© 2004 European Society for Medical Oncology
Original Article |
Irinotecan in combination with 5-fluorouracil and folinic acid or with cisplatin in patients with advanced gastric or esophageal-gastric junction adenocarcinoma: results of a randomized phase II study
1 Catholic University of Sacred Heart, Rome, Italy; 2 Szt Margarit Hospital, Budapest, Hungary; 3 III Med. Klinik, Munich, Germany; 4 All Union CRC, Moscow, Russia; 5 Estonian Oncology Center, Tallin, Estonia; 6 Hielkoskopie Centrum, Poznan, Poland; 7 Moscow Oncological Center, Moscow, Russia; 8 Aventis Pharma, Antony; 9 Institut Claudius Regaud, Toulouse, France
* Correspondence to: Dr C. Barone, Medical Oncology, Catholic University of the Sacred Heart, Largo Francesco Vito, 1.00168 Rome, Italy. Tel: +39-06-3015-4844; Fax: +39-06-3017-334; Email: carlobarone{at}rm.unicatt.it
Background: To identify the most effective of two combinations, irinotecan/5-fluorouracil (5-FU)/folinic acid (FA) and irinotecan/cisplatin, in the treatment of advanced gastric cancer, for investigation in a phase III trial.
Patients and methods: Patients were randomized to receive irinotecan [80 mg/m2 intravenously (i.v.)], FA (500 mg/m2 i.v.) and a 22-h infusion of 5-FU (2000 mg/m2 i.v.), weekly for 6 weeks with a 1-week rest, or irinotecan (200 mg/m2 i.v.) and cisplatin (60 mg/m2 i.v.), on day 1 for 3 weeks.
Results: A total of 115 patients were eligible for analysis in the per-protocol population. The overall response rate in the irinotecan/5-FU/FA arm (n=59) was 42.4%, with a complete response rate of 5.1%. Corresponding figures for the irinotecan/cisplatin arm (n=56) were 32.1% and 1.8%, respectively. The median time to progression was 6.5 months (irinotecan/5-FU/FA) and 4.2 months (irinotecan/cisplatin) (P < 0.0001), with median survival times of 10.7 and 6.9 months, respectively (P=0.0018). The major toxicity was grade 3/4 neutropenia, which was more pronounced with irinotecan/cisplatin than with irinotecan/5-FU/FA (65.7% versus 27%). Diarrhea was the main grade 3/4 non-hematological toxicity with both irinotecan/5-FU/FA (27.0%) and irinotecan/cisplatin (18.1%).
Conclusions: Both combinations were active, with acceptable safety profiles. Irinotecan/5-FU/FA was selected as the most effective combination for investigation in a phase III trial in advanced gastric cancer.
Key words: advanced gastric cancer, cisplatin, 5-FU/FA, irinotecan, phase II
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