Treatment of patients with advanced gastric carcinoma with a 5-fluorouracil-based or a cisplatin-based regimen : Two parallel randomized phase II studies

✍ Scribed by Carlo Barone; Domenico C. Corsi; Carmelo Pozzo; Alessandra Cassano; Tecla Fontana; Maria R. Noviello; Matteo Landriscina; Giuseppe Colloca; Antonio Astone

• Publisher: John Wiley and Sons
• Year: 1998
• Tongue: English
• Weight: 109 KB
• Volume: 82
• Category: Article
• ISSN: 0008-543X
• DOI: 10.1002/(sici)1097-0142(19980415)82:8<1460::aid-cncr5>3.0.co;2-d

✦ Synopsis

370 mg/m 2 , on Days 1-5 and 36 others in Study B received epirubicin, 30 mg/m 2 , cina Interna e Geriatria, Universita `Cattolica del on Days 1 and 5; etoposide, 100 mg/m 2 , on Days 1, 3, and 5; cisplatin, 30 mg/m 2 , S. Cuore, Rome, Italy.

on Days 2 and 4; and lonidamine, 150 mg/day.

RESULTS.

There were 6 partial responses (18.2%) (95% confidence interval [CI] { 13.2) in Study A and 7 partial responses (21.9%) (95% CI { 14.3) in Study B. Partial responses were more frequent in patients with resected tumors or with an Eastern Cooperative Oncology Group PS of 0-1. The median duration of response was 8.8 and 8.3 months, respectively, in Study A and Study B. The median survival reached 8 months in Study A and 9 months in Study B. In the whole population of patients survival was significantly higher in patients with a PS of 0-1 (P õ 0.05). Patients with a PS of 0-1 and a resected tumor had the significantly longest survival both in EEP-L treated patients and in all evaluable patients in the two studies. The most frequent World Health Organization Grade 3-4 toxic effects were gastrointestinal in Study A and hematologic in Study B. No treatment-related death was observed.

CONCLUSIONS.

The efficacy of 5-FU, modulated with 6S-LV, is moderate in patients with advanced gastric carcinoma, similar to cisplatin-containing regimens. PS and other prognostic factors could influence the response rate, which does not appear to be a reliable parameter for evaluating the outcome of chemotherapy trials.