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

S. B. Kaye, G. M. Mead, S. Fossa, M. Cullen, R. DeWit, I. Bodrogi, C. Van Groeningen, R. Sylvester, L. Collette, S. Stenning, L. De Prijck, E. Lallemand, P. DeMulder

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Abstract

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 non- seminomatous germ cell tumors (NSGCTs). Patients and Methods: Patients had one or more of the following: a retroperitoneal mass ≤ 10 cm in diameter; mediastinal or supraclavicular mass ≤ 5 cm in diameter; at least 20 lung metastases (any size); liver, bone, or brain metastases; and serum beta human chorionic gonadotropin (βHCG) ≤ 10,000 IU/L or alfa fetoprotein (AFP) ≤ 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 on improvement in response rate or survival compared with treatment with BEP/EP.

Original languageEnglish
Pages (from-to)692-701
Number of pages10
JournalJournal of Clinical Oncology
Volume16
Issue number2
DOIs
Publication statusPublished - Feb 1998

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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