BACKGROUND.
In a randomized Phase I1 study, the authors evaluated the activity and toxicity of the new cisplatin, doxorubicin, and mitomycin C (PAM) comhination, that includes cisplatin (P) instead of 5-fluorouracil as in the 5-fluorouracil, doxorubicin, and mitomycin C (FAM) Combination, in patients with advanced gastric carcinoma. FAM was utilized as a control treatment arm.
METHODS.
Fifty eligible patients were assigned to the FAM (5-fluorouracil600 mg/ m2 intravenous (i.v.) on Days 1, 8, 29, 36; doxoruhicin 30 mg/m2 i.v. on Days 1 and 29; mitomycin C 10 mg/m2 i.v. on Day 1; every 8 weeks) and 52 to the PAM combination (cisplatin 60 mg/mZ i.v. on Days 1 and 29; doxorubicin 30 mglm' i.v. on Days 1 and 29; mitomycin C 10 mglm' i.v. on Day 1; every 8 weeks). All eligible patients were included in the evaluation of response, toxicity and survival.
RESULTS.
The PAM combination complete response (CR) rate was 8%, and the CR plus partial response (PR) rate was 21% (95% confidence interval [CI] from 10% to 32%). The median time to progression, duration of response, and duration of survival were 15, 26, and 29 weeks, respectively. The FAM combination CR rate was 2% and the CR plus PR rate was 26% (95% CI from 14% to 38%). The median time to progression, duration of response, and duration of survival were 17, 27, and 23 weeks, respectively. Hematologic and nonhematologic toxicity were mild with both regimens.
CONCLUSIONS.
This study shows that this new combination, that does not include 5-fluorouracil, is active in patients with advanced gastric carcinoma. Since treatment with 5-fluorouracil alone is still considered the standard according to some authors, the PAM combination may be included among the sequential clinical options before or after treatment with 5-fluorouracil alone. Cancer 1996; 72245-50.