THE COMBINATION OF CISPLATIN, DOXORUBICIN, AND MITOMYCIN (PAM) COMPARED WITH THE FAM REGIMEN IN TREATING ADVANCED GASTRIC-CARCINOMA - A PHASE-II RANDOMIZED TRIAL OF THE ITALIAN ONCOLOGY GROUP FOR CLINICAL RESEARCH

BACKGROUND. In a randomized Phase II study, the authors evaluated the activity and toxicity of the new cisplatin, doxorubicin, and mitomycin C (PAM) combination, that includes cisplatin (P) instead of 5-fluorou racil as in the 5-fluorouracil, doxorubicin, and mitomycin C (FAM) com bination, in patients with advanced gastric carcinoma. FAM was utilize d as a control treatment arm. METHODS. Fifty eligible patients were as signed to the FAM (5-fluorouracil 600 mg/ m(2) intravenous (i.v.) on D ays 1, 8, 29, 36; doxorubicin 30 mg/m(2) i.v. on Days 1 and 29; mitomy cin C 10 mg/m(2) i.v. on Day 1; every 8 weeks) and 52 to the PAM combi nation (cisplatin 60 mg/m(2) i.v. on Days 1 and 29; doxorubicin 30 mg/ m(2) i.v. on Days 1 and 29; mitomycin C 10 mg/m(2) i.v. on Day 1; ever y 8 weeks). All eligible patients were included in the evaluation of r esponse, 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 tim e 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 we re 17, 27, and 23 weeks, respectively. Hematologic and nonhematologic toxicity were mild with both regimens. CONCLUSIONS. This study shows t hat this new combination, that does not include 5-fluorouracil, is act ive in patients with advanced gastric carcinoma. Since treatment with 5-fluorouracil alone is still considered the standard according to som e authors, the PAM combination may be included among the sequential cl inical options before or after treatment with 5-fluorouracil alone. Ca ncer 1996; 77:245-50. (C) 1996 American Cancer Society.