Annals of Oncology Advance Access originally published online on June 20, 2006
Annals of Oncology 2006 17(9):1404-1411; doi:10.1093/annonc/mdl133
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© 2006 European Society for Medical Oncology
gastrointestinal tumors |
A phase II trial of neoadjuvant cisplatin–fluorouracil followed by postoperative intraperitoneal floxuridine–leucovorin in patients with locally advanced gastric cancer
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
*Correspondence to: Dr D. P. Kelsen, The Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York 10021, USA. Tel: +1-212-639-8470; Fax: +1-646-422-2107; E-mail: kelsend{at}mskcc.org
Background: The aim of the study was to evaluate the efficacy and toxicity of neoadjuvant chemotherapy with intravenous (i.v.) cisplatin and fluorouracil (5-FU), surgery and postoperative intraperitoneal (i.p.) floxuridine (FUdR) and leucovorin (LV) in patients with locally advanced gastric cancer.
Patients and methods: Preoperative staging was confirmed by laparoscopy (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 a radical gastrectomy and a D2 lymphadenectomy. Patients having R0 resections were to receive three cycles of i.p. FUdR (1000 mg/m2) and LV (240 mg/m2), given on days 1–3, 15–17 and 29–31. Intraperitoneal chemotherapy was begun 5–10 days from surgery.
Results: Thirty-eight patients were treated. Both preoperative and postoperative chemotherapy were well tolerated. T stage downstaging (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 operative mortality 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 associated with better survival (P = 0.053). Peritoneal and hepatic failures were found in 22% and 9% of patients, respectively. Quality of life seemed to be preserved.
Conclusions: Neoadjuvant cisplatin/5-FU followed by postoperative i.p. FUdR/LV can be safely delivered to patients undergoing radical gastrectomy and D2 lymphadenectomy. The R0 resection and the survival rates are encouraging. An association between pathologic response and patient outcome was suggested.
Key words: locally advanced gastric cancer, neoadjuvant chemotherapy, intraperitoneal treatment
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