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Unresectable pancreatic cancer: survival and secondary resections after chemoradiotherapy followed by gemcitabine compared to gemcitabine alone (SFRO/FFCD 2000-01 phase III trial).
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International audience. Background: In patients (pts) with locally advanced non metastatic pancreatic adenocarcinoma (LAPC), 5 FU-based chemoradiotherapy (CHRT) followed by IV 5FU was the standard treatment since the GITSG studies. The aim of this phase III trial was to compare an initial CHRT plus systemic gemcitabine (G) to G alone in term of Overall Survival (OS), toxicity and secondary resections. Methods: Pts in PS (WHO) 0–2, with cyto/histologically proven LAPC without distant metastasis at CT-scan, and unresectable due to vascular extension, were randomized between CHRT (60 Gy in 6 weeks, 2 Gy/fraction, with 5 days per week of 5-FU, 300 mg/ m2/24 h as a continuous infusion and cisplatin: 20 mg/m2/d, day 1–5 at week 1 and 5) or chemotherapy alone: G: 1000 mg/m2 weekly 7q8w as induction treatment. Chemotherapy were thereafter administered to all patients (G: 1000 mg/m2 weekly 3q4w) until progression, secondary resection or limiting toxicity. Stratification criteria were: center, PS and initial surgery. It was planed to include 176 pts to detect an expected change in median OS from 6 to 12 months (bilateral a = 1% and b = 10%.) however the study has been closed based on IDMC advise due to few probability of significant difference in OS. Intent to treat survival analysis and Log-rank test have been used. We present the interim results of this study. Results: Between 03/00 and 07/05, 119 pts were randomized, CHRT: 59 and G: 60. Pt characteristics were well balanced (CHRT/G) with mean age (60.1/62.7 year), sex ratio (1/1.4) and PS (0–1: 88%/73%, 2: 9%/23%). During the induction phase, more than 75% of the planned dose was completed in 81.4% of pts for radiotherapy, 52.5% for 5-FU and 50.8% for cisplatin and 76.7% of pts in the G arm. Arm 1: CHRT (59 pts) Arm 2: G (60 pts) P (stratified log-rank) OS at 12 months 24% 51% Median survival (months) 8.4 14.3 P = 0.014 Toxicity gr 3/4: leukopenia non-haematological 17% 10% 37% 17% Secondary resection 2 (3.4%) 3 (5%) Ns; Total: 5/119 (4.2%) One treatment-related death was observed in the CHRT arm (aplasia). Secondary resection of the LAPC has been feasible in 5 cases, with prolonged OS (13.7, 20+, 22.3, 30.8+ and 65 months) after resection. Conclusion: This study demonstrates that a systemic chemotherapy using gemcitabine alone is an acceptable therapeutic option which, as reported after CHRT, allows secondary local resection in selected responding patients. Acknowledgements F Maskouri and the FFCD research team for help in data collection, and the support from the French ‘Ligue Nationale contre le Cancer
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