Cisplatin, etoposide and either bleomycin or ifosfamide
in the treatment of disseminated germ cell tumors.
Hinton S, Catalano PJ, Einhorn LH, Nichols CR, David Crawford E, Vogelzang N,
Trump D, Loehrer PJ Sr.
Department of Medicine, Indiana University Medical Center and The Walther Cancer
Institute, Indianapolis, Indiana.
BACKGROUND: Various staging systems have been proposed for disseminated germ
cell neoplasms. The Indiana University staging system was based on clinical and
radiographic findings only, whereas the newly created International Germ Cell
Cancer Collaborative Group (IGCCCG) staging system also utilized serum markers
as a prognostic factor. This study updated the intergroup trial that compared
the standard therapy of bleomycin, etoposide, and cisplatin (BEP) with etoposide,
ifosfamide, and cisplatin (VIP) in advanced germ cell tumors and reanalyzed the
results using the IGCCCG staging system. METHODS: From October 1987 to April
1992, 304 patients with advanced-stage germ cell tumors (using the Indiana
University staging system) were randomized to receive four cycles of BEP or VIP.
Two hundred and eighty-six patients were eligible and fully evaluable. With a
median follow-up of 7.3 years, 283 of the 286 evaluable patients from the
Eastern Cooperative Oncology Group protocol, E3887, were reclassified using the
IGCCCG staging system. Progression-free survival (PFS), overall survival (OS),
and toxicity were assessed for the treatment arms. RESULTS: With a longer
follow-up of 7.3 years and using the Indiana University staging system, the PFS
rates were 64% versus 58% and the OS rates were 69% versus 67% in the VIP and
BEP arms, respectively. For patients reclassified with the IGCCCG staging
system, the PFS rates were 81%, 72%, and 54% and the OS rates were 89%, 81%, and
60% for good, intermediate, and poor-risk patients, respectively. Differences in
OS (VIP, 62%; BEP, 57%) and PFS (VIP, 56%; BEP, 49%) for the subset of patients
reclassified as poor risk by the IGCCCG staging system were not significantly
different. More toxicity, primarily hematologic toxicity, occurred on the VIP
arm. CONCLUSIONS: With a median follow-up of 7.3 years and with a
reclassification based on the IGCCCG, OS and PFS rates were comparable between
BEP and VIP. Toxicity, primarily hematologic, was modestly greater with the
ifosfamide-containing arm. The VIP regimen may be considered a treatment
alternative for patients with underlying pulmonary disease. In most patients
with poor and intermediate-risk germ cell tumors, four cycles of BEP remain the
standard therapy. Cancer 2003;97:1869-75. Copyright 2003 American Cancer
Society.DOI 10.1002/cncr.11271
