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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
Author(s) -
De Lisi Vincenzo,
Cocconi Giorgio,
Angelini Francesco,
Cavicchi Francesco,
Di Costanzo Francesco,
Gilli Germana,
Rodinò Carmelina,
Soldani Marcello,
Tonato Maurizio,
Finardi Cecilia
Publication year - 1996
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/(sici)1097-0142(19960115)77:2<245::aid-cncr4>3.0.co;2-l
Subject(s) - medicine , regimen , mitomycin c , fluorouracil , doxorubicin , gastroenterology , cisplatin , phases of clinical research , chemotherapy , toxicity , surgery
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‐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‐fluorouracil 600 mg/m 2 intravenous (i.v.) on Days 1, 8, 29, 36; doxorubicin 30 mg/m 2 i.v. on Days 1 and 29; mitomycin C 10 mg/m 2 i.v. on Day 1; every 8 weeks) and 52 to the PAM combination (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; 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;77:245‐50.