Gemcitabine plus oxaliplatin (GEMOX) post-surgery adjuvant therapy does not improve relapse-free survival (RFS) among patients with biliary tract cancer, according to a presentation at the 2017 Gastrointestinal Symposium.1
There is no standard recommendation for post-operative adjuvant therapy to prevent disease relapse in this patient population. For this randomized phase 3 study (ClinicalTrials.gov Identifier: NCT01313377), researchers assessed whether GEMOX would improve RFS vs surveillance while maintaining health-related quality of life.
One hundred and ninety-six patients were enrolled; median follow-up was 44.3 months. Relapse events occurred in 54 patients with GEMOX and in 64 patients under surveillance. Median RFS was 30.4 months with GEMOX vs 22 months with surveillance; 4-year RFS rates were 39.3% and 33.2%, respectively. The differences were not significant.
Grade 4 adverse events occurred among 17% of patients receiving GEMOX and 9.1% of patients under surveillance. One patient died from each group.
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Health-related quality of life scores did not differ at 1-year and 2-year time points.
The authors concluded that while toxicities were expected and health-related quality of life did not deteriorate with GEMOX, there were no significant differences in RFS.
- Edeline J, Bonnetain F, Phelip JM, et al. Gemox versus surveillance following surgery of localized biliary tract cancer: Results of the PRODIGE 12-ACCORD 18 (UNICANCER GI) phase III trial. J Clin Oncol. 2017;35(suppl):4S. Abstract 225.