Journal of Clinical Oncology, Vol 16, 692-701, Copyright © 1998 by American Society of Clinical Oncology
Intensive induction-sequential chemotherapy with BOP/VIP-B compared with treatment with BEP/EP for poor-prognosis metastatic nonseminomatous germ cell tumor: a Randomized Medical Research Council/European Organization for Research and Treatment of Cancer study
SB Kaye, GM Mead, S Fossa, M Cullen, R deWit, I Bodrogi, C van Groeningen, R Sylvester, L Collette, S Stenning, L De Prijck, E Lallemand and P deMulder
Cancer Research Campaign Department of Medical Oncology, University of Glasgow, Western Infirmary, UK. s.b.kaye@beatson.gla.ac.uk
PURPOSE: The aim of this randomized trial was to assess the potential
therapeutic advantage of an intensive induction-sequential chemotherapy
schedule (bleomycin, vincristine, cisplatin [BOP])/etoposide, ifosfamide,
cisplatin, and bleomycin [VIP-B]), compared with a regimen based on
bleomycin, etoposide, and cisplatin (BEP) (BEP/etoposide and cisplatin
[EP]) for the treatment of patients with poor-prognosis metastatic
nonseminomatous germ cell tumors (NSGCTs). PATIENTS AND METHODS: Patients
had one or more of the following: a retroperitoneal mass > or = 10 cm in
diameter; mediastinal or supraclavicular mass > or = 5 cm in diameter;
at least 20 lung metastases (any size); liver, bone, or brain metastases;
and serum beta human chorionic gonadotropin (betaHCG) > or = 10,000 IU/L
or alfa fetoprotein (AFP) > or = 1,000 IU/L. A total of 380 patients
were accrued between May 1990 and June 1994 into this joint Medical
Research Council (MRC)/European Organization for Research and Treatment of
Cancer (EORTC) trial; of these, nine patients were deemed ineligible.
RESULTS: There was no significant difference between the two arms in the
proportion of patients who achieved a complete response (CR) with
chemotherapy alone, ie, 79 of 185 assessable patients (57%) with BEP/EP and
72 of 186 (54%) with BOP/VIP-B (P = 0.687). With a median follow-up of 3.1
years (maximum, 5.8), a total of 107 patients (28%) had progressive
disease. There was no significant difference in time to first disease
progression, or failure-free or overall survival between the two arms (P =
0.21, 0.101, and 0.190, respectively). The 1-year failure-free survival
rates for BEP/EP and BOP/VIP-B were 60% (95% confidence interval [CI], 53%
to 67%) and 53% (95% CI, 47% to 61%). Grade 3 or 4 myelosuppression,
febrile neutropenia, and weight loss were more pronounced with BOP/VIP-B
than with BEP/EP, and there were more toxic deaths with BOP/VIP-B than
BEP/EP (18 [9%] v nine [5%]). CONCLUSION: The intensive BOP/VIP-B therapy
was associated with more toxicity, but there was no evidence of an
improvement in response rate or survival compared with treatment with
BEP/EP.
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