PRODIGE-12

Regimen

Experimental
Gemcitabine 1000 mg/m2 d1, d8 + oxaliplatin 85 mg/m2 d1 q3w × 12 cycles (GEMOX regimen, 36 weeks)
Control
Surveillance (observation)

Population

Resected biliary tract cancer (intrahepatic + extrahepatic cholangiocarcinoma + GBC), R0 or R1 resection, mixed BTC subtypes, France multicenter (UNICANCER/FFCD)

Key finding

PRODIGE-12 failed to demonstrate a significant improvement in RFS or OS with adjuvant GEMOX versus observation. This was likely underpowered (target 190 events, actual 170) and suffered from slower accrual. The trial is important as a counterpoint to BILCAP: it shows that not all adjuvant doublets are effective, and that GEMOX (the regimen used in many advanced BTC patients at the time) does not translate to an adjuvant benefit. The individual patient data meta-analysis combining BCAT and PRODIGE-12 (PMID 35182925) similarly showed no RFS/OS benefit for gemcitabine-based adjuvant therapy across both trials.

Source: PMID 30707660

Timeline

    Guideline citations

    • NCCN BTC (p.67)