Multicenter phase 2 trial of nab-paclitaxel plus gemcitabine and mFOLFOX6 for metastatic pancreatic cancer

Sequential nab-paclitaxel plus gemcitabine followed by modified FOLFOX6 (nab-P/Gem-mFOLFOX) showed activity and tolerability in the phase 1 SEQUENCE trial of patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). A multicenter randomized phase 2 trial in Spain compared this treatment versus standard nab-paclitaxel plus gemcitabine (nab-P/Gem) for previously untreated mPDAC. The 12-month overall survival rate was 55.3% with nab-P/Gem-mFOLFOX versus 35.4% with nab-P/Gem (p=0.002). The 24-month OS rate was 22.4% versus 7.6%. The median OS was 13.2 months versus 9.7 months (HR 0.68; 95% CI 0.48-0.95). The safety profile showed a higher incidence of grade 3 or higher adverse events with nab-P/Gem-mFOLFOX compared with nab-P/Gem, including two treatment-related deaths with nab-P/Gem-mFOLFOX versus none with nab-P/Gem. The authors conclude that addition of mFOLFOX to nab-P/Gem resulted in improvement of 12-month survival rate at the cost of greater toxicity.