SAN FRANCISCO (FRONTLINE MEDICAL NEWS) – Post-surgery adjuvant treatment with gemcitabine and oxaliplatin (GEMOX) was feasible, but failed to significantly improve relapse-free survival when compared with surveillance among patients with localized biliary tract cancer in the randomized phase III PRODIGE 12-ACCORD 18 (UNICANCER GI) trial.

Relapse-free survival at a median of 44.3 months in 196 patients who were randomized within 3 months of R0 or R1 resection of a localized biliary tract cancer to receive either GEMOX for 12 cycles or surveillance was 30.4 months vs. 22.0 months in the groups, respectively. At 4 years, relapse-free survival was 39.3% and 33.2%, respectively, Julien Edeline, MD, of Oncology Medical Eugene Marquis Comprehensive Cancer Center, Rennes, France, reported at the symposium, sponsored by ASCO, ASTRO, the American Gastroenterological Association, and Society of Surgical Oncology.

No difference was seen between the groups with respect to the co-primary endpoint of 12- and 24-month global health-related quality of life scores (70.8 vs. 83.3, and 75.0 vs. 83.3, respectively), he said.

Study subjects had localized intra-hepatic, perihilar, or extra-hepatic cholangiocarcinoma, or gallbladder cancer and were enrolled from 33 centers between July 2009 and February 2014. They had ECOG performance status of 0-2, and adequate liver function. The treatment and surveillance arms were well balanced, with similar primary disease sites, Dr. Edeline said.

Those in the GEMOX arm received 12 cycles (6 months) of gemcitabine 1,000 mg/m2 on day 1 and oxaliplatin 85 mg/m2 on day 2. Those in the surveillance arm underwent ACE, CA19.9 testing, and CT scans every 3 months for 2 years then every 6 months for 3 years.

In the treatment and surveillance arms, respectively, R0 resection rates were 86.2% and 87.9%, and lymph node invasion was present in 37.2% and 36.4%.

The maximal grade of adverse events was 3 in 57.5% vs. 22.2% of patients in the groups, respectively, and grade 4 in 17.0% vs. 9.1%. One patient in each arm died during treatment.

The main grade 3 or greater adverse events were peripheral neuropathy in 50.0% vs. 1.1% and neutropenia in 22.3% vs. 0% for GEMOX vs. surveillance group patients.

“As you know, there is a high risk of relapse following surgery for localized biliary tract cancer. There is currently no proven adjuvant or neoadjuvant treatment,” Dr. Edeline said. “In the palliative setting, we know that the combination of gemcitabine and cisplatin improves overall survival. GEMOX is considered an active regimen based on data from phase II trials. At the time of the design of our study, GEMOX was considered the standard first line treatment for biliary tract cancer.”

Based on this background, the aim of the current phase III trial was to assess whether GEMOX would increase relapse-free survival while maintaining health-related quality of life in patients with localized disease.

“We showed that adjuvant GEMOX was feasible. Toxicities were as expected and manageable, and we didn’t see detrimental effects on quality of life. However, adjuvant GEMOX was not associated in the PRODIGE 12 trial with an improvement in relapse-free survival,” he said, noting that this was also true in subgroup analyses, which showed no benefit of GEMOX with respect to relapse-free survival in any predefined subgroups.

“Clearly, further research through international collaboration is required to improve outcomes in these patients,” he concluded.

Dr. Edeline reported having no disclosures.


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