Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 24, No 18S (June 20 Supplement), 2006: 4026
© 2006 American Society of Clinical Oncology

This Article Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Download to citation manager Rights & Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Ychou, M. Articles by Rougier, P. Search for Related Content PubMed Articles by Ychou, M. Articles by Rougier, P.

Abstract

Phase III preliminary results of preoperative fluorouracil (F) and cisplatin (P) versus surgery alone in adenocarcinoma of stomach and lower esophagus (ASLE): FNLCC 94012-FFCD 9703 trial

CRLC Val d’Aurelle, Montpellier, France; Institut Gustave Roussy, Villejuif, France; CLCC Alexis Vautrin, Nancy, France; CHU Robert Debré, Reims, France; CHU Côte de Nacre, Caen, France; Hôpital du Bocage, Dijon, France; Hôpital Ambroise Paré, Boulogne, France

4026

Background: The combination of 5FU in continuous infusion and cisplatin (FP) is one of the more active regimen in advanced ASLE. The trial was designed to evaluate the impact on survival of 2–3 cycles of preoperative FP in resectable ASLE. Methods: Patients (pts) with resectable adenocarcima of the stomach (S) without cardia involvement, cardia (C) or lower esophagus (LE), age 75 yrs, WHO performance status (PS) < 2 were eligible. Pts were centrally randomized between surgery alone (arm 1) and preoperative FP (arm 2). Chemotherapy (CT) included 2–3, cycles of P (100 mg/m²) and F (800 mg/m² d1-d5 continuous infusion) every 28 days. Post-operative FP was recommended in arm 2 in case of response to FP preoperative or stable disease with pN+. The main endpoint was overall survival. Sample size was 250 (20 % vs 35 % 5-year rates, two-sided logrank test, = 5 %, ß = 20 %). Results: Between 1995 and 2003, 224 pts (arm 1 = 111 pts, arm 2 = 113 pts) were randomized from 28 centers with early stopping because of low accrual. Initial pts characteristics were equally balanced for age (61 yrs), gender (83 % male), PS (75 % WHO 0), tumor site (S = 25 %,C = 64 %, LE = 11 %). In arm 2, FP was given before surgery in 109 pts (98 pts > 2 cycles) and after surgery in 54 pts. Preoperative FP toxicity : 41 pts with at least one grade 3–4 toxicity (polynuclear, 22 pts, vomiting 10 pts), 9 treatment interruption, 1 toxic death. The number of patients with no surgery / no tumor resection / macroscopic incomplete resection (R2)/ microscopic incomplete resection (R1) by arm were 1/10/12/6 in arm 1 and 4/7/2/4 in arm 2. The number of postoperative deaths were 5 in each arm. Complete resection (R0) rate were 73 % in arm 1 versus 84 % in arm 2 (p=0.04). Among eligible RO, R1 patients (85 & 98 pts in arm 1 & 2): the numbers of pts with T0–2/N0/M+ were 27/17/6 and 41/32/1 en arm 1 & 2, the corresponding p-value were 0.16, 0.05 and 0.05 respectively; 3 pts with complete response in arm 2. For DFS, 160 events are observed so far with a median follow-up of 5 years. Conclusions: Preoperative chemotherapy was well tolerated and led to an increase in R0 resection rate, and a decrease in N+/M+ tumors. Disease-free survival will be presented at the meeting.

No significant financial relationships to disclose.

Abstract presentation from the 2006 ASCO Annual Meeting