Surgical Oncology

Positive surgical margins alone do not predict death from prostate cancer in men who undergo radical prostatectomy, investigators reported in the April issue of European Urology.

Positive surgical margins (PSMs) were not significantly associated with prostate cancer–specific mortality after adjustment for fixed covariates and postoperative radiotherapy, reported Dr. Andrew J. Stephenson, of the Cleveland Clinic’s Glickman Urological & Kidney Institute, and his associates.

Investigators analyzed data from 11,521 men with localized prostate cancer. Patients had undergone radical prostatectomy at four universities and cancer centers between 1987 and 2005.

At 15 years of follow-up, the prostate cancer–specific mortality for men with negative surgical margins was 6%, compared with 10% for men with PSMs (P less than .001).

But PSMs did not independently predict prostate cancer–specific mortality in regression models, the investigators reported (Eur. Urol. 2004;65:675-80).

That finding was true when researchers modeled only fixed covariates, such as age, Gleason score, seminal vesicle invasion, lymph node involvement, prostate-specific antigen (PSA), and extraprostatic extension (hazard ratio, 1.04; 95% confidence interval, 0.7-1.5), and also when they adjusted for postoperative radiotherapy, either as a single parameter (HR, 0.96; 95% CI, 0.7-1.4) or as early versus late treatment (HR, 1.01; 95% CI, 0.7-1.4).

The lack of an association called into question "the rationale for postoperative radiotherapy for PSMs in the absence of other adverse features," as well as "the relevance of PSM rates as a measure of surgical proficiency," the investigators said.

Even expert pathologists may not agree on PSMs and whether PSMs could be artifacts from surgery or pathologic processing, they noted. In addition, residual cancer from PSMs could lack biological characteristics needed for progression.

However, PSMs "should be avoided" because they worry patients and significantly increase the risks of biochemical recurrence and need for secondary treatment, Dr. Stephenson and associates said.

All patients in the study were treated at high-volume hospitals, and PSMs at low-volume hospitals could have a different prognosis. The study also lacked data on length and number of PSMs, the investigators noted.

Dr. Stephenson was partially supported by the Robert Wood Johnson Foundation Physician Faculty Scholars Program and the Astellas/American Urological Association Rising Stars in Urology Program. He reported no relevant financial conflicts of interest.

Positive surgical margins alone do not predict death from prostate cancer in men who undergo radical prostatectomy, investigators reported in the April issue of European Urology.

Positive surgical margins (PSMs) were not significantly associated with prostate cancer–specific mortality after adjustment for fixed covariates and postoperative radiotherapy, reported Dr. Andrew J. Stephenson, of the Cleveland Clinic’s Glickman Urological & Kidney Institute, and his associates.

Investigators analyzed data from 11,521 men with localized prostate cancer. Patients had undergone radical prostatectomy at four universities and cancer centers between 1987 and 2005.

At 15 years of follow-up, the prostate cancer–specific mortality for men with negative surgical margins was 6%, compared with 10% for men with PSMs (P less than .001).

But PSMs did not independently predict prostate cancer–specific mortality in regression models, the investigators reported (Eur. Urol. 2004;65:675-80).

That finding was true when researchers modeled only fixed covariates, such as age, Gleason score, seminal vesicle invasion, lymph node involvement, prostate-specific antigen (PSA), and extraprostatic extension (hazard ratio, 1.04; 95% confidence interval, 0.7-1.5), and also when they adjusted for postoperative radiotherapy, either as a single parameter (HR, 0.96; 95% CI, 0.7-1.4) or as early versus late treatment (HR, 1.01; 95% CI, 0.7-1.4).

The lack of an association called into question "the rationale for postoperative radiotherapy for PSMs in the absence of other adverse features," as well as "the relevance of PSM rates as a measure of surgical proficiency," the investigators said.

Even expert pathologists may not agree on PSMs and whether PSMs could be artifacts from surgery or pathologic processing, they noted. In addition, residual cancer from PSMs could lack biological characteristics needed for progression.

However, PSMs "should be avoided" because they worry patients and significantly increase the risks of biochemical recurrence and need for secondary treatment, Dr. Stephenson and associates said.

All patients in the study were treated at high-volume hospitals, and PSMs at low-volume hospitals could have a different prognosis. The study also lacked data on length and number of PSMs, the investigators noted.

Dr. Stephenson was partially supported by the Robert Wood Johnson Foundation Physician Faculty Scholars Program and the Astellas/American Urological Association Rising Stars in Urology Program. He reported no relevant financial conflicts of interest.

Positive surgical margins alone do not predict death from prostate cancer in men who undergo radical prostatectomy, investigators reported in the April issue of European Urology.

Positive surgical margins (PSMs) were not significantly associated with prostate cancer–specific mortality after adjustment for fixed covariates and postoperative radiotherapy, reported Dr. Andrew J. Stephenson, of the Cleveland Clinic’s Glickman Urological & Kidney Institute, and his associates.

Investigators analyzed data from 11,521 men with localized prostate cancer. Patients had undergone radical prostatectomy at four universities and cancer centers between 1987 and 2005.

At 15 years of follow-up, the prostate cancer–specific mortality for men with negative surgical margins was 6%, compared with 10% for men with PSMs (P less than .001).

But PSMs did not independently predict prostate cancer–specific mortality in regression models, the investigators reported (Eur. Urol. 2004;65:675-80).

That finding was true when researchers modeled only fixed covariates, such as age, Gleason score, seminal vesicle invasion, lymph node involvement, prostate-specific antigen (PSA), and extraprostatic extension (hazard ratio, 1.04; 95% confidence interval, 0.7-1.5), and also when they adjusted for postoperative radiotherapy, either as a single parameter (HR, 0.96; 95% CI, 0.7-1.4) or as early versus late treatment (HR, 1.01; 95% CI, 0.7-1.4).

The lack of an association called into question "the rationale for postoperative radiotherapy for PSMs in the absence of other adverse features," as well as "the relevance of PSM rates as a measure of surgical proficiency," the investigators said.

Even expert pathologists may not agree on PSMs and whether PSMs could be artifacts from surgery or pathologic processing, they noted. In addition, residual cancer from PSMs could lack biological characteristics needed for progression.

However, PSMs "should be avoided" because they worry patients and significantly increase the risks of biochemical recurrence and need for secondary treatment, Dr. Stephenson and associates said.

All patients in the study were treated at high-volume hospitals, and PSMs at low-volume hospitals could have a different prognosis. The study also lacked data on length and number of PSMs, the investigators noted.

Dr. Stephenson was partially supported by the Robert Wood Johnson Foundation Physician Faculty Scholars Program and the Astellas/American Urological Association Rising Stars in Urology Program. He reported no relevant financial conflicts of interest.

MIAMI BEACH – An elevated bilirubin level on postoperative day 3 after major hepatectomy may be a harbinger of hepatic insufficiency that leads to poor outcomes – including an increased risk of death.

Compared with patients who had lower bilirubin levels, a level of 3 mg/dL or higher was associated with an eightfold increase in the risk of both a major complication and of dying within 90 days of surgery, Dr. Joanna W. Etra said at the annual meeting of the Americas Hepato-Pancreato-Biliary Association.

Unfortunately, said Dr. Etra of the Winship Cancer Institute of Emory University, Atlanta, there seems to be no way to predict before surgery who will develop the elevated levels, and no preemptive treatment. Still, she said, the finding could be a good way to be alert to the possibility of a problem.

She presented a retrospective study of 535 patients who underwent a major hepatectomy at the center from 2000 to 2012. Their mean age was 55 years. Most (73%) had cancer; 39% had undergone preoperative chemotherapy. About a third (38%) had colorectal metastases in the liver. The average preoperative bilirubin level was 0.7 mg/dL. Most of the procedures (83%) were open, with a right hepatectomy most common (44%)

Postoperatively, 10% of the group developed hepatic insufficiency. Postoperative complications developed in 58%; of these, of which 22% were major. Death within 90 days occurred in 4.5% of the entire group.

Dr. Etra and her colleagues divided the group by postoperative day 3 bilirubin levels: lower than 3 mg/dL and 3 mg/dL or higher. They examined outcomes among the two groups.

Postoperative complications were significantly more common among those with the higher bilirubin levels (76% vs. 54%), as were major complications (46% vs. 18%), and 90-day mortality (16% vs. 2%).

A multivariate analysis found that the higher level doubled the risk of any complication, and tripled the risk of both a major complication and 90-day mortality,

"Having identified this association with outcomes, we refocused on the dichotomized bilirubin groups to see if we could also identify any pre- or intraoperative factors that might predict this elevated bilirubin," she said. "But in a multifactorial analysis, we found that no single factor – age, gender, cancer, preoperative platelets, MELD [model for end-stage liver disease] score, blood loss or transfusion – was a significant predictor."

Dr. Etra had no financial disclosures.

[email protected]

MIAMI BEACH – An elevated bilirubin level on postoperative day 3 after major hepatectomy may be a harbinger of hepatic insufficiency that leads to poor outcomes – including an increased risk of death.

Compared with patients who had lower bilirubin levels, a level of 3 mg/dL or higher was associated with an eightfold increase in the risk of both a major complication and of dying within 90 days of surgery, Dr. Joanna W. Etra said at the annual meeting of the Americas Hepato-Pancreato-Biliary Association.

Unfortunately, said Dr. Etra of the Winship Cancer Institute of Emory University, Atlanta, there seems to be no way to predict before surgery who will develop the elevated levels, and no preemptive treatment. Still, she said, the finding could be a good way to be alert to the possibility of a problem.

She presented a retrospective study of 535 patients who underwent a major hepatectomy at the center from 2000 to 2012. Their mean age was 55 years. Most (73%) had cancer; 39% had undergone preoperative chemotherapy. About a third (38%) had colorectal metastases in the liver. The average preoperative bilirubin level was 0.7 mg/dL. Most of the procedures (83%) were open, with a right hepatectomy most common (44%)

Postoperatively, 10% of the group developed hepatic insufficiency. Postoperative complications developed in 58%; of these, of which 22% were major. Death within 90 days occurred in 4.5% of the entire group.

Dr. Etra and her colleagues divided the group by postoperative day 3 bilirubin levels: lower than 3 mg/dL and 3 mg/dL or higher. They examined outcomes among the two groups.

Postoperative complications were significantly more common among those with the higher bilirubin levels (76% vs. 54%), as were major complications (46% vs. 18%), and 90-day mortality (16% vs. 2%).

A multivariate analysis found that the higher level doubled the risk of any complication, and tripled the risk of both a major complication and 90-day mortality,

"Having identified this association with outcomes, we refocused on the dichotomized bilirubin groups to see if we could also identify any pre- or intraoperative factors that might predict this elevated bilirubin," she said. "But in a multifactorial analysis, we found that no single factor – age, gender, cancer, preoperative platelets, MELD [model for end-stage liver disease] score, blood loss or transfusion – was a significant predictor."

Dr. Etra had no financial disclosures.

[email protected]

MIAMI BEACH – An elevated bilirubin level on postoperative day 3 after major hepatectomy may be a harbinger of hepatic insufficiency that leads to poor outcomes – including an increased risk of death.

Compared with patients who had lower bilirubin levels, a level of 3 mg/dL or higher was associated with an eightfold increase in the risk of both a major complication and of dying within 90 days of surgery, Dr. Joanna W. Etra said at the annual meeting of the Americas Hepato-Pancreato-Biliary Association.

Unfortunately, said Dr. Etra of the Winship Cancer Institute of Emory University, Atlanta, there seems to be no way to predict before surgery who will develop the elevated levels, and no preemptive treatment. Still, she said, the finding could be a good way to be alert to the possibility of a problem.

She presented a retrospective study of 535 patients who underwent a major hepatectomy at the center from 2000 to 2012. Their mean age was 55 years. Most (73%) had cancer; 39% had undergone preoperative chemotherapy. About a third (38%) had colorectal metastases in the liver. The average preoperative bilirubin level was 0.7 mg/dL. Most of the procedures (83%) were open, with a right hepatectomy most common (44%)

Postoperatively, 10% of the group developed hepatic insufficiency. Postoperative complications developed in 58%; of these, of which 22% were major. Death within 90 days occurred in 4.5% of the entire group.

Dr. Etra and her colleagues divided the group by postoperative day 3 bilirubin levels: lower than 3 mg/dL and 3 mg/dL or higher. They examined outcomes among the two groups.

Postoperative complications were significantly more common among those with the higher bilirubin levels (76% vs. 54%), as were major complications (46% vs. 18%), and 90-day mortality (16% vs. 2%).

A multivariate analysis found that the higher level doubled the risk of any complication, and tripled the risk of both a major complication and 90-day mortality,

"Having identified this association with outcomes, we refocused on the dichotomized bilirubin groups to see if we could also identify any pre- or intraoperative factors that might predict this elevated bilirubin," she said. "But in a multifactorial analysis, we found that no single factor – age, gender, cancer, preoperative platelets, MELD [model for end-stage liver disease] score, blood loss or transfusion – was a significant predictor."

Dr. Etra had no financial disclosures.

[email protected]

MIAMI BEACH – A combination of teamwork and leadership led to a 50% reduction in readmission after pancreatectomy in a large academic facility.

The readmission rate at Indiana University Hospital fell from a high of 23% to just over 11% over 5 years – even though length of stay and mortality remained stable, Dr. Eugene Ceppa reported at the annual meeting of the Americas Hepato-Pancreato-Biliary Association.

The multifaceted project made some progress during the first few years of implementation, said Dr. Ceppa of Indiana University Hospital, Indianapolis. But the biggest changes really came in years 4 and 5, after the team adopted its own version of a national readmission prevention plan, and created a "discharge coach" – a staff member dedicated to ensuring that patients were ready to leave the hospital, with plenty of support at home.

Studies generally show that pancreatectomy has a very high readmission rate, hovering around 18%. The situation was tolerated over the years, according to Dr. Henry Pitt, who coauthored the paper. But in 2008, the Centers for Medicare & Medicaid Services introduced the idea that hospital readmissions were eating away at health care dollars.

In a landmark paper, Dr. Brian Jack and colleagues noted that only 13% of discharged patients needed repeat hospitalizations, but these patients used up to 60% of the $753 billion spent on discharge in 2003.

Project RED (ReEngineering Discharge), originating from Boston University Medical Center, suggested that reducing readmissions could save $5 billion each year. Originally focused on reducing readmissions for heart failure, Project RED has been successfully adapted to multiple models – including surgery.

Changes have not come about overnight, said Dr. Pitt, now chief quality officer for Temple University Health System in Philadelphia. "There was denial at first that readmission was a problem," he said in an interview. "Then there was a period of time when there was acceptance but no idea of how to fix it. Now we are beginning to do so."

As pay-for-performance became ever more important, pancreatic surgeons at Indiana University Hospital decided to attack the problem of readmission for their pancreatectomy patients. Over a 5-year period, from 2007 to 2012, they implemented a number of reforms, beginning with renewed efforts to decrease surgical morbidity – especially their 24% rate of surgical site infections after pancreatectomy. Dr. Pitt and his colleagues had already shown that these infections were a leading cause of surgical morbidity, and reducing them was a logical first step toward reducing readmission.

The next step was to create a discharge team that would work cooperatively to make sure patients were in optimal condition to leave the hospital. The Readmission Quality Improvement Team consisted of physicians, nurses, physical and occupational therapists, case managers, pharmacists, and dietitians. Because of their efforts, the number of pancreatectomy patients discharged with some kind of home health care support increased from 20% to 50%.

At the same time, the surgeons made a policy change: There would be no readmissions without the approval of the attending surgeon. Because patients often traveled far to the university hospital, they would frequently go to their local hospitals when problems arose after they went home.

"A lot of the calls to us from patients would go to residents," Dr. Pitt said. "The default was to send them to their local emergency department, because the patients were so far away. And then we would get calls for transfers. We said that house staff would no longer have the authority to make those admissions. If they thought readmission was necessary, they had to call the attending surgeon. Just improving that decision-making process made a big difference, with fewer people going to the ED in the first place. Often it was just a matter of reassuring the patient."

By 2010, readmissions had dropped from 24% to 16%. In 2011, the team employed its own adaptation of Project RED. Each discharge included an 11-point checklist of things that had to be completed before a patient could leave. Those tasks include the following:

• Reconcile medications.

• Reconcile discharge plan with national guidelines.

• Make follow-up appointments.

• Follow up on any outstanding tests.

• Arrange for postdischarge services.

• Explain to the patient what do if a problem arises.

• Conduct patient education.

• Communicate discharge information to primary care physician.

• Make a follow-up call within 3 days of discharge.

The final puzzle piece was the discharge coach, Dr. Pitt said. The coach is a highly experienced nurse whose job it is to make sure each patient receives consistent discharge care and follow-through.

Last year, the team reviewed the project’s results, which Dr. Ceppa presented during the meeting. From 2007 to 2012, 1,147 patients underwent pancreatectomy at the facility. The mean age was 58 years. Pancreatic adenocarcinoma was the most common indication for surgery.

During the study period, neither mortality (2.7%) nor mean length of stay (10 days) changed. But readmission steadily decreased from the 2007 high of 23%. From 2008 through 2011, the readmission ranged from 18% to 15%. But after the changes implemented in 2011, the rate dropped to 11% – a significant decrease from baseline. Dr. Ceppa and Dr. Pitt attributed this to a combination of factors: stepped up discharge planning, attending-only readmission, and the discharge coach.

"I think the major thing we learned is that improving something like this isn’t simple or quick," Dr Pitt said. "You have to be persistent and really work on all the puzzle pieces until they fit into place."

Neither Dr. Pitt nor Dr. Ceppa had any financial disclosures.

[email protected]

MIAMI BEACH – A combination of teamwork and leadership led to a 50% reduction in readmission after pancreatectomy in a large academic facility.

The readmission rate at Indiana University Hospital fell from a high of 23% to just over 11% over 5 years – even though length of stay and mortality remained stable, Dr. Eugene Ceppa reported at the annual meeting of the Americas Hepato-Pancreato-Biliary Association.

The multifaceted project made some progress during the first few years of implementation, said Dr. Ceppa of Indiana University Hospital, Indianapolis. But the biggest changes really came in years 4 and 5, after the team adopted its own version of a national readmission prevention plan, and created a "discharge coach" – a staff member dedicated to ensuring that patients were ready to leave the hospital, with plenty of support at home.

Studies generally show that pancreatectomy has a very high readmission rate, hovering around 18%. The situation was tolerated over the years, according to Dr. Henry Pitt, who coauthored the paper. But in 2008, the Centers for Medicare & Medicaid Services introduced the idea that hospital readmissions were eating away at health care dollars.

In a landmark paper, Dr. Brian Jack and colleagues noted that only 13% of discharged patients needed repeat hospitalizations, but these patients used up to 60% of the $753 billion spent on discharge in 2003.

Project RED (ReEngineering Discharge), originating from Boston University Medical Center, suggested that reducing readmissions could save $5 billion each year. Originally focused on reducing readmissions for heart failure, Project RED has been successfully adapted to multiple models – including surgery.

Changes have not come about overnight, said Dr. Pitt, now chief quality officer for Temple University Health System in Philadelphia. "There was denial at first that readmission was a problem," he said in an interview. "Then there was a period of time when there was acceptance but no idea of how to fix it. Now we are beginning to do so."

As pay-for-performance became ever more important, pancreatic surgeons at Indiana University Hospital decided to attack the problem of readmission for their pancreatectomy patients. Over a 5-year period, from 2007 to 2012, they implemented a number of reforms, beginning with renewed efforts to decrease surgical morbidity – especially their 24% rate of surgical site infections after pancreatectomy. Dr. Pitt and his colleagues had already shown that these infections were a leading cause of surgical morbidity, and reducing them was a logical first step toward reducing readmission.

The next step was to create a discharge team that would work cooperatively to make sure patients were in optimal condition to leave the hospital. The Readmission Quality Improvement Team consisted of physicians, nurses, physical and occupational therapists, case managers, pharmacists, and dietitians. Because of their efforts, the number of pancreatectomy patients discharged with some kind of home health care support increased from 20% to 50%.

At the same time, the surgeons made a policy change: There would be no readmissions without the approval of the attending surgeon. Because patients often traveled far to the university hospital, they would frequently go to their local hospitals when problems arose after they went home.

"A lot of the calls to us from patients would go to residents," Dr. Pitt said. "The default was to send them to their local emergency department, because the patients were so far away. And then we would get calls for transfers. We said that house staff would no longer have the authority to make those admissions. If they thought readmission was necessary, they had to call the attending surgeon. Just improving that decision-making process made a big difference, with fewer people going to the ED in the first place. Often it was just a matter of reassuring the patient."

By 2010, readmissions had dropped from 24% to 16%. In 2011, the team employed its own adaptation of Project RED. Each discharge included an 11-point checklist of things that had to be completed before a patient could leave. Those tasks include the following:

• Reconcile medications.

• Reconcile discharge plan with national guidelines.

• Make follow-up appointments.

• Follow up on any outstanding tests.

• Arrange for postdischarge services.

• Explain to the patient what do if a problem arises.

• Conduct patient education.

• Communicate discharge information to primary care physician.

• Make a follow-up call within 3 days of discharge.

The final puzzle piece was the discharge coach, Dr. Pitt said. The coach is a highly experienced nurse whose job it is to make sure each patient receives consistent discharge care and follow-through.

Last year, the team reviewed the project’s results, which Dr. Ceppa presented during the meeting. From 2007 to 2012, 1,147 patients underwent pancreatectomy at the facility. The mean age was 58 years. Pancreatic adenocarcinoma was the most common indication for surgery.

During the study period, neither mortality (2.7%) nor mean length of stay (10 days) changed. But readmission steadily decreased from the 2007 high of 23%. From 2008 through 2011, the readmission ranged from 18% to 15%. But after the changes implemented in 2011, the rate dropped to 11% – a significant decrease from baseline. Dr. Ceppa and Dr. Pitt attributed this to a combination of factors: stepped up discharge planning, attending-only readmission, and the discharge coach.

"I think the major thing we learned is that improving something like this isn’t simple or quick," Dr Pitt said. "You have to be persistent and really work on all the puzzle pieces until they fit into place."

Neither Dr. Pitt nor Dr. Ceppa had any financial disclosures.

[email protected]

MIAMI BEACH – A combination of teamwork and leadership led to a 50% reduction in readmission after pancreatectomy in a large academic facility.

The readmission rate at Indiana University Hospital fell from a high of 23% to just over 11% over 5 years – even though length of stay and mortality remained stable, Dr. Eugene Ceppa reported at the annual meeting of the Americas Hepato-Pancreato-Biliary Association.

The multifaceted project made some progress during the first few years of implementation, said Dr. Ceppa of Indiana University Hospital, Indianapolis. But the biggest changes really came in years 4 and 5, after the team adopted its own version of a national readmission prevention plan, and created a "discharge coach" – a staff member dedicated to ensuring that patients were ready to leave the hospital, with plenty of support at home.

Studies generally show that pancreatectomy has a very high readmission rate, hovering around 18%. The situation was tolerated over the years, according to Dr. Henry Pitt, who coauthored the paper. But in 2008, the Centers for Medicare & Medicaid Services introduced the idea that hospital readmissions were eating away at health care dollars.

In a landmark paper, Dr. Brian Jack and colleagues noted that only 13% of discharged patients needed repeat hospitalizations, but these patients used up to 60% of the $753 billion spent on discharge in 2003.

Project RED (ReEngineering Discharge), originating from Boston University Medical Center, suggested that reducing readmissions could save $5 billion each year. Originally focused on reducing readmissions for heart failure, Project RED has been successfully adapted to multiple models – including surgery.

Changes have not come about overnight, said Dr. Pitt, now chief quality officer for Temple University Health System in Philadelphia. "There was denial at first that readmission was a problem," he said in an interview. "Then there was a period of time when there was acceptance but no idea of how to fix it. Now we are beginning to do so."

As pay-for-performance became ever more important, pancreatic surgeons at Indiana University Hospital decided to attack the problem of readmission for their pancreatectomy patients. Over a 5-year period, from 2007 to 2012, they implemented a number of reforms, beginning with renewed efforts to decrease surgical morbidity – especially their 24% rate of surgical site infections after pancreatectomy. Dr. Pitt and his colleagues had already shown that these infections were a leading cause of surgical morbidity, and reducing them was a logical first step toward reducing readmission.

The next step was to create a discharge team that would work cooperatively to make sure patients were in optimal condition to leave the hospital. The Readmission Quality Improvement Team consisted of physicians, nurses, physical and occupational therapists, case managers, pharmacists, and dietitians. Because of their efforts, the number of pancreatectomy patients discharged with some kind of home health care support increased from 20% to 50%.

At the same time, the surgeons made a policy change: There would be no readmissions without the approval of the attending surgeon. Because patients often traveled far to the university hospital, they would frequently go to their local hospitals when problems arose after they went home.

"A lot of the calls to us from patients would go to residents," Dr. Pitt said. "The default was to send them to their local emergency department, because the patients were so far away. And then we would get calls for transfers. We said that house staff would no longer have the authority to make those admissions. If they thought readmission was necessary, they had to call the attending surgeon. Just improving that decision-making process made a big difference, with fewer people going to the ED in the first place. Often it was just a matter of reassuring the patient."

By 2010, readmissions had dropped from 24% to 16%. In 2011, the team employed its own adaptation of Project RED. Each discharge included an 11-point checklist of things that had to be completed before a patient could leave. Those tasks include the following:

• Reconcile medications.

• Reconcile discharge plan with national guidelines.

• Make follow-up appointments.

• Follow up on any outstanding tests.

• Arrange for postdischarge services.

• Explain to the patient what do if a problem arises.

• Conduct patient education.

• Communicate discharge information to primary care physician.

• Make a follow-up call within 3 days of discharge.

The final puzzle piece was the discharge coach, Dr. Pitt said. The coach is a highly experienced nurse whose job it is to make sure each patient receives consistent discharge care and follow-through.

Last year, the team reviewed the project’s results, which Dr. Ceppa presented during the meeting. From 2007 to 2012, 1,147 patients underwent pancreatectomy at the facility. The mean age was 58 years. Pancreatic adenocarcinoma was the most common indication for surgery.

During the study period, neither mortality (2.7%) nor mean length of stay (10 days) changed. But readmission steadily decreased from the 2007 high of 23%. From 2008 through 2011, the readmission ranged from 18% to 15%. But after the changes implemented in 2011, the rate dropped to 11% – a significant decrease from baseline. Dr. Ceppa and Dr. Pitt attributed this to a combination of factors: stepped up discharge planning, attending-only readmission, and the discharge coach.

"I think the major thing we learned is that improving something like this isn’t simple or quick," Dr Pitt said. "You have to be persistent and really work on all the puzzle pieces until they fit into place."

Neither Dr. Pitt nor Dr. Ceppa had any financial disclosures.

[email protected]

Endoscopic resection for mucosal esophageal adenocarcinoma is safe and highly effective, and should be the new standard of care.

That’s according to Dr. Oliver Pech, whose study in the March issue of Gastroenterology showed a complete remission rate of 93.8% over nearly 5 years of follow-up (doi: 10.1053/j.gastro.2013.11.006).

Dr. Pech, of the University of Regensburg, Germany, and his colleagues looked at 1,000 consecutive patients (mean age, 69 years; 861 men) with mucosal adenocarcinoma of the esophagus, who were referred to a single center between October 1996 and September 2010.

All patients had mucosal Barrett’s carcinoma; lesions judged resectable were first subjected to diagnostic endoscopic resection for staging, even when the macroscopic appearance suggested submucosal disease. Patients with low-grade dysplasia, high-grade dysplasia, and submucosal or more advanced cancer (T1 or greater) were excluded.

In total, 481 patients had short-segment Barrett’s esophagus, and the remainder had long-segment Barrett’s. The majority (n = 493) had intraepithelial adenocarcinoma, according to staging by endoscopic resection, while 240 patients had adenocarcinoma invading the tunica propria, 124 had invasion of the first layer of the muscularis mucosae, and the remaining 143 had disease of the second layer of the muscularis mucosae.

En bloc resection was performed in 508 patients and piecemeal resection in the rest.

The authors found that complete remission, defined as an R0 resection plus one normal surveillance endoscopy, was achieved in 963 (96.3%) of the 1,000 patients in the study.

Among these, recurrence of neoplasia (high-grade dysplasia or adenocarcinoma) was detected in 14.5% of the patients (140 out of the 963) after a median 26.5 months; 115 were successfully retreated with additional endoscopic resection.

That translated to a long-term complete remission rate of 93.8% (mean, 56.6 months) and a 5-year survival rate of 91.5%.

Looking at safety, Dr. Pech reported that 15 patients experienced major complications, including bleeding with a corresponding drop in hemoglobin of at least 2 g/dL (in 14 cases) and perforation (in 1).

He added that the relatively minor complication of stenosis requiring dilation occurred in 13 cases, all of which were managed endoscopically. Finally, in an analysis of which patients were more likely to have successful endoscopic treatment, the authors determined that long-segment Barrett’s as well as poorly differentiated mucosal adenocarcinoma (as opposed to well-differentiated lesions) had a significantly higher risk for failure (P less than .0001 for both).

The authors conceded that referral bias cannot be excluded in this cohort, "because it is possible that only patients with early Barrett’s carcinoma that was endoscopically well treatable may have been referred."

Additionally, over the long course of the study, best practices for Barrett’s esophagus and high grade-dysplasia have evolved considerably, "moving away from multimodal therapy for early Barrett’s carcinoma using a combination of [endoscopic resection], photodynamic therapy, [argon plasma coagulation], and laser toward a strict and purely resectional form of treatment."

Nevertheless, "the data presented here on the largest series published to date on endoscopic therapy for mucosal adenocarcinomas in 1,000 patients confirm the safety of endoscopic resection," the authors wrote.

"Endoscopic therapy for mucosal Barrett’s carcinoma should therefore become the international gold standard for treatment," they added.

The authors stated that they had no conflicts of interest to disclose. They disclosed no funding.

Endoscopic resection for mucosal esophageal adenocarcinoma is safe and highly effective, and should be the new standard of care.

That’s according to Dr. Oliver Pech, whose study in the March issue of Gastroenterology showed a complete remission rate of 93.8% over nearly 5 years of follow-up (doi: 10.1053/j.gastro.2013.11.006).

Dr. Pech, of the University of Regensburg, Germany, and his colleagues looked at 1,000 consecutive patients (mean age, 69 years; 861 men) with mucosal adenocarcinoma of the esophagus, who were referred to a single center between October 1996 and September 2010.

All patients had mucosal Barrett’s carcinoma; lesions judged resectable were first subjected to diagnostic endoscopic resection for staging, even when the macroscopic appearance suggested submucosal disease. Patients with low-grade dysplasia, high-grade dysplasia, and submucosal or more advanced cancer (T1 or greater) were excluded.

In total, 481 patients had short-segment Barrett’s esophagus, and the remainder had long-segment Barrett’s. The majority (n = 493) had intraepithelial adenocarcinoma, according to staging by endoscopic resection, while 240 patients had adenocarcinoma invading the tunica propria, 124 had invasion of the first layer of the muscularis mucosae, and the remaining 143 had disease of the second layer of the muscularis mucosae.

En bloc resection was performed in 508 patients and piecemeal resection in the rest.

The authors found that complete remission, defined as an R0 resection plus one normal surveillance endoscopy, was achieved in 963 (96.3%) of the 1,000 patients in the study.

Among these, recurrence of neoplasia (high-grade dysplasia or adenocarcinoma) was detected in 14.5% of the patients (140 out of the 963) after a median 26.5 months; 115 were successfully retreated with additional endoscopic resection.

That translated to a long-term complete remission rate of 93.8% (mean, 56.6 months) and a 5-year survival rate of 91.5%.

Looking at safety, Dr. Pech reported that 15 patients experienced major complications, including bleeding with a corresponding drop in hemoglobin of at least 2 g/dL (in 14 cases) and perforation (in 1).

He added that the relatively minor complication of stenosis requiring dilation occurred in 13 cases, all of which were managed endoscopically. Finally, in an analysis of which patients were more likely to have successful endoscopic treatment, the authors determined that long-segment Barrett’s as well as poorly differentiated mucosal adenocarcinoma (as opposed to well-differentiated lesions) had a significantly higher risk for failure (P less than .0001 for both).

The authors conceded that referral bias cannot be excluded in this cohort, "because it is possible that only patients with early Barrett’s carcinoma that was endoscopically well treatable may have been referred."

Additionally, over the long course of the study, best practices for Barrett’s esophagus and high grade-dysplasia have evolved considerably, "moving away from multimodal therapy for early Barrett’s carcinoma using a combination of [endoscopic resection], photodynamic therapy, [argon plasma coagulation], and laser toward a strict and purely resectional form of treatment."

Nevertheless, "the data presented here on the largest series published to date on endoscopic therapy for mucosal adenocarcinomas in 1,000 patients confirm the safety of endoscopic resection," the authors wrote.

"Endoscopic therapy for mucosal Barrett’s carcinoma should therefore become the international gold standard for treatment," they added.

The authors stated that they had no conflicts of interest to disclose. They disclosed no funding.

Endoscopic resection for mucosal esophageal adenocarcinoma is safe and highly effective, and should be the new standard of care.

That’s according to Dr. Oliver Pech, whose study in the March issue of Gastroenterology showed a complete remission rate of 93.8% over nearly 5 years of follow-up (doi: 10.1053/j.gastro.2013.11.006).

Dr. Pech, of the University of Regensburg, Germany, and his colleagues looked at 1,000 consecutive patients (mean age, 69 years; 861 men) with mucosal adenocarcinoma of the esophagus, who were referred to a single center between October 1996 and September 2010.

All patients had mucosal Barrett’s carcinoma; lesions judged resectable were first subjected to diagnostic endoscopic resection for staging, even when the macroscopic appearance suggested submucosal disease. Patients with low-grade dysplasia, high-grade dysplasia, and submucosal or more advanced cancer (T1 or greater) were excluded.

In total, 481 patients had short-segment Barrett’s esophagus, and the remainder had long-segment Barrett’s. The majority (n = 493) had intraepithelial adenocarcinoma, according to staging by endoscopic resection, while 240 patients had adenocarcinoma invading the tunica propria, 124 had invasion of the first layer of the muscularis mucosae, and the remaining 143 had disease of the second layer of the muscularis mucosae.

En bloc resection was performed in 508 patients and piecemeal resection in the rest.

The authors found that complete remission, defined as an R0 resection plus one normal surveillance endoscopy, was achieved in 963 (96.3%) of the 1,000 patients in the study.

Among these, recurrence of neoplasia (high-grade dysplasia or adenocarcinoma) was detected in 14.5% of the patients (140 out of the 963) after a median 26.5 months; 115 were successfully retreated with additional endoscopic resection.

That translated to a long-term complete remission rate of 93.8% (mean, 56.6 months) and a 5-year survival rate of 91.5%.

Looking at safety, Dr. Pech reported that 15 patients experienced major complications, including bleeding with a corresponding drop in hemoglobin of at least 2 g/dL (in 14 cases) and perforation (in 1).

He added that the relatively minor complication of stenosis requiring dilation occurred in 13 cases, all of which were managed endoscopically. Finally, in an analysis of which patients were more likely to have successful endoscopic treatment, the authors determined that long-segment Barrett’s as well as poorly differentiated mucosal adenocarcinoma (as opposed to well-differentiated lesions) had a significantly higher risk for failure (P less than .0001 for both).

The authors conceded that referral bias cannot be excluded in this cohort, "because it is possible that only patients with early Barrett’s carcinoma that was endoscopically well treatable may have been referred."

Additionally, over the long course of the study, best practices for Barrett’s esophagus and high grade-dysplasia have evolved considerably, "moving away from multimodal therapy for early Barrett’s carcinoma using a combination of [endoscopic resection], photodynamic therapy, [argon plasma coagulation], and laser toward a strict and purely resectional form of treatment."

Nevertheless, "the data presented here on the largest series published to date on endoscopic therapy for mucosal adenocarcinomas in 1,000 patients confirm the safety of endoscopic resection," the authors wrote.

"Endoscopic therapy for mucosal Barrett’s carcinoma should therefore become the international gold standard for treatment," they added.

The authors stated that they had no conflicts of interest to disclose. They disclosed no funding.

ORLANDO – Prior lung resection is associated with increased early mortality and with a more than twofold increased risk of renal failure requiring dialysis in lung transplant recipients, data from the United Network for Organ Sharing suggest.

Prior resection is not, however, associated with increased long-term mortality, prolonged hospital length of stay, or airway dehiscence, Dr. Asvin M. Ganapathi reported at the annual meeting of the Society of Thoracic Surgeons.

Of 15,300 adult lung transplant recipients in the UNOS database who received lungs between October 1999 and December 2011, 80 had a prior lobectomy and 22 had a prior pneumonectomy. After 3:1 propensity matching based on 17 recipient variables known to affect perioperative morbidity and mortality, 90-day mortality in 306 nonresection patients was 5.8%, compared with 13.9% in the 102 with prior resection. Renal failure requiring dialysis occurred in 6.6% and 13.9% of patients in the groups, respectively, said Dr. Ganapathi of the anesthesiology division of Duke University, Durham, N.C.

Hospital length of stay longer than 25 days was required in 36.9% and 36.4% of the nonresection and resection groups, respectively, and airway dehiscence occurred in 1.3% and 2%, he said.

Survival at 1 and 5 years was 83.6% and 48.4% in the nonresection group, and 78.9% and 45.6% in the prior-resection group.

A subanalysis comparing the prior-lobectomy patients with patients with no prior resection revealed no differences between the two groups in any of the examined outcomes, although there was a trend toward increased 90-day mortality in the lobectomy patient, and a more than twofold increase in renal failure requiring dialysis. A subanalysis comparing those with prior pneumonectomy with those with no prior resection showed a significantly greater need for dialysis in the pneumonectomy patients (8.9% vs. 3.8%), and a trend toward increased 90-day mortality in the pneumonectomy patients, but no differences in the other examined outcomes.

The propensity-matched groups were similar with respect to recipient, donor, and operative characteristics. There were 10 double and 12 single lung transplants after pneumonectomy, and 51 double and 29 single transplants after lobectomy.

Lung transplantation provides a durable, efficacious treatment for end-stage lung disease, but indications for transplant can vary, and as a result, a select group of patients may have had prior lung resection for treatment of their underlying disease, Dr. Ganapathi said.

Both lobectomy and pneumonectomy are known to cause anatomic changes such as mediastinal shift and vascular abnormalities.

"As such, a history of previous lung resection may affect selection of donor organs and increase the difficulty of transplantation," he said.

In fact, historically, prior thoracic surgery was considered a relative contraindication to lung transplantation because of increased risk of poor outcomes, but recent case reports and single-institution case series – though limited by small patient numbers and the inclusion of both major and minor thoracic procedures ranging from chest tube insertion to pneumonectomy – have suggested that transplantation is feasible in these patients, he said.

Studies specifically looking at lung transplant after resection are lacking; the largest series involved pneumonectomy and included only 14 patients, he said.

The current findings suggest that prior resection should not preclude lung transplantation.

Notable limits of the study include its retrospective design, which may have introduced unexpected bias into the analysis; the fact that the analysis is limited to the variable collected for the UNOS database; and the number of patients with prior resection, although this may be secondary to underreporting of prior thoracic procedures in the UNOS candidate registration form or a result of data being collected only from 1999 onward.

Other variables that may have been of interest for the current analysis were knowledge of laterality of prior resection, time from resection to treatment, days of postoperative ventilator use, and operative time, Dr. Ganapathi noted. Specifically, in cases of single lung transplant, the issue of laterality would be of great interest, he said.

"In conclusion, lung transplantation subsequent to previous major lung resection is associated with an increased risk of early mortality, but did not demonstrate any significant long-term survival differences. Additionally, prior major lung resection predisposes to increased morbidity in the form of renal failure requiring dialysis," he said. The increased rate of dialysis may be secondary to longer operative time, the need for cardiopulmonary bypass, or other unquantified factors, he added.

Careful, individualized preoperative recipient evaluation and technical planning are necessary to minimize these risks in the patients, he concluded.

Dr. Ganapathi reported having no relevant disclosures.

ORLANDO – Prior lung resection is associated with increased early mortality and with a more than twofold increased risk of renal failure requiring dialysis in lung transplant recipients, data from the United Network for Organ Sharing suggest.

Prior resection is not, however, associated with increased long-term mortality, prolonged hospital length of stay, or airway dehiscence, Dr. Asvin M. Ganapathi reported at the annual meeting of the Society of Thoracic Surgeons.

Of 15,300 adult lung transplant recipients in the UNOS database who received lungs between October 1999 and December 2011, 80 had a prior lobectomy and 22 had a prior pneumonectomy. After 3:1 propensity matching based on 17 recipient variables known to affect perioperative morbidity and mortality, 90-day mortality in 306 nonresection patients was 5.8%, compared with 13.9% in the 102 with prior resection. Renal failure requiring dialysis occurred in 6.6% and 13.9% of patients in the groups, respectively, said Dr. Ganapathi of the anesthesiology division of Duke University, Durham, N.C.

Hospital length of stay longer than 25 days was required in 36.9% and 36.4% of the nonresection and resection groups, respectively, and airway dehiscence occurred in 1.3% and 2%, he said.

Survival at 1 and 5 years was 83.6% and 48.4% in the nonresection group, and 78.9% and 45.6% in the prior-resection group.

A subanalysis comparing the prior-lobectomy patients with patients with no prior resection revealed no differences between the two groups in any of the examined outcomes, although there was a trend toward increased 90-day mortality in the lobectomy patient, and a more than twofold increase in renal failure requiring dialysis. A subanalysis comparing those with prior pneumonectomy with those with no prior resection showed a significantly greater need for dialysis in the pneumonectomy patients (8.9% vs. 3.8%), and a trend toward increased 90-day mortality in the pneumonectomy patients, but no differences in the other examined outcomes.

The propensity-matched groups were similar with respect to recipient, donor, and operative characteristics. There were 10 double and 12 single lung transplants after pneumonectomy, and 51 double and 29 single transplants after lobectomy.

Lung transplantation provides a durable, efficacious treatment for end-stage lung disease, but indications for transplant can vary, and as a result, a select group of patients may have had prior lung resection for treatment of their underlying disease, Dr. Ganapathi said.

Both lobectomy and pneumonectomy are known to cause anatomic changes such as mediastinal shift and vascular abnormalities.

"As such, a history of previous lung resection may affect selection of donor organs and increase the difficulty of transplantation," he said.

In fact, historically, prior thoracic surgery was considered a relative contraindication to lung transplantation because of increased risk of poor outcomes, but recent case reports and single-institution case series – though limited by small patient numbers and the inclusion of both major and minor thoracic procedures ranging from chest tube insertion to pneumonectomy – have suggested that transplantation is feasible in these patients, he said.

Studies specifically looking at lung transplant after resection are lacking; the largest series involved pneumonectomy and included only 14 patients, he said.

The current findings suggest that prior resection should not preclude lung transplantation.

Notable limits of the study include its retrospective design, which may have introduced unexpected bias into the analysis; the fact that the analysis is limited to the variable collected for the UNOS database; and the number of patients with prior resection, although this may be secondary to underreporting of prior thoracic procedures in the UNOS candidate registration form or a result of data being collected only from 1999 onward.

Other variables that may have been of interest for the current analysis were knowledge of laterality of prior resection, time from resection to treatment, days of postoperative ventilator use, and operative time, Dr. Ganapathi noted. Specifically, in cases of single lung transplant, the issue of laterality would be of great interest, he said.

"In conclusion, lung transplantation subsequent to previous major lung resection is associated with an increased risk of early mortality, but did not demonstrate any significant long-term survival differences. Additionally, prior major lung resection predisposes to increased morbidity in the form of renal failure requiring dialysis," he said. The increased rate of dialysis may be secondary to longer operative time, the need for cardiopulmonary bypass, or other unquantified factors, he added.

Careful, individualized preoperative recipient evaluation and technical planning are necessary to minimize these risks in the patients, he concluded.

Dr. Ganapathi reported having no relevant disclosures.

ORLANDO – Prior lung resection is associated with increased early mortality and with a more than twofold increased risk of renal failure requiring dialysis in lung transplant recipients, data from the United Network for Organ Sharing suggest.

Prior resection is not, however, associated with increased long-term mortality, prolonged hospital length of stay, or airway dehiscence, Dr. Asvin M. Ganapathi reported at the annual meeting of the Society of Thoracic Surgeons.

Of 15,300 adult lung transplant recipients in the UNOS database who received lungs between October 1999 and December 2011, 80 had a prior lobectomy and 22 had a prior pneumonectomy. After 3:1 propensity matching based on 17 recipient variables known to affect perioperative morbidity and mortality, 90-day mortality in 306 nonresection patients was 5.8%, compared with 13.9% in the 102 with prior resection. Renal failure requiring dialysis occurred in 6.6% and 13.9% of patients in the groups, respectively, said Dr. Ganapathi of the anesthesiology division of Duke University, Durham, N.C.

Hospital length of stay longer than 25 days was required in 36.9% and 36.4% of the nonresection and resection groups, respectively, and airway dehiscence occurred in 1.3% and 2%, he said.

Survival at 1 and 5 years was 83.6% and 48.4% in the nonresection group, and 78.9% and 45.6% in the prior-resection group.

A subanalysis comparing the prior-lobectomy patients with patients with no prior resection revealed no differences between the two groups in any of the examined outcomes, although there was a trend toward increased 90-day mortality in the lobectomy patient, and a more than twofold increase in renal failure requiring dialysis. A subanalysis comparing those with prior pneumonectomy with those with no prior resection showed a significantly greater need for dialysis in the pneumonectomy patients (8.9% vs. 3.8%), and a trend toward increased 90-day mortality in the pneumonectomy patients, but no differences in the other examined outcomes.

The propensity-matched groups were similar with respect to recipient, donor, and operative characteristics. There were 10 double and 12 single lung transplants after pneumonectomy, and 51 double and 29 single transplants after lobectomy.

Lung transplantation provides a durable, efficacious treatment for end-stage lung disease, but indications for transplant can vary, and as a result, a select group of patients may have had prior lung resection for treatment of their underlying disease, Dr. Ganapathi said.

Both lobectomy and pneumonectomy are known to cause anatomic changes such as mediastinal shift and vascular abnormalities.

"As such, a history of previous lung resection may affect selection of donor organs and increase the difficulty of transplantation," he said.

In fact, historically, prior thoracic surgery was considered a relative contraindication to lung transplantation because of increased risk of poor outcomes, but recent case reports and single-institution case series – though limited by small patient numbers and the inclusion of both major and minor thoracic procedures ranging from chest tube insertion to pneumonectomy – have suggested that transplantation is feasible in these patients, he said.

Studies specifically looking at lung transplant after resection are lacking; the largest series involved pneumonectomy and included only 14 patients, he said.

The current findings suggest that prior resection should not preclude lung transplantation.

Notable limits of the study include its retrospective design, which may have introduced unexpected bias into the analysis; the fact that the analysis is limited to the variable collected for the UNOS database; and the number of patients with prior resection, although this may be secondary to underreporting of prior thoracic procedures in the UNOS candidate registration form or a result of data being collected only from 1999 onward.

Other variables that may have been of interest for the current analysis were knowledge of laterality of prior resection, time from resection to treatment, days of postoperative ventilator use, and operative time, Dr. Ganapathi noted. Specifically, in cases of single lung transplant, the issue of laterality would be of great interest, he said.

"In conclusion, lung transplantation subsequent to previous major lung resection is associated with an increased risk of early mortality, but did not demonstrate any significant long-term survival differences. Additionally, prior major lung resection predisposes to increased morbidity in the form of renal failure requiring dialysis," he said. The increased rate of dialysis may be secondary to longer operative time, the need for cardiopulmonary bypass, or other unquantified factors, he added.

Careful, individualized preoperative recipient evaluation and technical planning are necessary to minimize these risks in the patients, he concluded.

Dr. Ganapathi reported having no relevant disclosures.

BRUSSELS – National Cancer Institute Director Catherine Alfano, Ph.D., summarizes the institute’s work on improving cancer survivor planning, better coordinating survivor care, and gathering new data on long-term outcomes. She made her remarks during the Cancer Survivorship Summit in a video interview.

[email protected]

On Twitter @mitchelzoler

BRUSSELS – National Cancer Institute Director Catherine Alfano, Ph.D., summarizes the institute’s work on improving cancer survivor planning, better coordinating survivor care, and gathering new data on long-term outcomes. She made her remarks during the Cancer Survivorship Summit in a video interview.

[email protected]

On Twitter @mitchelzoler

BRUSSELS – National Cancer Institute Director Catherine Alfano, Ph.D., summarizes the institute’s work on improving cancer survivor planning, better coordinating survivor care, and gathering new data on long-term outcomes. She made her remarks during the Cancer Survivorship Summit in a video interview.

[email protected]

On Twitter @mitchelzoler

ORLANDO – Tumor response nodes obtained from patients who undergo esophagectomy for early-stage adenocarcinoma provide valuable prognostic information, according to Dr. Dylan Nieman.

Such nodes – lymph nodes with evidence of neoadjuvant treatment effect without residual cancer cells – may mark the prior spread of tumor, and should be counted as positive, Dr. Nieman of the University of Rochester (N.Y.) said at the annual meeting of the Society of Thoracic Surgeons.

The current practice of ignoring these nodes likely results in systematic pathologic understaging, he explained.

In 90 patients who underwent esophagectomy after neoadjuvant therapy for esophageal adenocarcinoma, the median number of nodes found per resection specimen was 18. A total of 100 tumor response nodes without viable malignant cells were identified in 38 (42%) of the patients.

The majority of the patients with treatment response nodes had only one node detected, Dr. Nieman said.

The median survival for the entire cohort was 55.6 months, and the 5-year survival was 35%. The median survival of patients with evidence of treatment response nodes was poorer, but not significantly different from those without treatment response nodes (45.9 vs. 55.6 months), he noted.

"However, for a subset of 62 patients classified as having limited or no nodal involvement – that is, AJCC N0 or N1 – the presence of treatment response nodes was associated with significantly poorer survival. This effect remained when adjusting for patient age and [American Joint Committee on Cancer] stage (hazard ratio, 2.7)," he said.

In a subset of 46 patients with pathologic AJCC stage 2B or less, the presence of treatment response nodes was still associated with poorer survival, even after adjustment for age and AJCC stage.

"To look at this a different way, if tumor response nodes were to be counted as positive, the nodal status of 29 of these patients would be upstaged. This includes 18 of 39 patients, or 46%, who were classified as node negative, and 8 of 23 patients, or 34%, who were classified as N1 by AJCC pathological assessment," he said.

The recategorization of those 29 patients resulted in better survival for the entire group, but particularly for those in the lowest-stage group, he noted.

When investigators modeled stage-adjusted survival, the counting of tumor response nodes as positive offered a better model fit, compared with following the current practice of ignoring tumor response nodes, he explained.

Patients included in the study were identified from a prospectively collected clinical database of esophagectomy patients, and were treated with neoadjuvant therapy for esophageal adenocarcinoma between 2006 and 2011. Most (82 of 90) were men. The patients had a mean age of 62 years, and were followed for a median of 27 months. Forty patients received preoperative chemotherapy, and 50 received preoperative chemoradiation.

In all cases, pathologic resection margins were negative.

On pathologic review, the majority had T3 tumors. More than 40% were staged as node negative, and more than two-thirds were staged with N0 or N1 disease.

"Prior to neoadjuvant therapy, all of these patients were clinically staged stage 2 or stage 3, but at the time of resection after neoadjuvant therapy, by AJCC staging, 24% of the patients were stage 0 or 1, 27% were stage 2, and almost half were stage 3," he said.

The findings are notable, because the current AJCC pathologic staging for esophageal adenocarcinoma is derived from the experience of patients undergoing esophagectomy alone. This approach has unclear relevance in patients who receive multimodality therapy, which has supplanted primary surgery as the standard of care for locoregionally advanced esophageal adenocarcinoma, he said.

"Future efforts at revising the staging system for esophageal adenocarcinoma should consider treatment response lymph nodes. ... We currently have pathological staging models that are of limited usefulness for our neoadjuvantly treated population. Perhaps consideration of these nodes can help improve that," he concluded.

Dr. Nieman reported having no financial disclosures.

ORLANDO – Tumor response nodes obtained from patients who undergo esophagectomy for early-stage adenocarcinoma provide valuable prognostic information, according to Dr. Dylan Nieman.

Such nodes – lymph nodes with evidence of neoadjuvant treatment effect without residual cancer cells – may mark the prior spread of tumor, and should be counted as positive, Dr. Nieman of the University of Rochester (N.Y.) said at the annual meeting of the Society of Thoracic Surgeons.

The current practice of ignoring these nodes likely results in systematic pathologic understaging, he explained.

In 90 patients who underwent esophagectomy after neoadjuvant therapy for esophageal adenocarcinoma, the median number of nodes found per resection specimen was 18. A total of 100 tumor response nodes without viable malignant cells were identified in 38 (42%) of the patients.

The majority of the patients with treatment response nodes had only one node detected, Dr. Nieman said.

The median survival for the entire cohort was 55.6 months, and the 5-year survival was 35%. The median survival of patients with evidence of treatment response nodes was poorer, but not significantly different from those without treatment response nodes (45.9 vs. 55.6 months), he noted.

"However, for a subset of 62 patients classified as having limited or no nodal involvement – that is, AJCC N0 or N1 – the presence of treatment response nodes was associated with significantly poorer survival. This effect remained when adjusting for patient age and [American Joint Committee on Cancer] stage (hazard ratio, 2.7)," he said.

In a subset of 46 patients with pathologic AJCC stage 2B or less, the presence of treatment response nodes was still associated with poorer survival, even after adjustment for age and AJCC stage.

"To look at this a different way, if tumor response nodes were to be counted as positive, the nodal status of 29 of these patients would be upstaged. This includes 18 of 39 patients, or 46%, who were classified as node negative, and 8 of 23 patients, or 34%, who were classified as N1 by AJCC pathological assessment," he said.

The recategorization of those 29 patients resulted in better survival for the entire group, but particularly for those in the lowest-stage group, he noted.

When investigators modeled stage-adjusted survival, the counting of tumor response nodes as positive offered a better model fit, compared with following the current practice of ignoring tumor response nodes, he explained.

Patients included in the study were identified from a prospectively collected clinical database of esophagectomy patients, and were treated with neoadjuvant therapy for esophageal adenocarcinoma between 2006 and 2011. Most (82 of 90) were men. The patients had a mean age of 62 years, and were followed for a median of 27 months. Forty patients received preoperative chemotherapy, and 50 received preoperative chemoradiation.

In all cases, pathologic resection margins were negative.

On pathologic review, the majority had T3 tumors. More than 40% were staged as node negative, and more than two-thirds were staged with N0 or N1 disease.

"Prior to neoadjuvant therapy, all of these patients were clinically staged stage 2 or stage 3, but at the time of resection after neoadjuvant therapy, by AJCC staging, 24% of the patients were stage 0 or 1, 27% were stage 2, and almost half were stage 3," he said.

The findings are notable, because the current AJCC pathologic staging for esophageal adenocarcinoma is derived from the experience of patients undergoing esophagectomy alone. This approach has unclear relevance in patients who receive multimodality therapy, which has supplanted primary surgery as the standard of care for locoregionally advanced esophageal adenocarcinoma, he said.

"Future efforts at revising the staging system for esophageal adenocarcinoma should consider treatment response lymph nodes. ... We currently have pathological staging models that are of limited usefulness for our neoadjuvantly treated population. Perhaps consideration of these nodes can help improve that," he concluded.

Dr. Nieman reported having no financial disclosures.

ORLANDO – Tumor response nodes obtained from patients who undergo esophagectomy for early-stage adenocarcinoma provide valuable prognostic information, according to Dr. Dylan Nieman.

Such nodes – lymph nodes with evidence of neoadjuvant treatment effect without residual cancer cells – may mark the prior spread of tumor, and should be counted as positive, Dr. Nieman of the University of Rochester (N.Y.) said at the annual meeting of the Society of Thoracic Surgeons.

The current practice of ignoring these nodes likely results in systematic pathologic understaging, he explained.

In 90 patients who underwent esophagectomy after neoadjuvant therapy for esophageal adenocarcinoma, the median number of nodes found per resection specimen was 18. A total of 100 tumor response nodes without viable malignant cells were identified in 38 (42%) of the patients.

The majority of the patients with treatment response nodes had only one node detected, Dr. Nieman said.

The median survival for the entire cohort was 55.6 months, and the 5-year survival was 35%. The median survival of patients with evidence of treatment response nodes was poorer, but not significantly different from those without treatment response nodes (45.9 vs. 55.6 months), he noted.

"However, for a subset of 62 patients classified as having limited or no nodal involvement – that is, AJCC N0 or N1 – the presence of treatment response nodes was associated with significantly poorer survival. This effect remained when adjusting for patient age and [American Joint Committee on Cancer] stage (hazard ratio, 2.7)," he said.

In a subset of 46 patients with pathologic AJCC stage 2B or less, the presence of treatment response nodes was still associated with poorer survival, even after adjustment for age and AJCC stage.

"To look at this a different way, if tumor response nodes were to be counted as positive, the nodal status of 29 of these patients would be upstaged. This includes 18 of 39 patients, or 46%, who were classified as node negative, and 8 of 23 patients, or 34%, who were classified as N1 by AJCC pathological assessment," he said.

The recategorization of those 29 patients resulted in better survival for the entire group, but particularly for those in the lowest-stage group, he noted.

When investigators modeled stage-adjusted survival, the counting of tumor response nodes as positive offered a better model fit, compared with following the current practice of ignoring tumor response nodes, he explained.

Patients included in the study were identified from a prospectively collected clinical database of esophagectomy patients, and were treated with neoadjuvant therapy for esophageal adenocarcinoma between 2006 and 2011. Most (82 of 90) were men. The patients had a mean age of 62 years, and were followed for a median of 27 months. Forty patients received preoperative chemotherapy, and 50 received preoperative chemoradiation.

In all cases, pathologic resection margins were negative.

On pathologic review, the majority had T3 tumors. More than 40% were staged as node negative, and more than two-thirds were staged with N0 or N1 disease.

"Prior to neoadjuvant therapy, all of these patients were clinically staged stage 2 or stage 3, but at the time of resection after neoadjuvant therapy, by AJCC staging, 24% of the patients were stage 0 or 1, 27% were stage 2, and almost half were stage 3," he said.

The findings are notable, because the current AJCC pathologic staging for esophageal adenocarcinoma is derived from the experience of patients undergoing esophagectomy alone. This approach has unclear relevance in patients who receive multimodality therapy, which has supplanted primary surgery as the standard of care for locoregionally advanced esophageal adenocarcinoma, he said.

"Future efforts at revising the staging system for esophageal adenocarcinoma should consider treatment response lymph nodes. ... We currently have pathological staging models that are of limited usefulness for our neoadjuvantly treated population. Perhaps consideration of these nodes can help improve that," he concluded.

Dr. Nieman reported having no financial disclosures.

Negative surgical margins defined by the absence of any ink on the excised tumor are adequate in most cases of early-stage breast cancer treated with breast-conserving therapy, suggest new consensus guidelines from the Society of Surgical Oncology and American Society for Radiation Oncology.

"The use of no ink on tumor as the standard for an adequate margin in invasive cancer in the era of multidisciplinary therapy is associated with low rates of ipsilateral breast tumor recurrence and has the potential to decrease re-excision rates, improve cosmetic outcomes, and decrease health care costs," concludes the 12-member multidisciplinary panel. "The routine practice to obtain negative margin widths wider than no ink on tumor is not indicated" (J. Clin. Oncol. 2014 Feb. 10 [doi:10.1200/JCO.2013.53.3935]).

The panel used as their evidence a systematic review and a meta-analysis based on 33 studies having a total of 28,162 patients with stage I or II breast cancer who were treated with breast-conserving surgery plus whole-breast radiation therapy.

Results showed that, compared with peers having negative margins, patients having positive margins were twice as likely to experience an ipsilateral recurrence, regardless of whether they had favorable tumor biology, were given a radiation boost, or received endocrine therapy (Int. J. Radiation Oncol. Biol. Phys. 2014;88:553-64).

But taking wider margins beyond the point of no ink on tumor did not further reduce the risk of ipsilateral recurrence in the patients overall or in a variety of subsets having unfavorable features (young age, aggressive biology, lobular cancers, or tumors with an extensive intraductal component).

"Our hope is that this guideline will ultimately lead to significant reductions in the high re-excision rate for women with early-stage breast cancer undergoing breast-conserving surgery. Based on the consensus panel’s extensive review of the literature, the vast majority of re-excisions are unnecessary because disease control in the breast is excellent for women with early-stage disease when radiation and hormonal therapy and/or chemotherapy are added to a women’s treatment plan," panel cochair Dr. Meena S. Moran of Yale University, New Haven, Conn., commented in a prepared statement.

In an accompanying editorial, Dr. Reshma Jagsi, University of Michigan, Ann Arbor, and her colleagues write, "We agree with the general idea that routine reexcision of close margins (beyond no ink on tumor) is not necessary, and we expect that these guidelines will have a substantial impact on the community of practicing surgeons. Therefore, radiation oncologists should be prepared to encounter an increasing number of patients with microscopically close margins who might have undergone re-excision in previous years" (Int. J. Radiation Oncol. Biol. Phys. 2014;88:535-36).

At the same time, they note that the wording of the new guidelines gives physicians and patients latitude in individualizing decisions about whether re-excision is warranted.

"Physicians applying these guidelines must have an appreciation of the rationale for the recommendations, as well as the limitations of the evidence available, so that they can interpret and apply the guidelines appropriately. Only with a sophisticated understanding of these issues can we, as a profession, continue to deliver individualized care of consistently high quality, avoiding the sort of ‘cookbook medicine’ that serves well neither physicians nor patients," the editorialists conclude.

The studies included in the meta-analysis were published between 1965 and early 2013 and had a median or mean follow-up of at least 4 years. Patients were excluded if they received neoadjuvant chemotherapy or had only ductal carcinoma in situ.

Overall, 78% of the patients studied had negative margins, defined as no ink on the invasive tumor or any ductal carcinoma in situ component. After a median follow-up of 6.6 years, the median prevalence of ipsilateral recurrence was 5.3% overall.

Patients with positive or close margins were twice as likely to have an ipsilateral recurrence (odds ratio, 1.96). In the subset of studies that were able to separate out close margins, risk was elevated with both positive margins (OR, 2.44) and close margins (OR, 1.74).

The adverse impact of positive margins was still evident in analyses taking into account use of a radiation boost (OR, 2.45) and receipt of endocrine therapy (OR, 2.53), and among patients with favorable biology in the form of estrogen receptor–positive tumors (OR, 2.66).

When the impact of the width of the negative margin was evaluated, the risks of ipsilateral recurrence with 2-mm and 5-mm margins were statistically indistinguishable from those with 1-mm margins.

The analysis confirmed that giving systemic therapy (endocrine therapy, chemotherapy, and/or biologic therapy) reduces the risk of ipsilateral recurrence. But the evidence also suggested that in the small number of patients who do not receive this therapy, wider margins beyond no ink on tumor do not further reduce that risk.

In additional findings, there was no evidence that wider margins beyond no ink on tumor are indicated in patients having more aggressive biological subtypes of breast cancer, invasive lobular carcinoma, or tumors with an extensive intraductal component, or in patients aged 40 years or younger.

The panel also concluded that margin width should not dictate the choice of whole-breast radiation therapy delivery technique, fractionation, and boost dose.

Negative surgical margins defined by the absence of any ink on the excised tumor are adequate in most cases of early-stage breast cancer treated with breast-conserving therapy, suggest new consensus guidelines from the Society of Surgical Oncology and American Society for Radiation Oncology.

"The use of no ink on tumor as the standard for an adequate margin in invasive cancer in the era of multidisciplinary therapy is associated with low rates of ipsilateral breast tumor recurrence and has the potential to decrease re-excision rates, improve cosmetic outcomes, and decrease health care costs," concludes the 12-member multidisciplinary panel. "The routine practice to obtain negative margin widths wider than no ink on tumor is not indicated" (J. Clin. Oncol. 2014 Feb. 10 [doi:10.1200/JCO.2013.53.3935]).

The panel used as their evidence a systematic review and a meta-analysis based on 33 studies having a total of 28,162 patients with stage I or II breast cancer who were treated with breast-conserving surgery plus whole-breast radiation therapy.

Results showed that, compared with peers having negative margins, patients having positive margins were twice as likely to experience an ipsilateral recurrence, regardless of whether they had favorable tumor biology, were given a radiation boost, or received endocrine therapy (Int. J. Radiation Oncol. Biol. Phys. 2014;88:553-64).

But taking wider margins beyond the point of no ink on tumor did not further reduce the risk of ipsilateral recurrence in the patients overall or in a variety of subsets having unfavorable features (young age, aggressive biology, lobular cancers, or tumors with an extensive intraductal component).

"Our hope is that this guideline will ultimately lead to significant reductions in the high re-excision rate for women with early-stage breast cancer undergoing breast-conserving surgery. Based on the consensus panel’s extensive review of the literature, the vast majority of re-excisions are unnecessary because disease control in the breast is excellent for women with early-stage disease when radiation and hormonal therapy and/or chemotherapy are added to a women’s treatment plan," panel cochair Dr. Meena S. Moran of Yale University, New Haven, Conn., commented in a prepared statement.

In an accompanying editorial, Dr. Reshma Jagsi, University of Michigan, Ann Arbor, and her colleagues write, "We agree with the general idea that routine reexcision of close margins (beyond no ink on tumor) is not necessary, and we expect that these guidelines will have a substantial impact on the community of practicing surgeons. Therefore, radiation oncologists should be prepared to encounter an increasing number of patients with microscopically close margins who might have undergone re-excision in previous years" (Int. J. Radiation Oncol. Biol. Phys. 2014;88:535-36).

At the same time, they note that the wording of the new guidelines gives physicians and patients latitude in individualizing decisions about whether re-excision is warranted.

"Physicians applying these guidelines must have an appreciation of the rationale for the recommendations, as well as the limitations of the evidence available, so that they can interpret and apply the guidelines appropriately. Only with a sophisticated understanding of these issues can we, as a profession, continue to deliver individualized care of consistently high quality, avoiding the sort of ‘cookbook medicine’ that serves well neither physicians nor patients," the editorialists conclude.

The studies included in the meta-analysis were published between 1965 and early 2013 and had a median or mean follow-up of at least 4 years. Patients were excluded if they received neoadjuvant chemotherapy or had only ductal carcinoma in situ.

Overall, 78% of the patients studied had negative margins, defined as no ink on the invasive tumor or any ductal carcinoma in situ component. After a median follow-up of 6.6 years, the median prevalence of ipsilateral recurrence was 5.3% overall.

Patients with positive or close margins were twice as likely to have an ipsilateral recurrence (odds ratio, 1.96). In the subset of studies that were able to separate out close margins, risk was elevated with both positive margins (OR, 2.44) and close margins (OR, 1.74).

The adverse impact of positive margins was still evident in analyses taking into account use of a radiation boost (OR, 2.45) and receipt of endocrine therapy (OR, 2.53), and among patients with favorable biology in the form of estrogen receptor–positive tumors (OR, 2.66).

When the impact of the width of the negative margin was evaluated, the risks of ipsilateral recurrence with 2-mm and 5-mm margins were statistically indistinguishable from those with 1-mm margins.

The analysis confirmed that giving systemic therapy (endocrine therapy, chemotherapy, and/or biologic therapy) reduces the risk of ipsilateral recurrence. But the evidence also suggested that in the small number of patients who do not receive this therapy, wider margins beyond no ink on tumor do not further reduce that risk.

In additional findings, there was no evidence that wider margins beyond no ink on tumor are indicated in patients having more aggressive biological subtypes of breast cancer, invasive lobular carcinoma, or tumors with an extensive intraductal component, or in patients aged 40 years or younger.

The panel also concluded that margin width should not dictate the choice of whole-breast radiation therapy delivery technique, fractionation, and boost dose.

Negative surgical margins defined by the absence of any ink on the excised tumor are adequate in most cases of early-stage breast cancer treated with breast-conserving therapy, suggest new consensus guidelines from the Society of Surgical Oncology and American Society for Radiation Oncology.

"The use of no ink on tumor as the standard for an adequate margin in invasive cancer in the era of multidisciplinary therapy is associated with low rates of ipsilateral breast tumor recurrence and has the potential to decrease re-excision rates, improve cosmetic outcomes, and decrease health care costs," concludes the 12-member multidisciplinary panel. "The routine practice to obtain negative margin widths wider than no ink on tumor is not indicated" (J. Clin. Oncol. 2014 Feb. 10 [doi:10.1200/JCO.2013.53.3935]).

The panel used as their evidence a systematic review and a meta-analysis based on 33 studies having a total of 28,162 patients with stage I or II breast cancer who were treated with breast-conserving surgery plus whole-breast radiation therapy.

Results showed that, compared with peers having negative margins, patients having positive margins were twice as likely to experience an ipsilateral recurrence, regardless of whether they had favorable tumor biology, were given a radiation boost, or received endocrine therapy (Int. J. Radiation Oncol. Biol. Phys. 2014;88:553-64).

But taking wider margins beyond the point of no ink on tumor did not further reduce the risk of ipsilateral recurrence in the patients overall or in a variety of subsets having unfavorable features (young age, aggressive biology, lobular cancers, or tumors with an extensive intraductal component).

"Our hope is that this guideline will ultimately lead to significant reductions in the high re-excision rate for women with early-stage breast cancer undergoing breast-conserving surgery. Based on the consensus panel’s extensive review of the literature, the vast majority of re-excisions are unnecessary because disease control in the breast is excellent for women with early-stage disease when radiation and hormonal therapy and/or chemotherapy are added to a women’s treatment plan," panel cochair Dr. Meena S. Moran of Yale University, New Haven, Conn., commented in a prepared statement.

In an accompanying editorial, Dr. Reshma Jagsi, University of Michigan, Ann Arbor, and her colleagues write, "We agree with the general idea that routine reexcision of close margins (beyond no ink on tumor) is not necessary, and we expect that these guidelines will have a substantial impact on the community of practicing surgeons. Therefore, radiation oncologists should be prepared to encounter an increasing number of patients with microscopically close margins who might have undergone re-excision in previous years" (Int. J. Radiation Oncol. Biol. Phys. 2014;88:535-36).

At the same time, they note that the wording of the new guidelines gives physicians and patients latitude in individualizing decisions about whether re-excision is warranted.

"Physicians applying these guidelines must have an appreciation of the rationale for the recommendations, as well as the limitations of the evidence available, so that they can interpret and apply the guidelines appropriately. Only with a sophisticated understanding of these issues can we, as a profession, continue to deliver individualized care of consistently high quality, avoiding the sort of ‘cookbook medicine’ that serves well neither physicians nor patients," the editorialists conclude.

The studies included in the meta-analysis were published between 1965 and early 2013 and had a median or mean follow-up of at least 4 years. Patients were excluded if they received neoadjuvant chemotherapy or had only ductal carcinoma in situ.

Overall, 78% of the patients studied had negative margins, defined as no ink on the invasive tumor or any ductal carcinoma in situ component. After a median follow-up of 6.6 years, the median prevalence of ipsilateral recurrence was 5.3% overall.

Patients with positive or close margins were twice as likely to have an ipsilateral recurrence (odds ratio, 1.96). In the subset of studies that were able to separate out close margins, risk was elevated with both positive margins (OR, 2.44) and close margins (OR, 1.74).

The adverse impact of positive margins was still evident in analyses taking into account use of a radiation boost (OR, 2.45) and receipt of endocrine therapy (OR, 2.53), and among patients with favorable biology in the form of estrogen receptor–positive tumors (OR, 2.66).

When the impact of the width of the negative margin was evaluated, the risks of ipsilateral recurrence with 2-mm and 5-mm margins were statistically indistinguishable from those with 1-mm margins.

The analysis confirmed that giving systemic therapy (endocrine therapy, chemotherapy, and/or biologic therapy) reduces the risk of ipsilateral recurrence. But the evidence also suggested that in the small number of patients who do not receive this therapy, wider margins beyond no ink on tumor do not further reduce that risk.

In additional findings, there was no evidence that wider margins beyond no ink on tumor are indicated in patients having more aggressive biological subtypes of breast cancer, invasive lobular carcinoma, or tumors with an extensive intraductal component, or in patients aged 40 years or younger.

The panel also concluded that margin width should not dictate the choice of whole-breast radiation therapy delivery technique, fractionation, and boost dose.

Almost one-fifth of adult cancer clinical trials fail to reach completion for reasons unrelated to efficacy or adverse effects, according to data being reported at the 2014 Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology. Poor accrual is the leading cause.

Trials were more likely to fail completion if they were phase II, single center, funded by industry, or conducted solely in the United States. Trials among patients with genitourinary cancers were no more or less likely to fail than trials among patients with other cancers.

"These findings really underscore the clinical trial accrual problem that we have in the United States. Not only does poor accrual lead to more expensive trials and trials that generate answers much more slowly, but it also prevents many trials from generating answers at all," senior author Dr. Matthew D. Galsky, director of the genitourinary medical oncology program, Icahn School of Medicine at Mount Sinai, New York, said in a press briefing at the 2014 Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology.

The study is not meant to indict any specific stakeholders, Dr. Galsky stressed. "Rather, what we wanted to do was hold up a mirror to our activities as a cancer clinical trials community and really ask whether the system is optimized to bring better treatments to our patients as efficiently as possible. And clearly there is some work to do.

"Based on this analysis and others, it’s apparent that we need better collaboration and communication within the system and to use novel approaches to increase accrual to cancer clinical trials, which has really been quite steady at 3% to 5% of the adult cancer population for decades."

"This is a really interesting presentation which casts some light on one of the major frustrations that I think ... our whole community shares in designing and implementing clinical trials," said press briefing moderator Dr. Charles J. Ryan, leader of the genitourinary medical oncology program at the University of California, San Francisco. "Hopefully, this may be the beginning of a broader discussion that helps improve some of the efficiencies here."

Dr. Galsky speculated that the explanation for poor accrual is multifactorial. "Clearly, we need to engage patients more in the design of trials. We need to design trials that are more pragmatic; eligibility for trials is often so restrictive that only the patients who are the fittest and represent kind of an extreme of cancer patients can actually enroll," he said.

Other issues likely include financial barriers (such as whether insurers reimburse the costs of care for patients in trials); geographic accessibility; and the time and regulatory burdens of participating, especially as they affect community oncology practices. "Addressing the cancer clinical trials enterprise at large requires making the burden of participation lower because that does address accrual, that does address generalizability, that does address accessibility. It’s a problem that needs to be part of this conversation," Dr. Galsky maintained.

Dr. Ryan, the moderator, cited rapid treatment advances as yet another possible reason for poor accrual. "Some trials may take 2 or 3 years to accrue. During the first year, the standards of care may be one thing, and during the third year, the standards of care may have changed. We are really seeing very rapid evolution in our standards of care, so that could be one issue," he elaborated.

Introducing the study, Dr. Galsky noted that trials that fail to complete (that is, close without enrolling the intended number of patients) represent a major inefficiency of the cancer clinical trials enterprise. "Such trials contribute little knowledge, waste finite resources, and potentially divert patients from participating in other trials," he said.

The Institute of Medicine previously issued a report suggesting that about 40% of trials sponsored by the National Cancer Institute fail to achieve completion. But such trials account for only about 15% of all cancer trials.

The researchers analyzed 7,776 phase II or III interventional adult cancer clinical trials registered on ClinicalTrials.gov that had start dates between 2005 and 2011. They searched for those that had failed to reach completion, meaning that the trial had been stopped and had a "terminated" or "withdrawn" status.

The trials had a total of about 48,000 patients. Overall, 10% were trials in prostate, kidney, bladder, or testicular cancer.

The cumulative incidence of failure to reach completion for reasons unrelated to the efficacy or safety of the intervention was about 20%, according to Dr. Galsky.

Among all noncompleted trials, the largest share, 39%, failed to achieve completion because of poor accrual, topping other reasons such as logistics and efficacy/safety.

Trials were more likely to fail completion if they were funded by industry as compared with the federal government (hazard ratio, 1.97), were phase II as compared with phase III (HR, 1.29), or were single center as compared with multicenter (HR, 1.93).

On the other hand, trials were less likely to fail completion if they were conducted solely outside the United States (HR, 0.65) or both in and outside the United States (HR, 0.67), as compared with solely in the United States.

Dr. Galsky disclosed no relevant conflicts of interest.

Almost one-fifth of adult cancer clinical trials fail to reach completion for reasons unrelated to efficacy or adverse effects, according to data being reported at the 2014 Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology. Poor accrual is the leading cause.

Trials were more likely to fail completion if they were phase II, single center, funded by industry, or conducted solely in the United States. Trials among patients with genitourinary cancers were no more or less likely to fail than trials among patients with other cancers.

"These findings really underscore the clinical trial accrual problem that we have in the United States. Not only does poor accrual lead to more expensive trials and trials that generate answers much more slowly, but it also prevents many trials from generating answers at all," senior author Dr. Matthew D. Galsky, director of the genitourinary medical oncology program, Icahn School of Medicine at Mount Sinai, New York, said in a press briefing at the 2014 Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology.

The study is not meant to indict any specific stakeholders, Dr. Galsky stressed. "Rather, what we wanted to do was hold up a mirror to our activities as a cancer clinical trials community and really ask whether the system is optimized to bring better treatments to our patients as efficiently as possible. And clearly there is some work to do.

"Based on this analysis and others, it’s apparent that we need better collaboration and communication within the system and to use novel approaches to increase accrual to cancer clinical trials, which has really been quite steady at 3% to 5% of the adult cancer population for decades."

"This is a really interesting presentation which casts some light on one of the major frustrations that I think ... our whole community shares in designing and implementing clinical trials," said press briefing moderator Dr. Charles J. Ryan, leader of the genitourinary medical oncology program at the University of California, San Francisco. "Hopefully, this may be the beginning of a broader discussion that helps improve some of the efficiencies here."

Dr. Galsky speculated that the explanation for poor accrual is multifactorial. "Clearly, we need to engage patients more in the design of trials. We need to design trials that are more pragmatic; eligibility for trials is often so restrictive that only the patients who are the fittest and represent kind of an extreme of cancer patients can actually enroll," he said.

Other issues likely include financial barriers (such as whether insurers reimburse the costs of care for patients in trials); geographic accessibility; and the time and regulatory burdens of participating, especially as they affect community oncology practices. "Addressing the cancer clinical trials enterprise at large requires making the burden of participation lower because that does address accrual, that does address generalizability, that does address accessibility. It’s a problem that needs to be part of this conversation," Dr. Galsky maintained.

Dr. Ryan, the moderator, cited rapid treatment advances as yet another possible reason for poor accrual. "Some trials may take 2 or 3 years to accrue. During the first year, the standards of care may be one thing, and during the third year, the standards of care may have changed. We are really seeing very rapid evolution in our standards of care, so that could be one issue," he elaborated.

Introducing the study, Dr. Galsky noted that trials that fail to complete (that is, close without enrolling the intended number of patients) represent a major inefficiency of the cancer clinical trials enterprise. "Such trials contribute little knowledge, waste finite resources, and potentially divert patients from participating in other trials," he said.

The Institute of Medicine previously issued a report suggesting that about 40% of trials sponsored by the National Cancer Institute fail to achieve completion. But such trials account for only about 15% of all cancer trials.

The researchers analyzed 7,776 phase II or III interventional adult cancer clinical trials registered on ClinicalTrials.gov that had start dates between 2005 and 2011. They searched for those that had failed to reach completion, meaning that the trial had been stopped and had a "terminated" or "withdrawn" status.

The trials had a total of about 48,000 patients. Overall, 10% were trials in prostate, kidney, bladder, or testicular cancer.

The cumulative incidence of failure to reach completion for reasons unrelated to the efficacy or safety of the intervention was about 20%, according to Dr. Galsky.

Among all noncompleted trials, the largest share, 39%, failed to achieve completion because of poor accrual, topping other reasons such as logistics and efficacy/safety.

Trials were more likely to fail completion if they were funded by industry as compared with the federal government (hazard ratio, 1.97), were phase II as compared with phase III (HR, 1.29), or were single center as compared with multicenter (HR, 1.93).

On the other hand, trials were less likely to fail completion if they were conducted solely outside the United States (HR, 0.65) or both in and outside the United States (HR, 0.67), as compared with solely in the United States.

Dr. Galsky disclosed no relevant conflicts of interest.

Almost one-fifth of adult cancer clinical trials fail to reach completion for reasons unrelated to efficacy or adverse effects, according to data being reported at the 2014 Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology. Poor accrual is the leading cause.

Trials were more likely to fail completion if they were phase II, single center, funded by industry, or conducted solely in the United States. Trials among patients with genitourinary cancers were no more or less likely to fail than trials among patients with other cancers.

"These findings really underscore the clinical trial accrual problem that we have in the United States. Not only does poor accrual lead to more expensive trials and trials that generate answers much more slowly, but it also prevents many trials from generating answers at all," senior author Dr. Matthew D. Galsky, director of the genitourinary medical oncology program, Icahn School of Medicine at Mount Sinai, New York, said in a press briefing at the 2014 Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology.

The study is not meant to indict any specific stakeholders, Dr. Galsky stressed. "Rather, what we wanted to do was hold up a mirror to our activities as a cancer clinical trials community and really ask whether the system is optimized to bring better treatments to our patients as efficiently as possible. And clearly there is some work to do.

"Based on this analysis and others, it’s apparent that we need better collaboration and communication within the system and to use novel approaches to increase accrual to cancer clinical trials, which has really been quite steady at 3% to 5% of the adult cancer population for decades."

"This is a really interesting presentation which casts some light on one of the major frustrations that I think ... our whole community shares in designing and implementing clinical trials," said press briefing moderator Dr. Charles J. Ryan, leader of the genitourinary medical oncology program at the University of California, San Francisco. "Hopefully, this may be the beginning of a broader discussion that helps improve some of the efficiencies here."

Dr. Galsky speculated that the explanation for poor accrual is multifactorial. "Clearly, we need to engage patients more in the design of trials. We need to design trials that are more pragmatic; eligibility for trials is often so restrictive that only the patients who are the fittest and represent kind of an extreme of cancer patients can actually enroll," he said.

Other issues likely include financial barriers (such as whether insurers reimburse the costs of care for patients in trials); geographic accessibility; and the time and regulatory burdens of participating, especially as they affect community oncology practices. "Addressing the cancer clinical trials enterprise at large requires making the burden of participation lower because that does address accrual, that does address generalizability, that does address accessibility. It’s a problem that needs to be part of this conversation," Dr. Galsky maintained.

Dr. Ryan, the moderator, cited rapid treatment advances as yet another possible reason for poor accrual. "Some trials may take 2 or 3 years to accrue. During the first year, the standards of care may be one thing, and during the third year, the standards of care may have changed. We are really seeing very rapid evolution in our standards of care, so that could be one issue," he elaborated.

Introducing the study, Dr. Galsky noted that trials that fail to complete (that is, close without enrolling the intended number of patients) represent a major inefficiency of the cancer clinical trials enterprise. "Such trials contribute little knowledge, waste finite resources, and potentially divert patients from participating in other trials," he said.

The Institute of Medicine previously issued a report suggesting that about 40% of trials sponsored by the National Cancer Institute fail to achieve completion. But such trials account for only about 15% of all cancer trials.

The researchers analyzed 7,776 phase II or III interventional adult cancer clinical trials registered on ClinicalTrials.gov that had start dates between 2005 and 2011. They searched for those that had failed to reach completion, meaning that the trial had been stopped and had a "terminated" or "withdrawn" status.

The trials had a total of about 48,000 patients. Overall, 10% were trials in prostate, kidney, bladder, or testicular cancer.

The cumulative incidence of failure to reach completion for reasons unrelated to the efficacy or safety of the intervention was about 20%, according to Dr. Galsky.

Among all noncompleted trials, the largest share, 39%, failed to achieve completion because of poor accrual, topping other reasons such as logistics and efficacy/safety.

Trials were more likely to fail completion if they were funded by industry as compared with the federal government (hazard ratio, 1.97), were phase II as compared with phase III (HR, 1.29), or were single center as compared with multicenter (HR, 1.93).

On the other hand, trials were less likely to fail completion if they were conducted solely outside the United States (HR, 0.65) or both in and outside the United States (HR, 0.67), as compared with solely in the United States.

Dr. Galsky disclosed no relevant conflicts of interest.