Résumé
Abstract only 4087
Background: The DCF regimen is superior to 5-FU-Cisplatin in term of response rate (RR) and overall survival (OS) in advanced gastric cancer, but is also more toxic. Oxaliplatin is better tolerated and can effectively replace cisplatin in AGC patients (pts). We hypothesize that incorporating Docetaxel into a simplified FOLFOX regimen should be a tolerable and efficient option, and could facilitate the use of this drug in 1
st
line in AGC. Methods: TFOX regimen was given biweekly as follow: Docetaxel (50mg/m2), oxaliplatin (85mg/m2), leucoverin (400mg/m2) and 5FU continuous infusion 48h (2400mg/m2). Main inclusion criteria were: pts with histollogically proven metastatic or locally advanced gastric or oesogastric junction adenocarcinoma, previously untreated, PS≤2. Using Fleming design the primary end point was response rate, needing a sample size of 40 pts. Results: Between 02/2008 and 07/2011, 41 pts with AGC were enrolled (oesogastric junction: 17 pts, diffuse type: 22 pts, metastatic: 37 pts); mean age was 53.5 years (31-73), 26 pts were male. PS 0/1/2: 11/24/6 pts, 14 pts had a relapse after a R0 resection. The total number of cycles administered was 310 (mean 7.6 cycles/pts) and 90% of pts received at least 4 cycles. No toxic death occurred. Grade 3-4 toxicities were observed in 20 pts (48%). Grade 3-4 toxicities were neutropenia (29%) febrile neutropenia (7%), neurotoxicity (10%), asthenia (10%). ORR was 63% (n=26) [IC95% 48-78], with 2 complete responses. Disease control rate (CR+PR+SD) was 78% (n=32) [IC95% 65-90]. Median progression free survival and overall survival were 6.5 months [IC95% 5.02-10.85] and 12.1 months [IC95% 7.25-15.28], respectively. Conclusions: TFOX is effective with a manageable toxicity profile in first line treatment for AGC pts. Tolerability of this regimen compares favourably with DCF reported tolerability. TFOX may be an alternative option for intensive 1
st
line treatment and should now be evaluated in randomized trials.