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.

Reference

    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.