Journal
BRITISH JOURNAL OF CANCER
Volume 92, Issue 11, Pages 1976-1983Publisher
NATURE PUBLISHING GROUP
DOI: 10.1038/sj.bjc.6602572
Keywords
-
Categories
Ask authors/readers for more resources
The purpose of the study was to establish the optimal dose of capecitabine ( X) to be used within a multicentre, randomised study evaluating the potential roles of oxaliplatin (O) and X in chemonaive patients (pts) with advanced oesophagogastric cancer. Two by two design was used, and pts were randomised to one of four regimens and stratified for extent of disease, performance status ( PS) and centre. The treatment regimens are epirubicin, cisplatin, 5-fluorouracil (ECF), EOF, ECX or EOX. Doses: E 50 mg m(-2), C 60 mg m(-2) and O 130 mg m(-2) i. v. 3 weekly; F 200 mg m(-2) day(-1) i. v. and X 500 mg m(-2) b. i. d.(-1) ( escalated to 625 mg m(-2) b. i. d.(-1) after results of first interim analysis) p. o., continuously. First interim analysis was performed when 80 pts had been randomised. Dose-limiting fluoropyrimidine toxicities were stomatitis, palmar plantar erythema (PPE) and diarrhoea; 5.1% of X-treated pts experienced grade 3/4 toxicity. Protocol planned dose escalation of X to 625 mg m(-2) b. i. d.(-1) was instituted and a second interim analysis has been performed; results are presented in this paper. A total of 204 pts were randomised at the time of the protocol planned 2nd interim analysis. Grade 3/4 fluoropyrimidine-related toxicity was seen in 13.7% pts receiving F, 8.4% pts receiving X 500 mgm(-2) b. i. d.(-1) and 14.7% pts receiving X 625 mg m(-2) b. i. d.(-1). Combined complete and partial response rates were ECF 31% (95% CI 18.7 - 46.3), EOF 39% ( 95% CI 25.9 - 53.1), ECX 35% ( 95% CI 21.4 - 50.3), EOX 48% ( 95% CI 33.3 - 62.8). Grade 3/4 fluoropyrimidine toxicity affected 14.7% of pts treated with X 625 mgm(-2) b. i. d.(-1), which is similar to that observed with F, confirming this to be the optimal dose. The replacement of C by O and F by X does not appear to impair efficacy. The trial continues to total accrual of 1000 pts.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available