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CHICAGO – , according to findings from the randomized phase 3 UNICANCER Prodige 7 trial.
At a median follow up of 63.8 months, median overall survival – the primary endpoint of the study – was “completely comparable” at 41.7 and 41.2 months, respectively, in 133 patients randomized to receive HIPEC with oxaliplatin after cytoreductive surgery and 132 randomized to the cytoreductive surgery–only arm, François Quenet, MD, reported during a press briefing at the annual meeting of the American Society of Clinical Oncology.
The postoperative mortality rate was 1.5% at 30 days in both groups, he said, noting that no difference was seen between the groups in the rate of side effects during the first 30 days after surgery.
“However, we did find a difference between the two arms concerning late, severe complications within 60 days,” said, explaining that the 60-day complication rate was nearly double in the HIPEC group vs. the no-HIPEC group (24.1% vs. 13.6%).
Patients in the trial had stage IV colorectal cancer with isolated peritoneal carcinomatosis and a median age of 60 years. They were enrolled and randomized at 17 centers in France between February 2008 and January 2014.
The survival rate of the surgery-alone group was unexpectedly high, Dr. Quenet said, adding that all colorectal cancer patients with an isolated peritoneal carcinomatosis should therefore be considered for surgery.
The use of HIPEC with cytoreductive surgery was introduced about 15 years ago and has become an accepted treatment option – and in some centers, a standard of care; the combination has been considered an effective treatment for peritoneal carcinomatosis, a metastatic tumor of the peritoneum that occurs in about 20% of colorectal cancer patients. The role of HIPEC in the success of the approach, however, has been unclear.
The current findings suggest that cytoreductive surgery alone is as effective as surgery with HIPEC, which “does not influence the survival result,” in most patients, Dr. Quenet said, noting that about 15% of patients were cured.
Additional study is needed to determine if there are certain subsets of patients who might benefit from HIPEC, he added, explaining that a subgroup analysis in the current study suggested that those with a midrange amount of disease in the abdominal cavity (peritoneal cancer index of 11-15) might experience some benefit with HIPEC, but the numbers were too small to be conclusive.
More research also is needed to determine if chemotherapy agents other than the oxaliplatin used with HIPEC in this study might be more effective, he said.
Prodige 7 was funded by UNICANCER. Dr. Quenet has received honoraria from Sanofi/Aventis, Ethicon, and Gamida Cell, as well as travel/accommodations/expenses from Sanofi, Novartis, and Ethicon.
SOURCE: Quenet F et al. ASCO 2018, Abstract LBA3503.
CHICAGO – , according to findings from the randomized phase 3 UNICANCER Prodige 7 trial.
At a median follow up of 63.8 months, median overall survival – the primary endpoint of the study – was “completely comparable” at 41.7 and 41.2 months, respectively, in 133 patients randomized to receive HIPEC with oxaliplatin after cytoreductive surgery and 132 randomized to the cytoreductive surgery–only arm, François Quenet, MD, reported during a press briefing at the annual meeting of the American Society of Clinical Oncology.
The postoperative mortality rate was 1.5% at 30 days in both groups, he said, noting that no difference was seen between the groups in the rate of side effects during the first 30 days after surgery.
“However, we did find a difference between the two arms concerning late, severe complications within 60 days,” said, explaining that the 60-day complication rate was nearly double in the HIPEC group vs. the no-HIPEC group (24.1% vs. 13.6%).
Patients in the trial had stage IV colorectal cancer with isolated peritoneal carcinomatosis and a median age of 60 years. They were enrolled and randomized at 17 centers in France between February 2008 and January 2014.
The survival rate of the surgery-alone group was unexpectedly high, Dr. Quenet said, adding that all colorectal cancer patients with an isolated peritoneal carcinomatosis should therefore be considered for surgery.
The use of HIPEC with cytoreductive surgery was introduced about 15 years ago and has become an accepted treatment option – and in some centers, a standard of care; the combination has been considered an effective treatment for peritoneal carcinomatosis, a metastatic tumor of the peritoneum that occurs in about 20% of colorectal cancer patients. The role of HIPEC in the success of the approach, however, has been unclear.
The current findings suggest that cytoreductive surgery alone is as effective as surgery with HIPEC, which “does not influence the survival result,” in most patients, Dr. Quenet said, noting that about 15% of patients were cured.
Additional study is needed to determine if there are certain subsets of patients who might benefit from HIPEC, he added, explaining that a subgroup analysis in the current study suggested that those with a midrange amount of disease in the abdominal cavity (peritoneal cancer index of 11-15) might experience some benefit with HIPEC, but the numbers were too small to be conclusive.
More research also is needed to determine if chemotherapy agents other than the oxaliplatin used with HIPEC in this study might be more effective, he said.
Prodige 7 was funded by UNICANCER. Dr. Quenet has received honoraria from Sanofi/Aventis, Ethicon, and Gamida Cell, as well as travel/accommodations/expenses from Sanofi, Novartis, and Ethicon.
SOURCE: Quenet F et al. ASCO 2018, Abstract LBA3503.
CHICAGO – , according to findings from the randomized phase 3 UNICANCER Prodige 7 trial.
At a median follow up of 63.8 months, median overall survival – the primary endpoint of the study – was “completely comparable” at 41.7 and 41.2 months, respectively, in 133 patients randomized to receive HIPEC with oxaliplatin after cytoreductive surgery and 132 randomized to the cytoreductive surgery–only arm, François Quenet, MD, reported during a press briefing at the annual meeting of the American Society of Clinical Oncology.
The postoperative mortality rate was 1.5% at 30 days in both groups, he said, noting that no difference was seen between the groups in the rate of side effects during the first 30 days after surgery.
“However, we did find a difference between the two arms concerning late, severe complications within 60 days,” said, explaining that the 60-day complication rate was nearly double in the HIPEC group vs. the no-HIPEC group (24.1% vs. 13.6%).
Patients in the trial had stage IV colorectal cancer with isolated peritoneal carcinomatosis and a median age of 60 years. They were enrolled and randomized at 17 centers in France between February 2008 and January 2014.
The survival rate of the surgery-alone group was unexpectedly high, Dr. Quenet said, adding that all colorectal cancer patients with an isolated peritoneal carcinomatosis should therefore be considered for surgery.
The use of HIPEC with cytoreductive surgery was introduced about 15 years ago and has become an accepted treatment option – and in some centers, a standard of care; the combination has been considered an effective treatment for peritoneal carcinomatosis, a metastatic tumor of the peritoneum that occurs in about 20% of colorectal cancer patients. The role of HIPEC in the success of the approach, however, has been unclear.
The current findings suggest that cytoreductive surgery alone is as effective as surgery with HIPEC, which “does not influence the survival result,” in most patients, Dr. Quenet said, noting that about 15% of patients were cured.
Additional study is needed to determine if there are certain subsets of patients who might benefit from HIPEC, he added, explaining that a subgroup analysis in the current study suggested that those with a midrange amount of disease in the abdominal cavity (peritoneal cancer index of 11-15) might experience some benefit with HIPEC, but the numbers were too small to be conclusive.
More research also is needed to determine if chemotherapy agents other than the oxaliplatin used with HIPEC in this study might be more effective, he said.
Prodige 7 was funded by UNICANCER. Dr. Quenet has received honoraria from Sanofi/Aventis, Ethicon, and Gamida Cell, as well as travel/accommodations/expenses from Sanofi, Novartis, and Ethicon.
SOURCE: Quenet F et al. ASCO 2018, Abstract LBA3503.
REPORTING FROM ASCO 2018
Key clinical point: HIPEC with oxaliplatin after surgery offers no survival benefit in patients with advanced colorectal cancer.
Major finding: Median overall survival was comparable at 41.7 and 41.2 months, respectively, in the HIPEC and no-HIPEC groups.
Study details: The randomized phase 3 Prodige 7 trial of 265 patients.
Disclosures: Prodige 7 was funded by UNICANCER. Dr. Quenet has received honoraria from Sanofi/Aventis, Ethicon, and Gamida Cell, as well as travel/accommodations/expenses from Sanofi, Novartis, and Ethicon.
Source: Quenet F et al. ASCO 2018, LBA3503.