RANDOMIZED PHASE-II TRIAL OF CISPLATIN WITH MITOMYCIN OR DOXORUBICIN FOR MALIGNANT MESOTHELIOMA BY THE CANCER AND LEUKEMIA GROUP-B

被引:125
作者
CHAHINIAN, AP
ANTMAN, K
GOUTSOU, M
CORSON, JM
SUZUKI, Y
MODEAS, C
HERNDON, JE
AISNER, J
ELLISON, RR
LEONE, L
VOGELZANG, NJ
GREEN, MR
机构
[1] UNIV MARYLAND,CTR CANC,BALTIMORE,MD 21201
[2] COLUMBIA UNIV COLL PHYS & SURG,DEPT MED,NEW YORK,NY 10032
[3] RHODE ISL HOSP,DEPT MED ONCOL,PROVIDENCE,RI 02902
[4] UNIV CHICAGO,JOINT SECT HEMATOL ONCOL,CHICAGO,IL 60637
[5] UNIV CALIF SAN DIEGO,DEPT MED,SAN DIEGO,CA 92103
[6] UNIV CALIF SAN DIEGO,CTR CANC,SAN DIEGO,CA 92103
[7] HARVARD UNIV,BRIGHAM & WOMENS HOSP,SCH MED,DIV SURG PATHOL,BOSTON,MA 02115
[8] FRONTIER SCI & TECHNOL RES FDN INC,AMHERST,NY
[9] DUKE UNIV,MED CTR,CTR STAT,CANC & LEUKEMIA GRP B,DURHAM,NC 27710
[10] CUNY MT SINAI SCH MED,DEPT NEOPLAST DIS,NEW YORK,NY 10029
[11] CUNY MT SINAI SCH MED,DEPT COMMUNITY MED & PATHOL,NEW YORK,NY 10029
[12] HARVARD UNIV,SCH MED,DANA FARBER CANC INST,BOSTON,MA 02115
[13] HARVARD UNIV,SCH PUBL HLTH,DEPT BIOSTAT,BOSTON,MA 02115
关键词
D O I
10.1200/JCO.1993.11.8.1559
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose: The Cancer and Leukemia Group B (CALGB) conducted a randomized phase II multicenter trial to evaluate the activity of two cisplatin- containing regimens (cisplatin and mitomycin [CM], or cisplatin and doxorubicin [CD]) in patients with malignant pleural or peritoneal mesothelioma (protocol CALGB 8435). Patients and Methods: Seventy-nine patients were entered between June 1984 and October 1986. Eligibility included a performance status of 0 to 2 by CALGB criteria, and no prior chemotherapy. Central pathology review was performed. Randomization was stratified according to the cell type (epithelial v mixed or sarcomatous) and the presence of measurable versus assessable disease. Of the 79 patients entered, 70 were included in this analysis (35 on CM and 35 on CD), including 48 with epithelial cell type and 22 with mixed or sarcomatous cell types. Sixty-six patients had pleural mesothelioma and four had peritoneal mesothelioma. There were 34 cases with measurable disease and 36 with assessable disease. Results: The overall response rate was 26% for CM (two complete responses [CRs], three partial responses [PRs], and four regressions) and 14% for CD (four PRs and one regression). Median time to treatment failure was 3.6 months for CM and 4.8 months for CD, and median survival duration from study entry was 7.7 and 8.8 months, respectively, with no significant differences between treatments. Good performance status (0 or 1) was associated with significantly longer survival duration (P = .013). Both regimens were well tolerated and there were no treatment-related deaths due to toxicity. Conclusion: Moderate antitumor activity has been observed with both regimens. In this randomized phase II trial, the overall response rates, time to treatment failure, and overall survival appear to be similar for the two regimens tested.
引用
收藏
页码:1559 / 1565
页数:7
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