A phase II trial of neoadjuvant cisplatin-fluorouracil followed by postoperative intraperitoneal floxuridine-leucovorin in patients with locally advanced gastric cancer |
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Authors: | Brenner, B Shah, MA Karpeh, MS Gonen, M Brennan, MF Coit, DG Klimstra, DS Tang, LH Kelsen, DP |
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Affiliation: | Gastrointestinal Oncology Service, Department of Medicine, the Gastric and Mixed Tumor Service, Department of Surgery, the Department of Epidemiology and Biostatistics and the Department of Pathology, Memorial Sloan-Kettering Cancer Center, and the Weill School of Medicine, Cornell University of New York, New York 10021, USA |
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Abstract: | Background: The aim of the study was to evaluate the efficacyand toxicity of neoadjuvant chemotherapy with intravenous (i.v.)cisplatin and fluorouracil (5-FU), surgery and postoperativeintraperitoneal (i.p.) floxuridine (FUdR) and leucovorin (LV)in patients with locally advanced gastric cancer. Patients and methods: Preoperative staging was confirmed bylaparoscopy (LAP). Two cycles of i.v. cisplatin (20 mg/m2/day,rapid infusion) and 5-FU (1000 mg/m2, continuous 24-h infusion),given on days 15 and 2934, were followed by aradical gastrectomy and a D2 lymphadenectomy. Patients havingR0 resections were to receive three cycles of i.p. FUdR (1000mg/m2) and LV (240 mg/m2), given on days 13, 1517and 2931. Intraperitoneal chemotherapy was begun 510days from surgery. Results: Thirty-eight patients were treated. Both preoperativeand postoperative chemotherapy were well tolerated. T stagedownstaging (pretreatment LAP versus surgical pathological stage)was seen in 23% of patients. The R0 resection rate was 84%.Neither an increase in postoperative morbidity nor operativemortality was noted. With a median follow-up of 43.0 months,15 patients (39.5%) are still alive (median survival 30.3 months).Good pathologic response, seen in five patients (15%), was associatedwith better survival (P = 0.053). Peritoneal and hepatic failureswere found in 22% and 9% of patients, respectively. Qualityof life seemed to be preserved. Conclusions: Neoadjuvant cisplatin/5-FU followed by postoperativei.p. FUdR/LV can be safely delivered to patients undergoingradical gastrectomy and D2 lymphadenectomy. The R0 resectionand the survival rates are encouraging. An association betweenpathologic response and patient outcome was suggested. Key words: locally advanced gastric cancer, neoadjuvant chemotherapy, intraperitoneal treatment |
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