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OK‐432 and 5‐fluorouracil, doxorubicin, and mitomycin C (FAM‐P) versus FAM chemotherapy in patients with curatively resected gastric carcinoma
Author(s) -
Kim SiYoung,
Park Ho C.,
Yoon Choong,
Yoon Hwi J.,
Choi Yong M.,
Cho Kyung S.
Publication year - 1998
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(19981115)83:10<2054::aid-cncr2>3.0.co;2-1
Subject(s) - medicine , fluorouracil , mitomycin c , chemotherapy , doxorubicin , gastric carcinoma , carcinoma , oncology , gastroenterology , surgery , cancer
BACKGROUND The streptococcal agent OK‐432 is used widely as a potent biologic response modifier. Accumulated evidence suggests that OK‐432 exerts antineoplastic effects by a direct cytotoxic or inhibitory effect on tumor cells. The clinical efficacy of OK‐432 has been reported for various tumors. In this randomized Phase III study, the authors compared 5‐fluorouracil (5‐FU), doxorubicin, mitomycin C, and the intradermal administration of OK‐432 (FAM‐P) with the standard FAM regimen in patients with gastric carcinoma who underwent curative resection. METHODS From May 1988 until November 1991, a total of 99 patients were entered into this randomized trial. The patients were stratified according to the American Joint Committee on Cancer stage of disease (i.e., Stage IB, II, and III). Fifty patients were treated with the FAM regimen here and throughout text.: 5‐FU, 750 mg intravenously (i.v.), on Days 1, 8, 29, and 36; doxorubicin, 30 mg/m 2 i.v., on Days 1 and 29; and mitomycin C, 10 mg/m 2 i.v., on Day 1. Forty‐nine patients received the FAM‐P regimen: 5‐FU, 750 mg i.v., on Days 1, 8, 29, and 36; doxorubicin, 30 mg/m 2 i.v., on Days 1 and 29; mitomycin C, 10 mg/m 2 i.v., on Day 1; and OK‐432 5.0 Klinishe Einheit (clinical unit) injected intradermally weekly. RESULTS The survival difference was statistically significant between the patients receiving the FAM and FAM‐P regimens (5‐year survival of 52% vs. 62%; P = 0.04). A comparison between disease free survival in FAM and FAM‐P patients showed a borderline advantage for the FAM‐P group ( P = 0.053). When Stage IB, Stage II, and Stage III patients were analyzed separately, the difference in survival between two regimens was significant in Stage III patients ( P = 0.049) and the disease free survival was of borderline significance ( P = 0.06), but not in patients with Stage IB and II disease. The significant toxicity of OK‐432 was mild fever, which was controlled with acetaminophen. CONCLUSIONS The results of this study show that OK‐432 may be an active, well tolerated agent for the treatment of curatively resected gastric carcinoma. However, these findings should be confirmed by a multicenter randomized study with a large sample size. Cancer 1998;83:2054‐2059. © 1998 American Cancer Society.