Abstracts
1999 Digestive Disease Week

# 2192 NEOADJUVANT RADIO-CHEMOTHERAPY OF LOCALLY ADVANCED GASTRIC CANCER: A PHASE I-II PILOT STUDY
Olivier Huber, A Roth, A Allal, R de Peyer, I Doussis, A Hadengue, Ph Morel, Univ Hosp of Geneva, Geneva Switzerland

Results of surgery alone for locally advanced gastric cancer are very poor. In September 1994, we initiated a neoadjuvant protocol for locally advanced gastric and cardia cancers, including 2 cycles of chemotherapy [Cisplatin 100 mg/m2 D1, 5FU 800 mg/m2 D1-4, Leucovorin 120 mg/D1-4, weeks 1 and 4] and radiotherapy (RT) with a dose escalation regimen [31 (n=6), 39 (n=9) and 45 Gy (n=2)]. RT was given by 2 daily fractions of 1.2 Gy. By November 1998, 17 patients [4F and 13M, median age 59] have been included after extensive work-up (including endosonography) and informed consent. Two patients were staged cT2, 10 cT3 and 5 cT4; 6 were staged cN0, 8 cN1 and 3 cN2. Overall, 5 patients were clinically stage II, 10 stage IIIA and 2 stage IIIB (UICC 1992). Radiotherapy was stopped in 2 patients for toxicity; the second cycle of chemotherapy was delayed in 2 patients for toxicity, and refused by a third. Complications WHO grade 3-4 were observed in 86% of the patients (mucitis in 53%, granulopenia in 86%, thrombopenia in 20% and fever in 20%). An evident clinical down-staging was shown in 7 patients. All patients could be operated on the scheduled date ± 10d.: 16 underwent a D2 total and one a D2 subtotal gastrectomy, by laparotomy in 14 and thoraco-abdominal access in the 3 others. Operative mortality was nil. One surgical complication occurred (anastomotic fistula). Unsuspected peritoneal carcinomatosis was discovered in 2 patients (R2 resection); surgery was R0 in the 15 others. A clear histological response was demonstrated in 5 patients. After a median follow-up of 38 months [15-51], 12 patients are free of disease, 2 patients are alive with disease and 3 died of their tumor; all relapses were observed in the first 11 postoperative months. Therefore, a combined radio-chemotherapeutic neoadjuvant approach seems applicable to this disease and compatible with an acceptable operative risk; these preliminary results seem very promising; a randomized multicentric study of such an approach should be seriously contemplated.

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