Report of two protocol planned interim analyses in a randomised multicentre phase III study comparing capecitabine with fluorouracil and oxaliplatin with cisplatin in patients with advanced oesophagogastric cancer receiving ECF.

摘要: The purpose of the study was to establish optimal dose capecitabine (X) be used within a multicentre, randomised evaluating potential roles oxaliplatin (O) and X in chemonaive patients (pts) with advanced oesophagogastric cancer. Two by two design used, pts were one four regimens stratified for extent disease, performance status (PS) centre. treatment are epirubicin, cisplatin, 5-fluorouracil (ECF), EOF, ECX or EOX. Doses: E 50 mg m−2, C 60 mg m−2 O 130 mg m−2 i.v. 3 weekly; F 200 mg m−2 day−1 500 mg m−2 b.i.d.−1 (escalated 625 mg m−2 b.i.d.−1 after results first interim analysis) p.o., continuously. First analysis performed when 80 had been randomised. Dose-limiting fluoropyrimidine toxicities stomatitis, palmar plantar erythema (PPE) diarrhoea; 5.1% X-treated experienced grade 3/4 toxicity. Protocol planned escalation instituted second has performed; presented this paper. A total 204 at time protocol 2nd analysis. Grade fluoropyrimidine-related toxicity seen 13.7% receiving F, 8.4% 14.7% 625 mg m−2 b.i.d.−1. Combined complete partial response rates ECF 31% (95% CI 18.7–46.3), EOF 39% 25.9–53.1), 35% 21.4–50.3), EOX 48% 33.3–62.8). affected treated 625 mg m−2 b.i.d.−1, which is similar that observed confirming dose. replacement does not appear impair efficacy. trial continues accrual 1000 pts.