Randomized comparison of cisplatin and etoposide and either bleomycin or ifosfamide in treatment of advanced-disseminated germ cell tumors: An eastern cooperative oncology group, southwest oncology group, and cancer and leukemia group B study
Randomized comparison of cisplatin and etoposide and either bleomycin or ifosfamide in treatment of advanced-disseminated germ cell tumors: An eastern cooperative oncology group, southwest oncology group, and cancer and leukemia group B study
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DOI：
10.1200/jco.1998.16.4.1287
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发表时间：
1998-04-01
影响因子：
45.3
通讯作者：
Loehrer, PJ
中科院分区：
文献类型：
--
作者：
Nichols, CR;Catalano, PJ;Loehrer, PJ
目的：比较博来霉素、依托泊苷和顺铂（BEP）标准治疗与依托泊苷、异环磷酰胺和顺铂（VIP）实验治疗对晚期弥散性生殖细胞肿瘤患者的主要治疗效果。共304例晚期弥散性生殖细胞谣言患者随机分为4个疗程，其中毒性评估299例，反应评估286例，完全缓解率，良好反应（完全缓解，手术无病，持续部分缓解2年以上），治疗失败时间，总生存期。结果：总体完全缓解率(VIP, 37%；BEP, 31%)，良好缓解率（VIP, 63%； BEP, 60%）， 2年无故障（VIP, 64%； BEP, 60%）， 2年总生存率(VIP, 74%；BEP（71%）在两种治疗间无显著性差异，3级及以下毒性，特别是血液和泌尿生殖系统毒性在VIP患者中更为常见。在低风险生殖细胞肿瘤患者中，BEP和VIP的疗效相当，但异环磷酰胺替代博来霉素的毒性更大，四个疗程的BEP仍然是晚期弥散性生殖细胞肿瘤的标准治疗方法。(C)美国临床肿瘤学会1998。
Purpose: To compare standard therapy with bleomycin, etoposide, and cisplatin (BEP) to experimental therapy with etoposide, ifosfamide, and cisplatin (VIP) as primary treatment of men with advanced, disseminated germ cell tumors,Patients and Methods: A total of 304 men with advanced disseminated germ cell rumors were randomly allocated to receive four courses of BEP or VIP, Two hundred ninety-nine patients were assessable for toxicity and 286 were assessable for response, Complete response rates, favorable response (complete remission, surgical free of disease, continuous partial remission for 2+ years), time to treatment failure, and overall survival were assessed,Results: Overall complete remission rate (VIP, 37%; BEP, 31%), favorable response rate (VIP, 63%; BEP, 60%), failure-free at 2 years (VIP, 64%; BEP, 60%), and 2-year overall survival (VIP, 74%; BEP, 71%) were not significantly different between the two treatments, Grade 3 or worse toxicity, particularly hematologic and genitourinary toxicity, was significantly more common in patients who received VIP,Conclusion: BEP and VIP produce comparable favorable response rare and survival in patients with poor-risk germ cell tumors, The substitution of ifosfamide for bleomycin, however, was associated with significantly greater toxicity, Four courses of BEP remain the standard treatment for advanced disseminated germ cell tumors. (C) 1998 by American Society of Clinical Oncology.