This is the report of an individual patient data meta-analysis of all patients included in the phase 3 BCAT and PRODIGE-12 trials of adjuvant gemcitabine-based chemotherapy for biliary tract cancer (BTC). 212 vs 207 patients were randomized in the gemcitabine-based chemotherapy versus observation arms. There was no difference in RFS (log-rank p=0.45; HR=0.91; 95%CI 0.71-1.16; p=0.46). RFS rates at 5 years were 40.8% (95%CI 33.9%-47.5%) for gemcitabine-based chemotherapy versus 36.6% (95%CI 29.8%-43.4%) for observation. There was no difference in OS (log-rank p=0.83; HR=1.03; 95%CI 0.78-1.35; p=0.85). OS rates at 5 years were 50.5% (95%CI 43.1%-57.4%) for gemcitabine-based chemotherapy versus 49.3% (95%CI 41.6%-56.5%) for observation. This analysis confirms that gemcitabine-based chemotherapy should not be used as an adjuvant treatment for BTC.

(Edeline, J., et al. – Eur J Cancer, March 2022)

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