P-0042 - Efficacy and Safety of Triweekly Docetaxel, Oxaliplatin, Fluorouracil, and Folinic Acid (DOFF) in Patients with Advanced Gastric or Gastroesophageal Adenocarcinoma

Abstract

Introduction: Docetaxel, cisplatin, fluorouracil (DCF) regimen improved response rate, quality of life and survival for patients with advanced gastric cancer, but is limited by significant toxicity. In attempt to reduce the toxicity of DCF, we evaluated the efficacy and tolerability of docetaxel associated with oxaliplatin and fluorouracil in a triweekly schedule. Methods: Patients with histologically confirmed locally advanced, recurrent or metastatic gastric or esophagogastric adenocarcinoma treated in our center were reviewed. Patients received docetaxel 75 mg/m2, oxaliplatin 100mg/m2 on day 1, and fluorouracil 400mg/m2 in 2 hours intravenous infusions from day 1 to day 5 preceded by Folonic acid 200mg/m2, every 3 weeks. Responses were evaluated every three cycles according to RECIST criteria and toxicities were graded according to NCI-CTC- AE v3 scale. Results: Twenty two patients were included in this study. Median age was 59 years [range: 35-79]. The majority (77.3%) of patients had good (0-1) Performance Status (ECOG scale). Primary tumor location was the stomach in 16 patients (72.7%) and the esophagogastric junction in 6 (27.3%). Disease was locally advanced in 7 patients (31.8%) and metastatic in 15 patients (68.2%). The most common sites of metastasis were lymph nodes (66.6%), liver (46.6%) and peritoneum (40%). Treatment was administrated as first line in 17 patients (77.3%) and second line in 5 patients (22.7%). Median number of cycles received was 6 [range: 2-12]. Grade 3 or 4 hematological toxicities consisted in neutropenia (18.2%) and anemia (4.5%). Febrile neutropenia was observed in two patients (9.1%). Main G3-4 non hematological toxicities were diarrhea (13.6%) and peripheral neuropathy (13.6%). Dose reductions of drugs were required in fifteen patients (68.2%) but there were no treatment-related deaths. Eighteen patients (81.8%) had measurable disease; objective response rate was 50% with a complete response in four patients (22.2%) and partial response in 5 (27.8%). Stable disease was observed in one patient (5.5%). After a median follow-up of 15.2 months, 9 patients (40.9%) had died. Median time to progression was 4.2 months. The disease control rate at 6 months was 36.4%. Tumor downstaging allowed curative surgery in 5 of the seven patients (71.1%) with locally advanced disease initially considered as unresectable. Conclusion: Triweekly Docetaxel, Oxaliplatin, Fluorouracil and Folinic acid (DOFF) has an acceptable safety profile for patients with advanced gastric or esophagogastric cancer and could favor tumor resection in the neoadjuvant setting.