A phase II trial of neoadjuvant cisplatin-fluorouracil followed by postoperative intraperitoneal floxuridine-leucovorin in patients with locally advanced gastric cancer

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 1–5 and 29–34, 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 1–3, 15–17and 29–31. Intraperitoneal chemotherapy was begun 5–10days 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