Adjuvant gemcitabine alone versus gemcitabine-based chemoradiation after curative resection for pancreatic cancer: Updated results of a randomized EORTC/FFCD/GERCOR phase II study (40013–22012/9203)

Abstract

4527 Background: The role of adjuvant chemoradiotherapy (CRT) in resectable pancreatic cancer is debated. This randomized phase II intergroup study demonstrated the feasibility and tolerability of a gemcitabine-based CRT regimen after R0 resection of pancreatic head cancer (Proc ASCO 2008, 4514). Long term and survival data are now reported. Methods: Patients were randomized within 8 weeks after surgery to receive either 4 cycles of gemcitabine 1000 mg/m2 given over 30 minutes every 3 weeks (control arm) or gemcitabine 1000 mg/m2 for 2 cycles followed by weekly gemcitabine 300 mg/m2 with concurrent radiation of 50.4 Gy given in 28 fractions of 1.8 Gy (experimental arm). The co-primary endpoints were completion of treatment and tolerability. Secondary endpoints were late toxicity, DFS and OS. Results: Between 9/04 and 1/07, 90 patients were randomized by 29 centers (45:45). Treatment arms were balanced in terms of patient/tumour characteristics. Follow-up was equal for both arms with an overall median follow-up of 27.1 months. In the control arm, 5 patients were ineligible, including 2 not treated. In the experimental arm, CRT was delivered to 36 of 45 patients (80%). Treatment was completed per protocol by 86.7% and 73.3% (80% CI 63.1–81.9%) of randomized patients in the control and experimental arms, respectively. Grade 4 toxicity was 0% and 4.4%, respectively. In the CRT arm, 2 patients experienced grade 3 late toxicity (anorexia 1 and epigastric pain 1). In the CRT experimental arm, 33 DFS events were noted and 23 deaths versus 34 and 24, respectively, in the control arm. Median DFS was 12 months in the experimental arm vs. 11 months in the control arm (p=0.6). Median overall survival was 24 months both in the experimental arm and the control arm. Distant progression was similar in both arms while the rate of first local recurrence was lower in the chemoradiation arm (11 vs 24 %, p=0.16). Conclusions: Post-op modern gemcitabine-based CRT is feasible and well- tolerated after long-term follow-up, and a larger trial should assess its true benefit to that of standard gemcitabine alone. [Table: see text]