P-284 NESC Multicenter phase II trial in the Preoperative Treatment of gastric adenocarcinoma consisting of chemotherapy using docetaxel-cisplatin-5FU + lenograstim followed by chemoradiation (RTCT) based 5FU and oxaliplatin and surgery

Abstract

Introduction: Perioperative chemotherapy is a standard treatment (Magic trial, fnclcc trial). The 5‐year survival being 36% for patients treated with chemotherapy versus 23% for surgery alone. Progression‐free survival was also significantly prolonged. The combination of Docetaxel‐ Cisplatin‐5FU provides greater clinical benefit and induces to consider the triple combination as a reference treatment in metastatic gastric cancer in patients under 65 years with high response rate. Preoperative RTCT is expected to increase the rate of curative resections and complete histological response. Two studies evaluating the feasibility of preoperative RTCT in operable gastric adenocarcinoma with continuous 5FU (+ or ‐ paclitaxel) and 45 Gy are available and the combination 5FU oxaliplatin has been assessed in the esophagus and rectum tumors.We investigate the efficacy of an optimal 2 cycles of chemotherapy with Docetaxel ‐ Cisplatin ‐ 5FU + lenograstim then preoperative RTCT with oxaliplatin ‐ 5FU in gastric adenocarcinoma. Methods: Between 2009 and 2014, 33 patients with gastric adenocarcinoma were included. Inclusion criteria adenocarcinoma of the stomach, cardia, Siewert II, III, according to staging classification TNM Scannographic and ultrasonography: T2banyN, T3anyN, T4anyN M0) optional laparoscopy, loss of weight ≤ 15% and age ≤65 years. Treatment consisted of DCF docetaxel 75 mg/m2 I.V. day 1, cisplatin 75 mg/m2 I.V. day 1, 5‐FU 750 mg/m2 continuous infusion for 120 h, every 3 weeks for 2 cycles and lenograstim 5 days followed by RTCT delivered in 25 daily fractions of 1.8 Gy in 5 weeks with 5Fu 250mg/m2 continuous infusion per day on days 1 to 35 and oxaliplatin 85mg/m2 day 1‐14‐28. Surgery was performed 4‐6 weeks after RTCT. The primary endpoints were pathological response rate and secondary endpoint PFS, overall survival, quality of life, morbidity and post operative mortality, toxicity. Results: 34 patients were included, 29 were operated, 1 patient withdrew consent, 1 patient progressive disease after 2 cycles of DCF 32 patients received RTCT and 2 patients progressive disease after RTCT, 1 patient refused surgery (complete endoscopic response). 29 patients were operated and 3 non resected ( peritoneal metastasis). 26 patients underwent surgery after RTCT (total gastrectomy n = 12, total gastrectomy and diaphragm surgery n = 1 lewis santy n = 11, subtotal gastrectomy n = 1, Enlarged gastrectomy transverse colectomy and partial pancreatic n = 1 D1 (n = 5) and D2 (n = 20 and D2 with splenectomy n = 1) R0 resection rate was n = 26/26. Postoperative morbidity (n = 12) and mortality (n = 2), histology mean nodes examined and involved respectively 16 and 2,5. pT0pN0 23% pT1pN0 19% pTpN2N3 20% others 38%. <10% residual tumor 27% histologic complete response 23%. Conclusion: Promising results from trials involving preoperative chemoradiation followed by surgery in gastric cancer (pathologic complete response 23%) need to be further evaluated in a Phase III setting and compared with perioperative chemotherapy but morbidity and mortality is high.