Journal of Clinical Oncology, Vol 16, 1287-1293, Copyright © 1998 by American Society of Clinical Oncology
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
CR Nichols, PJ Catalano, ED Crawford, NJ Vogelzang, LH Einhorn and PJ Loehrer
Indiana University Medical Center, Indianapolis, USA. craigvnichols@iucc.iupui.edu
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 tumors 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
rate 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.
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