LV5FU2-cisplatin followed by gemcitabine or the reverse sequence in metastatic pancreatic cancer: Preliminary results of a randomized phase III trial (FFCD 0301)

• DOI: 10.1200/jco.2008.26.15_suppl.4513
• Publication Date: 2017-02-24T07:33:44Z
• Authors: E. Mitry; L. Dahan; M. Ychou; J. Arthaud; M. Gasmi; J. Raoul; C. Mariette; J. M. Phelip; L. Bedenne; J. Seitz
• Keywords: Clinical endpoint; Regimen

4513 Background: Pts with metastatic pancreatic adenocarcinoma (MPA) have a poor prognosis no major survival improvement since the introduction of gemcitabine (Burris 1997). The LV5FU2-P regimen was reported as safe and active 9 months median overall (OS) in phase II trial (Taïeb 2002). This randomized multicenter III compared followed by arm A versus B to evaluate best sequence. Methods: measurable MPA, PS 0–2, non prior CT, were randomly assigned receive either (2-hour infusion LV 200 mg/m2 FU bolus 400 46-hour 2,400 every 2 weeks, cisplatin 50 2-hour on D1 or 2, (1,000 for 7 weeks out 8 then 3 4) at progression toxicity (arm A) opposite sequence B). Randomization done using minimization stratification according center, tumoral localization duration. Primary endpoint OS. It required include 202 pts observe 170 deaths detect an expected OS from 6.5 10 (bilateral α = 5% β 20%). Secondary endpoints included free-survival (PFS) after first second line, toxicity, quality life (QLQ-C30) percentage line each arm. Results: From 08/2003 05/2006, 33 centers, 102 100 B. Median age (62 [40 - 84] vs 64 [39 81] years), male/female ratio (1.7 1.7), 0–1 (76.5% 83%), previous surgery (22.5% 27%). After follow-up 33,6 [min 17; max 48], 185 had died. 6.6 [95% CI- 5.2 8.4] 8.2 6.1 9.7] (HR 0.95 CI 0.71 1.27], Log Rank p 0.72). 1- year 2-year rates 29.5% 8% 34.5% 3.5% B, respectively. Conclusions: failed reach its primary both sequences achieved similar efficacy significant differences between two arms Updated results (including response, PFS analyses) will be presented meeting. No financial relationships disclose.