Patrice Wendling

Two Food and Drug Administration advisory panels voted 18-6 against use of Mycobacterium phlei cell wall-nucleic acid complex (MCNA), an intravesical drug being evaluated for the treatment of non–muscle-invasive bladder cancer at high risk of recurrence or progression in adults failing prior Bacillus Calmette-Guérin (BCG) immunotherapy.

At a meeting of the FDA’s Oncologic Drugs Advisory Committee (ODAC) and the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC), several panel members expressed being conflicted in their vote, but said they ultimately felt MCNA did not show a clear risk:benefit advantage based on the data presented from a small, single pivotal trial that failed to meet its primary efficacy end point.

“I think it is an effective drug that would be a nice alternative to BCG, but I wasn’t convinced that there was enough of a difference in mechanism of action to accept a single-arm study that wasn’t overwhelmingly convincing that it was better than what is currently being done for these patients,” said Dr. David L. Bartlett, a CTGTAC member with the University of Pittsburgh Medical Center.

Also voting no was ODAC member Dr. Harold J. Burstein of the Dana-Farber Cancer Institute in Boston, who said the toxicity may be low with MCNA, but that he was unclear how to talk to patients about its benefits.

“What do you tell the patient that it does? I can’t answer that question,” he said. “It’s not clear that it spares the bladder. It’s not clear that it improves their longevity. Most of these patients we’ve been told aren’t going to be candidates for cystectomy for any number of reasons, so it doesn’t seem likely that it’s going to avoid or prevent a cystectomy in these patients.”

Although the data submitted for priority review by Telesta Therapeutics was less than stellar, CTGTAC and ODAC jointly considered the biologics license application because limited treatment options exist for patients with BCG-refractory non–muscle-invasive bladder cancer (NMIBC).

Current U.S. and European guidelines recommend cystectomy for high-risk NMIBC after BCG failure, but not all patients are candidates for or want to undergo bladder removal because of the associated high morbidity and poor quality of life. No new intravesical treatments for NMIBC have been approved since valrubicin (Valstar) in 1998 and it is indicated only for BCG-refractory carcinoma in situ (CIS).

MCNA is a suspension containing M. phlei cell wall fragments complexed with nucleic acid oligomers. It is thought to have a dual mechanism of action: direct anti-proliferative/cytotoxic action and indirect immune stimulant activity.

The clinical evidence for MCNA was based on the single-arm, phase III Study 301 in 129 patients with NMIBC at high risk of progression treated with six weekly instillations of MCNA during induction followed by maintenance therapy up to month 24. The disease-free survival (DFS) rate at 1 year was 23.7%, well short of the 40% target set for the primary endpoint.

Still, responses lasted a median of 34 months in the 28 responders and overall progression rates were similar to historical data in BCG-naive controls, according to Zvi Cohen, Ph.D., director of clinical research at Telesta. The rate of bladder removal at 1 year was almost three times lower among responders than among nonresponders (18% vs. 49.5%). In all, 55 (43%) patients went on to cystectomy.

The key safety concern for the panelists was whether treatment with MCNA would put patients at greater risk of muscle-invasive disease and metastasis by delaying cystectomy, the main treatment option for high-risk NMIBC following BCG failure. Notably, 15 (11.6%) patients in Study 301 developed metastatic bladder cancer, Dr. Cohen said.

In patients with CIS-containing disease, the complete response rate was 27% at 6 months and median duration of response was 15.1 months. Active CIS does not typically regress on its own, suggesting a treatment effect from MCNA.

In the subgroup with papillary tumors only, the DFS rate was 35.1% at 1 year, but it was unclear whether this was due to MCNA treatment or because these patients were required to undergo tumor resection within 56 days of their first dose.

The FDA took issue with statistical considerations in Study 301, including the definition of DFS duration, and conducted its own landmark analysis showing a DFS rate at 1 year of 20.9%. Higher DFS rates at 1 year were seen in papillary only vs. CIS-containing disease (27.8% vs. 18.8%) and in BCG-relapsing vs. BCG-refractory disease (36.4% vs. 17.8%), reported Dr. Kristin Baird, medical officer with the Office of Cellular, Tissue, and Gene Therapies (OCTGT) at the FDA’s Center for Biologics Evaluation and Research (CBER).

Common local drug-related adverse events occurring in at least 10% of patients in Study 301 were hematuria, dysuria, urinary tract infection, pollakiuria, and micturition urgency. Fatigue was the most common systemic adverse event.

Two drug-related serious adverse events occurred: moderate hematuria and severe urinary tract infection, Dr. Cohen said. Four deaths occurred during the study, but none were thought to be drug related.

The study did not enroll BCG-naive patients, so it is unclear whether MCNA may be altered by BCG or whether prior BCG is necessary to prime responses to MCNA. In vitro data using a prior formulation of the drug suggested benefit in BCG-naive patients, but it was noted that MCNA is eliminated more quickly than BCG and that de novo studies would be needed to sort out this issue.

One panelist pointed out the practical consideration that BCG shortages have been a frequent problem for patients, despite the drug’s being around for decades, and that there may be some pressure to use MCNA first-line if BCG is unavailable. Cost data were not provided for BCG.

Dr. Patrick C. Walsh, professor and director of Brady Urological Institute at Johns Hopkins Medical Institutions, Baltimore, agreed that the action of MCNA may be limited, but voted in favor of approval.

“My concern was delay in cystectomy and I’ve been convinced at this meeting that if you delayed cystectomy for 6 months and you gave this drug and it didn’t work, I don’t think the patient would be harmed,” he said.

CTGTAC chair Dr. Timothy P. Cripe of Ohio State University, Columbus, also voted in favor, noting that the risk:benefit ratio was favorable because there is clearly some benefit to the drug and very little risk.

“With immunotherapies on the rise, if this were approved, I’m sure there’d be a lot more trials and combinations that would augment its activity,” he added.

CTGTAC member Dr. Bruce J. Roth of Washington University, St. Louis, voted no because of the quality of the data, but suggested, as did others, that he would like MCNA to return before the FDA in other, better-designed trials.

The initial vote was 19 for and 6 against approval, but it was discovered that one vote was made via proxy, which is not allowed, and the official record was amended to 18 for and 6 against.

MCNA was granted priority review status in September and the Prescription Drug User Fee Act (PDUFA) date set was for Feb. 27, 2016. Following news of the negative vote, Telesta’s share price fell 50%.

Members of FDA advisory panels have been cleared of potential conflicts of interest by the FDA prior to the meeting.

[email protected]

Two Food and Drug Administration advisory panels voted 18-6 against use of Mycobacterium phlei cell wall-nucleic acid complex (MCNA), an intravesical drug being evaluated for the treatment of non–muscle-invasive bladder cancer at high risk of recurrence or progression in adults failing prior Bacillus Calmette-Guérin (BCG) immunotherapy.

At a meeting of the FDA’s Oncologic Drugs Advisory Committee (ODAC) and the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC), several panel members expressed being conflicted in their vote, but said they ultimately felt MCNA did not show a clear risk:benefit advantage based on the data presented from a small, single pivotal trial that failed to meet its primary efficacy end point.

“I think it is an effective drug that would be a nice alternative to BCG, but I wasn’t convinced that there was enough of a difference in mechanism of action to accept a single-arm study that wasn’t overwhelmingly convincing that it was better than what is currently being done for these patients,” said Dr. David L. Bartlett, a CTGTAC member with the University of Pittsburgh Medical Center.

Also voting no was ODAC member Dr. Harold J. Burstein of the Dana-Farber Cancer Institute in Boston, who said the toxicity may be low with MCNA, but that he was unclear how to talk to patients about its benefits.

“What do you tell the patient that it does? I can’t answer that question,” he said. “It’s not clear that it spares the bladder. It’s not clear that it improves their longevity. Most of these patients we’ve been told aren’t going to be candidates for cystectomy for any number of reasons, so it doesn’t seem likely that it’s going to avoid or prevent a cystectomy in these patients.”

Although the data submitted for priority review by Telesta Therapeutics was less than stellar, CTGTAC and ODAC jointly considered the biologics license application because limited treatment options exist for patients with BCG-refractory non–muscle-invasive bladder cancer (NMIBC).

Current U.S. and European guidelines recommend cystectomy for high-risk NMIBC after BCG failure, but not all patients are candidates for or want to undergo bladder removal because of the associated high morbidity and poor quality of life. No new intravesical treatments for NMIBC have been approved since valrubicin (Valstar) in 1998 and it is indicated only for BCG-refractory carcinoma in situ (CIS).

MCNA is a suspension containing M. phlei cell wall fragments complexed with nucleic acid oligomers. It is thought to have a dual mechanism of action: direct anti-proliferative/cytotoxic action and indirect immune stimulant activity.

The clinical evidence for MCNA was based on the single-arm, phase III Study 301 in 129 patients with NMIBC at high risk of progression treated with six weekly instillations of MCNA during induction followed by maintenance therapy up to month 24. The disease-free survival (DFS) rate at 1 year was 23.7%, well short of the 40% target set for the primary endpoint.

Still, responses lasted a median of 34 months in the 28 responders and overall progression rates were similar to historical data in BCG-naive controls, according to Zvi Cohen, Ph.D., director of clinical research at Telesta. The rate of bladder removal at 1 year was almost three times lower among responders than among nonresponders (18% vs. 49.5%). In all, 55 (43%) patients went on to cystectomy.

The key safety concern for the panelists was whether treatment with MCNA would put patients at greater risk of muscle-invasive disease and metastasis by delaying cystectomy, the main treatment option for high-risk NMIBC following BCG failure. Notably, 15 (11.6%) patients in Study 301 developed metastatic bladder cancer, Dr. Cohen said.

In patients with CIS-containing disease, the complete response rate was 27% at 6 months and median duration of response was 15.1 months. Active CIS does not typically regress on its own, suggesting a treatment effect from MCNA.

In the subgroup with papillary tumors only, the DFS rate was 35.1% at 1 year, but it was unclear whether this was due to MCNA treatment or because these patients were required to undergo tumor resection within 56 days of their first dose.

The FDA took issue with statistical considerations in Study 301, including the definition of DFS duration, and conducted its own landmark analysis showing a DFS rate at 1 year of 20.9%. Higher DFS rates at 1 year were seen in papillary only vs. CIS-containing disease (27.8% vs. 18.8%) and in BCG-relapsing vs. BCG-refractory disease (36.4% vs. 17.8%), reported Dr. Kristin Baird, medical officer with the Office of Cellular, Tissue, and Gene Therapies (OCTGT) at the FDA’s Center for Biologics Evaluation and Research (CBER).

Common local drug-related adverse events occurring in at least 10% of patients in Study 301 were hematuria, dysuria, urinary tract infection, pollakiuria, and micturition urgency. Fatigue was the most common systemic adverse event.

Two drug-related serious adverse events occurred: moderate hematuria and severe urinary tract infection, Dr. Cohen said. Four deaths occurred during the study, but none were thought to be drug related.

The study did not enroll BCG-naive patients, so it is unclear whether MCNA may be altered by BCG or whether prior BCG is necessary to prime responses to MCNA. In vitro data using a prior formulation of the drug suggested benefit in BCG-naive patients, but it was noted that MCNA is eliminated more quickly than BCG and that de novo studies would be needed to sort out this issue.

One panelist pointed out the practical consideration that BCG shortages have been a frequent problem for patients, despite the drug’s being around for decades, and that there may be some pressure to use MCNA first-line if BCG is unavailable. Cost data were not provided for BCG.

Dr. Patrick C. Walsh, professor and director of Brady Urological Institute at Johns Hopkins Medical Institutions, Baltimore, agreed that the action of MCNA may be limited, but voted in favor of approval.

“My concern was delay in cystectomy and I’ve been convinced at this meeting that if you delayed cystectomy for 6 months and you gave this drug and it didn’t work, I don’t think the patient would be harmed,” he said.

CTGTAC chair Dr. Timothy P. Cripe of Ohio State University, Columbus, also voted in favor, noting that the risk:benefit ratio was favorable because there is clearly some benefit to the drug and very little risk.

“With immunotherapies on the rise, if this were approved, I’m sure there’d be a lot more trials and combinations that would augment its activity,” he added.

CTGTAC member Dr. Bruce J. Roth of Washington University, St. Louis, voted no because of the quality of the data, but suggested, as did others, that he would like MCNA to return before the FDA in other, better-designed trials.

The initial vote was 19 for and 6 against approval, but it was discovered that one vote was made via proxy, which is not allowed, and the official record was amended to 18 for and 6 against.

MCNA was granted priority review status in September and the Prescription Drug User Fee Act (PDUFA) date set was for Feb. 27, 2016. Following news of the negative vote, Telesta’s share price fell 50%.

Members of FDA advisory panels have been cleared of potential conflicts of interest by the FDA prior to the meeting.

[email protected]

Two Food and Drug Administration advisory panels voted 18-6 against use of Mycobacterium phlei cell wall-nucleic acid complex (MCNA), an intravesical drug being evaluated for the treatment of non–muscle-invasive bladder cancer at high risk of recurrence or progression in adults failing prior Bacillus Calmette-Guérin (BCG) immunotherapy.

At a meeting of the FDA’s Oncologic Drugs Advisory Committee (ODAC) and the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC), several panel members expressed being conflicted in their vote, but said they ultimately felt MCNA did not show a clear risk:benefit advantage based on the data presented from a small, single pivotal trial that failed to meet its primary efficacy end point.

“I think it is an effective drug that would be a nice alternative to BCG, but I wasn’t convinced that there was enough of a difference in mechanism of action to accept a single-arm study that wasn’t overwhelmingly convincing that it was better than what is currently being done for these patients,” said Dr. David L. Bartlett, a CTGTAC member with the University of Pittsburgh Medical Center.

Also voting no was ODAC member Dr. Harold J. Burstein of the Dana-Farber Cancer Institute in Boston, who said the toxicity may be low with MCNA, but that he was unclear how to talk to patients about its benefits.

“What do you tell the patient that it does? I can’t answer that question,” he said. “It’s not clear that it spares the bladder. It’s not clear that it improves their longevity. Most of these patients we’ve been told aren’t going to be candidates for cystectomy for any number of reasons, so it doesn’t seem likely that it’s going to avoid or prevent a cystectomy in these patients.”

Although the data submitted for priority review by Telesta Therapeutics was less than stellar, CTGTAC and ODAC jointly considered the biologics license application because limited treatment options exist for patients with BCG-refractory non–muscle-invasive bladder cancer (NMIBC).

Current U.S. and European guidelines recommend cystectomy for high-risk NMIBC after BCG failure, but not all patients are candidates for or want to undergo bladder removal because of the associated high morbidity and poor quality of life. No new intravesical treatments for NMIBC have been approved since valrubicin (Valstar) in 1998 and it is indicated only for BCG-refractory carcinoma in situ (CIS).

MCNA is a suspension containing M. phlei cell wall fragments complexed with nucleic acid oligomers. It is thought to have a dual mechanism of action: direct anti-proliferative/cytotoxic action and indirect immune stimulant activity.

The clinical evidence for MCNA was based on the single-arm, phase III Study 301 in 129 patients with NMIBC at high risk of progression treated with six weekly instillations of MCNA during induction followed by maintenance therapy up to month 24. The disease-free survival (DFS) rate at 1 year was 23.7%, well short of the 40% target set for the primary endpoint.

Still, responses lasted a median of 34 months in the 28 responders and overall progression rates were similar to historical data in BCG-naive controls, according to Zvi Cohen, Ph.D., director of clinical research at Telesta. The rate of bladder removal at 1 year was almost three times lower among responders than among nonresponders (18% vs. 49.5%). In all, 55 (43%) patients went on to cystectomy.

The key safety concern for the panelists was whether treatment with MCNA would put patients at greater risk of muscle-invasive disease and metastasis by delaying cystectomy, the main treatment option for high-risk NMIBC following BCG failure. Notably, 15 (11.6%) patients in Study 301 developed metastatic bladder cancer, Dr. Cohen said.

In patients with CIS-containing disease, the complete response rate was 27% at 6 months and median duration of response was 15.1 months. Active CIS does not typically regress on its own, suggesting a treatment effect from MCNA.

In the subgroup with papillary tumors only, the DFS rate was 35.1% at 1 year, but it was unclear whether this was due to MCNA treatment or because these patients were required to undergo tumor resection within 56 days of their first dose.

The FDA took issue with statistical considerations in Study 301, including the definition of DFS duration, and conducted its own landmark analysis showing a DFS rate at 1 year of 20.9%. Higher DFS rates at 1 year were seen in papillary only vs. CIS-containing disease (27.8% vs. 18.8%) and in BCG-relapsing vs. BCG-refractory disease (36.4% vs. 17.8%), reported Dr. Kristin Baird, medical officer with the Office of Cellular, Tissue, and Gene Therapies (OCTGT) at the FDA’s Center for Biologics Evaluation and Research (CBER).

Common local drug-related adverse events occurring in at least 10% of patients in Study 301 were hematuria, dysuria, urinary tract infection, pollakiuria, and micturition urgency. Fatigue was the most common systemic adverse event.

Two drug-related serious adverse events occurred: moderate hematuria and severe urinary tract infection, Dr. Cohen said. Four deaths occurred during the study, but none were thought to be drug related.

The study did not enroll BCG-naive patients, so it is unclear whether MCNA may be altered by BCG or whether prior BCG is necessary to prime responses to MCNA. In vitro data using a prior formulation of the drug suggested benefit in BCG-naive patients, but it was noted that MCNA is eliminated more quickly than BCG and that de novo studies would be needed to sort out this issue.

One panelist pointed out the practical consideration that BCG shortages have been a frequent problem for patients, despite the drug’s being around for decades, and that there may be some pressure to use MCNA first-line if BCG is unavailable. Cost data were not provided for BCG.

Dr. Patrick C. Walsh, professor and director of Brady Urological Institute at Johns Hopkins Medical Institutions, Baltimore, agreed that the action of MCNA may be limited, but voted in favor of approval.

“My concern was delay in cystectomy and I’ve been convinced at this meeting that if you delayed cystectomy for 6 months and you gave this drug and it didn’t work, I don’t think the patient would be harmed,” he said.

CTGTAC chair Dr. Timothy P. Cripe of Ohio State University, Columbus, also voted in favor, noting that the risk:benefit ratio was favorable because there is clearly some benefit to the drug and very little risk.

“With immunotherapies on the rise, if this were approved, I’m sure there’d be a lot more trials and combinations that would augment its activity,” he added.

CTGTAC member Dr. Bruce J. Roth of Washington University, St. Louis, voted no because of the quality of the data, but suggested, as did others, that he would like MCNA to return before the FDA in other, better-designed trials.

The initial vote was 19 for and 6 against approval, but it was discovered that one vote was made via proxy, which is not allowed, and the official record was amended to 18 for and 6 against.

MCNA was granted priority review status in September and the Prescription Drug User Fee Act (PDUFA) date set was for Feb. 27, 2016. Following news of the negative vote, Telesta’s share price fell 50%.

Members of FDA advisory panels have been cleared of potential conflicts of interest by the FDA prior to the meeting.

[email protected]

LOS ANGELES – Revisional surgery after failed adjustable gastric banding (AGB) is associated with an increased risk of adverse events and resource utilization, according to Dr. Steven Poplawski, medical director for Barix Clinics in Ypsilanti, Mich.

His conclusion is based on safety outcomes at 30 days for 55,237 patients who underwent primary bariatric surgery and 1,417 patients who underwent AGB revision between June 2006 and July 2015 in the Michigan Bariatric Surgery Collaborative. Patients were excluded from the retrospective evaluation if they had urgent/emergent procedures or more than one previous bariatric operation.

The primary bariatric surgery was Roux-en-Y gastric bypass (RYGB) in 43%, sleeve gastrectomy in 37%, AGB in 19%, and biliopancreatic diversion with duodenal switch (BPD/DS) in 1%.

The patients turned to AGB revision for the same reasons that have prompted its dramatic decline in utilization: weight loss failure (38%), band complications (33%), or both (29%). AGB revisional procedures were sleeve gastrectomy in 54%, RYGB in 35%, AGB in 9%, and BPD/DS in 2%.

Patients undergoing band-to-RYGB conversions had significantly more serious complications, compared with primary RYGB procedures (10.2% vs. 4.4%; P less than .0001), reoperations (5.1% vs. 2.3%; P = .0001), and hospital readmissions (10% vs. 7.3%; P = .0064), and a nonsignificant trend toward more leaks (1.3% vs. 0.7%; P = .13), Dr. Poplawski reported.

Patients undergoing band-to-sleeve conversions had significantly more serious complications when compared with primary sleeve gastrectomy (5% vs. 1.8%; P less than .0001), reoperations (3.3% vs. 1%; P less than .0001), and leaks (1.5% vs. 0.5%; P = .0001), and a nonsignificant trend toward more readmissions (7.7% vs. 4.6%; P = .0685).

Outcomes were not reported for the smaller number of patients undergoing AGB-to-AGB or AGB-to-BPD/DS conversions.

A secondary analysis was performed examining a one-stage versus a two-stage procedure in 525 patients undergoing revisional surgery for weight loss failure only. The only safety outcome to show a significant difference at 30 days was hospital readmissions in the RYGB-conversion group, favoring the one-stage over the two-stage procedure (7.1% vs. 11.5%; P = .0164).

“Clearly, the benefit of a one-stage procedure versus a two-stage procedure is unclear in the way it was studied here,” Dr. Poplawski said at Obesity Week 2015, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

“You can read in some reports that [surgeons] do all [of these procedures as] two-stage because they think it’s safer, but I don’t know that there’s much support for that here. I think it’s reasonable to get most of them done in one stage because there’s also two hospitalizations, two periods of convalescence, and when we talk about the complications of the two-stage operation we aren’t even including the costs to remove the initial band, which are not insignificant,” he noted.

Dr. Raul Rosenthal of the Cleveland Clinic in Weston, Fla., who comoderated the session, said the takeaway message is that “reoperative surgery pays a price. No matter how you look at it, one stage, two stages, with bands or sleeve, you’re going to get in trouble.”

[email protected]

LOS ANGELES – Revisional surgery after failed adjustable gastric banding (AGB) is associated with an increased risk of adverse events and resource utilization, according to Dr. Steven Poplawski, medical director for Barix Clinics in Ypsilanti, Mich.

His conclusion is based on safety outcomes at 30 days for 55,237 patients who underwent primary bariatric surgery and 1,417 patients who underwent AGB revision between June 2006 and July 2015 in the Michigan Bariatric Surgery Collaborative. Patients were excluded from the retrospective evaluation if they had urgent/emergent procedures or more than one previous bariatric operation.

The primary bariatric surgery was Roux-en-Y gastric bypass (RYGB) in 43%, sleeve gastrectomy in 37%, AGB in 19%, and biliopancreatic diversion with duodenal switch (BPD/DS) in 1%.

The patients turned to AGB revision for the same reasons that have prompted its dramatic decline in utilization: weight loss failure (38%), band complications (33%), or both (29%). AGB revisional procedures were sleeve gastrectomy in 54%, RYGB in 35%, AGB in 9%, and BPD/DS in 2%.

Patients undergoing band-to-RYGB conversions had significantly more serious complications, compared with primary RYGB procedures (10.2% vs. 4.4%; P less than .0001), reoperations (5.1% vs. 2.3%; P = .0001), and hospital readmissions (10% vs. 7.3%; P = .0064), and a nonsignificant trend toward more leaks (1.3% vs. 0.7%; P = .13), Dr. Poplawski reported.

Patients undergoing band-to-sleeve conversions had significantly more serious complications when compared with primary sleeve gastrectomy (5% vs. 1.8%; P less than .0001), reoperations (3.3% vs. 1%; P less than .0001), and leaks (1.5% vs. 0.5%; P = .0001), and a nonsignificant trend toward more readmissions (7.7% vs. 4.6%; P = .0685).

Outcomes were not reported for the smaller number of patients undergoing AGB-to-AGB or AGB-to-BPD/DS conversions.

A secondary analysis was performed examining a one-stage versus a two-stage procedure in 525 patients undergoing revisional surgery for weight loss failure only. The only safety outcome to show a significant difference at 30 days was hospital readmissions in the RYGB-conversion group, favoring the one-stage over the two-stage procedure (7.1% vs. 11.5%; P = .0164).

“Clearly, the benefit of a one-stage procedure versus a two-stage procedure is unclear in the way it was studied here,” Dr. Poplawski said at Obesity Week 2015, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

“You can read in some reports that [surgeons] do all [of these procedures as] two-stage because they think it’s safer, but I don’t know that there’s much support for that here. I think it’s reasonable to get most of them done in one stage because there’s also two hospitalizations, two periods of convalescence, and when we talk about the complications of the two-stage operation we aren’t even including the costs to remove the initial band, which are not insignificant,” he noted.

Dr. Raul Rosenthal of the Cleveland Clinic in Weston, Fla., who comoderated the session, said the takeaway message is that “reoperative surgery pays a price. No matter how you look at it, one stage, two stages, with bands or sleeve, you’re going to get in trouble.”

[email protected]

LOS ANGELES – Revisional surgery after failed adjustable gastric banding (AGB) is associated with an increased risk of adverse events and resource utilization, according to Dr. Steven Poplawski, medical director for Barix Clinics in Ypsilanti, Mich.

His conclusion is based on safety outcomes at 30 days for 55,237 patients who underwent primary bariatric surgery and 1,417 patients who underwent AGB revision between June 2006 and July 2015 in the Michigan Bariatric Surgery Collaborative. Patients were excluded from the retrospective evaluation if they had urgent/emergent procedures or more than one previous bariatric operation.

The primary bariatric surgery was Roux-en-Y gastric bypass (RYGB) in 43%, sleeve gastrectomy in 37%, AGB in 19%, and biliopancreatic diversion with duodenal switch (BPD/DS) in 1%.

The patients turned to AGB revision for the same reasons that have prompted its dramatic decline in utilization: weight loss failure (38%), band complications (33%), or both (29%). AGB revisional procedures were sleeve gastrectomy in 54%, RYGB in 35%, AGB in 9%, and BPD/DS in 2%.

Patients undergoing band-to-RYGB conversions had significantly more serious complications, compared with primary RYGB procedures (10.2% vs. 4.4%; P less than .0001), reoperations (5.1% vs. 2.3%; P = .0001), and hospital readmissions (10% vs. 7.3%; P = .0064), and a nonsignificant trend toward more leaks (1.3% vs. 0.7%; P = .13), Dr. Poplawski reported.

Patients undergoing band-to-sleeve conversions had significantly more serious complications when compared with primary sleeve gastrectomy (5% vs. 1.8%; P less than .0001), reoperations (3.3% vs. 1%; P less than .0001), and leaks (1.5% vs. 0.5%; P = .0001), and a nonsignificant trend toward more readmissions (7.7% vs. 4.6%; P = .0685).

Outcomes were not reported for the smaller number of patients undergoing AGB-to-AGB or AGB-to-BPD/DS conversions.

A secondary analysis was performed examining a one-stage versus a two-stage procedure in 525 patients undergoing revisional surgery for weight loss failure only. The only safety outcome to show a significant difference at 30 days was hospital readmissions in the RYGB-conversion group, favoring the one-stage over the two-stage procedure (7.1% vs. 11.5%; P = .0164).

“Clearly, the benefit of a one-stage procedure versus a two-stage procedure is unclear in the way it was studied here,” Dr. Poplawski said at Obesity Week 2015, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

“You can read in some reports that [surgeons] do all [of these procedures as] two-stage because they think it’s safer, but I don’t know that there’s much support for that here. I think it’s reasonable to get most of them done in one stage because there’s also two hospitalizations, two periods of convalescence, and when we talk about the complications of the two-stage operation we aren’t even including the costs to remove the initial band, which are not insignificant,” he noted.

Dr. Raul Rosenthal of the Cleveland Clinic in Weston, Fla., who comoderated the session, said the takeaway message is that “reoperative surgery pays a price. No matter how you look at it, one stage, two stages, with bands or sleeve, you’re going to get in trouble.”

[email protected]

Osimertinib (Tagrisso) is approved by the Food and Drug Administration for patients with metastatic EGFR T790M mutation–positive non–small cell lung cancer (NSCLC), the agency announced Nov. 13.

The approval was based on two, single-arm trials, AURA and AURA2, in patients who received osimertinib 80 mg tablets once daily after progressing on systemic therapy, including an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI).

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

First-generation EGFR TKI inhibitors are effective in non–small cell lung cancer (NSCLC), but most tumors develop drug resistance. In nearly two-thirds of cases, the T790 mutation is the culprit.

Osimertinib, a third-generation EGFR TKI, is the first drug to be approved for patients with metastatic EGFR T790M mutation–positive NSCLC. It’s accelerated approval came 3 months ahead of the target approval date of Feb. 6, 2016.

Osimertinib’s approval represents a “milestone for lung cancer patients who urgently needed new treatment options,” and follows one of the fastest development programs, taking a little more than 2.5 years from the first in human clinical trials to approval, according to drug maker AstraZeneca Pharmaceuticals.

Rociletinib, another oral third-generation TKI, is under FDA review for the treatment of previously treated EGFR T790 mutation–positive NSCLC.

The approval of osimertinib was based on tumor response rate and duration of response among 411 patients in the two trials. The objective response rate according to blinded independent review was 57% in AURA and 61% in AURA2 (N Engl J Med. 2015 Apr 30;372[18]:1689-99). Responses were ongoing in most patients in both trials and median duration had not been reached. Ongoing responses ranged from 1.1 months to 5.6 months.

The most common adverse events with osimertinib in the 411 patients were diarrhea (42%), rash (41%), dry skin (31%), nail toxicity (25%), eye disorders (18%), nausea (17%), decreased appetite (16%), and constipation (15%).

The most common grade 3-4 adverse events were pneumonia and pulmonary embolism (2% each).

The full prescribing information for osimertinib is available here.

Under the accelerated approval, phase III confirmatory trials may be needed. The phase III AURA3 trial is underway examining the efficacy and safety of osimertinib vs. platinum-based doublet chemotherapy in EGFR T790M–positive locally advanced or metastatic NSCLC failing EGFR TKI therapy.

[email protected]

Osimertinib (Tagrisso) is approved by the Food and Drug Administration for patients with metastatic EGFR T790M mutation–positive non–small cell lung cancer (NSCLC), the agency announced Nov. 13.

The approval was based on two, single-arm trials, AURA and AURA2, in patients who received osimertinib 80 mg tablets once daily after progressing on systemic therapy, including an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI).

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

First-generation EGFR TKI inhibitors are effective in non–small cell lung cancer (NSCLC), but most tumors develop drug resistance. In nearly two-thirds of cases, the T790 mutation is the culprit.

Osimertinib, a third-generation EGFR TKI, is the first drug to be approved for patients with metastatic EGFR T790M mutation–positive NSCLC. It’s accelerated approval came 3 months ahead of the target approval date of Feb. 6, 2016.

Osimertinib’s approval represents a “milestone for lung cancer patients who urgently needed new treatment options,” and follows one of the fastest development programs, taking a little more than 2.5 years from the first in human clinical trials to approval, according to drug maker AstraZeneca Pharmaceuticals.

Rociletinib, another oral third-generation TKI, is under FDA review for the treatment of previously treated EGFR T790 mutation–positive NSCLC.

The approval of osimertinib was based on tumor response rate and duration of response among 411 patients in the two trials. The objective response rate according to blinded independent review was 57% in AURA and 61% in AURA2 (N Engl J Med. 2015 Apr 30;372[18]:1689-99). Responses were ongoing in most patients in both trials and median duration had not been reached. Ongoing responses ranged from 1.1 months to 5.6 months.

The most common adverse events with osimertinib in the 411 patients were diarrhea (42%), rash (41%), dry skin (31%), nail toxicity (25%), eye disorders (18%), nausea (17%), decreased appetite (16%), and constipation (15%).

The most common grade 3-4 adverse events were pneumonia and pulmonary embolism (2% each).

The full prescribing information for osimertinib is available here.

Under the accelerated approval, phase III confirmatory trials may be needed. The phase III AURA3 trial is underway examining the efficacy and safety of osimertinib vs. platinum-based doublet chemotherapy in EGFR T790M–positive locally advanced or metastatic NSCLC failing EGFR TKI therapy.

[email protected]

Osimertinib (Tagrisso) is approved by the Food and Drug Administration for patients with metastatic EGFR T790M mutation–positive non–small cell lung cancer (NSCLC), the agency announced Nov. 13.

The approval was based on two, single-arm trials, AURA and AURA2, in patients who received osimertinib 80 mg tablets once daily after progressing on systemic therapy, including an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI).

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

First-generation EGFR TKI inhibitors are effective in non–small cell lung cancer (NSCLC), but most tumors develop drug resistance. In nearly two-thirds of cases, the T790 mutation is the culprit.

Osimertinib, a third-generation EGFR TKI, is the first drug to be approved for patients with metastatic EGFR T790M mutation–positive NSCLC. It’s accelerated approval came 3 months ahead of the target approval date of Feb. 6, 2016.

Osimertinib’s approval represents a “milestone for lung cancer patients who urgently needed new treatment options,” and follows one of the fastest development programs, taking a little more than 2.5 years from the first in human clinical trials to approval, according to drug maker AstraZeneca Pharmaceuticals.

Rociletinib, another oral third-generation TKI, is under FDA review for the treatment of previously treated EGFR T790 mutation–positive NSCLC.

The approval of osimertinib was based on tumor response rate and duration of response among 411 patients in the two trials. The objective response rate according to blinded independent review was 57% in AURA and 61% in AURA2 (N Engl J Med. 2015 Apr 30;372[18]:1689-99). Responses were ongoing in most patients in both trials and median duration had not been reached. Ongoing responses ranged from 1.1 months to 5.6 months.

The most common adverse events with osimertinib in the 411 patients were diarrhea (42%), rash (41%), dry skin (31%), nail toxicity (25%), eye disorders (18%), nausea (17%), decreased appetite (16%), and constipation (15%).

The most common grade 3-4 adverse events were pneumonia and pulmonary embolism (2% each).

The full prescribing information for osimertinib is available here.

Under the accelerated approval, phase III confirmatory trials may be needed. The phase III AURA3 trial is underway examining the efficacy and safety of osimertinib vs. platinum-based doublet chemotherapy in EGFR T790M–positive locally advanced or metastatic NSCLC failing EGFR TKI therapy.

[email protected]

LOS ANGELES – A nationwide analysis shows modest early morbidity and low mortality following bariatric surgery in patients with type 2 diabetes who are not morbidly obese.

At 30 days’ follow-up among 1,003 patients, the composite complication rate, defined as the presence of any of 16 adverse events, was 4.2%; the reoperation rate was 1.6%; and two patients (0.2%) died.

Patrice Wendling/Frontline Medical News

“A 2-hour surgical procedure requiring a 2-day hospital stay that is associated with low morbidity and mortality can lead to remission of a chronic, progressive, and disabling disease,” lead author Dr. Ali Aminian of the Cleveland Clinic said at Obesity Week 2015.

“Based on these findings, bariatric surgery can be considered a relatively safe option for managing type 2 diabetes in patients with mild obesity.”

The analysis included adults with a body mass index of at least 25 kg/m², but less than 35 kg/m² (mean, 33 kg/m²).

These data are important because most patients with type 2 diabetes fall into this BMI category, he said.

Most of the patients were women (74.3%), 40% were using insulin, 78% had hypertension, and 9% had cardiac disease, according to the analysis, drawn from the American College of Surgery National Surgical Quality Improvement Program 2005-2013 database.

Roux-en-Y bypass was performed in 574 patients, adjustable gastric banding in 227, sleeve gastrectomy in 189, and duodenal switch in 13.

The most common adverse events overall were blood transfusion and reoperation (both 1.6%), a hospital stay longer than 7 days (0.6%), and organ space surgical-site infection (0.5%).

Composite morbidity and mortality was highest in the Roux-en-Y bypass group, compared with the adjustable banding and sleeve groups (5% vs. 3.1% vs. 3.2%, respectively), Dr. Aminian said at the meeting, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Only 3 of 46 patients with a BMI of less than 30 kg/m² had an adverse event.

Available randomized controlled trials can’t clearly resolve the safety concerns of bariatric surgery in the subgroup of patients with type 2 diabetes who are overweight and mildly obese because such small trials are unlikely to reveal uncommon but clinically serious complications, Dr. Aminian said. In addition, many of the trials have screened out low-BMI and high-risk patients.

Those in attendance at the presentation, however, weren’t entirely convinced the current analysis could allay all safety concerns.

Session comoderator Dr. Daniel Cottam, a bariatric surgeon in group practice in Salt Lake City, said, “I like the summary; however, the use of the word ‘safe’ can be taken to mean a lot of things. It’s one of those squishy words.”

Though the authors have shown that bariatric surgery can be performed in diabetics with a low BMI, in order to say it is safe, the comparison needs to be drawn to the all-cause mortality for these patients in the general population and with other surgical procedures.

“That would be useful in the manuscript because as we approach our patients, we want to be able to say, ‘Listen, if you live with diabetes and a BMI of 25-35 for 5 years, this is your all-cause mortality, and surgery is going to save your life, not hurt it,’ ” Dr. Cottam said.

Along the same lines, Dr. Harvey Sugerman emeritus professor of surgery at Virginia Commonwealth University in Richmond, commented, “Like the old days of routinely operating on any patient with diabetes and gallstones, the data were that just having one death in a young person and the quality-of-life-years lost, it would take you thousands of gallbladders to make up for that one death.”

Dr. Sugarmen also asked for details on the deaths including where they occurred, in whom, and whether the centers were inexperienced.

Dr. Aminian could not recall at the time, but in an interview with this news organization said one death was in a 61-year-old with a history of cardiac disease and chronic kidney failure secondary to insulin-dependent diabetes who developed postop bleeding after gastric bypass. The second was in a 59-year-old patient, again on insulin, who was discharged without problems after gastric bypass, but died within 30 days after surgery.

Although most serious complications occur in this period, the main limitation of the study is that the dataset does not capture adverse events beyond 30 days after surgery, which can lead to underestimation of real risk, Dr. Aminian told the crowd.

“Further large clinical studies on long-term safety and efficacy outcomes of bariatric surgery in patients with type 2 diabetes and low BMI are warranted,” he said.

[email protected]

LOS ANGELES – A nationwide analysis shows modest early morbidity and low mortality following bariatric surgery in patients with type 2 diabetes who are not morbidly obese.

At 30 days’ follow-up among 1,003 patients, the composite complication rate, defined as the presence of any of 16 adverse events, was 4.2%; the reoperation rate was 1.6%; and two patients (0.2%) died.

Patrice Wendling/Frontline Medical News

“A 2-hour surgical procedure requiring a 2-day hospital stay that is associated with low morbidity and mortality can lead to remission of a chronic, progressive, and disabling disease,” lead author Dr. Ali Aminian of the Cleveland Clinic said at Obesity Week 2015.

“Based on these findings, bariatric surgery can be considered a relatively safe option for managing type 2 diabetes in patients with mild obesity.”

The analysis included adults with a body mass index of at least 25 kg/m², but less than 35 kg/m² (mean, 33 kg/m²).

These data are important because most patients with type 2 diabetes fall into this BMI category, he said.

Most of the patients were women (74.3%), 40% were using insulin, 78% had hypertension, and 9% had cardiac disease, according to the analysis, drawn from the American College of Surgery National Surgical Quality Improvement Program 2005-2013 database.

Roux-en-Y bypass was performed in 574 patients, adjustable gastric banding in 227, sleeve gastrectomy in 189, and duodenal switch in 13.

The most common adverse events overall were blood transfusion and reoperation (both 1.6%), a hospital stay longer than 7 days (0.6%), and organ space surgical-site infection (0.5%).

Composite morbidity and mortality was highest in the Roux-en-Y bypass group, compared with the adjustable banding and sleeve groups (5% vs. 3.1% vs. 3.2%, respectively), Dr. Aminian said at the meeting, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Only 3 of 46 patients with a BMI of less than 30 kg/m² had an adverse event.

Available randomized controlled trials can’t clearly resolve the safety concerns of bariatric surgery in the subgroup of patients with type 2 diabetes who are overweight and mildly obese because such small trials are unlikely to reveal uncommon but clinically serious complications, Dr. Aminian said. In addition, many of the trials have screened out low-BMI and high-risk patients.

Those in attendance at the presentation, however, weren’t entirely convinced the current analysis could allay all safety concerns.

Session comoderator Dr. Daniel Cottam, a bariatric surgeon in group practice in Salt Lake City, said, “I like the summary; however, the use of the word ‘safe’ can be taken to mean a lot of things. It’s one of those squishy words.”

Though the authors have shown that bariatric surgery can be performed in diabetics with a low BMI, in order to say it is safe, the comparison needs to be drawn to the all-cause mortality for these patients in the general population and with other surgical procedures.

“That would be useful in the manuscript because as we approach our patients, we want to be able to say, ‘Listen, if you live with diabetes and a BMI of 25-35 for 5 years, this is your all-cause mortality, and surgery is going to save your life, not hurt it,’ ” Dr. Cottam said.

Along the same lines, Dr. Harvey Sugerman emeritus professor of surgery at Virginia Commonwealth University in Richmond, commented, “Like the old days of routinely operating on any patient with diabetes and gallstones, the data were that just having one death in a young person and the quality-of-life-years lost, it would take you thousands of gallbladders to make up for that one death.”

Dr. Sugarmen also asked for details on the deaths including where they occurred, in whom, and whether the centers were inexperienced.

Dr. Aminian could not recall at the time, but in an interview with this news organization said one death was in a 61-year-old with a history of cardiac disease and chronic kidney failure secondary to insulin-dependent diabetes who developed postop bleeding after gastric bypass. The second was in a 59-year-old patient, again on insulin, who was discharged without problems after gastric bypass, but died within 30 days after surgery.

Although most serious complications occur in this period, the main limitation of the study is that the dataset does not capture adverse events beyond 30 days after surgery, which can lead to underestimation of real risk, Dr. Aminian told the crowd.

“Further large clinical studies on long-term safety and efficacy outcomes of bariatric surgery in patients with type 2 diabetes and low BMI are warranted,” he said.

[email protected]

LOS ANGELES – A nationwide analysis shows modest early morbidity and low mortality following bariatric surgery in patients with type 2 diabetes who are not morbidly obese.

At 30 days’ follow-up among 1,003 patients, the composite complication rate, defined as the presence of any of 16 adverse events, was 4.2%; the reoperation rate was 1.6%; and two patients (0.2%) died.

Patrice Wendling/Frontline Medical News

“A 2-hour surgical procedure requiring a 2-day hospital stay that is associated with low morbidity and mortality can lead to remission of a chronic, progressive, and disabling disease,” lead author Dr. Ali Aminian of the Cleveland Clinic said at Obesity Week 2015.

“Based on these findings, bariatric surgery can be considered a relatively safe option for managing type 2 diabetes in patients with mild obesity.”

The analysis included adults with a body mass index of at least 25 kg/m², but less than 35 kg/m² (mean, 33 kg/m²).

These data are important because most patients with type 2 diabetes fall into this BMI category, he said.

Most of the patients were women (74.3%), 40% were using insulin, 78% had hypertension, and 9% had cardiac disease, according to the analysis, drawn from the American College of Surgery National Surgical Quality Improvement Program 2005-2013 database.

Roux-en-Y bypass was performed in 574 patients, adjustable gastric banding in 227, sleeve gastrectomy in 189, and duodenal switch in 13.

The most common adverse events overall were blood transfusion and reoperation (both 1.6%), a hospital stay longer than 7 days (0.6%), and organ space surgical-site infection (0.5%).

Composite morbidity and mortality was highest in the Roux-en-Y bypass group, compared with the adjustable banding and sleeve groups (5% vs. 3.1% vs. 3.2%, respectively), Dr. Aminian said at the meeting, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Only 3 of 46 patients with a BMI of less than 30 kg/m² had an adverse event.

Available randomized controlled trials can’t clearly resolve the safety concerns of bariatric surgery in the subgroup of patients with type 2 diabetes who are overweight and mildly obese because such small trials are unlikely to reveal uncommon but clinically serious complications, Dr. Aminian said. In addition, many of the trials have screened out low-BMI and high-risk patients.

Those in attendance at the presentation, however, weren’t entirely convinced the current analysis could allay all safety concerns.

Session comoderator Dr. Daniel Cottam, a bariatric surgeon in group practice in Salt Lake City, said, “I like the summary; however, the use of the word ‘safe’ can be taken to mean a lot of things. It’s one of those squishy words.”

Though the authors have shown that bariatric surgery can be performed in diabetics with a low BMI, in order to say it is safe, the comparison needs to be drawn to the all-cause mortality for these patients in the general population and with other surgical procedures.

“That would be useful in the manuscript because as we approach our patients, we want to be able to say, ‘Listen, if you live with diabetes and a BMI of 25-35 for 5 years, this is your all-cause mortality, and surgery is going to save your life, not hurt it,’ ” Dr. Cottam said.

Along the same lines, Dr. Harvey Sugerman emeritus professor of surgery at Virginia Commonwealth University in Richmond, commented, “Like the old days of routinely operating on any patient with diabetes and gallstones, the data were that just having one death in a young person and the quality-of-life-years lost, it would take you thousands of gallbladders to make up for that one death.”

Dr. Sugarmen also asked for details on the deaths including where they occurred, in whom, and whether the centers were inexperienced.

Dr. Aminian could not recall at the time, but in an interview with this news organization said one death was in a 61-year-old with a history of cardiac disease and chronic kidney failure secondary to insulin-dependent diabetes who developed postop bleeding after gastric bypass. The second was in a 59-year-old patient, again on insulin, who was discharged without problems after gastric bypass, but died within 30 days after surgery.

Although most serious complications occur in this period, the main limitation of the study is that the dataset does not capture adverse events beyond 30 days after surgery, which can lead to underestimation of real risk, Dr. Aminian told the crowd.

“Further large clinical studies on long-term safety and efficacy outcomes of bariatric surgery in patients with type 2 diabetes and low BMI are warranted,” he said.

[email protected]

CHICAGO – Contralateral prophylactic mastectomy is more expensive and provides a lower quality of life than unilateral mastectomy in younger women with sporadic breast cancer, a cost-effectiveness analysis shows.

“Unilateral mastectomy dominated contralateral prophylactic mastectomy in the treatment of unilateral, sporadic breast cancer,” Robert C. Keskey said at the annual clinical congress of the American College of Surgeons.

Patrice Wendling/Frontline Medical News

Among these women without a family history of breast cancer, unilateral mastectomy (UM) with 20 years of routine surveillance cost an average of $5,583 less than contralateral prophylactic mastectomy (CPM) ($13,703 vs. $19,286).

Women who chose UM also gained 0.21 quality adjusted life-years (QALYs), or about 2-3 months in perfect health (21.75 vs. 21.54).

Despite a decline in contralateral breast cancers, the national rate of CPM has risen from 9.7% to 24% in women 45 years of age or younger, due in part to the Angelina Jolie effect.

CPM reduces the risk of contralateral breast cancer by up to 95%, but has not been proven to provide a survival advantage and increases complications, Mr. Keskey of the University of Louisville (Ky.) said.

Discussant Dr. Judy Boughey of the Mayo Clinic in Rochester, Minn., observed that this is the third model to tackle this important issue and that all three came up with different results and conclusions.

“This probably highlights that our models are highly dependent on the assumptions made and the costs that are involved in building the model,” she said.

The first model developed at the Mayo Clinic by Dr. Boughey and others, reported that CPM is cost effective for women younger than 70 years. However, it did not take into account reconstruction and complications (J Clin Oncol. 2011;29:2993-3000), Mr. Keskey said during his talk.

The second model showed that CPM is cost saving, but provides a lower quality of life than UM in women younger than 50 years (Ann Surg Oncol. 2014 Jul;21:2209-17). This study only provided 10-year follow-up and overestimated reconstruction and complication rates, he said.

Dr. Boughey observed that the new model did not include symmetry, which was shown to be a big driver of CPM in a separate University of Michigan survey presented during the same session.

In addition, the quality-of-life assumptions used are the same as those in the second model, but significantly different from those in the Mayo model. In that analysis, if a patient felt that their quality of life was improved by a CPM, then the CPM was clearly cost effective, Dr. Boughey noted.

“So for a patient you see in the clinic who feels their quality of life is better with a CPM than without a CPM, does this model really apply?” she asked.

Mr. Keskey replied, “I think it still does in terms of the patient understanding what they’re going to face financially. It’s an important component of the puzzle. If they’re okay spending that money because they feel that either psychologically they are going to have a better quality of life or they feel their outcomes will be positive no matter what, then I think it’s important to understand this difference in cost and use that to make their decision.”

Study details

The investigators, led by Dr. Nicolas Ajkay, also of Louisville, created a decision tree using TreeAge Pro 2015 software to analyze the long-term costs of CPM vs. UM with routine surveillance in women aged 45 years and younger with sporadic breast cancer. The model included 16 event probabilities taken from the recent literature including complications with and without reconstruction, 5- and 10-year contralateral breast cancer risk, cancer stage, and hormone-receptor status.

Effectiveness was measured by QALYs taken from surveyed breast cancer patients. Medical costs were obtained from the 2014 Medicare physician fee schedule.

Because the physician fee schedule is not all inclusive, the investigators compared CPM and UM using costs from the Healthcare Cost and Utilization Project (HCUP), which contain total costs on hospital discharge after a procedure. When this was done, CPM cost an average of $15,425 more than UM and provided a lower quality of life, Mr. Keskey said.

The investigators also replaced yearly mammography in the unilateral mastectomy group with more expensive surveillance using breast magnetic resonance imaging. In this model, CPM actually saved about $300 ($19,286 vs. $19,560), but again provided a lower quality of life (21.54 vs. 21.75), he said. It resulted in a savings of $1,300 per QALY lost, which is not enough to be deemed cost effective.

“So even using a more expensive surveillance method, contralateral prophylactic mastectomy was still not cost effective,” Mr. Keskey said.

Finally, reconstruction rates were varied to see whether this would impact outcomes. The national reconstruction rate following unilateral mastectomy is about 28%, which resulted in a lifetime cost in the initial analysis model of about $13,703.

In order to make CPM less expensive than UM, the reconstruction rate following CPM would have to be dropped to 0% ($12,580) from the national rate of 75% ($19,286), he said. Further, even if the UM reconstruction rate was hiked to 100%, the lifetime costs associated with a unilateral mastectomy were cheaper at $19,275.

Limitations of the model include the subjective nature of QALYs, the cost-effectiveness analysis is a theoretical model, and its costs need to be validated against real-world numbers, Mr. Keskey said.

During a discussion of the study, however, an attendee expressed concern that the data will be used to deny insurance coverage for women seeking a prophylactic contralateral mastectomy.

The decision to undergo prophylactic mastectomy is very personal and needs to be individualized, despite the suggestion of increased cost and less quality of life in the study, according to senior author and colleague Dr. Nicolas Ajkay.

“For some patients, the thought of repeating breast cancer treatment, though a low probability, may be unacceptable; for others, imaging surveillance may not be a reasonable option; and a patient with preexisting breast asymmetry may consider bilateral mastectomy as a way to achieve symmetry and better cosmesis,” he said in an interview. “Our objective from the inception of the study, even before analyzing the results, was that this information could be part of a patient-physician discussion, never the main factor in the decision-making process.”

The authors and Dr. Boughey reported no conflicts of interest.

[email protected]

CHICAGO – Contralateral prophylactic mastectomy is more expensive and provides a lower quality of life than unilateral mastectomy in younger women with sporadic breast cancer, a cost-effectiveness analysis shows.

“Unilateral mastectomy dominated contralateral prophylactic mastectomy in the treatment of unilateral, sporadic breast cancer,” Robert C. Keskey said at the annual clinical congress of the American College of Surgeons.

Patrice Wendling/Frontline Medical News

Among these women without a family history of breast cancer, unilateral mastectomy (UM) with 20 years of routine surveillance cost an average of $5,583 less than contralateral prophylactic mastectomy (CPM) ($13,703 vs. $19,286).

Women who chose UM also gained 0.21 quality adjusted life-years (QALYs), or about 2-3 months in perfect health (21.75 vs. 21.54).

Despite a decline in contralateral breast cancers, the national rate of CPM has risen from 9.7% to 24% in women 45 years of age or younger, due in part to the Angelina Jolie effect.

CPM reduces the risk of contralateral breast cancer by up to 95%, but has not been proven to provide a survival advantage and increases complications, Mr. Keskey of the University of Louisville (Ky.) said.

Discussant Dr. Judy Boughey of the Mayo Clinic in Rochester, Minn., observed that this is the third model to tackle this important issue and that all three came up with different results and conclusions.

“This probably highlights that our models are highly dependent on the assumptions made and the costs that are involved in building the model,” she said.

The first model developed at the Mayo Clinic by Dr. Boughey and others, reported that CPM is cost effective for women younger than 70 years. However, it did not take into account reconstruction and complications (J Clin Oncol. 2011;29:2993-3000), Mr. Keskey said during his talk.

The second model showed that CPM is cost saving, but provides a lower quality of life than UM in women younger than 50 years (Ann Surg Oncol. 2014 Jul;21:2209-17). This study only provided 10-year follow-up and overestimated reconstruction and complication rates, he said.

Dr. Boughey observed that the new model did not include symmetry, which was shown to be a big driver of CPM in a separate University of Michigan survey presented during the same session.

In addition, the quality-of-life assumptions used are the same as those in the second model, but significantly different from those in the Mayo model. In that analysis, if a patient felt that their quality of life was improved by a CPM, then the CPM was clearly cost effective, Dr. Boughey noted.

“So for a patient you see in the clinic who feels their quality of life is better with a CPM than without a CPM, does this model really apply?” she asked.

Mr. Keskey replied, “I think it still does in terms of the patient understanding what they’re going to face financially. It’s an important component of the puzzle. If they’re okay spending that money because they feel that either psychologically they are going to have a better quality of life or they feel their outcomes will be positive no matter what, then I think it’s important to understand this difference in cost and use that to make their decision.”

Study details

The investigators, led by Dr. Nicolas Ajkay, also of Louisville, created a decision tree using TreeAge Pro 2015 software to analyze the long-term costs of CPM vs. UM with routine surveillance in women aged 45 years and younger with sporadic breast cancer. The model included 16 event probabilities taken from the recent literature including complications with and without reconstruction, 5- and 10-year contralateral breast cancer risk, cancer stage, and hormone-receptor status.

Effectiveness was measured by QALYs taken from surveyed breast cancer patients. Medical costs were obtained from the 2014 Medicare physician fee schedule.

Because the physician fee schedule is not all inclusive, the investigators compared CPM and UM using costs from the Healthcare Cost and Utilization Project (HCUP), which contain total costs on hospital discharge after a procedure. When this was done, CPM cost an average of $15,425 more than UM and provided a lower quality of life, Mr. Keskey said.

The investigators also replaced yearly mammography in the unilateral mastectomy group with more expensive surveillance using breast magnetic resonance imaging. In this model, CPM actually saved about $300 ($19,286 vs. $19,560), but again provided a lower quality of life (21.54 vs. 21.75), he said. It resulted in a savings of $1,300 per QALY lost, which is not enough to be deemed cost effective.

“So even using a more expensive surveillance method, contralateral prophylactic mastectomy was still not cost effective,” Mr. Keskey said.

Finally, reconstruction rates were varied to see whether this would impact outcomes. The national reconstruction rate following unilateral mastectomy is about 28%, which resulted in a lifetime cost in the initial analysis model of about $13,703.

In order to make CPM less expensive than UM, the reconstruction rate following CPM would have to be dropped to 0% ($12,580) from the national rate of 75% ($19,286), he said. Further, even if the UM reconstruction rate was hiked to 100%, the lifetime costs associated with a unilateral mastectomy were cheaper at $19,275.

Limitations of the model include the subjective nature of QALYs, the cost-effectiveness analysis is a theoretical model, and its costs need to be validated against real-world numbers, Mr. Keskey said.

During a discussion of the study, however, an attendee expressed concern that the data will be used to deny insurance coverage for women seeking a prophylactic contralateral mastectomy.

The decision to undergo prophylactic mastectomy is very personal and needs to be individualized, despite the suggestion of increased cost and less quality of life in the study, according to senior author and colleague Dr. Nicolas Ajkay.

“For some patients, the thought of repeating breast cancer treatment, though a low probability, may be unacceptable; for others, imaging surveillance may not be a reasonable option; and a patient with preexisting breast asymmetry may consider bilateral mastectomy as a way to achieve symmetry and better cosmesis,” he said in an interview. “Our objective from the inception of the study, even before analyzing the results, was that this information could be part of a patient-physician discussion, never the main factor in the decision-making process.”

The authors and Dr. Boughey reported no conflicts of interest.

[email protected]

CHICAGO – Contralateral prophylactic mastectomy is more expensive and provides a lower quality of life than unilateral mastectomy in younger women with sporadic breast cancer, a cost-effectiveness analysis shows.

“Unilateral mastectomy dominated contralateral prophylactic mastectomy in the treatment of unilateral, sporadic breast cancer,” Robert C. Keskey said at the annual clinical congress of the American College of Surgeons.

Patrice Wendling/Frontline Medical News

Among these women without a family history of breast cancer, unilateral mastectomy (UM) with 20 years of routine surveillance cost an average of $5,583 less than contralateral prophylactic mastectomy (CPM) ($13,703 vs. $19,286).

Women who chose UM also gained 0.21 quality adjusted life-years (QALYs), or about 2-3 months in perfect health (21.75 vs. 21.54).

Despite a decline in contralateral breast cancers, the national rate of CPM has risen from 9.7% to 24% in women 45 years of age or younger, due in part to the Angelina Jolie effect.

CPM reduces the risk of contralateral breast cancer by up to 95%, but has not been proven to provide a survival advantage and increases complications, Mr. Keskey of the University of Louisville (Ky.) said.

Discussant Dr. Judy Boughey of the Mayo Clinic in Rochester, Minn., observed that this is the third model to tackle this important issue and that all three came up with different results and conclusions.

“This probably highlights that our models are highly dependent on the assumptions made and the costs that are involved in building the model,” she said.

The first model developed at the Mayo Clinic by Dr. Boughey and others, reported that CPM is cost effective for women younger than 70 years. However, it did not take into account reconstruction and complications (J Clin Oncol. 2011;29:2993-3000), Mr. Keskey said during his talk.

The second model showed that CPM is cost saving, but provides a lower quality of life than UM in women younger than 50 years (Ann Surg Oncol. 2014 Jul;21:2209-17). This study only provided 10-year follow-up and overestimated reconstruction and complication rates, he said.

Dr. Boughey observed that the new model did not include symmetry, which was shown to be a big driver of CPM in a separate University of Michigan survey presented during the same session.

In addition, the quality-of-life assumptions used are the same as those in the second model, but significantly different from those in the Mayo model. In that analysis, if a patient felt that their quality of life was improved by a CPM, then the CPM was clearly cost effective, Dr. Boughey noted.

“So for a patient you see in the clinic who feels their quality of life is better with a CPM than without a CPM, does this model really apply?” she asked.

Mr. Keskey replied, “I think it still does in terms of the patient understanding what they’re going to face financially. It’s an important component of the puzzle. If they’re okay spending that money because they feel that either psychologically they are going to have a better quality of life or they feel their outcomes will be positive no matter what, then I think it’s important to understand this difference in cost and use that to make their decision.”

Study details

The investigators, led by Dr. Nicolas Ajkay, also of Louisville, created a decision tree using TreeAge Pro 2015 software to analyze the long-term costs of CPM vs. UM with routine surveillance in women aged 45 years and younger with sporadic breast cancer. The model included 16 event probabilities taken from the recent literature including complications with and without reconstruction, 5- and 10-year contralateral breast cancer risk, cancer stage, and hormone-receptor status.

Effectiveness was measured by QALYs taken from surveyed breast cancer patients. Medical costs were obtained from the 2014 Medicare physician fee schedule.

Because the physician fee schedule is not all inclusive, the investigators compared CPM and UM using costs from the Healthcare Cost and Utilization Project (HCUP), which contain total costs on hospital discharge after a procedure. When this was done, CPM cost an average of $15,425 more than UM and provided a lower quality of life, Mr. Keskey said.

The investigators also replaced yearly mammography in the unilateral mastectomy group with more expensive surveillance using breast magnetic resonance imaging. In this model, CPM actually saved about $300 ($19,286 vs. $19,560), but again provided a lower quality of life (21.54 vs. 21.75), he said. It resulted in a savings of $1,300 per QALY lost, which is not enough to be deemed cost effective.

“So even using a more expensive surveillance method, contralateral prophylactic mastectomy was still not cost effective,” Mr. Keskey said.

Finally, reconstruction rates were varied to see whether this would impact outcomes. The national reconstruction rate following unilateral mastectomy is about 28%, which resulted in a lifetime cost in the initial analysis model of about $13,703.

In order to make CPM less expensive than UM, the reconstruction rate following CPM would have to be dropped to 0% ($12,580) from the national rate of 75% ($19,286), he said. Further, even if the UM reconstruction rate was hiked to 100%, the lifetime costs associated with a unilateral mastectomy were cheaper at $19,275.

Limitations of the model include the subjective nature of QALYs, the cost-effectiveness analysis is a theoretical model, and its costs need to be validated against real-world numbers, Mr. Keskey said.

During a discussion of the study, however, an attendee expressed concern that the data will be used to deny insurance coverage for women seeking a prophylactic contralateral mastectomy.

The decision to undergo prophylactic mastectomy is very personal and needs to be individualized, despite the suggestion of increased cost and less quality of life in the study, according to senior author and colleague Dr. Nicolas Ajkay.

“For some patients, the thought of repeating breast cancer treatment, though a low probability, may be unacceptable; for others, imaging surveillance may not be a reasonable option; and a patient with preexisting breast asymmetry may consider bilateral mastectomy as a way to achieve symmetry and better cosmesis,” he said in an interview. “Our objective from the inception of the study, even before analyzing the results, was that this information could be part of a patient-physician discussion, never the main factor in the decision-making process.”

The authors and Dr. Boughey reported no conflicts of interest.

[email protected]

LOS ANGELES – In the 3 years following bariatric surgery, 50%-70% of adults will experience clinically meaningful easing of bodily pain and improved physical function, a collaborative study shows.

Further, 75% of patients with severe knee and hip pain or disability had lessening of symptoms indicative of osteoarthritis, Wendy C. King, Ph.D., of the University of Pittsburgh Graduate School of Public Health, reported at Obesity Week 2015.

The study also sheds new light on several factors associated with easing of the debilitating joint pain and physical limitations that are common among patients undergoing bariatric surgery.

Previous studies have reported lessening of symptoms after surgery but had small sample sizes, short-term follow-up of 1 year or less, or used obsolete surgical procedures, she said.

The investigators followed 2,221 patients participating in the prospective, observational Longitudinal Assessment of Bariatric Surgery-2 (LABS-2) study who underwent weight-loss surgery at any of ten U.S. hospitals. Most (70%) had Roux-en-Y bypass, 25% laparoscopic adjustable gastric banding, and 5% other procedures. Their median age was 47 years, median body mass index 46 kg/m², and 79% were female. Follow-up assessment with several validated measures was available in 1,724 (72%) of patients at 3 years.

Short Form Health Survey (SF-36) scores at years 1, 2, and 3 of follow-up were 57.6, 53.5, and 48.6 for bodily pain and 76.5, 74.2, and 70.2 for physical function, Dr. King said.

Knee pain scores on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) were 75.1 at 1 year, 71.6 at year 2, and 71.3 at year 3.

In Poisson mixed models, younger age, higher household income, and fewer depressive symptoms before surgery were among the factors independently related to a higher likelihood of easing of pain and improvements in function, she said. In addition, greater weight loss and lessening of depressive symptoms after surgery predicted easing of pain and improved physical function.

Opioid use and mobility deficits after bariatric surgery, however, proved more thorny outcomes to alter, Dr. King acknowledged.

Less than half of the 353 patients who reported opioid pain medication use at baseline discontinued opioids at years 1, 2, and 3 of follow-up (42.2%, 40.2%, 45.7%).

Only younger age and higher household income at baseline predicted discontinuation, she said. When the SF-36 pain score was added to the model to account for perceived pain, only having less presurgical pain and a more significant postsurgical lessening of pain were related to postsurgical cessation of opioid use.

“It’s possible that the improvement in depressive symptoms and improvement in pain and function are bidirectional,” Dr. King said. “So if you have improvement in pain and function, you may have improvement in depressive symptoms. But I think it’s noteworthy that presurgery depressive symptoms predicted lower likelihood of improvement in pain, suggesting that depressive symptoms may contribute to pain perception in this population.”

Mobility deficits, defined as the inability to complete a timed 400-m walk in 7 minutes, were present in 836 patients (44%) at entry, with deficit remission rates holding steady at each year of follow-up (55.6%, 55.8%, 56.5%).

After controlling for factors related to pain and function (age, income, depressive symptoms, weight loss), baseline pain and easing of pain were related to improvement in function. Thus, effective pain management may also improve physical function in this population, Dr. King suggested.

“These findings may help clinicians identify patients likely to require additional intervention to address pain and physical limitations that may otherwise limit or reduce their quality of life and pose significant barriers to their ability to adopt an active lifestyle,” she said at the meeting, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery. “There was some decline in the original improvement between year 1 and year 3, so I think it will be really important for us to get the 7-year data out there to see if that trend continues.”

[email protected]

LOS ANGELES – In the 3 years following bariatric surgery, 50%-70% of adults will experience clinically meaningful easing of bodily pain and improved physical function, a collaborative study shows.

Further, 75% of patients with severe knee and hip pain or disability had lessening of symptoms indicative of osteoarthritis, Wendy C. King, Ph.D., of the University of Pittsburgh Graduate School of Public Health, reported at Obesity Week 2015.

The study also sheds new light on several factors associated with easing of the debilitating joint pain and physical limitations that are common among patients undergoing bariatric surgery.

Previous studies have reported lessening of symptoms after surgery but had small sample sizes, short-term follow-up of 1 year or less, or used obsolete surgical procedures, she said.

The investigators followed 2,221 patients participating in the prospective, observational Longitudinal Assessment of Bariatric Surgery-2 (LABS-2) study who underwent weight-loss surgery at any of ten U.S. hospitals. Most (70%) had Roux-en-Y bypass, 25% laparoscopic adjustable gastric banding, and 5% other procedures. Their median age was 47 years, median body mass index 46 kg/m², and 79% were female. Follow-up assessment with several validated measures was available in 1,724 (72%) of patients at 3 years.

Short Form Health Survey (SF-36) scores at years 1, 2, and 3 of follow-up were 57.6, 53.5, and 48.6 for bodily pain and 76.5, 74.2, and 70.2 for physical function, Dr. King said.

Knee pain scores on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) were 75.1 at 1 year, 71.6 at year 2, and 71.3 at year 3.

In Poisson mixed models, younger age, higher household income, and fewer depressive symptoms before surgery were among the factors independently related to a higher likelihood of easing of pain and improvements in function, she said. In addition, greater weight loss and lessening of depressive symptoms after surgery predicted easing of pain and improved physical function.

Opioid use and mobility deficits after bariatric surgery, however, proved more thorny outcomes to alter, Dr. King acknowledged.

Less than half of the 353 patients who reported opioid pain medication use at baseline discontinued opioids at years 1, 2, and 3 of follow-up (42.2%, 40.2%, 45.7%).

Only younger age and higher household income at baseline predicted discontinuation, she said. When the SF-36 pain score was added to the model to account for perceived pain, only having less presurgical pain and a more significant postsurgical lessening of pain were related to postsurgical cessation of opioid use.

“It’s possible that the improvement in depressive symptoms and improvement in pain and function are bidirectional,” Dr. King said. “So if you have improvement in pain and function, you may have improvement in depressive symptoms. But I think it’s noteworthy that presurgery depressive symptoms predicted lower likelihood of improvement in pain, suggesting that depressive symptoms may contribute to pain perception in this population.”

Mobility deficits, defined as the inability to complete a timed 400-m walk in 7 minutes, were present in 836 patients (44%) at entry, with deficit remission rates holding steady at each year of follow-up (55.6%, 55.8%, 56.5%).

After controlling for factors related to pain and function (age, income, depressive symptoms, weight loss), baseline pain and easing of pain were related to improvement in function. Thus, effective pain management may also improve physical function in this population, Dr. King suggested.

“These findings may help clinicians identify patients likely to require additional intervention to address pain and physical limitations that may otherwise limit or reduce their quality of life and pose significant barriers to their ability to adopt an active lifestyle,” she said at the meeting, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery. “There was some decline in the original improvement between year 1 and year 3, so I think it will be really important for us to get the 7-year data out there to see if that trend continues.”

[email protected]

LOS ANGELES – In the 3 years following bariatric surgery, 50%-70% of adults will experience clinically meaningful easing of bodily pain and improved physical function, a collaborative study shows.

Further, 75% of patients with severe knee and hip pain or disability had lessening of symptoms indicative of osteoarthritis, Wendy C. King, Ph.D., of the University of Pittsburgh Graduate School of Public Health, reported at Obesity Week 2015.

The study also sheds new light on several factors associated with easing of the debilitating joint pain and physical limitations that are common among patients undergoing bariatric surgery.

Previous studies have reported lessening of symptoms after surgery but had small sample sizes, short-term follow-up of 1 year or less, or used obsolete surgical procedures, she said.

The investigators followed 2,221 patients participating in the prospective, observational Longitudinal Assessment of Bariatric Surgery-2 (LABS-2) study who underwent weight-loss surgery at any of ten U.S. hospitals. Most (70%) had Roux-en-Y bypass, 25% laparoscopic adjustable gastric banding, and 5% other procedures. Their median age was 47 years, median body mass index 46 kg/m², and 79% were female. Follow-up assessment with several validated measures was available in 1,724 (72%) of patients at 3 years.

Short Form Health Survey (SF-36) scores at years 1, 2, and 3 of follow-up were 57.6, 53.5, and 48.6 for bodily pain and 76.5, 74.2, and 70.2 for physical function, Dr. King said.

Knee pain scores on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) were 75.1 at 1 year, 71.6 at year 2, and 71.3 at year 3.

In Poisson mixed models, younger age, higher household income, and fewer depressive symptoms before surgery were among the factors independently related to a higher likelihood of easing of pain and improvements in function, she said. In addition, greater weight loss and lessening of depressive symptoms after surgery predicted easing of pain and improved physical function.

Opioid use and mobility deficits after bariatric surgery, however, proved more thorny outcomes to alter, Dr. King acknowledged.

Less than half of the 353 patients who reported opioid pain medication use at baseline discontinued opioids at years 1, 2, and 3 of follow-up (42.2%, 40.2%, 45.7%).

Only younger age and higher household income at baseline predicted discontinuation, she said. When the SF-36 pain score was added to the model to account for perceived pain, only having less presurgical pain and a more significant postsurgical lessening of pain were related to postsurgical cessation of opioid use.

“It’s possible that the improvement in depressive symptoms and improvement in pain and function are bidirectional,” Dr. King said. “So if you have improvement in pain and function, you may have improvement in depressive symptoms. But I think it’s noteworthy that presurgery depressive symptoms predicted lower likelihood of improvement in pain, suggesting that depressive symptoms may contribute to pain perception in this population.”

Mobility deficits, defined as the inability to complete a timed 400-m walk in 7 minutes, were present in 836 patients (44%) at entry, with deficit remission rates holding steady at each year of follow-up (55.6%, 55.8%, 56.5%).

After controlling for factors related to pain and function (age, income, depressive symptoms, weight loss), baseline pain and easing of pain were related to improvement in function. Thus, effective pain management may also improve physical function in this population, Dr. King suggested.

“These findings may help clinicians identify patients likely to require additional intervention to address pain and physical limitations that may otherwise limit or reduce their quality of life and pose significant barriers to their ability to adopt an active lifestyle,” she said at the meeting, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery. “There was some decline in the original improvement between year 1 and year 3, so I think it will be really important for us to get the 7-year data out there to see if that trend continues.”

[email protected]

LOS ANGELES – A provocative study opens the door for psoriasis and psoriatic arthritis to be added to the growing list of benefits following bariatric surgery.

“Although the natural history of psoriasis and psoriatic arthritis is typically chronic, the majority of patients experience improvement after bariatric surgery, Dr. Monica Sethi of New York University said at Obesity Week 2015.

Patrice Wendling/Frontline Medical News

At an average of 6 years after bariatric surgery, 55% of patients with psoriasis and 62% of those with psoriatic arthritis (PsA) reported subjective lessening of their disease.

Preoperative disease severity ratings on a 10-point scale significantly decreased at the most recent follow-up for psoriasis (5.6 vs. 3.3; P less than .01) and PsA (6.4 vs. 3.9; P = .02).

“Our results indicate an association between excess weight loss and symptomatic improvement in severe cases of psoriasis, and a possible improvement in psoriatic arthritis,” she said.

Although the effects of surgical weight loss on psoriasis and PsA are unknown, obesity is known to be more prevalent among patients with psoriasis and PsA. This correlation appears to be related to fat tissue–driven systemic inflammation, Dr. Sethi said.

The investigators surveyed 128 patients with a preoperative diagnosis of psoriasis identified from a single-center database of 9,073 bariatric surgeries performed between 2002 and 2013. A total of 86 patients completed the study, with 21 patients also having a preoperative diagnosis of PsA. Their mean preoperative weight was 288 pounds and preoperative body mass index 45.8 kg/m². The average duration of psoriasis and PsA at the time of surgery was significant at 18.7 years, Dr. Sethi noted.

The mean time from surgery was 6.1 years, with a mean excess weight loss of 46.2% and total weight loss of 23.8%. Laparoscopic adjustable gastric banding was the most common surgery (91%), followed by Roux-en-Y bypass (7%).

In secondary analyses, a higher percent of excess weight loss at recent follow-up was significantly associated with an easing of psoriasis severity (59.5% vs. 43.5%; P = .046), while higher percent of excess weight loss at 1 year was associated with a trend in PsA improvement (55.4% vs. 43.8%; P = .47), Dr. Sethi said.

Easing of disease severity after surgery was associated with a higher rating of disease at the time of surgery (8.9 vs. 7.4; P less than .01) and older age at diagnosis (36.9 years vs. 25.9 years; P = .02), suggesting that these factors may be used to identify patients with a greater likelihood of improvement.

“Larger prospective studies are needed to further define the true effect of surgical weight loss on psoriasis and psoriatic arthritis,” she said at the meeting, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery (ASMBS).

Session comoderator Dr. Peter T. Hallowell of the University of Virginia, Charlottesville, agreed that further studies are needed, but said the interesting thing is how bariatric surgery improves multiple problems.

“The results are pretty impressive with the moderate weight loss they got with laparoscopic gastric banding,” he said in an interview. “With gastric bypass or a sleeve, where we would expect greater weight loss and greater decrease in the inflammatory mediators, we may see an even greater improved outcome.”

A larger prospective study is being planned between New York University’s psoriasis and bariatric centers in about 60 patients with psoriasis and PsA undergoing bariatric surgery, mostly sleeve gastrectomy and gastric bypass, Dr. Sethi said in an interview.

LOS ANGELES – A provocative study opens the door for psoriasis and psoriatic arthritis to be added to the growing list of benefits following bariatric surgery.

“Although the natural history of psoriasis and psoriatic arthritis is typically chronic, the majority of patients experience improvement after bariatric surgery, Dr. Monica Sethi of New York University said at Obesity Week 2015.

Patrice Wendling/Frontline Medical News

At an average of 6 years after bariatric surgery, 55% of patients with psoriasis and 62% of those with psoriatic arthritis (PsA) reported subjective lessening of their disease.

Preoperative disease severity ratings on a 10-point scale significantly decreased at the most recent follow-up for psoriasis (5.6 vs. 3.3; P less than .01) and PsA (6.4 vs. 3.9; P = .02).

“Our results indicate an association between excess weight loss and symptomatic improvement in severe cases of psoriasis, and a possible improvement in psoriatic arthritis,” she said.

Although the effects of surgical weight loss on psoriasis and PsA are unknown, obesity is known to be more prevalent among patients with psoriasis and PsA. This correlation appears to be related to fat tissue–driven systemic inflammation, Dr. Sethi said.

The investigators surveyed 128 patients with a preoperative diagnosis of psoriasis identified from a single-center database of 9,073 bariatric surgeries performed between 2002 and 2013. A total of 86 patients completed the study, with 21 patients also having a preoperative diagnosis of PsA. Their mean preoperative weight was 288 pounds and preoperative body mass index 45.8 kg/m². The average duration of psoriasis and PsA at the time of surgery was significant at 18.7 years, Dr. Sethi noted.

The mean time from surgery was 6.1 years, with a mean excess weight loss of 46.2% and total weight loss of 23.8%. Laparoscopic adjustable gastric banding was the most common surgery (91%), followed by Roux-en-Y bypass (7%).

In secondary analyses, a higher percent of excess weight loss at recent follow-up was significantly associated with an easing of psoriasis severity (59.5% vs. 43.5%; P = .046), while higher percent of excess weight loss at 1 year was associated with a trend in PsA improvement (55.4% vs. 43.8%; P = .47), Dr. Sethi said.

Easing of disease severity after surgery was associated with a higher rating of disease at the time of surgery (8.9 vs. 7.4; P less than .01) and older age at diagnosis (36.9 years vs. 25.9 years; P = .02), suggesting that these factors may be used to identify patients with a greater likelihood of improvement.

“Larger prospective studies are needed to further define the true effect of surgical weight loss on psoriasis and psoriatic arthritis,” she said at the meeting, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery (ASMBS).

Session comoderator Dr. Peter T. Hallowell of the University of Virginia, Charlottesville, agreed that further studies are needed, but said the interesting thing is how bariatric surgery improves multiple problems.

“The results are pretty impressive with the moderate weight loss they got with laparoscopic gastric banding,” he said in an interview. “With gastric bypass or a sleeve, where we would expect greater weight loss and greater decrease in the inflammatory mediators, we may see an even greater improved outcome.”

A larger prospective study is being planned between New York University’s psoriasis and bariatric centers in about 60 patients with psoriasis and PsA undergoing bariatric surgery, mostly sleeve gastrectomy and gastric bypass, Dr. Sethi said in an interview.

LOS ANGELES – A provocative study opens the door for psoriasis and psoriatic arthritis to be added to the growing list of benefits following bariatric surgery.

“Although the natural history of psoriasis and psoriatic arthritis is typically chronic, the majority of patients experience improvement after bariatric surgery, Dr. Monica Sethi of New York University said at Obesity Week 2015.

Patrice Wendling/Frontline Medical News

At an average of 6 years after bariatric surgery, 55% of patients with psoriasis and 62% of those with psoriatic arthritis (PsA) reported subjective lessening of their disease.

Preoperative disease severity ratings on a 10-point scale significantly decreased at the most recent follow-up for psoriasis (5.6 vs. 3.3; P less than .01) and PsA (6.4 vs. 3.9; P = .02).

“Our results indicate an association between excess weight loss and symptomatic improvement in severe cases of psoriasis, and a possible improvement in psoriatic arthritis,” she said.

Although the effects of surgical weight loss on psoriasis and PsA are unknown, obesity is known to be more prevalent among patients with psoriasis and PsA. This correlation appears to be related to fat tissue–driven systemic inflammation, Dr. Sethi said.

The investigators surveyed 128 patients with a preoperative diagnosis of psoriasis identified from a single-center database of 9,073 bariatric surgeries performed between 2002 and 2013. A total of 86 patients completed the study, with 21 patients also having a preoperative diagnosis of PsA. Their mean preoperative weight was 288 pounds and preoperative body mass index 45.8 kg/m². The average duration of psoriasis and PsA at the time of surgery was significant at 18.7 years, Dr. Sethi noted.

The mean time from surgery was 6.1 years, with a mean excess weight loss of 46.2% and total weight loss of 23.8%. Laparoscopic adjustable gastric banding was the most common surgery (91%), followed by Roux-en-Y bypass (7%).

In secondary analyses, a higher percent of excess weight loss at recent follow-up was significantly associated with an easing of psoriasis severity (59.5% vs. 43.5%; P = .046), while higher percent of excess weight loss at 1 year was associated with a trend in PsA improvement (55.4% vs. 43.8%; P = .47), Dr. Sethi said.

Easing of disease severity after surgery was associated with a higher rating of disease at the time of surgery (8.9 vs. 7.4; P less than .01) and older age at diagnosis (36.9 years vs. 25.9 years; P = .02), suggesting that these factors may be used to identify patients with a greater likelihood of improvement.

“Larger prospective studies are needed to further define the true effect of surgical weight loss on psoriasis and psoriatic arthritis,” she said at the meeting, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery (ASMBS).

Session comoderator Dr. Peter T. Hallowell of the University of Virginia, Charlottesville, agreed that further studies are needed, but said the interesting thing is how bariatric surgery improves multiple problems.

“The results are pretty impressive with the moderate weight loss they got with laparoscopic gastric banding,” he said in an interview. “With gastric bypass or a sleeve, where we would expect greater weight loss and greater decrease in the inflammatory mediators, we may see an even greater improved outcome.”

A larger prospective study is being planned between New York University’s psoriasis and bariatric centers in about 60 patients with psoriasis and PsA undergoing bariatric surgery, mostly sleeve gastrectomy and gastric bypass, Dr. Sethi said in an interview.

LOS ANGELES – A provocative study opens the door for psoriasis and psoriatic arthritis to be added to the growing list of benefits following bariatric surgery.

“Although the natural history of psoriasis and psoriatic arthritis is typically chronic, the majority of patients experience improvement after bariatric surgery, Dr. Monica Sethi of New York University said at Obesity Week 2015.

Patrice Wendling/Frontline Medical News

At an average of 6 years after bariatric surgery, 55% of patients with psoriasis and 62% of those with psoriatic arthritis (PsA) reported subjective lessening of their disease.

Preoperative disease severity ratings on a 10-point scale significantly decreased at the most recent follow-up for psoriasis (5.6 vs. 3.3; P less than .01) and PsA (6.4 vs. 3.9; P = .02).

“Our results indicate an association between excess weight loss and symptomatic improvement in severe cases of psoriasis, and a possible improvement in psoriatic arthritis,” she said.

Although the effects of surgical weight loss on psoriasis and PsA are unknown, obesity is known to be more prevalent among patients with psoriasis and PsA. This correlation appears to be related to fat tissue–driven systemic inflammation, Dr. Sethi said.

The investigators surveyed 128 patients with a preoperative diagnosis of psoriasis identified from a single-center database of 9,073 bariatric surgeries performed between 2002 and 2013. A total of 86 patients completed the study, with 21 patients also having a preoperative diagnosis of PsA. Their mean preoperative weight was 288 pounds and preoperative body mass index 45.8 kg/m². The average duration of psoriasis and PsA at the time of surgery was significant at 18.7 years, Dr. Sethi noted.

The mean time from surgery was 6.1 years, with a mean excess weight loss of 46.2% and total weight loss of 23.8%. Laparoscopic adjustable gastric banding was the most common surgery (91%), followed by Roux-en-Y bypass (7%).

In secondary analyses, a higher percent of excess weight loss at recent follow-up was significantly associated with an easing of psoriasis severity (59.5% vs. 43.5%; P = .046), while higher percent of excess weight loss at 1 year was associated with a trend in PsA improvement (55.4% vs. 43.8%; P = .47), Dr. Sethi said.

Easing of disease severity after surgery was associated with a higher rating of disease at the time of surgery (8.9 vs. 7.4; P less than .01) and older age at diagnosis (36.9 years vs. 25.9 years; P = .02), suggesting that these factors may be used to identify patients with a greater likelihood of improvement.

“Larger prospective studies are needed to further define the true effect of surgical weight loss on psoriasis and psoriatic arthritis,” she said at the meeting, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery (ASMBS).

Session comoderator Dr. Peter T. Hallowell of the University of Virginia, Charlottesville, agreed that further studies are needed, but said the interesting thing is how bariatric surgery improves multiple problems.

“The results are pretty impressive with the moderate weight loss they got with laparoscopic gastric banding,” he said in an interview. “With gastric bypass or a sleeve, where we would expect greater weight loss and greater decrease in the inflammatory mediators, we may see an even greater improved outcome.”

A larger prospective study is being planned between New York University’s psoriasis and bariatric centers in about 60 patients with psoriasis and PsA undergoing bariatric surgery, mostly sleeve gastrectomy and gastric bypass, Dr. Sethi said in an interview.

[email protected]

LOS ANGELES – A provocative study opens the door for psoriasis and psoriatic arthritis to be added to the growing list of benefits following bariatric surgery.

“Although the natural history of psoriasis and psoriatic arthritis is typically chronic, the majority of patients experience improvement after bariatric surgery, Dr. Monica Sethi of New York University said at Obesity Week 2015.

Patrice Wendling/Frontline Medical News

At an average of 6 years after bariatric surgery, 55% of patients with psoriasis and 62% of those with psoriatic arthritis (PsA) reported subjective lessening of their disease.

Preoperative disease severity ratings on a 10-point scale significantly decreased at the most recent follow-up for psoriasis (5.6 vs. 3.3; P less than .01) and PsA (6.4 vs. 3.9; P = .02).

“Our results indicate an association between excess weight loss and symptomatic improvement in severe cases of psoriasis, and a possible improvement in psoriatic arthritis,” she said.

Although the effects of surgical weight loss on psoriasis and PsA are unknown, obesity is known to be more prevalent among patients with psoriasis and PsA. This correlation appears to be related to fat tissue–driven systemic inflammation, Dr. Sethi said.

The investigators surveyed 128 patients with a preoperative diagnosis of psoriasis identified from a single-center database of 9,073 bariatric surgeries performed between 2002 and 2013. A total of 86 patients completed the study, with 21 patients also having a preoperative diagnosis of PsA. Their mean preoperative weight was 288 pounds and preoperative body mass index 45.8 kg/m². The average duration of psoriasis and PsA at the time of surgery was significant at 18.7 years, Dr. Sethi noted.

The mean time from surgery was 6.1 years, with a mean excess weight loss of 46.2% and total weight loss of 23.8%. Laparoscopic adjustable gastric banding was the most common surgery (91%), followed by Roux-en-Y bypass (7%).

In secondary analyses, a higher percent of excess weight loss at recent follow-up was significantly associated with an easing of psoriasis severity (59.5% vs. 43.5%; P = .046), while higher percent of excess weight loss at 1 year was associated with a trend in PsA improvement (55.4% vs. 43.8%; P = .47), Dr. Sethi said.

Easing of disease severity after surgery was associated with a higher rating of disease at the time of surgery (8.9 vs. 7.4; P less than .01) and older age at diagnosis (36.9 years vs. 25.9 years; P = .02), suggesting that these factors may be used to identify patients with a greater likelihood of improvement.

“Larger prospective studies are needed to further define the true effect of surgical weight loss on psoriasis and psoriatic arthritis,” she said at the meeting, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery (ASMBS).

Session comoderator Dr. Peter T. Hallowell of the University of Virginia, Charlottesville, agreed that further studies are needed, but said the interesting thing is how bariatric surgery improves multiple problems.

“The results are pretty impressive with the moderate weight loss they got with laparoscopic gastric banding,” he said in an interview. “With gastric bypass or a sleeve, where we would expect greater weight loss and greater decrease in the inflammatory mediators, we may see an even greater improved outcome.”

A larger prospective study is being planned between New York University’s psoriasis and bariatric centers in about 60 patients with psoriasis and PsA undergoing bariatric surgery, mostly sleeve gastrectomy and gastric bypass, Dr. Sethi said in an interview.

[email protected]

LOS ANGELES – A provocative study opens the door for psoriasis and psoriatic arthritis to be added to the growing list of benefits following bariatric surgery.

“Although the natural history of psoriasis and psoriatic arthritis is typically chronic, the majority of patients experience improvement after bariatric surgery, Dr. Monica Sethi of New York University said at Obesity Week 2015.

Patrice Wendling/Frontline Medical News

At an average of 6 years after bariatric surgery, 55% of patients with psoriasis and 62% of those with psoriatic arthritis (PsA) reported subjective lessening of their disease.

Preoperative disease severity ratings on a 10-point scale significantly decreased at the most recent follow-up for psoriasis (5.6 vs. 3.3; P less than .01) and PsA (6.4 vs. 3.9; P = .02).

“Our results indicate an association between excess weight loss and symptomatic improvement in severe cases of psoriasis, and a possible improvement in psoriatic arthritis,” she said.

Although the effects of surgical weight loss on psoriasis and PsA are unknown, obesity is known to be more prevalent among patients with psoriasis and PsA. This correlation appears to be related to fat tissue–driven systemic inflammation, Dr. Sethi said.

The investigators surveyed 128 patients with a preoperative diagnosis of psoriasis identified from a single-center database of 9,073 bariatric surgeries performed between 2002 and 2013. A total of 86 patients completed the study, with 21 patients also having a preoperative diagnosis of PsA. Their mean preoperative weight was 288 pounds and preoperative body mass index 45.8 kg/m². The average duration of psoriasis and PsA at the time of surgery was significant at 18.7 years, Dr. Sethi noted.

The mean time from surgery was 6.1 years, with a mean excess weight loss of 46.2% and total weight loss of 23.8%. Laparoscopic adjustable gastric banding was the most common surgery (91%), followed by Roux-en-Y bypass (7%).

In secondary analyses, a higher percent of excess weight loss at recent follow-up was significantly associated with an easing of psoriasis severity (59.5% vs. 43.5%; P = .046), while higher percent of excess weight loss at 1 year was associated with a trend in PsA improvement (55.4% vs. 43.8%; P = .47), Dr. Sethi said.

Easing of disease severity after surgery was associated with a higher rating of disease at the time of surgery (8.9 vs. 7.4; P less than .01) and older age at diagnosis (36.9 years vs. 25.9 years; P = .02), suggesting that these factors may be used to identify patients with a greater likelihood of improvement.

“Larger prospective studies are needed to further define the true effect of surgical weight loss on psoriasis and psoriatic arthritis,” she said at the meeting, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery (ASMBS).

Session comoderator Dr. Peter T. Hallowell of the University of Virginia, Charlottesville, agreed that further studies are needed, but said the interesting thing is how bariatric surgery improves multiple problems.

“The results are pretty impressive with the moderate weight loss they got with laparoscopic gastric banding,” he said in an interview. “With gastric bypass or a sleeve, where we would expect greater weight loss and greater decrease in the inflammatory mediators, we may see an even greater improved outcome.”

A larger prospective study is being planned between New York University’s psoriasis and bariatric centers in about 60 patients with psoriasis and PsA undergoing bariatric surgery, mostly sleeve gastrectomy and gastric bypass, Dr. Sethi said in an interview.

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LOS ANGELES – An increasing number of adolescents are undergoing gastric band removal after 2 years post operation, a prospective, longitudinal study shows.

“At 2 years most bands are still in place, with 96% of patients having them. After this point, however, multiple bands are removed each year, demonstrating that 2 years perhaps is only the tip of the iceberg,” Dr. Christine Schad said at Obesity Week.

Indeed, the number of adolescents with bands in place reduced to 87%, 76%, and 53% at years 3, 4, and 5 of follow-up. After 5 years, patients continued to undergo band removal.

Like their adult counterparts, adolescents underwent band removal secondary to weight loss failure, reflux esophagitis, and refractory gastric prolapse, Dr. Schad of Morgan Stanley Children’s Hospital, New York-Presbyterian Columbia University Medical Center, New York, said.

Weight loss seemed to plateau over time among the 79 evaluable adolescents, with less than 39% of patients able to lose more than 50% of their excess body weight over the 5-year study.

“Although gastric banding can be performed safely, 2 years seems inadequate to evaluate efficacy,” she said.

The use of adjustable gastric banding rose rapidly after Food and Drug Administration approval in 2001, thanks to low perioperative morbidity, reversibility, and good early results.

Gastric banding has fallen sharply, however, with recent adult studies showing a high incidence of weight loss failure, weight regain, and device-related complications.

Previous studies have reported on the safety of laparoscopic adjustable gastric banding in adolescents; however, these studies are limited to 3-year follow-up at most, Dr. Schad said at the meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

The investigators enrolled 137 morbidly obese adolescents, aged 14-18 years, who underwent laparoscopic adjustable gastric banding from 2006 to 2011. The current analysis included patients with at least 5 years follow-up and patients who had band removal at any point or who did not survive to study end. There were two deaths. The remaining patients had not reached the 5-year follow-up mark or still had their bands in place.

The 79 evaluable patients had a preoperative weight of 138 kg, body mass index of 49.3 kg/m², and excess body weight of 47.2%. At the time of surgery, their average age was 16.9 years, 71% were female, 43% Hispanic, 36.7% white, and 16.5% black.

Even though gastric banding is declining, the results are important because there has been little information about adolescents, and in some parts of the country, gastric banding may be the only available option, session comoderator Dr. Robert Carpenter of Scott & White Healthcare in Temple, Tex., said in an interview.

“The other issue is that there are a lot of pediatricians that only want their patients to have nonstapled, nondivided operations,” he said. “If that’s the case, and we now know that perhaps for adolescents there is a 30%, 40%, 50% conversion and/or failure rate, then we are putting these kids at an extreme risk.”

Oftentimes, these adolescents also won’t have an opportunity for another operation.

“Many insurance companies that they’ll transition to away from their parents will actually have a complete exclusion for bariatric surgery or they have a onetime, lifetime operative opportunity,” Dr. Carpenter said. “So, if that’s been burned, it’s burned.”

[email protected]

LOS ANGELES – An increasing number of adolescents are undergoing gastric band removal after 2 years post operation, a prospective, longitudinal study shows.

“At 2 years most bands are still in place, with 96% of patients having them. After this point, however, multiple bands are removed each year, demonstrating that 2 years perhaps is only the tip of the iceberg,” Dr. Christine Schad said at Obesity Week.

Indeed, the number of adolescents with bands in place reduced to 87%, 76%, and 53% at years 3, 4, and 5 of follow-up. After 5 years, patients continued to undergo band removal.

Like their adult counterparts, adolescents underwent band removal secondary to weight loss failure, reflux esophagitis, and refractory gastric prolapse, Dr. Schad of Morgan Stanley Children’s Hospital, New York-Presbyterian Columbia University Medical Center, New York, said.

Weight loss seemed to plateau over time among the 79 evaluable adolescents, with less than 39% of patients able to lose more than 50% of their excess body weight over the 5-year study.

“Although gastric banding can be performed safely, 2 years seems inadequate to evaluate efficacy,” she said.

The use of adjustable gastric banding rose rapidly after Food and Drug Administration approval in 2001, thanks to low perioperative morbidity, reversibility, and good early results.

Gastric banding has fallen sharply, however, with recent adult studies showing a high incidence of weight loss failure, weight regain, and device-related complications.

Previous studies have reported on the safety of laparoscopic adjustable gastric banding in adolescents; however, these studies are limited to 3-year follow-up at most, Dr. Schad said at the meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

The investigators enrolled 137 morbidly obese adolescents, aged 14-18 years, who underwent laparoscopic adjustable gastric banding from 2006 to 2011. The current analysis included patients with at least 5 years follow-up and patients who had band removal at any point or who did not survive to study end. There were two deaths. The remaining patients had not reached the 5-year follow-up mark or still had their bands in place.

The 79 evaluable patients had a preoperative weight of 138 kg, body mass index of 49.3 kg/m², and excess body weight of 47.2%. At the time of surgery, their average age was 16.9 years, 71% were female, 43% Hispanic, 36.7% white, and 16.5% black.

Even though gastric banding is declining, the results are important because there has been little information about adolescents, and in some parts of the country, gastric banding may be the only available option, session comoderator Dr. Robert Carpenter of Scott & White Healthcare in Temple, Tex., said in an interview.

“The other issue is that there are a lot of pediatricians that only want their patients to have nonstapled, nondivided operations,” he said. “If that’s the case, and we now know that perhaps for adolescents there is a 30%, 40%, 50% conversion and/or failure rate, then we are putting these kids at an extreme risk.”

Oftentimes, these adolescents also won’t have an opportunity for another operation.

“Many insurance companies that they’ll transition to away from their parents will actually have a complete exclusion for bariatric surgery or they have a onetime, lifetime operative opportunity,” Dr. Carpenter said. “So, if that’s been burned, it’s burned.”

[email protected]

LOS ANGELES – An increasing number of adolescents are undergoing gastric band removal after 2 years post operation, a prospective, longitudinal study shows.

“At 2 years most bands are still in place, with 96% of patients having them. After this point, however, multiple bands are removed each year, demonstrating that 2 years perhaps is only the tip of the iceberg,” Dr. Christine Schad said at Obesity Week.

Indeed, the number of adolescents with bands in place reduced to 87%, 76%, and 53% at years 3, 4, and 5 of follow-up. After 5 years, patients continued to undergo band removal.

Like their adult counterparts, adolescents underwent band removal secondary to weight loss failure, reflux esophagitis, and refractory gastric prolapse, Dr. Schad of Morgan Stanley Children’s Hospital, New York-Presbyterian Columbia University Medical Center, New York, said.

Weight loss seemed to plateau over time among the 79 evaluable adolescents, with less than 39% of patients able to lose more than 50% of their excess body weight over the 5-year study.

“Although gastric banding can be performed safely, 2 years seems inadequate to evaluate efficacy,” she said.

The use of adjustable gastric banding rose rapidly after Food and Drug Administration approval in 2001, thanks to low perioperative morbidity, reversibility, and good early results.

Gastric banding has fallen sharply, however, with recent adult studies showing a high incidence of weight loss failure, weight regain, and device-related complications.

Previous studies have reported on the safety of laparoscopic adjustable gastric banding in adolescents; however, these studies are limited to 3-year follow-up at most, Dr. Schad said at the meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

The investigators enrolled 137 morbidly obese adolescents, aged 14-18 years, who underwent laparoscopic adjustable gastric banding from 2006 to 2011. The current analysis included patients with at least 5 years follow-up and patients who had band removal at any point or who did not survive to study end. There were two deaths. The remaining patients had not reached the 5-year follow-up mark or still had their bands in place.

The 79 evaluable patients had a preoperative weight of 138 kg, body mass index of 49.3 kg/m², and excess body weight of 47.2%. At the time of surgery, their average age was 16.9 years, 71% were female, 43% Hispanic, 36.7% white, and 16.5% black.

Even though gastric banding is declining, the results are important because there has been little information about adolescents, and in some parts of the country, gastric banding may be the only available option, session comoderator Dr. Robert Carpenter of Scott & White Healthcare in Temple, Tex., said in an interview.

“The other issue is that there are a lot of pediatricians that only want their patients to have nonstapled, nondivided operations,” he said. “If that’s the case, and we now know that perhaps for adolescents there is a 30%, 40%, 50% conversion and/or failure rate, then we are putting these kids at an extreme risk.”

Oftentimes, these adolescents also won’t have an opportunity for another operation.

“Many insurance companies that they’ll transition to away from their parents will actually have a complete exclusion for bariatric surgery or they have a onetime, lifetime operative opportunity,” Dr. Carpenter said. “So, if that’s been burned, it’s burned.”

[email protected]