Weekly cisplatin given for 2 months versus cisplatin plus cyclophosphamide given for 5 months after cytoreductive surgery for advanced ovarian cancer

被引:38
作者
Bolis, G
Favalli, G
Danese, S
Zanaboni, F
Mangili, G
Scarabelli, C
Tateo, S
Valsecchi, MG
Scarfone, G
Richiardi, G
Frigerio, I
Melpignano, M
Villa, A
Parazzini, F
机构
[1] IST RIC FARMACOL MARIO NEGRI,I-20157 MILAN,ITALY
[2] UNIV MILAN,CLIN OSTETR GINECOL 1,MILAN,ITALY
[3] UNIV MILAN,IST STAT MED & BIOMETRIA,I-20122 MILAN,ITALY
[4] IST TUMORI,DIV ONCOL GINECOL,MILAN,ITALY
[5] UNIV BRESCIA,CLIN OSTETR GINECOL,BRESCIA,ITALY
[6] UNIV PAVIA,CLIN OSTETR & GINECOL,VARESE,ITALY
[7] UNIV MILAN,OSPED S RAFFAELE,CLIN OSTETR & GINECOL,SEGRATE,ITALY
[8] OSPED VOGHERA,DIV OSTETRICIA & GINECOL,VOGHERA,ITALY
[9] UNIV PAVIA,CLIN OSTETR GINECOL,I-27100 PAVIA,ITALY
[10] UNIV PARMA,CLIN OSTETR GINECOL,I-43100 PARMA,ITALY
[11] OSPED S ANNA,DIV OSTETRICIA & GINECOL,TURIN,ITALY
关键词
D O I
10.1200/JCO.1997.15.5.1938
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose: To compare the efficacy of a treatment with cisplatin plus cyclophosphamide given for 5 months and a short treatment with cisplatin alone in advanced ovarian cancer, we conducted a multicenter randomized clinical trial. Patients and Methods: Eligibility criteria were as follows: first diagnosis of histologically confirmed invasive epithelial ovarian cancer of International Federation of Gynecology and Obstetric (FIGO) stage Ill-IV, age younger than 75 years, and Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2. Within 28 days of cytoreductive surgery, eligible women were randomly assigned treatment with weekly cisplatin 50 mg/m(2) for nine courses or cisplatin 75 mg/m(2) plus cyclophosphamide 750 mg/m(2) every 21 days for six courses. Results: A total of 607 women were entered onto the study, There was no difference in the response to treatment. Pathologic complete response (CR) was documented in 63 of the weekly cisplatin cases and 70 of the cisplatin plus cyclophosphamide group (chi(1)(2) = 1.43; P = .23). The median follow-up time was 3 years. There were 151 and 148 deaths in the weekly cisplatin and cyclophosphamide plus cisplatin arms, respectively. Survival curves were similar in the two groups, with a 3-year percent survival estimate of 44.1 (SE = 3.4) in the weekly cisplatin and 44.6 (SE = 3.4) in the cisplatin plus cyclophosphamide group (log-rank test chi(1)(2) = 0.004; P = .96). Conclusion: This study found that 5-month monochemotherapy treatment with cisplatin wets as effective as 5-month polychemotherapy including cisplatin at a similar doses but different dose-intensity plus cyclophosphamide. (C) 1997 by American Society of Clinical Oncology.
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页码:1938 / 1944
页数:7
相关论文
共 20 条
[1]  
*ADV OV CANC TRIAL, 1991, BRIT MED J, V303, P884
[2]  
BOLIS G, 1994, P AN M AM SOC CLIN, V13, P259
[3]  
COLOMBO N, 1993, P AN M AM SOC CLIN, V12, P255
[4]  
COX DR, 1972, J R STAT SOC B, V34, P187
[5]  
Freedman L S, 1982, Stat Med, V1, P121, DOI 10.1002/sim.4780010204
[6]  
GORE ME, 1996, P AN M AM SOC CLIN, V15, P284
[7]   MEASUREMENT OF DRUG-DOSAGE INTENSITY IN MVPP THERAPY IN HODGKINS-DISEASE [J].
GREEN, JA ;
DAWSON, AA ;
FELL, LF ;
MURRAY, S .
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 1980, 9 (05) :511-514
[8]   DOSE-RESPONSE IN THE TREATMENT OF BREAST-CANCER - A CRITICAL-REVIEW [J].
HENDERSON, IC ;
HAYES, DF ;
GELMAN, R .
JOURNAL OF CLINICAL ONCOLOGY, 1988, 6 (09) :1501-1515
[9]   NONPARAMETRIC-ESTIMATION FROM INCOMPLETE OBSERVATIONS [J].
KAPLAN, EL ;
MEIER, P .
JOURNAL OF THE AMERICAN STATISTICAL ASSOCIATION, 1958, 53 (282) :457-481
[10]   Mature results of a randomized trial of two doses of cisplatin for the treatment of ovarian cancer [J].
Kaye, SB ;
Paul, J ;
Cassidy, J ;
Lewis, CR ;
Duncan, ID ;
Gordon, HK ;
Kitchener, HC ;
Cruickshank, DJ ;
Atkinson, RJ ;
Soukop, M ;
Rankin, EM ;
Davis, JA ;
Reed, NS ;
Crawford, SM ;
MacLean, A ;
Parkin, D ;
Sarkar, TK ;
Kennedy, J ;
Symonds, RP .
JOURNAL OF CLINICAL ONCOLOGY, 1996, 14 (07) :2113-2119