there were about 1,900 per month at the peak in April 2014. Much the same pattern was seen for “power morcellator,” he said.

Dr. Balica noted that the rapid cascade of events set into motion has had a profound impact for the field, including banning of morcellation at many hospitals and Johnson & Johnson withdrawing its power morcellator, which accounted for an estimated 72% of the devices used, from the market.

“Medical and surgical practice is going to be changed by the media,” he predicted. Thus, studying how the morcellator controversy unfolded in this venue can help inform strategies for addressing public perceptions.

His own hospital has stopped using power morcellation, according to Dr. Balica. “This is just the battle. Hopefully, we aren’t going to lose the war,” he concluded.

Dr. Balica disclosed that he had no relevant conflicts of interest.

VANCOUVER, B.C. – The media played a major role in determining the fate of uterine morcellation, suggested a study reported at a meeting sponsored by AAGL.

“How did we lose this battle of uterine morcellation? We lost it in the media,” asserted lead investigator Dr. Adrian C. Balica, director of the minimally invasive gynecologic surgery program at the Robert Wood Johnson Medical School in New Brunswick, N.J.

He and his colleagues used the Google Adwords Keyword Planner to collect Internet search data for a variety of relevant terms used in 2013 and in 2014 through August.

This interval spanned events that included the first report of the issue in the mainstream media (December 2013), the Food and Drug Administration’s initial statement discouraging use of power morcellation for uterine fibroids (April 2014), and the issuance of analyses and rebuttals by several medical professional associations (May 2104 and thereafter).

Subsequent to the AAGL meeting, the FDA issued a new warning on Nov. 24, 2014, not to use power morcellation in the majority of women undergoing hysterectomy or myomectomy for uterine fibroids because “there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma” that morcellation could spread. The agency estimated that about 1 in 350 fibroid patients actually have an occult sarcoma.

Results showed that the average monthly number of Google searches for the term “morcellation” held steady throughout most of 2013 at about 250 per month, reported Dr. Balica. There was, however, a sharp uptick in December 2013 to more than 2,000 per month, and the number continued to rise to a peak of about 18,000 per month in July 2014. A similar pattern was seen for the terms “morcellator,” “fibroids in uterus,” and “morcellation of uterine fibroid.”

Additionally, there were virtually no searches for “power morcellation” in 2013, but there were about 1,900 per month at the peak in April 2014. Much the same pattern was seen for “power morcellator,” he said.

Dr. Balica noted that the rapid cascade of events set into motion has had a profound impact for the field, including banning of morcellation at many hospitals and Johnson & Johnson withdrawing its power morcellator, which accounted for an estimated 72% of the devices used, from the market.

“Medical and surgical practice is going to be changed by the media,” he predicted. Thus, studying how the morcellator controversy unfolded in this venue can help inform strategies for addressing public perceptions.

His own hospital has stopped using power morcellation, according to Dr. Balica. “This is just the battle. Hopefully, we aren’t going to lose the war,” he concluded.

Dr. Balica disclosed that he had no relevant conflicts of interest.

VANCOUVER, B.C. – The media played a major role in determining the fate of uterine morcellation, suggested a study reported at a meeting sponsored by AAGL.

“How did we lose this battle of uterine morcellation? We lost it in the media,” asserted lead investigator Dr. Adrian C. Balica, director of the minimally invasive gynecologic surgery program at the Robert Wood Johnson Medical School in New Brunswick, N.J.

He and his colleagues used the Google Adwords Keyword Planner to collect Internet search data for a variety of relevant terms used in 2013 and in 2014 through August.

This interval spanned events that included the first report of the issue in the mainstream media (December 2013), the Food and Drug Administration’s initial statement discouraging use of power morcellation for uterine fibroids (April 2014), and the issuance of analyses and rebuttals by several medical professional associations (May 2104 and thereafter).

Subsequent to the AAGL meeting, the FDA issued a new warning on Nov. 24, 2014, not to use power morcellation in the majority of women undergoing hysterectomy or myomectomy for uterine fibroids because “there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma” that morcellation could spread. The agency estimated that about 1 in 350 fibroid patients actually have an occult sarcoma.

Results showed that the average monthly number of Google searches for the term “morcellation” held steady throughout most of 2013 at about 250 per month, reported Dr. Balica. There was, however, a sharp uptick in December 2013 to more than 2,000 per month, and the number continued to rise to a peak of about 18,000 per month in July 2014. A similar pattern was seen for the terms “morcellator,” “fibroids in uterus,” and “morcellation of uterine fibroid.”

Additionally, there were virtually no searches for “power morcellation” in 2013, but there were about 1,900 per month at the peak in April 2014. Much the same pattern was seen for “power morcellator,” he said.

Dr. Balica noted that the rapid cascade of events set into motion has had a profound impact for the field, including banning of morcellation at many hospitals and Johnson & Johnson withdrawing its power morcellator, which accounted for an estimated 72% of the devices used, from the market.

“Medical and surgical practice is going to be changed by the media,” he predicted. Thus, studying how the morcellator controversy unfolded in this venue can help inform strategies for addressing public perceptions.

His own hospital has stopped using power morcellation, according to Dr. Balica. “This is just the battle. Hopefully, we aren’t going to lose the war,” he concluded.

Dr. Balica disclosed that he had no relevant conflicts of interest.

SAN FRANCISCO – Performance of more elective colectomies for diverticulitis in recent years does not seem to be preventing the need for emergent or urgent colectomies, investigators reported at the annual clinical congress of the American College of Surgeons.

The investigators analyzed data from the Comprehensive Hospital Abstract Reporting System (CHARS), a Washington State inpatient database, for the years 1987-2012.

Results showed that the age- and sex-adjusted rate of elective colectomies for diverticulitis increased from about 7 per 100,000 people to more than 20 per 100,000 people. But the rate of nonelective (emergent or urgent) colectomies for this indication remained fairly stable, if anything, increasing slightly.

Courtesy Wikimedia Commons/ Hellerhoff/Creative Commons

“Despite 15 years of evolving guidelines to operate less, we are actually seeing a threefold increase in elective colectomy for diverticulitis. We did not see a decrease in emergency surgery during the same time,” commented lead investigator Dr. Vlad V. Simianu, a research fellow in the department of surgery, University of Washington, Seattle.

Several hypotheses might explain this disconnect, he proposed: a rising incidence of diverticulitis, increasing severity of disease (although data do not support this), or surgeons’ adoption of a lower threshold for elective colectomy. “In fact, if you look at where the biggest climb in elective surgery was, it was sort of in the early 2000s, which was the time contemporaneous to when the first laparoscopic colorectal randomized trials were being published, and training programs were incorporating laparoscopy into their training. That’s really where we see the biggest jump. So it may be that what we are seeing is an increase in this procedure [laparoscopic colectomy], the same as what we saw with laparoscopic cholecystectomy.”

“Whatever you choose ... to believe about what’s driving this, what remains certain going forward is that routine elective colectomy is not supported by the most recent guidelines [from the American Society of Colon and Rectal Surgeons], and actually these guidelines are for the first time recommending that the decision to offer elective surgery be individualized,” Dr. Simianu noted.

“Our group is actually doing some neat work in this space trying to identify which metrics should be used to individualize surgery, so we look forward to sharing that with you in the future,” he added.

Session comoderator Dr. James J. Mezhir of the University of Iowa, Iowa City, asked, “It may be difficult, but are you able to look at general surgeons versus those who are colorectal trained?”

The database does not specify surgeon training, according to Dr. Simianu, who disclosed that he had no relevant conflicts of interest. “What is interesting is that in Washington State, about half the surgery is done laparoscopically, in recent years at least. Whether laparoscopy is lowering the threshold, we know that colorectal surgeons are trained to do more laparoscopic colectomy maybe than their general surgeon counterparts.”

Another state database has provided some additional relevant information, he noted. “When laparoscopy first started being adopted, we saw a spike in right-sided colon surgery, which was previously a pretty rare colectomy for diverticulitis. So it is hard to know who is sort of driving this.”

Dr. Mezhir also wanted to know, “How generalizable is this across the United States? Have you looked at something like the nationwide inpatient sample or some other data set to say whether this is something you are seeing in Washington or is this something across the U.S.?”

Similar national trends have been reported in studies using that database, according to Dr. Simianu. “One of the things they point out is that there is a spike in diverticulitis in the younger population, which is something we are seeing in Washington State as well,” he noted.

Another session attendee noted that patients with acute diverticulitis sometimes have immediate procedures, such as drainage, but then go on to have colectomy not long afterward. Thus, he wondered about misclassification, asking, “Are you capturing it as elective although it’s sorted out as an acute episode?”

“That’s a great question, said another way, are we actually just delaying things into the elective category, as opposed to operating on them emergently?” Dr. Simianu replied. “It’s a little hard to tell. We do know that during this time, rates of percutaneous drainage have gone up. So it’s sort of the same conclusion that we are doing more elective surgery but we are not really preventing complications. But I think the crux of that is when these patients have complications and have emergency surgery, they have it on their first episode, 80%-90% of them. So offering a delayed operation ... to prevent [complications] where the likelihood is highest of having a complication, doesn’t seem to bear out in the data.”

SAN FRANCISCO – Performance of more elective colectomies for diverticulitis in recent years does not seem to be preventing the need for emergent or urgent colectomies, investigators reported at the annual clinical congress of the American College of Surgeons.

The investigators analyzed data from the Comprehensive Hospital Abstract Reporting System (CHARS), a Washington State inpatient database, for the years 1987-2012.

Results showed that the age- and sex-adjusted rate of elective colectomies for diverticulitis increased from about 7 per 100,000 people to more than 20 per 100,000 people. But the rate of nonelective (emergent or urgent) colectomies for this indication remained fairly stable, if anything, increasing slightly.

Courtesy Wikimedia Commons/ Hellerhoff/Creative Commons

“Despite 15 years of evolving guidelines to operate less, we are actually seeing a threefold increase in elective colectomy for diverticulitis. We did not see a decrease in emergency surgery during the same time,” commented lead investigator Dr. Vlad V. Simianu, a research fellow in the department of surgery, University of Washington, Seattle.

Several hypotheses might explain this disconnect, he proposed: a rising incidence of diverticulitis, increasing severity of disease (although data do not support this), or surgeons’ adoption of a lower threshold for elective colectomy. “In fact, if you look at where the biggest climb in elective surgery was, it was sort of in the early 2000s, which was the time contemporaneous to when the first laparoscopic colorectal randomized trials were being published, and training programs were incorporating laparoscopy into their training. That’s really where we see the biggest jump. So it may be that what we are seeing is an increase in this procedure [laparoscopic colectomy], the same as what we saw with laparoscopic cholecystectomy.”

“Whatever you choose ... to believe about what’s driving this, what remains certain going forward is that routine elective colectomy is not supported by the most recent guidelines [from the American Society of Colon and Rectal Surgeons], and actually these guidelines are for the first time recommending that the decision to offer elective surgery be individualized,” Dr. Simianu noted.

“Our group is actually doing some neat work in this space trying to identify which metrics should be used to individualize surgery, so we look forward to sharing that with you in the future,” he added.

Session comoderator Dr. James J. Mezhir of the University of Iowa, Iowa City, asked, “It may be difficult, but are you able to look at general surgeons versus those who are colorectal trained?”

The database does not specify surgeon training, according to Dr. Simianu, who disclosed that he had no relevant conflicts of interest. “What is interesting is that in Washington State, about half the surgery is done laparoscopically, in recent years at least. Whether laparoscopy is lowering the threshold, we know that colorectal surgeons are trained to do more laparoscopic colectomy maybe than their general surgeon counterparts.”

Another state database has provided some additional relevant information, he noted. “When laparoscopy first started being adopted, we saw a spike in right-sided colon surgery, which was previously a pretty rare colectomy for diverticulitis. So it is hard to know who is sort of driving this.”

Dr. Mezhir also wanted to know, “How generalizable is this across the United States? Have you looked at something like the nationwide inpatient sample or some other data set to say whether this is something you are seeing in Washington or is this something across the U.S.?”

Similar national trends have been reported in studies using that database, according to Dr. Simianu. “One of the things they point out is that there is a spike in diverticulitis in the younger population, which is something we are seeing in Washington State as well,” he noted.

Another session attendee noted that patients with acute diverticulitis sometimes have immediate procedures, such as drainage, but then go on to have colectomy not long afterward. Thus, he wondered about misclassification, asking, “Are you capturing it as elective although it’s sorted out as an acute episode?”

“That’s a great question, said another way, are we actually just delaying things into the elective category, as opposed to operating on them emergently?” Dr. Simianu replied. “It’s a little hard to tell. We do know that during this time, rates of percutaneous drainage have gone up. So it’s sort of the same conclusion that we are doing more elective surgery but we are not really preventing complications. But I think the crux of that is when these patients have complications and have emergency surgery, they have it on their first episode, 80%-90% of them. So offering a delayed operation ... to prevent [complications] where the likelihood is highest of having a complication, doesn’t seem to bear out in the data.”

SAN FRANCISCO – Performance of more elective colectomies for diverticulitis in recent years does not seem to be preventing the need for emergent or urgent colectomies, investigators reported at the annual clinical congress of the American College of Surgeons.

The investigators analyzed data from the Comprehensive Hospital Abstract Reporting System (CHARS), a Washington State inpatient database, for the years 1987-2012.

Results showed that the age- and sex-adjusted rate of elective colectomies for diverticulitis increased from about 7 per 100,000 people to more than 20 per 100,000 people. But the rate of nonelective (emergent or urgent) colectomies for this indication remained fairly stable, if anything, increasing slightly.

Courtesy Wikimedia Commons/ Hellerhoff/Creative Commons

“Despite 15 years of evolving guidelines to operate less, we are actually seeing a threefold increase in elective colectomy for diverticulitis. We did not see a decrease in emergency surgery during the same time,” commented lead investigator Dr. Vlad V. Simianu, a research fellow in the department of surgery, University of Washington, Seattle.

Several hypotheses might explain this disconnect, he proposed: a rising incidence of diverticulitis, increasing severity of disease (although data do not support this), or surgeons’ adoption of a lower threshold for elective colectomy. “In fact, if you look at where the biggest climb in elective surgery was, it was sort of in the early 2000s, which was the time contemporaneous to when the first laparoscopic colorectal randomized trials were being published, and training programs were incorporating laparoscopy into their training. That’s really where we see the biggest jump. So it may be that what we are seeing is an increase in this procedure [laparoscopic colectomy], the same as what we saw with laparoscopic cholecystectomy.”

“Whatever you choose ... to believe about what’s driving this, what remains certain going forward is that routine elective colectomy is not supported by the most recent guidelines [from the American Society of Colon and Rectal Surgeons], and actually these guidelines are for the first time recommending that the decision to offer elective surgery be individualized,” Dr. Simianu noted.

“Our group is actually doing some neat work in this space trying to identify which metrics should be used to individualize surgery, so we look forward to sharing that with you in the future,” he added.

Session comoderator Dr. James J. Mezhir of the University of Iowa, Iowa City, asked, “It may be difficult, but are you able to look at general surgeons versus those who are colorectal trained?”

The database does not specify surgeon training, according to Dr. Simianu, who disclosed that he had no relevant conflicts of interest. “What is interesting is that in Washington State, about half the surgery is done laparoscopically, in recent years at least. Whether laparoscopy is lowering the threshold, we know that colorectal surgeons are trained to do more laparoscopic colectomy maybe than their general surgeon counterparts.”

Another state database has provided some additional relevant information, he noted. “When laparoscopy first started being adopted, we saw a spike in right-sided colon surgery, which was previously a pretty rare colectomy for diverticulitis. So it is hard to know who is sort of driving this.”

Dr. Mezhir also wanted to know, “How generalizable is this across the United States? Have you looked at something like the nationwide inpatient sample or some other data set to say whether this is something you are seeing in Washington or is this something across the U.S.?”

Similar national trends have been reported in studies using that database, according to Dr. Simianu. “One of the things they point out is that there is a spike in diverticulitis in the younger population, which is something we are seeing in Washington State as well,” he noted.

Another session attendee noted that patients with acute diverticulitis sometimes have immediate procedures, such as drainage, but then go on to have colectomy not long afterward. Thus, he wondered about misclassification, asking, “Are you capturing it as elective although it’s sorted out as an acute episode?”

“That’s a great question, said another way, are we actually just delaying things into the elective category, as opposed to operating on them emergently?” Dr. Simianu replied. “It’s a little hard to tell. We do know that during this time, rates of percutaneous drainage have gone up. So it’s sort of the same conclusion that we are doing more elective surgery but we are not really preventing complications. But I think the crux of that is when these patients have complications and have emergency surgery, they have it on their first episode, 80%-90% of them. So offering a delayed operation ... to prevent [complications] where the likelihood is highest of having a complication, doesn’t seem to bear out in the data.”

SAN FRANCISCO – Hospital charges are not a reliable indicator of quality of care for patients undergoing bariatric surgery, according to results from a cohort study reported at the annual clinical congress of the American College of Surgeons.

Researchers queried the SPARCS (New York Statewide Planning and Research Cooperative System) administrative database and identified 46,180 adult patients who underwent primary bariatric surgery between 2004 and 2010.

Charges for this same surgery differed by more than $10,000 between hospitals with low, bottom-tertile charges (less than $25,027) and hospitals with high, top-tertile charges (more than $35,449), reported Dr. Aurora D. Pryor, chief of the general surgery division and director of the Bariatric and Metabolic Weight Loss Center at the State University of New York at Stony Brook Medical Center.

High-charge hospitals were more often located in New York City or on Long Island. Low-charge hospitals more commonly performed a Roux-en-Y gastric bypass surgical procedure and had proportionately more patients with diabetes and liver disease.

Overall, 24% of the patients were operated on in hospitals with low charges, 26% in those with medium charges, and 50% in those with high charges.

In univariate analysis, the rate of major perioperative complications differed significantly, at 4.1%, 4.8%, and 3.75% for patients undergoing surgery in low-, medium-, and high-charge hospitals, respectively. But in multivariate analysis that controlled for patient demographics, comorbidities, insurance provider, and operative procedure, differences were no longer significant.

Additionally, the hospitals were statistically indistinguishable with respect to rates of 30-day mortality and mortality beyond that time point.

“Hospital charge does not correlate with outcomes following bariatric surgery. The initial differences we think are really based on the higher-risk patients and higher-risk operations performed at the lower-cost centers,” Dr. Pryor proposed.

“I think we should be paying attention to the charges. They vary by geographic location, and I think it’s the higher-cost areas that have the higher charges,” she commented.

Session attendee Dr. Mark Ott, a surgeon with Intermountain Healthcare in Murray, Utah, asked, “So do you think if the patients had that information that they would travel outside New York City to go to a lower-cost center?”

“I think they might actually do that,” Dr. Pryor replied. “In particular, some of the self-pay patients are driving into New York City because they think they’ll have a better outcome, and maybe they should actually pay attention to the outcomes at their local places more.”

Dr. Benedict C. Nwomeh, one of the session’s comoderators and a pediatric surgeon at Nationwide Children’s Hospital, Columbus, Ohio, asked, “So what do you think is responsible for this disparity in charges?”

“I honestly think it’s the city effect and the cost of living in those places, that they are able to charge more for their patients,” Dr. Pryor replied.

In an interview, Dr. Maureen A. Killackey, the other comoderator and clinical director of the New York-Presbyterian/Lawrence Hospital Cancer Center in Bronxville, N.Y., commented, “This study is quite provocative, and it also adds to the body of evidence that we already have, like in colonoscopy, on the variation in charges. This information probably needs to get to the attention of both the private payers as well as the governmental payers, because it really does show a tremendous discrepancy.”

“New York is a highly regulated state, and I think this would be perhaps very interesting to the governmental payers of the state to see these differences in both charges as well as practices, as well as the case-mix index and the geographic access and utilization of these services,” she added.

Dr. Pryor disclosed that she had no relevant conflicts of interest.

SAN FRANCISCO – Hospital charges are not a reliable indicator of quality of care for patients undergoing bariatric surgery, according to results from a cohort study reported at the annual clinical congress of the American College of Surgeons.

Researchers queried the SPARCS (New York Statewide Planning and Research Cooperative System) administrative database and identified 46,180 adult patients who underwent primary bariatric surgery between 2004 and 2010.

Charges for this same surgery differed by more than $10,000 between hospitals with low, bottom-tertile charges (less than $25,027) and hospitals with high, top-tertile charges (more than $35,449), reported Dr. Aurora D. Pryor, chief of the general surgery division and director of the Bariatric and Metabolic Weight Loss Center at the State University of New York at Stony Brook Medical Center.

High-charge hospitals were more often located in New York City or on Long Island. Low-charge hospitals more commonly performed a Roux-en-Y gastric bypass surgical procedure and had proportionately more patients with diabetes and liver disease.

Overall, 24% of the patients were operated on in hospitals with low charges, 26% in those with medium charges, and 50% in those with high charges.

In univariate analysis, the rate of major perioperative complications differed significantly, at 4.1%, 4.8%, and 3.75% for patients undergoing surgery in low-, medium-, and high-charge hospitals, respectively. But in multivariate analysis that controlled for patient demographics, comorbidities, insurance provider, and operative procedure, differences were no longer significant.

Additionally, the hospitals were statistically indistinguishable with respect to rates of 30-day mortality and mortality beyond that time point.

“Hospital charge does not correlate with outcomes following bariatric surgery. The initial differences we think are really based on the higher-risk patients and higher-risk operations performed at the lower-cost centers,” Dr. Pryor proposed.

“I think we should be paying attention to the charges. They vary by geographic location, and I think it’s the higher-cost areas that have the higher charges,” she commented.

Session attendee Dr. Mark Ott, a surgeon with Intermountain Healthcare in Murray, Utah, asked, “So do you think if the patients had that information that they would travel outside New York City to go to a lower-cost center?”

“I think they might actually do that,” Dr. Pryor replied. “In particular, some of the self-pay patients are driving into New York City because they think they’ll have a better outcome, and maybe they should actually pay attention to the outcomes at their local places more.”

Dr. Benedict C. Nwomeh, one of the session’s comoderators and a pediatric surgeon at Nationwide Children’s Hospital, Columbus, Ohio, asked, “So what do you think is responsible for this disparity in charges?”

“I honestly think it’s the city effect and the cost of living in those places, that they are able to charge more for their patients,” Dr. Pryor replied.

In an interview, Dr. Maureen A. Killackey, the other comoderator and clinical director of the New York-Presbyterian/Lawrence Hospital Cancer Center in Bronxville, N.Y., commented, “This study is quite provocative, and it also adds to the body of evidence that we already have, like in colonoscopy, on the variation in charges. This information probably needs to get to the attention of both the private payers as well as the governmental payers, because it really does show a tremendous discrepancy.”

“New York is a highly regulated state, and I think this would be perhaps very interesting to the governmental payers of the state to see these differences in both charges as well as practices, as well as the case-mix index and the geographic access and utilization of these services,” she added.

Dr. Pryor disclosed that she had no relevant conflicts of interest.

SAN FRANCISCO – Hospital charges are not a reliable indicator of quality of care for patients undergoing bariatric surgery, according to results from a cohort study reported at the annual clinical congress of the American College of Surgeons.

Researchers queried the SPARCS (New York Statewide Planning and Research Cooperative System) administrative database and identified 46,180 adult patients who underwent primary bariatric surgery between 2004 and 2010.

Charges for this same surgery differed by more than $10,000 between hospitals with low, bottom-tertile charges (less than $25,027) and hospitals with high, top-tertile charges (more than $35,449), reported Dr. Aurora D. Pryor, chief of the general surgery division and director of the Bariatric and Metabolic Weight Loss Center at the State University of New York at Stony Brook Medical Center.

High-charge hospitals were more often located in New York City or on Long Island. Low-charge hospitals more commonly performed a Roux-en-Y gastric bypass surgical procedure and had proportionately more patients with diabetes and liver disease.

Overall, 24% of the patients were operated on in hospitals with low charges, 26% in those with medium charges, and 50% in those with high charges.

In univariate analysis, the rate of major perioperative complications differed significantly, at 4.1%, 4.8%, and 3.75% for patients undergoing surgery in low-, medium-, and high-charge hospitals, respectively. But in multivariate analysis that controlled for patient demographics, comorbidities, insurance provider, and operative procedure, differences were no longer significant.

Additionally, the hospitals were statistically indistinguishable with respect to rates of 30-day mortality and mortality beyond that time point.

“Hospital charge does not correlate with outcomes following bariatric surgery. The initial differences we think are really based on the higher-risk patients and higher-risk operations performed at the lower-cost centers,” Dr. Pryor proposed.

“I think we should be paying attention to the charges. They vary by geographic location, and I think it’s the higher-cost areas that have the higher charges,” she commented.

Session attendee Dr. Mark Ott, a surgeon with Intermountain Healthcare in Murray, Utah, asked, “So do you think if the patients had that information that they would travel outside New York City to go to a lower-cost center?”

“I think they might actually do that,” Dr. Pryor replied. “In particular, some of the self-pay patients are driving into New York City because they think they’ll have a better outcome, and maybe they should actually pay attention to the outcomes at their local places more.”

Dr. Benedict C. Nwomeh, one of the session’s comoderators and a pediatric surgeon at Nationwide Children’s Hospital, Columbus, Ohio, asked, “So what do you think is responsible for this disparity in charges?”

“I honestly think it’s the city effect and the cost of living in those places, that they are able to charge more for their patients,” Dr. Pryor replied.

In an interview, Dr. Maureen A. Killackey, the other comoderator and clinical director of the New York-Presbyterian/Lawrence Hospital Cancer Center in Bronxville, N.Y., commented, “This study is quite provocative, and it also adds to the body of evidence that we already have, like in colonoscopy, on the variation in charges. This information probably needs to get to the attention of both the private payers as well as the governmental payers, because it really does show a tremendous discrepancy.”

“New York is a highly regulated state, and I think this would be perhaps very interesting to the governmental payers of the state to see these differences in both charges as well as practices, as well as the case-mix index and the geographic access and utilization of these services,” she added.

Dr. Pryor disclosed that she had no relevant conflicts of interest.

SAN FRANCISCO – Patients undergoing colorectal surgery have lower rates of complications and are 20% less likely to die if a fellow is involved in the surgery as compared with a senior resident, new data show.

“Advanced trainee level was associated with improved outcomes in colorectal surgery,” first author Dr. Lilian Chen concluded at the annual clinical congress of the American College of Surgeons, where she presented the data.

“Future studies should attempt to delineate the relative contributions of trainees on intraoperative and postoperative patient care and effects on outcome, and perhaps emphasis on appropriate case selection and resident involvement to optimize patient outcomes,” she recommended.

Using data from the National Surgical Quality Improvement Program (NSQIP), the investigators analyzed outcomes of 68,327 common open and laparoscopic abdominal colorectal operations done during 2005-2012 in which trainees participated.

Outcomes were compared for junior residents in postgraduate years 1 through 3 (involved in 23% of surgeries), senior residents in postgraduate years 4 and 5 (61%), and fellows in postgraduate years beyond year 5 (16%).

The prevalence of many surgical risk factors differed significantly across the three groups of trainees, but most differences were not considered clinically important, according to Dr. Chen, who is a fellow at the Lahey Hospital and Medical Center in Burlington, Mass. “The exceptions were systemic sepsis and emergency cases, where it appears that the fellows are doing proportionately less of these cases,” she noted.

Rates of several 30-day outcomes – septic shock, stroke, unplanned intubation, postoperative pneumonia, wound disruption, acute renal failure, deep incisional surgical site infection, and return to the operating room – differed significantly across groups, being less common for fellows than for either resident group.

The rate of mortality also differed significantly, at 2% for fellows but 4% each for junior and senior residents. In multivariate analysis, patients were significantly less likely to die if a fellow was involved in their surgery as compared with a senior resident (odds ratio, 0.80), but there was no significant difference between junior and senior residents.

“Our limitations include the retrospective analysis, and our inability to adjust for the type of hospital and training program, attending surgeon experience, the presence of subspecialty training in those programs, and the actual level of involvement of the trainee in intraoperative as well as postoperative care of patients,” acknowledged Dr. Chen, who disclosed that she had no relevant conflicts of interest.

Indeed, several session attendees took issue with potential confounders. Dr. Mary T. Hawn, chief of Gastrointestinal Surgery at the University of Alabama at Birmingham, commented, “I think you have to be really careful about understanding the data that you are working with. The first thing is that you can’t adjust for hospital characteristics, so you don’t know that a patient didn’t get transferred to a higher level of care, where there are residents available. ...

“So, I would say you should exclude all emergency cases, you should exclude all patients who are transferred, and things like that, and really try to do propensity adjustment or [seek] some reason that might explain what level of trainee is involved,” she recommended, noting that adjustment does not rule out a role for that factor. “I think this is really concerning because it’s harmful to our community programs to publish data like these, where we don’t really understand the true involvement or the mechanisms of why having the trainee there might be associated with higher mortality.”

Another attendee agreed, saying, “If I’m doing a case with a fellow, I’m going to let the fellow do it, and perhaps assisting, sometimes watching, while I let the fellow do it with the junior resident. If I’m in there with the junior resident, I’m doing the case while the junior resident is assisting me. So I think you need to take things like that into account when you think about what your data actually mean.”

Residents are commonly involved in nighttime emergency cases because the fellow is not at the hospital, a third attendee noted. Additionally, “the fellows will tend to cherry-pick the cases they want to do. The fellow is going to be involved in the cases that are more likely to be quality elective cases. So the diabetic on oxygen who’s coming in for the right colon is potentially going to get handed over to someone else to pick it up. So I would agree, I think that just publishing this and having that as your statement can be very harmful. You really need to be very objective and truthful about owning up to these confounding factors that you can’t really measure.”

“I have to completely agree with that, there are certainly things that we can’t prove. All we can say is that fellows are associated with this reduction in mortality, but we can’t say why ... ” Dr. Chen concurred. “I can’t say the fellow is the reason. There are too many variables involved, one of those being that if you have a colorectal fellow, you are probably at a specialty center with a colorectal fellowship or oncology fellowship and that could be the reason why you have lower mortality, better outcomes. It is just because of the staff and the facility that’s equipped to take those complex cases. So it could have nothing to do with the fellows at all.”

SAN FRANCISCO – Patients undergoing colorectal surgery have lower rates of complications and are 20% less likely to die if a fellow is involved in the surgery as compared with a senior resident, new data show.

“Advanced trainee level was associated with improved outcomes in colorectal surgery,” first author Dr. Lilian Chen concluded at the annual clinical congress of the American College of Surgeons, where she presented the data.

“Future studies should attempt to delineate the relative contributions of trainees on intraoperative and postoperative patient care and effects on outcome, and perhaps emphasis on appropriate case selection and resident involvement to optimize patient outcomes,” she recommended.

Using data from the National Surgical Quality Improvement Program (NSQIP), the investigators analyzed outcomes of 68,327 common open and laparoscopic abdominal colorectal operations done during 2005-2012 in which trainees participated.

Outcomes were compared for junior residents in postgraduate years 1 through 3 (involved in 23% of surgeries), senior residents in postgraduate years 4 and 5 (61%), and fellows in postgraduate years beyond year 5 (16%).

The prevalence of many surgical risk factors differed significantly across the three groups of trainees, but most differences were not considered clinically important, according to Dr. Chen, who is a fellow at the Lahey Hospital and Medical Center in Burlington, Mass. “The exceptions were systemic sepsis and emergency cases, where it appears that the fellows are doing proportionately less of these cases,” she noted.

Rates of several 30-day outcomes – septic shock, stroke, unplanned intubation, postoperative pneumonia, wound disruption, acute renal failure, deep incisional surgical site infection, and return to the operating room – differed significantly across groups, being less common for fellows than for either resident group.

The rate of mortality also differed significantly, at 2% for fellows but 4% each for junior and senior residents. In multivariate analysis, patients were significantly less likely to die if a fellow was involved in their surgery as compared with a senior resident (odds ratio, 0.80), but there was no significant difference between junior and senior residents.

“Our limitations include the retrospective analysis, and our inability to adjust for the type of hospital and training program, attending surgeon experience, the presence of subspecialty training in those programs, and the actual level of involvement of the trainee in intraoperative as well as postoperative care of patients,” acknowledged Dr. Chen, who disclosed that she had no relevant conflicts of interest.

Indeed, several session attendees took issue with potential confounders. Dr. Mary T. Hawn, chief of Gastrointestinal Surgery at the University of Alabama at Birmingham, commented, “I think you have to be really careful about understanding the data that you are working with. The first thing is that you can’t adjust for hospital characteristics, so you don’t know that a patient didn’t get transferred to a higher level of care, where there are residents available. ...

“So, I would say you should exclude all emergency cases, you should exclude all patients who are transferred, and things like that, and really try to do propensity adjustment or [seek] some reason that might explain what level of trainee is involved,” she recommended, noting that adjustment does not rule out a role for that factor. “I think this is really concerning because it’s harmful to our community programs to publish data like these, where we don’t really understand the true involvement or the mechanisms of why having the trainee there might be associated with higher mortality.”

Another attendee agreed, saying, “If I’m doing a case with a fellow, I’m going to let the fellow do it, and perhaps assisting, sometimes watching, while I let the fellow do it with the junior resident. If I’m in there with the junior resident, I’m doing the case while the junior resident is assisting me. So I think you need to take things like that into account when you think about what your data actually mean.”

Residents are commonly involved in nighttime emergency cases because the fellow is not at the hospital, a third attendee noted. Additionally, “the fellows will tend to cherry-pick the cases they want to do. The fellow is going to be involved in the cases that are more likely to be quality elective cases. So the diabetic on oxygen who’s coming in for the right colon is potentially going to get handed over to someone else to pick it up. So I would agree, I think that just publishing this and having that as your statement can be very harmful. You really need to be very objective and truthful about owning up to these confounding factors that you can’t really measure.”

“I have to completely agree with that, there are certainly things that we can’t prove. All we can say is that fellows are associated with this reduction in mortality, but we can’t say why ... ” Dr. Chen concurred. “I can’t say the fellow is the reason. There are too many variables involved, one of those being that if you have a colorectal fellow, you are probably at a specialty center with a colorectal fellowship or oncology fellowship and that could be the reason why you have lower mortality, better outcomes. It is just because of the staff and the facility that’s equipped to take those complex cases. So it could have nothing to do with the fellows at all.”

SAN FRANCISCO – Patients undergoing colorectal surgery have lower rates of complications and are 20% less likely to die if a fellow is involved in the surgery as compared with a senior resident, new data show.

“Advanced trainee level was associated with improved outcomes in colorectal surgery,” first author Dr. Lilian Chen concluded at the annual clinical congress of the American College of Surgeons, where she presented the data.

“Future studies should attempt to delineate the relative contributions of trainees on intraoperative and postoperative patient care and effects on outcome, and perhaps emphasis on appropriate case selection and resident involvement to optimize patient outcomes,” she recommended.

Using data from the National Surgical Quality Improvement Program (NSQIP), the investigators analyzed outcomes of 68,327 common open and laparoscopic abdominal colorectal operations done during 2005-2012 in which trainees participated.

Outcomes were compared for junior residents in postgraduate years 1 through 3 (involved in 23% of surgeries), senior residents in postgraduate years 4 and 5 (61%), and fellows in postgraduate years beyond year 5 (16%).

The prevalence of many surgical risk factors differed significantly across the three groups of trainees, but most differences were not considered clinically important, according to Dr. Chen, who is a fellow at the Lahey Hospital and Medical Center in Burlington, Mass. “The exceptions were systemic sepsis and emergency cases, where it appears that the fellows are doing proportionately less of these cases,” she noted.

Rates of several 30-day outcomes – septic shock, stroke, unplanned intubation, postoperative pneumonia, wound disruption, acute renal failure, deep incisional surgical site infection, and return to the operating room – differed significantly across groups, being less common for fellows than for either resident group.

The rate of mortality also differed significantly, at 2% for fellows but 4% each for junior and senior residents. In multivariate analysis, patients were significantly less likely to die if a fellow was involved in their surgery as compared with a senior resident (odds ratio, 0.80), but there was no significant difference between junior and senior residents.

“Our limitations include the retrospective analysis, and our inability to adjust for the type of hospital and training program, attending surgeon experience, the presence of subspecialty training in those programs, and the actual level of involvement of the trainee in intraoperative as well as postoperative care of patients,” acknowledged Dr. Chen, who disclosed that she had no relevant conflicts of interest.

Indeed, several session attendees took issue with potential confounders. Dr. Mary T. Hawn, chief of Gastrointestinal Surgery at the University of Alabama at Birmingham, commented, “I think you have to be really careful about understanding the data that you are working with. The first thing is that you can’t adjust for hospital characteristics, so you don’t know that a patient didn’t get transferred to a higher level of care, where there are residents available. ...

“So, I would say you should exclude all emergency cases, you should exclude all patients who are transferred, and things like that, and really try to do propensity adjustment or [seek] some reason that might explain what level of trainee is involved,” she recommended, noting that adjustment does not rule out a role for that factor. “I think this is really concerning because it’s harmful to our community programs to publish data like these, where we don’t really understand the true involvement or the mechanisms of why having the trainee there might be associated with higher mortality.”

Another attendee agreed, saying, “If I’m doing a case with a fellow, I’m going to let the fellow do it, and perhaps assisting, sometimes watching, while I let the fellow do it with the junior resident. If I’m in there with the junior resident, I’m doing the case while the junior resident is assisting me. So I think you need to take things like that into account when you think about what your data actually mean.”

Residents are commonly involved in nighttime emergency cases because the fellow is not at the hospital, a third attendee noted. Additionally, “the fellows will tend to cherry-pick the cases they want to do. The fellow is going to be involved in the cases that are more likely to be quality elective cases. So the diabetic on oxygen who’s coming in for the right colon is potentially going to get handed over to someone else to pick it up. So I would agree, I think that just publishing this and having that as your statement can be very harmful. You really need to be very objective and truthful about owning up to these confounding factors that you can’t really measure.”

“I have to completely agree with that, there are certainly things that we can’t prove. All we can say is that fellows are associated with this reduction in mortality, but we can’t say why ... ” Dr. Chen concurred. “I can’t say the fellow is the reason. There are too many variables involved, one of those being that if you have a colorectal fellow, you are probably at a specialty center with a colorectal fellowship or oncology fellowship and that could be the reason why you have lower mortality, better outcomes. It is just because of the staff and the facility that’s equipped to take those complex cases. So it could have nothing to do with the fellows at all.”

SAN FRANCISCO – Use of a shorter, more convenient course of radiation therapy for prostate cancer or a technique that spares blood vessels critical for sexual function yields good long-term quality of life outcomes, according to a pair of studies.

The results were reported at the annual meeting of the American Society for Radiation Oncology.

The first study, a multicenter phase I/II trial, tested hypofractionation among 343 men with low- or intermediate-risk prostate cancer.

Susan London/Frontline Medical News

“Dose escalation, or increasing the total dose delivered, in prostate cancer has been shown to be of benefit. This, however, translates into increased treatment times and patient cost,” lead investigator Jeffrey V. Brower, a radiation oncologist at the University of Wisconsin Carbone Cancer Center in Madison, explained in a press briefing. “Hypofractionation is a method of delivering greater dose per fraction and ultimately shorter treatment times, greater patient convenience, and overall cost benefit,” said Dr. Brower.

In the trial, men underwent intensity-modulated radiation therapy treating the prostate and base of the seminal vesicles, with one of three increasing dose-per-fraction regimens having similar predicted late toxicity: 22 fractions of 2.94 Gy each, 16 fractions of 3.63 Gy each, or 12 fractions of 4.3 Gy each. The schedules yielded a similar equivalent dose in 2-Gy fractions (75-77 Gy) and a similar tumor equivalent dose in 2-Gy fractions (82 to 85 Gy). Seventeen percent of the men also received androgen deprivation therapy.

Results showed the same temporal patterns and no significant differences across groups at 3 years in patient-reported bowel and bladder function, assessed with the Fox Chase Bowel/Bladder Toxicity questionnaire; sexual function, assessed with the International Index of Erectile Function; and overall quality of life, assessed with the Spitzer Quality of Life Index.

The only significant changes from baseline to 3 years were a worsening of bowel function in the 22-fraction group and a worsening of sexual function in the study population overall.

Meanwhile, efficacy results showed that the 5-year probability of biochemical progression-free survival ranged from 91% to 94%, with no significant difference across groups.

“These favorable patient-scored quality of life outcomes are consistent with our previously reported physician-scored acute and late toxicities, providing further support for hypofractionation safety and tolerability,” said Dr. Brower.

“The increased cost-effectiveness and patient convenience of hypofractionation, in conjunction with good quality of life outcomes, may be leveraged to drive implementation of these regimens into clinical practice,” he concluded.

Susan London/Frontline Medical News

The second study tested a vessel-sparing technique that uses magnetic resonance imaging with time-of-flight angiography to identify and minimize irradiation of critical erectile tissues near the prostate, with the aim of preserving sexual quality of life (Int. J. Radiat. Oncol. Biol. Phys. 2005;61:20-31).

“When I started my career 25 years ago, all we wanted to do was cure these very aggressive cancers. I don’t think the quality of life term even came into being until about 15 years ago. But as the cure rates went up, then we turned to quality of life concerns,” said presenting investigator Patrick (Bill) McLaughlin, a radiation oncologist at the University of Michigan Comprehensive Cancer Center, Ann Arbor.

Dr. McLaughlin and his associates tested the vessel-sparing technique among men with any-risk prostate cancer who had minimal erectile dysfunction at baseline; 42 received external beam radiation therapy alone and 49 received a combination of external beam radiation therapy plus brachytherapy.

The external beam radiation therapy, in the form of intensity-modulated radiation therapy, was given to a dose of 75.8 to 79.55 Gy, and the combination was given to a total dose of 90 Gy external equivalent. “We never compromised treatment in an attempt to spare these [critical erectile] structures. We took them into account, we tried to avoid them as much as possible, but we always gave full dose to the prostate,” Dr. McLaughlin stressed.

Sexual function was assessed with two measures: the International Index of Erectile Function, which specifically asks about erections sufficient for intercourse, and the three-item questionnaire (Q3), which asks only about ability to be sexually active, without specifying the nature of that activity.

“We had excellent, maybe even spectacular, function preservation … considering these were very-high-dose treatments on both arms,” he reported. “But interestingly, we had greater preservation on the scale that was not dependent on intercourse.”

Specifically, at 5 years, 64% of men in the external beam group and 63% in the combination group were able to have erection sufficient for intercourse with aids, usually sildenafil (Viagra) or tadalafil (Cialis). But a much higher percentage – 79% and 92%, respectively – were able to be sexually active with aids.

“The difference between those outcomes by metric implies sexual activity apart from intercourse,” Dr. McLaughlin said. “The gap between sexual intercourse and sexual activity demonstrates the limitations of this scale, the International Index of Erectile Function, in this age-group.”

This finding lends support to the new concept of manopause, the male equivalent of menopause, he said. “For many couples, [with aging,] sexual intercourse becomes difficult or even painful, so they shift to other activities. My shorthand for that is 69 at 69, and I usually get a knowing chuckle when I say that to couples. But many couples will say, ‘Well, we still take care of each other even though it’s not sexual intercourse.’ ”

The vessel-sparing radiation therapy also was associated with very high cure rates: 98% for low-risk prostate cancer, 96% for intermediate-risk prostate cancer, and 87% for high-risk prostate cancer.

“Typically, intensive treatments will cause quite a decrement in quality of life,” Dr. McLaughlin noted. “So to have this kind of ‘have your cake and eat it too’ result, of cure and quality of life, I think is very hopeful for men.”

In multivariate analysis, neither radiation therapy group nor any dose parameters predicted sexual outcomes. However, when analyses incorporated data from 44 men treated off protocol who also received hormone therapy, considered to be a major confounder, that therapy was indeed associated with poorer sexual function.

The vessel-sparing technique is probably not ready for routine use, according to Dr. McLaughlin. “I think it’s not the standard and I can’t say it should be the standard based on our study yet, even those these are spectacular sexual function preservation results.”

He and his colleagues have developed an online teaching tool, called Prostadoodle, that shows radiation oncologists how to define these critical vessels if they want to do so. “You can actually do it without doing an MRI if you learn the anatomy, and you can definitely approximate it. But to do it the way we did it actually was what I would consider a research protocol – a lot of effort for each patient, hours and hours even for each patient. It just wasn’t a simple thing to reproduce. I think it’s going to be a while before we can say, ‘You must do this.’ But I do think these results are very promising,” he said.

“Depending on the anatomy and where the disease is, it could really make a difference as to whether you could vessel spare or not,” said Dr. Colleen Lawton, professor and vice chair and clinical director, department of radiation oncology, Medical College of Wisconsin, Milwaukee, and moderator of the press briefing. “If you’ve got disease low in the prostate, what we call the apex, which is close to all of these vessels, you don’t want to miss the disease. So it’s going to be a balancing act.”

SAN FRANCISCO – Use of a shorter, more convenient course of radiation therapy for prostate cancer or a technique that spares blood vessels critical for sexual function yields good long-term quality of life outcomes, according to a pair of studies.

The results were reported at the annual meeting of the American Society for Radiation Oncology.

The first study, a multicenter phase I/II trial, tested hypofractionation among 343 men with low- or intermediate-risk prostate cancer.

Susan London/Frontline Medical News

“Dose escalation, or increasing the total dose delivered, in prostate cancer has been shown to be of benefit. This, however, translates into increased treatment times and patient cost,” lead investigator Jeffrey V. Brower, a radiation oncologist at the University of Wisconsin Carbone Cancer Center in Madison, explained in a press briefing. “Hypofractionation is a method of delivering greater dose per fraction and ultimately shorter treatment times, greater patient convenience, and overall cost benefit,” said Dr. Brower.

In the trial, men underwent intensity-modulated radiation therapy treating the prostate and base of the seminal vesicles, with one of three increasing dose-per-fraction regimens having similar predicted late toxicity: 22 fractions of 2.94 Gy each, 16 fractions of 3.63 Gy each, or 12 fractions of 4.3 Gy each. The schedules yielded a similar equivalent dose in 2-Gy fractions (75-77 Gy) and a similar tumor equivalent dose in 2-Gy fractions (82 to 85 Gy). Seventeen percent of the men also received androgen deprivation therapy.

Results showed the same temporal patterns and no significant differences across groups at 3 years in patient-reported bowel and bladder function, assessed with the Fox Chase Bowel/Bladder Toxicity questionnaire; sexual function, assessed with the International Index of Erectile Function; and overall quality of life, assessed with the Spitzer Quality of Life Index.

The only significant changes from baseline to 3 years were a worsening of bowel function in the 22-fraction group and a worsening of sexual function in the study population overall.

Meanwhile, efficacy results showed that the 5-year probability of biochemical progression-free survival ranged from 91% to 94%, with no significant difference across groups.

“These favorable patient-scored quality of life outcomes are consistent with our previously reported physician-scored acute and late toxicities, providing further support for hypofractionation safety and tolerability,” said Dr. Brower.

“The increased cost-effectiveness and patient convenience of hypofractionation, in conjunction with good quality of life outcomes, may be leveraged to drive implementation of these regimens into clinical practice,” he concluded.

Susan London/Frontline Medical News

The second study tested a vessel-sparing technique that uses magnetic resonance imaging with time-of-flight angiography to identify and minimize irradiation of critical erectile tissues near the prostate, with the aim of preserving sexual quality of life (Int. J. Radiat. Oncol. Biol. Phys. 2005;61:20-31).

“When I started my career 25 years ago, all we wanted to do was cure these very aggressive cancers. I don’t think the quality of life term even came into being until about 15 years ago. But as the cure rates went up, then we turned to quality of life concerns,” said presenting investigator Patrick (Bill) McLaughlin, a radiation oncologist at the University of Michigan Comprehensive Cancer Center, Ann Arbor.

Dr. McLaughlin and his associates tested the vessel-sparing technique among men with any-risk prostate cancer who had minimal erectile dysfunction at baseline; 42 received external beam radiation therapy alone and 49 received a combination of external beam radiation therapy plus brachytherapy.

The external beam radiation therapy, in the form of intensity-modulated radiation therapy, was given to a dose of 75.8 to 79.55 Gy, and the combination was given to a total dose of 90 Gy external equivalent. “We never compromised treatment in an attempt to spare these [critical erectile] structures. We took them into account, we tried to avoid them as much as possible, but we always gave full dose to the prostate,” Dr. McLaughlin stressed.

Sexual function was assessed with two measures: the International Index of Erectile Function, which specifically asks about erections sufficient for intercourse, and the three-item questionnaire (Q3), which asks only about ability to be sexually active, without specifying the nature of that activity.

“We had excellent, maybe even spectacular, function preservation … considering these were very-high-dose treatments on both arms,” he reported. “But interestingly, we had greater preservation on the scale that was not dependent on intercourse.”

Specifically, at 5 years, 64% of men in the external beam group and 63% in the combination group were able to have erection sufficient for intercourse with aids, usually sildenafil (Viagra) or tadalafil (Cialis). But a much higher percentage – 79% and 92%, respectively – were able to be sexually active with aids.

“The difference between those outcomes by metric implies sexual activity apart from intercourse,” Dr. McLaughlin said. “The gap between sexual intercourse and sexual activity demonstrates the limitations of this scale, the International Index of Erectile Function, in this age-group.”

This finding lends support to the new concept of manopause, the male equivalent of menopause, he said. “For many couples, [with aging,] sexual intercourse becomes difficult or even painful, so they shift to other activities. My shorthand for that is 69 at 69, and I usually get a knowing chuckle when I say that to couples. But many couples will say, ‘Well, we still take care of each other even though it’s not sexual intercourse.’ ”

The vessel-sparing radiation therapy also was associated with very high cure rates: 98% for low-risk prostate cancer, 96% for intermediate-risk prostate cancer, and 87% for high-risk prostate cancer.

“Typically, intensive treatments will cause quite a decrement in quality of life,” Dr. McLaughlin noted. “So to have this kind of ‘have your cake and eat it too’ result, of cure and quality of life, I think is very hopeful for men.”

In multivariate analysis, neither radiation therapy group nor any dose parameters predicted sexual outcomes. However, when analyses incorporated data from 44 men treated off protocol who also received hormone therapy, considered to be a major confounder, that therapy was indeed associated with poorer sexual function.

The vessel-sparing technique is probably not ready for routine use, according to Dr. McLaughlin. “I think it’s not the standard and I can’t say it should be the standard based on our study yet, even those these are spectacular sexual function preservation results.”

He and his colleagues have developed an online teaching tool, called Prostadoodle, that shows radiation oncologists how to define these critical vessels if they want to do so. “You can actually do it without doing an MRI if you learn the anatomy, and you can definitely approximate it. But to do it the way we did it actually was what I would consider a research protocol – a lot of effort for each patient, hours and hours even for each patient. It just wasn’t a simple thing to reproduce. I think it’s going to be a while before we can say, ‘You must do this.’ But I do think these results are very promising,” he said.

“Depending on the anatomy and where the disease is, it could really make a difference as to whether you could vessel spare or not,” said Dr. Colleen Lawton, professor and vice chair and clinical director, department of radiation oncology, Medical College of Wisconsin, Milwaukee, and moderator of the press briefing. “If you’ve got disease low in the prostate, what we call the apex, which is close to all of these vessels, you don’t want to miss the disease. So it’s going to be a balancing act.”

SAN FRANCISCO – Use of a shorter, more convenient course of radiation therapy for prostate cancer or a technique that spares blood vessels critical for sexual function yields good long-term quality of life outcomes, according to a pair of studies.

The results were reported at the annual meeting of the American Society for Radiation Oncology.

The first study, a multicenter phase I/II trial, tested hypofractionation among 343 men with low- or intermediate-risk prostate cancer.

Susan London/Frontline Medical News

“Dose escalation, or increasing the total dose delivered, in prostate cancer has been shown to be of benefit. This, however, translates into increased treatment times and patient cost,” lead investigator Jeffrey V. Brower, a radiation oncologist at the University of Wisconsin Carbone Cancer Center in Madison, explained in a press briefing. “Hypofractionation is a method of delivering greater dose per fraction and ultimately shorter treatment times, greater patient convenience, and overall cost benefit,” said Dr. Brower.

In the trial, men underwent intensity-modulated radiation therapy treating the prostate and base of the seminal vesicles, with one of three increasing dose-per-fraction regimens having similar predicted late toxicity: 22 fractions of 2.94 Gy each, 16 fractions of 3.63 Gy each, or 12 fractions of 4.3 Gy each. The schedules yielded a similar equivalent dose in 2-Gy fractions (75-77 Gy) and a similar tumor equivalent dose in 2-Gy fractions (82 to 85 Gy). Seventeen percent of the men also received androgen deprivation therapy.

Results showed the same temporal patterns and no significant differences across groups at 3 years in patient-reported bowel and bladder function, assessed with the Fox Chase Bowel/Bladder Toxicity questionnaire; sexual function, assessed with the International Index of Erectile Function; and overall quality of life, assessed with the Spitzer Quality of Life Index.

The only significant changes from baseline to 3 years were a worsening of bowel function in the 22-fraction group and a worsening of sexual function in the study population overall.

Meanwhile, efficacy results showed that the 5-year probability of biochemical progression-free survival ranged from 91% to 94%, with no significant difference across groups.

“These favorable patient-scored quality of life outcomes are consistent with our previously reported physician-scored acute and late toxicities, providing further support for hypofractionation safety and tolerability,” said Dr. Brower.

“The increased cost-effectiveness and patient convenience of hypofractionation, in conjunction with good quality of life outcomes, may be leveraged to drive implementation of these regimens into clinical practice,” he concluded.

Susan London/Frontline Medical News

The second study tested a vessel-sparing technique that uses magnetic resonance imaging with time-of-flight angiography to identify and minimize irradiation of critical erectile tissues near the prostate, with the aim of preserving sexual quality of life (Int. J. Radiat. Oncol. Biol. Phys. 2005;61:20-31).

“When I started my career 25 years ago, all we wanted to do was cure these very aggressive cancers. I don’t think the quality of life term even came into being until about 15 years ago. But as the cure rates went up, then we turned to quality of life concerns,” said presenting investigator Patrick (Bill) McLaughlin, a radiation oncologist at the University of Michigan Comprehensive Cancer Center, Ann Arbor.

Dr. McLaughlin and his associates tested the vessel-sparing technique among men with any-risk prostate cancer who had minimal erectile dysfunction at baseline; 42 received external beam radiation therapy alone and 49 received a combination of external beam radiation therapy plus brachytherapy.

The external beam radiation therapy, in the form of intensity-modulated radiation therapy, was given to a dose of 75.8 to 79.55 Gy, and the combination was given to a total dose of 90 Gy external equivalent. “We never compromised treatment in an attempt to spare these [critical erectile] structures. We took them into account, we tried to avoid them as much as possible, but we always gave full dose to the prostate,” Dr. McLaughlin stressed.

Sexual function was assessed with two measures: the International Index of Erectile Function, which specifically asks about erections sufficient for intercourse, and the three-item questionnaire (Q3), which asks only about ability to be sexually active, without specifying the nature of that activity.

“We had excellent, maybe even spectacular, function preservation … considering these were very-high-dose treatments on both arms,” he reported. “But interestingly, we had greater preservation on the scale that was not dependent on intercourse.”

Specifically, at 5 years, 64% of men in the external beam group and 63% in the combination group were able to have erection sufficient for intercourse with aids, usually sildenafil (Viagra) or tadalafil (Cialis). But a much higher percentage – 79% and 92%, respectively – were able to be sexually active with aids.

“The difference between those outcomes by metric implies sexual activity apart from intercourse,” Dr. McLaughlin said. “The gap between sexual intercourse and sexual activity demonstrates the limitations of this scale, the International Index of Erectile Function, in this age-group.”

This finding lends support to the new concept of manopause, the male equivalent of menopause, he said. “For many couples, [with aging,] sexual intercourse becomes difficult or even painful, so they shift to other activities. My shorthand for that is 69 at 69, and I usually get a knowing chuckle when I say that to couples. But many couples will say, ‘Well, we still take care of each other even though it’s not sexual intercourse.’ ”

The vessel-sparing radiation therapy also was associated with very high cure rates: 98% for low-risk prostate cancer, 96% for intermediate-risk prostate cancer, and 87% for high-risk prostate cancer.

“Typically, intensive treatments will cause quite a decrement in quality of life,” Dr. McLaughlin noted. “So to have this kind of ‘have your cake and eat it too’ result, of cure and quality of life, I think is very hopeful for men.”

In multivariate analysis, neither radiation therapy group nor any dose parameters predicted sexual outcomes. However, when analyses incorporated data from 44 men treated off protocol who also received hormone therapy, considered to be a major confounder, that therapy was indeed associated with poorer sexual function.

The vessel-sparing technique is probably not ready for routine use, according to Dr. McLaughlin. “I think it’s not the standard and I can’t say it should be the standard based on our study yet, even those these are spectacular sexual function preservation results.”

He and his colleagues have developed an online teaching tool, called Prostadoodle, that shows radiation oncologists how to define these critical vessels if they want to do so. “You can actually do it without doing an MRI if you learn the anatomy, and you can definitely approximate it. But to do it the way we did it actually was what I would consider a research protocol – a lot of effort for each patient, hours and hours even for each patient. It just wasn’t a simple thing to reproduce. I think it’s going to be a while before we can say, ‘You must do this.’ But I do think these results are very promising,” he said.

“Depending on the anatomy and where the disease is, it could really make a difference as to whether you could vessel spare or not,” said Dr. Colleen Lawton, professor and vice chair and clinical director, department of radiation oncology, Medical College of Wisconsin, Milwaukee, and moderator of the press briefing. “If you’ve got disease low in the prostate, what we call the apex, which is close to all of these vessels, you don’t want to miss the disease. So it’s going to be a balancing act.”

SAN FRANCISCO – Chemoradiotherapy is not superior to radiotherapy alone for alleviating dysphagia in patients with advanced esophageal cancer. And it causes more nausea and vomiting.

These were among key findings of a randomized phase III trial reported in a session and a related press briefing at the annual meeting of the American Society for Radiation Oncology.

“This trial was powered to see if there was an improvement with chemotherapy, and it wasn’t powered to show equivalence, so it was a truly negative trial. However, we do know that chemotherapy added some toxicity and didn’t improve the quality of life parameters that we were looking at,” commented lead researcher Dr. Michael G. Penniment, director of Radiation Oncology at both the Royal Adelaide Hospital in Adelaide, Australia, and the Alan Walker Cancer Care Centre in Darwin, Australia.

ASTRO/Adam Donohue

“So I think that we can clearly say that radiotherapy alone remains an excellent tool for palliation of these patients with advanced esophageal cancer and should remain the standard of care,” he maintained. “And if you combine that with the fact that we have a proven role [for radiation] in patients who have curable esophageal cancer, I would say that all patients with esophageal cancer should have the opinion of a radiation oncologist, though I’m a little biased.”

There is no gold standard when it comes to palliative care for patients with advanced esophageal cancer, according to Dr. Penniment. “We can’t even explain to these patients facing a very difficult phase of their life what exactly the results of fairly basic treatments are. We need to give them better information about the chances the treatments we offer will actually help them and perhaps some more evidence about which patients fit into this group,” he said, giving some background to the research.

In the trial, 220 patients from Australia, New Zealand, Canada, and the United Kingdom with advanced esophageal cancer were randomized evenly to receive palliative radiation therapy — 30 Gy in 10 fractions or 35 Gy in 15 fractions, depending on the country — either alone or with concomitant chemotherapy. Three-fourths of the patients had metastases, and the rest had locally advanced tumors.

At 9 weeks after the start of radiation therapy, the proportion of patients whose dysphagia responded to treatment, which was defined as an improvement of at least 1 point on the 5-point Mellow Scale, was 68% with radiation alone and 74% with chemoradiation, a nonsignificant difference.

The respective proportions with a sustained response at 13 weeks, the trial’s primary endpoint, were 42% and 47%, also a nonsignificant difference.

But some patients did not live even this long, Dr. Penniment noted. “So there is a group of people we hope to be able to identify who really do exceedingly badly and it might be that simple radiotherapy, such as a single fraction, might be enough for those patients. Or indeed, unfortunately, there might be some people with such poor prognostic signs that a tube might do them if it’s only a week or something like that,” he said.

The 3-year rates of dysphagia, progression-free survival, and overall survival were statistically indistinguishable between groups. Median overall survival was 203 days with radiation and 210 days with chemoradiation.

On a bright note, however, there was a tail to the survival curve, with about 10% of patients in each group still alive at 2 years. “I think there is a message here,” Dr. Penniment said. “You don’t want to give people false hope, but there is certainly a group of patients who have advanced esophageal cancer with or without lymph node involvement for whom potential active cancer treatment may actually cause a reasonably long-term survival and local control. I suspect that this tail to the survival curve would probably not be seen in patients who are offered certainly no treatment, but people who are offered bypass with a stent or bypass tubes. And these are clearly patients that we would not go on to see.”

In quality of life assessments, 64% of patients treated with radiation alone and 50% of patients treated with chemoradiation had an improvement in the dysphagia domain on the esophageal module of the European Organisation for Research and Treatment of Cancer quality of life questionnaire (QLQ-OES18), a nonsignificant difference.

However, relative to the radiation group, the chemoradiation group had higher rates of both nausea and vomiting (P less than .01 for each).

Some patients who received radiotherapy alone went on to receive chemotherapy, according to Dr. Penniment, who reported having no financial disclosures. “The majority of those patients had no dysphagia but still got chemotherapy after radiotherapy alone. We will do more analysis on this, but I think there is a fixed belief, which hopefully this trial starts to break, that these people need to have chemotherapy,” he said.

SAN FRANCISCO – Chemoradiotherapy is not superior to radiotherapy alone for alleviating dysphagia in patients with advanced esophageal cancer. And it causes more nausea and vomiting.

These were among key findings of a randomized phase III trial reported in a session and a related press briefing at the annual meeting of the American Society for Radiation Oncology.

“This trial was powered to see if there was an improvement with chemotherapy, and it wasn’t powered to show equivalence, so it was a truly negative trial. However, we do know that chemotherapy added some toxicity and didn’t improve the quality of life parameters that we were looking at,” commented lead researcher Dr. Michael G. Penniment, director of Radiation Oncology at both the Royal Adelaide Hospital in Adelaide, Australia, and the Alan Walker Cancer Care Centre in Darwin, Australia.

ASTRO/Adam Donohue

“So I think that we can clearly say that radiotherapy alone remains an excellent tool for palliation of these patients with advanced esophageal cancer and should remain the standard of care,” he maintained. “And if you combine that with the fact that we have a proven role [for radiation] in patients who have curable esophageal cancer, I would say that all patients with esophageal cancer should have the opinion of a radiation oncologist, though I’m a little biased.”

There is no gold standard when it comes to palliative care for patients with advanced esophageal cancer, according to Dr. Penniment. “We can’t even explain to these patients facing a very difficult phase of their life what exactly the results of fairly basic treatments are. We need to give them better information about the chances the treatments we offer will actually help them and perhaps some more evidence about which patients fit into this group,” he said, giving some background to the research.

In the trial, 220 patients from Australia, New Zealand, Canada, and the United Kingdom with advanced esophageal cancer were randomized evenly to receive palliative radiation therapy — 30 Gy in 10 fractions or 35 Gy in 15 fractions, depending on the country — either alone or with concomitant chemotherapy. Three-fourths of the patients had metastases, and the rest had locally advanced tumors.

At 9 weeks after the start of radiation therapy, the proportion of patients whose dysphagia responded to treatment, which was defined as an improvement of at least 1 point on the 5-point Mellow Scale, was 68% with radiation alone and 74% with chemoradiation, a nonsignificant difference.

The respective proportions with a sustained response at 13 weeks, the trial’s primary endpoint, were 42% and 47%, also a nonsignificant difference.

But some patients did not live even this long, Dr. Penniment noted. “So there is a group of people we hope to be able to identify who really do exceedingly badly and it might be that simple radiotherapy, such as a single fraction, might be enough for those patients. Or indeed, unfortunately, there might be some people with such poor prognostic signs that a tube might do them if it’s only a week or something like that,” he said.

The 3-year rates of dysphagia, progression-free survival, and overall survival were statistically indistinguishable between groups. Median overall survival was 203 days with radiation and 210 days with chemoradiation.

On a bright note, however, there was a tail to the survival curve, with about 10% of patients in each group still alive at 2 years. “I think there is a message here,” Dr. Penniment said. “You don’t want to give people false hope, but there is certainly a group of patients who have advanced esophageal cancer with or without lymph node involvement for whom potential active cancer treatment may actually cause a reasonably long-term survival and local control. I suspect that this tail to the survival curve would probably not be seen in patients who are offered certainly no treatment, but people who are offered bypass with a stent or bypass tubes. And these are clearly patients that we would not go on to see.”

In quality of life assessments, 64% of patients treated with radiation alone and 50% of patients treated with chemoradiation had an improvement in the dysphagia domain on the esophageal module of the European Organisation for Research and Treatment of Cancer quality of life questionnaire (QLQ-OES18), a nonsignificant difference.

However, relative to the radiation group, the chemoradiation group had higher rates of both nausea and vomiting (P less than .01 for each).

Some patients who received radiotherapy alone went on to receive chemotherapy, according to Dr. Penniment, who reported having no financial disclosures. “The majority of those patients had no dysphagia but still got chemotherapy after radiotherapy alone. We will do more analysis on this, but I think there is a fixed belief, which hopefully this trial starts to break, that these people need to have chemotherapy,” he said.

SAN FRANCISCO – Chemoradiotherapy is not superior to radiotherapy alone for alleviating dysphagia in patients with advanced esophageal cancer. And it causes more nausea and vomiting.

These were among key findings of a randomized phase III trial reported in a session and a related press briefing at the annual meeting of the American Society for Radiation Oncology.

“This trial was powered to see if there was an improvement with chemotherapy, and it wasn’t powered to show equivalence, so it was a truly negative trial. However, we do know that chemotherapy added some toxicity and didn’t improve the quality of life parameters that we were looking at,” commented lead researcher Dr. Michael G. Penniment, director of Radiation Oncology at both the Royal Adelaide Hospital in Adelaide, Australia, and the Alan Walker Cancer Care Centre in Darwin, Australia.

ASTRO/Adam Donohue

“So I think that we can clearly say that radiotherapy alone remains an excellent tool for palliation of these patients with advanced esophageal cancer and should remain the standard of care,” he maintained. “And if you combine that with the fact that we have a proven role [for radiation] in patients who have curable esophageal cancer, I would say that all patients with esophageal cancer should have the opinion of a radiation oncologist, though I’m a little biased.”

There is no gold standard when it comes to palliative care for patients with advanced esophageal cancer, according to Dr. Penniment. “We can’t even explain to these patients facing a very difficult phase of their life what exactly the results of fairly basic treatments are. We need to give them better information about the chances the treatments we offer will actually help them and perhaps some more evidence about which patients fit into this group,” he said, giving some background to the research.

In the trial, 220 patients from Australia, New Zealand, Canada, and the United Kingdom with advanced esophageal cancer were randomized evenly to receive palliative radiation therapy — 30 Gy in 10 fractions or 35 Gy in 15 fractions, depending on the country — either alone or with concomitant chemotherapy. Three-fourths of the patients had metastases, and the rest had locally advanced tumors.

At 9 weeks after the start of radiation therapy, the proportion of patients whose dysphagia responded to treatment, which was defined as an improvement of at least 1 point on the 5-point Mellow Scale, was 68% with radiation alone and 74% with chemoradiation, a nonsignificant difference.

The respective proportions with a sustained response at 13 weeks, the trial’s primary endpoint, were 42% and 47%, also a nonsignificant difference.

But some patients did not live even this long, Dr. Penniment noted. “So there is a group of people we hope to be able to identify who really do exceedingly badly and it might be that simple radiotherapy, such as a single fraction, might be enough for those patients. Or indeed, unfortunately, there might be some people with such poor prognostic signs that a tube might do them if it’s only a week or something like that,” he said.

The 3-year rates of dysphagia, progression-free survival, and overall survival were statistically indistinguishable between groups. Median overall survival was 203 days with radiation and 210 days with chemoradiation.

On a bright note, however, there was a tail to the survival curve, with about 10% of patients in each group still alive at 2 years. “I think there is a message here,” Dr. Penniment said. “You don’t want to give people false hope, but there is certainly a group of patients who have advanced esophageal cancer with or without lymph node involvement for whom potential active cancer treatment may actually cause a reasonably long-term survival and local control. I suspect that this tail to the survival curve would probably not be seen in patients who are offered certainly no treatment, but people who are offered bypass with a stent or bypass tubes. And these are clearly patients that we would not go on to see.”

In quality of life assessments, 64% of patients treated with radiation alone and 50% of patients treated with chemoradiation had an improvement in the dysphagia domain on the esophageal module of the European Organisation for Research and Treatment of Cancer quality of life questionnaire (QLQ-OES18), a nonsignificant difference.

However, relative to the radiation group, the chemoradiation group had higher rates of both nausea and vomiting (P less than .01 for each).

Some patients who received radiotherapy alone went on to receive chemotherapy, according to Dr. Penniment, who reported having no financial disclosures. “The majority of those patients had no dysphagia but still got chemotherapy after radiotherapy alone. We will do more analysis on this, but I think there is a fixed belief, which hopefully this trial starts to break, that these people need to have chemotherapy,” he said.

SAN FRANCISCO – Men who undergo radiation therapy for high-risk prostate cancer are less likely to have a recurrence and to die if they also receive long-duration androgen deprivation therapy. A long duration roughly half of that typically used appears to strike a good balance between efficacy and quality of life.

These were among the key findings of a pair of phase III randomized trials reported at the annual scientific meeting of the American Society for Radiation Oncology.

“Quantity of life became the most important piece for us as we were trying to control prostate cancer. But today, so many of our localized prostate cancer patients are going to survive their illness that quality of life becomes exceedingly important,” said Dr. Colleen Lawton, vice chair and clinical director of the department of radiation oncology at the Medical College of Wisconsin, Milwaukee, and moderator of a related press briefing.

Efficacy data support long-duration ADT

In the first trial, called DART 01/05 (or AADLPC) and supported in part by the AstraZeneca Fund, investigators led by Dr. Almudena Zapatero, a radiation oncologist at Hospital Universitario de la Princesa, Madrid, studied 355 patients with intermediate- or high-risk prostate cancer.

The patients were randomized evenly to high-dose radiation therapy of at least 76 Gy, plus either short-duration ADT (4 months before and during radiation only) or long-duration ADT (4 months before and during radiation and 24 months afterward).

With a median follow-up of 63 months, relative to short-duration ADT, long-duration ADT was associated with better 5-year rates of biochemical disease–free survival according to the Phoenix definition (89.8% vs. 81.3%), overall survival (94.8% vs. 86.1%), and metastasis-free survival (93.6% vs. 83.4%), reported Dr. Zapatero. However, in stratified analyses, these benefits were seen only in the men with high-risk disease.

The two treatment groups did not differ significantly with respect to rates of acute and late rectal and urinary toxicity.

The study is noteworthy as it supports use of more costly high-dose radiation and hormonal therapy, said Dr. Zapatero. “We have demonstrated that we can get a 10% absolute benefit in PSA [prostate-specific antigen] control and overall survival and cancer-specific survival with acceptably low complications for high-risk disease. This is what we know now. We now know that … intermediate-risk disease probably doesn’t need any complementary [hormone therapy],” she said.

“We await longer follow-up to confirm these results and to determine the impact of long-term hormones according to the risk subgroup,” added Dr. Zapatero, noting that high-risk patients can be further stratified according to T3 stage, high Gleason score, and undifferentiated tumor histology. “Probably, if you have one factor, you are going to need less long of a duration of hormones, probably close to 18 months. And if you have two or three, what we call very high risk disease, you are going to need longer hormone therapy and the highest radiation [dose].”

Explaining the importance of the findings, Dr. Lawton, the press briefing moderator, said, “We have shown over time that increasing the dose [of radiation] to the prostate and immediate surrounding tissues improves outcomes. We have also shown for our high-risk patients that adding hormone therapy improves outcomes. But what we have yet to show is … do you really need the hormone therapy if you use dose escalation? And the answer is yes.”

Shortening duration of ADT improves testosterone recovery

In the second trial, known as PCS IV, investigators led by Dr. Abdenour Nabid, a radiation oncologist at Centre Hospitalier Universitaire de Sherbrooke, Quebec, Canada, studied 561 men with high-risk prostate cancer who had been treated with radiation therapy (44 Gy to the whole pelvis and 70 Gy to the prostate) and randomized to 18 months or 36 months of ADT. AstraZeneca collaborated on the trial.

Previously reported results suggested that 18 months was just as efficacious as 36 months for overall survival and cancer-specific survival (ASCO 2013 Annual Meeting. Abstract LBA4510).

With a median follow-up of 84 months, relative to counterparts who had received ADT for 36 months, patients who had received ADT for 18 months were more likely to have recovery of testosterone values into the normal range (55.7% vs. 44.9%, P = .01) and had a shorter median time to recovery (47.2 vs. 73.2 months, P less than .001).

Relative to counterparts who did not have testosterone recovery, patients who did had significantly better scores on 18 of 30 items on the European Organization for Research and Treatment of Cancer’s global quality of life questionnaire (EORTC30) (P less than .01 for each) and on 10 of 25 items on the related Prostate Module (PR25) (P less than .01 for each).

Clinically relevant differences, defined as ones of at least 10 points on the 100-point linearly transformed scales, were seen between men who did and did not have testosterone recovery for two of the global quality of life items – trouble doing strenuous activities and trouble taking long walks – and three of the prostate-related quality of life items – hot flushes, interest in sex, and sexual activity.

“In high-risk prostate cancer treated with radiation therapy and ADT, patients who recover normal testosterone levels have a better quality of life,” said Dr. Nabid. “There is a major advantage in the use of 18 months of ADT instead of 36 months since a higher proportion of patients recovered normal testosterone levels in a much shorter time without any apparent detriment in long-term outcomes.”

“If we succeed to demonstrate that 18 months is at least equal to 36 months, it’s a big jump because it’s a matter of quality of life, it’s a matter of cost also,” he added. The investigators expect to be able to publish final efficacy and quality of life results next year.

In the meantime, clinicians can follow national guidelines, according to Dr. Nabid. “If you look at the guidelines, like the NCCN guidelines for the U.S., what is written is that the long-term [ADT] could be between 24 and 36 months. So my advice would be, even if you wait for the final paper, to go for 24 months. It’s a good beginning,” he asserted.

However, “you have to use your clinical judgment,” he added, agreeing that disease factors can be used to further stratify high-risk patients; additionally, age, comorbidities, and other factors will play a role in tailoring the duration of ADT. And importantly, “one has to discuss this with his patients.”

Dr. Lawton noted that the definition of long-duration ADT has varied by world region, and has typically been 28 months in the United States and 36 months in Europe. On the basis of this trial’s findings, “I do think that 18 months is potentially our new long-term hormone therapy option. That data isn’t out in print yet, other than in abstract form, But I think going forward, the question for us should be, can we shorten it from there,” she said. “I don’t know that we’ve nailed [the optimal long duration], but we are certainly heading in the right direction.”

Dr. Zapatero disclosed no conflicts of interest; the trial was supported in part by the AstraZeneca Fund. Dr. Nabid disclosed ties with AstraZeneca and Sanofi; AstraZeneca collaborated on the trial.

SAN FRANCISCO – Men who undergo radiation therapy for high-risk prostate cancer are less likely to have a recurrence and to die if they also receive long-duration androgen deprivation therapy. A long duration roughly half of that typically used appears to strike a good balance between efficacy and quality of life.

These were among the key findings of a pair of phase III randomized trials reported at the annual scientific meeting of the American Society for Radiation Oncology.

“Quantity of life became the most important piece for us as we were trying to control prostate cancer. But today, so many of our localized prostate cancer patients are going to survive their illness that quality of life becomes exceedingly important,” said Dr. Colleen Lawton, vice chair and clinical director of the department of radiation oncology at the Medical College of Wisconsin, Milwaukee, and moderator of a related press briefing.

Efficacy data support long-duration ADT

In the first trial, called DART 01/05 (or AADLPC) and supported in part by the AstraZeneca Fund, investigators led by Dr. Almudena Zapatero, a radiation oncologist at Hospital Universitario de la Princesa, Madrid, studied 355 patients with intermediate- or high-risk prostate cancer.

The patients were randomized evenly to high-dose radiation therapy of at least 76 Gy, plus either short-duration ADT (4 months before and during radiation only) or long-duration ADT (4 months before and during radiation and 24 months afterward).

With a median follow-up of 63 months, relative to short-duration ADT, long-duration ADT was associated with better 5-year rates of biochemical disease–free survival according to the Phoenix definition (89.8% vs. 81.3%), overall survival (94.8% vs. 86.1%), and metastasis-free survival (93.6% vs. 83.4%), reported Dr. Zapatero. However, in stratified analyses, these benefits were seen only in the men with high-risk disease.

The two treatment groups did not differ significantly with respect to rates of acute and late rectal and urinary toxicity.

The study is noteworthy as it supports use of more costly high-dose radiation and hormonal therapy, said Dr. Zapatero. “We have demonstrated that we can get a 10% absolute benefit in PSA [prostate-specific antigen] control and overall survival and cancer-specific survival with acceptably low complications for high-risk disease. This is what we know now. We now know that … intermediate-risk disease probably doesn’t need any complementary [hormone therapy],” she said.

“We await longer follow-up to confirm these results and to determine the impact of long-term hormones according to the risk subgroup,” added Dr. Zapatero, noting that high-risk patients can be further stratified according to T3 stage, high Gleason score, and undifferentiated tumor histology. “Probably, if you have one factor, you are going to need less long of a duration of hormones, probably close to 18 months. And if you have two or three, what we call very high risk disease, you are going to need longer hormone therapy and the highest radiation [dose].”

Explaining the importance of the findings, Dr. Lawton, the press briefing moderator, said, “We have shown over time that increasing the dose [of radiation] to the prostate and immediate surrounding tissues improves outcomes. We have also shown for our high-risk patients that adding hormone therapy improves outcomes. But what we have yet to show is … do you really need the hormone therapy if you use dose escalation? And the answer is yes.”

Shortening duration of ADT improves testosterone recovery

In the second trial, known as PCS IV, investigators led by Dr. Abdenour Nabid, a radiation oncologist at Centre Hospitalier Universitaire de Sherbrooke, Quebec, Canada, studied 561 men with high-risk prostate cancer who had been treated with radiation therapy (44 Gy to the whole pelvis and 70 Gy to the prostate) and randomized to 18 months or 36 months of ADT. AstraZeneca collaborated on the trial.

Previously reported results suggested that 18 months was just as efficacious as 36 months for overall survival and cancer-specific survival (ASCO 2013 Annual Meeting. Abstract LBA4510).

With a median follow-up of 84 months, relative to counterparts who had received ADT for 36 months, patients who had received ADT for 18 months were more likely to have recovery of testosterone values into the normal range (55.7% vs. 44.9%, P = .01) and had a shorter median time to recovery (47.2 vs. 73.2 months, P less than .001).

Relative to counterparts who did not have testosterone recovery, patients who did had significantly better scores on 18 of 30 items on the European Organization for Research and Treatment of Cancer’s global quality of life questionnaire (EORTC30) (P less than .01 for each) and on 10 of 25 items on the related Prostate Module (PR25) (P less than .01 for each).

Clinically relevant differences, defined as ones of at least 10 points on the 100-point linearly transformed scales, were seen between men who did and did not have testosterone recovery for two of the global quality of life items – trouble doing strenuous activities and trouble taking long walks – and three of the prostate-related quality of life items – hot flushes, interest in sex, and sexual activity.

“In high-risk prostate cancer treated with radiation therapy and ADT, patients who recover normal testosterone levels have a better quality of life,” said Dr. Nabid. “There is a major advantage in the use of 18 months of ADT instead of 36 months since a higher proportion of patients recovered normal testosterone levels in a much shorter time without any apparent detriment in long-term outcomes.”

“If we succeed to demonstrate that 18 months is at least equal to 36 months, it’s a big jump because it’s a matter of quality of life, it’s a matter of cost also,” he added. The investigators expect to be able to publish final efficacy and quality of life results next year.

In the meantime, clinicians can follow national guidelines, according to Dr. Nabid. “If you look at the guidelines, like the NCCN guidelines for the U.S., what is written is that the long-term [ADT] could be between 24 and 36 months. So my advice would be, even if you wait for the final paper, to go for 24 months. It’s a good beginning,” he asserted.

However, “you have to use your clinical judgment,” he added, agreeing that disease factors can be used to further stratify high-risk patients; additionally, age, comorbidities, and other factors will play a role in tailoring the duration of ADT. And importantly, “one has to discuss this with his patients.”

Dr. Lawton noted that the definition of long-duration ADT has varied by world region, and has typically been 28 months in the United States and 36 months in Europe. On the basis of this trial’s findings, “I do think that 18 months is potentially our new long-term hormone therapy option. That data isn’t out in print yet, other than in abstract form, But I think going forward, the question for us should be, can we shorten it from there,” she said. “I don’t know that we’ve nailed [the optimal long duration], but we are certainly heading in the right direction.”

Dr. Zapatero disclosed no conflicts of interest; the trial was supported in part by the AstraZeneca Fund. Dr. Nabid disclosed ties with AstraZeneca and Sanofi; AstraZeneca collaborated on the trial.

SAN FRANCISCO – Men who undergo radiation therapy for high-risk prostate cancer are less likely to have a recurrence and to die if they also receive long-duration androgen deprivation therapy. A long duration roughly half of that typically used appears to strike a good balance between efficacy and quality of life.

These were among the key findings of a pair of phase III randomized trials reported at the annual scientific meeting of the American Society for Radiation Oncology.

“Quantity of life became the most important piece for us as we were trying to control prostate cancer. But today, so many of our localized prostate cancer patients are going to survive their illness that quality of life becomes exceedingly important,” said Dr. Colleen Lawton, vice chair and clinical director of the department of radiation oncology at the Medical College of Wisconsin, Milwaukee, and moderator of a related press briefing.

Efficacy data support long-duration ADT

In the first trial, called DART 01/05 (or AADLPC) and supported in part by the AstraZeneca Fund, investigators led by Dr. Almudena Zapatero, a radiation oncologist at Hospital Universitario de la Princesa, Madrid, studied 355 patients with intermediate- or high-risk prostate cancer.

The patients were randomized evenly to high-dose radiation therapy of at least 76 Gy, plus either short-duration ADT (4 months before and during radiation only) or long-duration ADT (4 months before and during radiation and 24 months afterward).

With a median follow-up of 63 months, relative to short-duration ADT, long-duration ADT was associated with better 5-year rates of biochemical disease–free survival according to the Phoenix definition (89.8% vs. 81.3%), overall survival (94.8% vs. 86.1%), and metastasis-free survival (93.6% vs. 83.4%), reported Dr. Zapatero. However, in stratified analyses, these benefits were seen only in the men with high-risk disease.

The two treatment groups did not differ significantly with respect to rates of acute and late rectal and urinary toxicity.

The study is noteworthy as it supports use of more costly high-dose radiation and hormonal therapy, said Dr. Zapatero. “We have demonstrated that we can get a 10% absolute benefit in PSA [prostate-specific antigen] control and overall survival and cancer-specific survival with acceptably low complications for high-risk disease. This is what we know now. We now know that … intermediate-risk disease probably doesn’t need any complementary [hormone therapy],” she said.

“We await longer follow-up to confirm these results and to determine the impact of long-term hormones according to the risk subgroup,” added Dr. Zapatero, noting that high-risk patients can be further stratified according to T3 stage, high Gleason score, and undifferentiated tumor histology. “Probably, if you have one factor, you are going to need less long of a duration of hormones, probably close to 18 months. And if you have two or three, what we call very high risk disease, you are going to need longer hormone therapy and the highest radiation [dose].”

Explaining the importance of the findings, Dr. Lawton, the press briefing moderator, said, “We have shown over time that increasing the dose [of radiation] to the prostate and immediate surrounding tissues improves outcomes. We have also shown for our high-risk patients that adding hormone therapy improves outcomes. But what we have yet to show is … do you really need the hormone therapy if you use dose escalation? And the answer is yes.”

Shortening duration of ADT improves testosterone recovery

In the second trial, known as PCS IV, investigators led by Dr. Abdenour Nabid, a radiation oncologist at Centre Hospitalier Universitaire de Sherbrooke, Quebec, Canada, studied 561 men with high-risk prostate cancer who had been treated with radiation therapy (44 Gy to the whole pelvis and 70 Gy to the prostate) and randomized to 18 months or 36 months of ADT. AstraZeneca collaborated on the trial.

Previously reported results suggested that 18 months was just as efficacious as 36 months for overall survival and cancer-specific survival (ASCO 2013 Annual Meeting. Abstract LBA4510).

With a median follow-up of 84 months, relative to counterparts who had received ADT for 36 months, patients who had received ADT for 18 months were more likely to have recovery of testosterone values into the normal range (55.7% vs. 44.9%, P = .01) and had a shorter median time to recovery (47.2 vs. 73.2 months, P less than .001).

Relative to counterparts who did not have testosterone recovery, patients who did had significantly better scores on 18 of 30 items on the European Organization for Research and Treatment of Cancer’s global quality of life questionnaire (EORTC30) (P less than .01 for each) and on 10 of 25 items on the related Prostate Module (PR25) (P less than .01 for each).

Clinically relevant differences, defined as ones of at least 10 points on the 100-point linearly transformed scales, were seen between men who did and did not have testosterone recovery for two of the global quality of life items – trouble doing strenuous activities and trouble taking long walks – and three of the prostate-related quality of life items – hot flushes, interest in sex, and sexual activity.

“In high-risk prostate cancer treated with radiation therapy and ADT, patients who recover normal testosterone levels have a better quality of life,” said Dr. Nabid. “There is a major advantage in the use of 18 months of ADT instead of 36 months since a higher proportion of patients recovered normal testosterone levels in a much shorter time without any apparent detriment in long-term outcomes.”

“If we succeed to demonstrate that 18 months is at least equal to 36 months, it’s a big jump because it’s a matter of quality of life, it’s a matter of cost also,” he added. The investigators expect to be able to publish final efficacy and quality of life results next year.

In the meantime, clinicians can follow national guidelines, according to Dr. Nabid. “If you look at the guidelines, like the NCCN guidelines for the U.S., what is written is that the long-term [ADT] could be between 24 and 36 months. So my advice would be, even if you wait for the final paper, to go for 24 months. It’s a good beginning,” he asserted.

However, “you have to use your clinical judgment,” he added, agreeing that disease factors can be used to further stratify high-risk patients; additionally, age, comorbidities, and other factors will play a role in tailoring the duration of ADT. And importantly, “one has to discuss this with his patients.”

Dr. Lawton noted that the definition of long-duration ADT has varied by world region, and has typically been 28 months in the United States and 36 months in Europe. On the basis of this trial’s findings, “I do think that 18 months is potentially our new long-term hormone therapy option. That data isn’t out in print yet, other than in abstract form, But I think going forward, the question for us should be, can we shorten it from there,” she said. “I don’t know that we’ve nailed [the optimal long duration], but we are certainly heading in the right direction.”

Dr. Zapatero disclosed no conflicts of interest; the trial was supported in part by the AstraZeneca Fund. Dr. Nabid disclosed ties with AstraZeneca and Sanofi; AstraZeneca collaborated on the trial.

SAN FRANCISCO – Patients with extensive small cell lung cancer that responds to chemotherapy fare better when given thoracic radiation in addition to prophylactic cranial irradiation, investigators reported at the annual scientific meeting of the American Society for Radiation Oncology.

“Thoracic radiotherapy ­– 30 Gy in 10 fractions – improves overall survival, progression-free survival, and intrathoracic control,” concluded Dr. Ben J. Slotman, professor and head of the department of radiation oncology at Vrije Universiteit Medical Center, Amsterdam. “We think that this should now be offered in addition to prophylactic cranial irradiation to patients with a response after initial chemotherapy,” he said.

“What are your thoughts about building on these results by using perhaps a higher dose of radiation or perhaps radiation to other extrathoracic sites using [stereotactic body radiation therapy] or other approaches like that?” asked session cochair Dr. Benjamin Movsas, a radiation oncologist at Henry Ford Hospital in Detroit.

“That’s an excellent point. The dose was chosen on the safe side – 10 times 3 Gy – and was given without much toxicity, so I think the next step would be to move … to a higher dose, perhaps 15 times 3 Gy,” Dr. Slotman replied. The findings also support use of radiation therapy to manage other sites of metastases. “I think this study really shows that if you give local treatment to this group of patients with disseminated disease, that you are still able to make a great impact,” he maintained.

In this patient population, prophylactic cranial irradiation alone reduces the risk of symptomatic brain metastases and improves overall survival, he noted, giving some background to the trial (N. Engl. J. Med. 2007;357:664-72). The large majority of patients, however, have persistent intrathoracic disease (76%) and experience intrathoracic progression (89%).

Patients from the Netherlands, United Kingdom, Norway, and Belgium were eligible for the phase III trial, known as the Chest Radiotherapy Extensive Stage Trial (CREST), if they had extensive-stage small cell lung cancer (disease beyond the hemithorax, hilar, mediastinal, and supraclavicular nodes) and had experienced a complete, partial, or good response to platinum-based chemotherapy. Additionally, they could not have any brain, leptomeningeal, or pleural metastases and could not have previously received radiation therapy to the thorax or brain.

The 498 patients were randomized evenly to receive thoracic radiation or no thoracic radiation. All received prophylactic cranial irradiation.

Overall survival curves for the two groups first began to diverge at about 9 months, Dr. Slotman noted.

Thoracic radiation was associated with a trend toward better 1-year overall survival (33% vs. 28%; hazard ratio, 0.84; P = .066) and significantly better 2-year overall survival (13% vs. 3%, P = .004), according to results reported at the meeting and simultaneously published online (Lancet 2014 Sept. 14 [doi:10.1016/S0140-6736(14)61085-0]).

Subgroup analyses suggested that thoracic radiation was similarly efficacious regardless of a variety of disease, clinical, and demographic characteristics, except for possibly having less benefit in patients who had had a complete response to chemotherapy and in patients who did not have intrathoracic disease, he said.

Thoracic radiation also was associated with better progression-free survival (HR, 0.73; P = .001).

The rate of intrathoracic progression was significantly lower in the thoracic radiation group as well, regardless of whether this applied to intrathoracic progression events overall (44% vs. 80%), to those that were the first site relapse (42% vs. 78%), or to those that were the only site of relapse (20% vs. 46%), Dr. Slotman reported.

The thorax was the leading site of first relapse in the control group. In contrast, sites outside the thorax and brain were most often the site of first relapse in the thoracic radiation group.

About 8% of patients overall experienced grade 3 or worse toxicity, with no significant difference between groups in the rate or nature of the events.

Dr. Slotman disclosed no relevant conflicts of interest.

SAN FRANCISCO – Patients with extensive small cell lung cancer that responds to chemotherapy fare better when given thoracic radiation in addition to prophylactic cranial irradiation, investigators reported at the annual scientific meeting of the American Society for Radiation Oncology.

“Thoracic radiotherapy ­– 30 Gy in 10 fractions – improves overall survival, progression-free survival, and intrathoracic control,” concluded Dr. Ben J. Slotman, professor and head of the department of radiation oncology at Vrije Universiteit Medical Center, Amsterdam. “We think that this should now be offered in addition to prophylactic cranial irradiation to patients with a response after initial chemotherapy,” he said.

“What are your thoughts about building on these results by using perhaps a higher dose of radiation or perhaps radiation to other extrathoracic sites using [stereotactic body radiation therapy] or other approaches like that?” asked session cochair Dr. Benjamin Movsas, a radiation oncologist at Henry Ford Hospital in Detroit.

“That’s an excellent point. The dose was chosen on the safe side – 10 times 3 Gy – and was given without much toxicity, so I think the next step would be to move … to a higher dose, perhaps 15 times 3 Gy,” Dr. Slotman replied. The findings also support use of radiation therapy to manage other sites of metastases. “I think this study really shows that if you give local treatment to this group of patients with disseminated disease, that you are still able to make a great impact,” he maintained.

In this patient population, prophylactic cranial irradiation alone reduces the risk of symptomatic brain metastases and improves overall survival, he noted, giving some background to the trial (N. Engl. J. Med. 2007;357:664-72). The large majority of patients, however, have persistent intrathoracic disease (76%) and experience intrathoracic progression (89%).

Patients from the Netherlands, United Kingdom, Norway, and Belgium were eligible for the phase III trial, known as the Chest Radiotherapy Extensive Stage Trial (CREST), if they had extensive-stage small cell lung cancer (disease beyond the hemithorax, hilar, mediastinal, and supraclavicular nodes) and had experienced a complete, partial, or good response to platinum-based chemotherapy. Additionally, they could not have any brain, leptomeningeal, or pleural metastases and could not have previously received radiation therapy to the thorax or brain.

The 498 patients were randomized evenly to receive thoracic radiation or no thoracic radiation. All received prophylactic cranial irradiation.

Overall survival curves for the two groups first began to diverge at about 9 months, Dr. Slotman noted.

Thoracic radiation was associated with a trend toward better 1-year overall survival (33% vs. 28%; hazard ratio, 0.84; P = .066) and significantly better 2-year overall survival (13% vs. 3%, P = .004), according to results reported at the meeting and simultaneously published online (Lancet 2014 Sept. 14 [doi:10.1016/S0140-6736(14)61085-0]).

Subgroup analyses suggested that thoracic radiation was similarly efficacious regardless of a variety of disease, clinical, and demographic characteristics, except for possibly having less benefit in patients who had had a complete response to chemotherapy and in patients who did not have intrathoracic disease, he said.

Thoracic radiation also was associated with better progression-free survival (HR, 0.73; P = .001).

The rate of intrathoracic progression was significantly lower in the thoracic radiation group as well, regardless of whether this applied to intrathoracic progression events overall (44% vs. 80%), to those that were the first site relapse (42% vs. 78%), or to those that were the only site of relapse (20% vs. 46%), Dr. Slotman reported.

The thorax was the leading site of first relapse in the control group. In contrast, sites outside the thorax and brain were most often the site of first relapse in the thoracic radiation group.

About 8% of patients overall experienced grade 3 or worse toxicity, with no significant difference between groups in the rate or nature of the events.

Dr. Slotman disclosed no relevant conflicts of interest.

SAN FRANCISCO – Patients with extensive small cell lung cancer that responds to chemotherapy fare better when given thoracic radiation in addition to prophylactic cranial irradiation, investigators reported at the annual scientific meeting of the American Society for Radiation Oncology.

“Thoracic radiotherapy ­– 30 Gy in 10 fractions – improves overall survival, progression-free survival, and intrathoracic control,” concluded Dr. Ben J. Slotman, professor and head of the department of radiation oncology at Vrije Universiteit Medical Center, Amsterdam. “We think that this should now be offered in addition to prophylactic cranial irradiation to patients with a response after initial chemotherapy,” he said.

“What are your thoughts about building on these results by using perhaps a higher dose of radiation or perhaps radiation to other extrathoracic sites using [stereotactic body radiation therapy] or other approaches like that?” asked session cochair Dr. Benjamin Movsas, a radiation oncologist at Henry Ford Hospital in Detroit.

“That’s an excellent point. The dose was chosen on the safe side – 10 times 3 Gy – and was given without much toxicity, so I think the next step would be to move … to a higher dose, perhaps 15 times 3 Gy,” Dr. Slotman replied. The findings also support use of radiation therapy to manage other sites of metastases. “I think this study really shows that if you give local treatment to this group of patients with disseminated disease, that you are still able to make a great impact,” he maintained.

In this patient population, prophylactic cranial irradiation alone reduces the risk of symptomatic brain metastases and improves overall survival, he noted, giving some background to the trial (N. Engl. J. Med. 2007;357:664-72). The large majority of patients, however, have persistent intrathoracic disease (76%) and experience intrathoracic progression (89%).

Patients from the Netherlands, United Kingdom, Norway, and Belgium were eligible for the phase III trial, known as the Chest Radiotherapy Extensive Stage Trial (CREST), if they had extensive-stage small cell lung cancer (disease beyond the hemithorax, hilar, mediastinal, and supraclavicular nodes) and had experienced a complete, partial, or good response to platinum-based chemotherapy. Additionally, they could not have any brain, leptomeningeal, or pleural metastases and could not have previously received radiation therapy to the thorax or brain.

The 498 patients were randomized evenly to receive thoracic radiation or no thoracic radiation. All received prophylactic cranial irradiation.

Overall survival curves for the two groups first began to diverge at about 9 months, Dr. Slotman noted.

Thoracic radiation was associated with a trend toward better 1-year overall survival (33% vs. 28%; hazard ratio, 0.84; P = .066) and significantly better 2-year overall survival (13% vs. 3%, P = .004), according to results reported at the meeting and simultaneously published online (Lancet 2014 Sept. 14 [doi:10.1016/S0140-6736(14)61085-0]).

Subgroup analyses suggested that thoracic radiation was similarly efficacious regardless of a variety of disease, clinical, and demographic characteristics, except for possibly having less benefit in patients who had had a complete response to chemotherapy and in patients who did not have intrathoracic disease, he said.

Thoracic radiation also was associated with better progression-free survival (HR, 0.73; P = .001).

The rate of intrathoracic progression was significantly lower in the thoracic radiation group as well, regardless of whether this applied to intrathoracic progression events overall (44% vs. 80%), to those that were the first site relapse (42% vs. 78%), or to those that were the only site of relapse (20% vs. 46%), Dr. Slotman reported.

The thorax was the leading site of first relapse in the control group. In contrast, sites outside the thorax and brain were most often the site of first relapse in the thoracic radiation group.

About 8% of patients overall experienced grade 3 or worse toxicity, with no significant difference between groups in the rate or nature of the events.

Dr. Slotman disclosed no relevant conflicts of interest.