Gemcitabine plus nab-paclitaxel until progression or alternating with FOLFIRI.3, as first-line treatment for patients with metastatic pancreatic adenocarcinoma: The Federation Francophone de Cancérologie Digestive-PRODIGE 37 randomised phase II study (FIRGEMAX).

摘要: Abstract Background Chemotherapy is effective in metastatic pancreatic adenocarcinoma (mPA), but new approaches are still needed to improve patients' survival and quality of life. We have previously published good efficacy tolerability results on a sequential treatment strategy gemcitabine followed by an intensified FOLFIRI (5FU+irinotecan) regimen. In the present study, we evaluated same sequence replaced gemcitabine + nab-paclitaxel standard first-line combination. Patients methods randomised chemotherapy-naive patients with proven mPA, bilirubin levels ≤1.5 upper limit normal values performance status 0–2 alternately receive for 2 months then FOLFIRI.3 arm A, or alone until progression B. The primary objective was increase 6-month progression-free (PFS) rate from 40% (H0) 60% (H1); using binomial exact method, 124 were required. Analyses carried out preplanned modified intention-to-treat (mITT) per-protocol (PP) populations. Results Between November 2015 2016, 127 enrolled. Main grade III–IV toxicities (% A/B) were: diarrhoea (12.5/1.7), neutropenia (46.9/31, including febrile neutropenia: 1.6/0), skin toxicity (6.3/13.8), peripheral neuropathy (6.3/8.6). No toxic deaths occurred. response 40.3% (95% confidence interval [CI]: 28.1–53.6) A 26.7% CI: 16.1–39.7) end-point (6-month PFS rate) 45.2% [one-sided 95% 34.3–56.4] 23.3% B 14.3–32.3] mITT population. PP population, median OS 7.6 6 14.5 12.2 B, respectively. Conclusions FIRGEMAX alternating every months, appears feasible effective, manageable toxicities, able reach >2mo treatment. Trial registration information EudraCT: 2014-004449-28: NCT: 0282701.