FOLFIRINOX until progression, FOLFIRINOX with maintenance treatment, or sequential treatment with gemcitabine and FOLFIRI.3 for first-line treatment of metastatic pancreatic cancer: A randomized phase II trial (PRODIGE 35-PANOPTIMOX).

• DOI: 10.1200/jco.2018.36.15_suppl.4000
• Publication Date: 2018-09-05T10:28:27Z
• Authors: Laetitia Dahan; Jean Marc Phelip; Karine Le Malicot; Nicolas Williet; Jérôme Desrame; Julien Volet; Caroline Petorin; David Malka; Christine Rebischung; Thomas Aparicio; Cedric Lecaille; Yves Rinaldi; Anthony Turpin; Anne Laure Bignon; Jean-Baptiste Bachet; Jean Francois Seitz; Come Lepage; Eric Francois
• Keywords: FOLFIRINOX; FOLFIRI; Progression-free survival; Clinical endpoint; FOLFOX

4000 Background: Metastatic pancreatic cancer (mPC) still harbors a dismal prognosis (5-year overall survival [OS] <5%). Our previous trial (PRODIGE4-ACCORD11) has demonstrated the superiority of 6-month [m] chemotherapy with FOLFIRINOX over gemcitabine in terms progression-free [PFS] (6.4 vs. 3.3 m; HR: 0.47; 95%CI: 0.37-0.59; p<0.001) and OS (11.1 6.8 0.57; 0.45-0.73; p<0.001), at expense higher toxicity, notably cumulative, often limiting, peripheral neuropathy oxaliplatin. In this randomized Phase II trial, we aimed to assess an oxaliplatin 'stop-and-go' strategy alternative sequential mPC. Methods: Patients (pts) were receive either 6m (arm A), 4m followed by LV5FU2 maintenance treatment for controlled pts, reintroduction disease progression B), or alternating FOLFIRI.3 every 2m C). The primary endpoint was evaluate 6m-PFS rate (H0: 30%, H1: 45%, Fleming design) order select best therapeutic future III clinical trial. Results: Between Jan 2015 Nov 2016, 273 pts (mean age: 63 years; range: 40-76) enrolled (A: 91; B: 92; C: 90). median durations 5.1, 6.2, 4.4 m A, B, C respectively. Grade 3/4 neurotoxicity occurred 10% arm A 19% B. Median ratio 83% 92% rates 47% 44% 34% C. objective response 35% 41% 17% PFS respectively 6.3, 5.7 4.5 B 10.1 11.2 7.3 duration first therapy (range: 0.03-22.6). Conclusions: Maintenance appears be feasible effective patients mPC after induction FOLFIRINOX. Severe arm, likely because cumulative dose.1Conroy NEJM 2011. Clinical information: NCT02352337.