Adjuvant bleomycin, vincristine and cisplatin (BOP) for high-risk stage I non-seminomatous germ cell tumours: a prospective trial (MRC TE17)

Br J Cancer. 2005 Jun 20;92(12):2107-13. doi: 10.1038/sj.bjc.6602624.

Abstract

Adjuvant BEP (bleomycin, etoposide, cisplatin) is effective treatment for high-risk clinical stage I (HRCS1) non-seminomatous germ cell tumours (NSGCT), but the known toxicities of etoposide, and the expansion of the HR group to any patient with vascular invasion (50% of patients), led the Medical Research Council to pilot the BOP regimen. Patients received two courses of BOP 14 days apart: cisplatin 50 mg m(-2) days 1 and 2, vincristine 1.4 mg m(-2) (max. 2 mg) days 2 and 8, bleomycin 30,000 IU days 2 and 8. Primary outcome was relapse rate; quality of life, fertility, hearing and lung function were assessed pre- and post-treatment. In all, 100 patients were required. A total of 115 eligible patients were registered, all received two courses of chemotherapy. Median follow-up is 70 months; two relapses have occurred and the 5-year relapse-free rate is 98.3% (95% confidence interval (CI) 95.5%, 99.9%). As assessed by clinicians during treatment, complete (reversible) alopecia was present in 20% of patients; World Health Organization (WHO) grade 1/2 neurotoxicity was present in 41%/5% of patients during treatment and 22%/1% at 6 months. However, 12% of patients reported 'quite a bit' or 'very much' pain/numbness/tingling in hands/feet 2 years after chemotherapy. Mature follow-up confirms high efficacy for two courses of cisplatin-based adjuvant chemotherapy in HRCS1 NSGCT. Substituting vincristine for etoposide decreases alopecia, but gives a low incidence of significant neuropathy. There are no clearcut advantages to 2 x BOP over 2 x BEP, except for patients who wish to maximise the chance of avoiding significant alopecia.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Multicenter Study

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Bleomycin / administration & dosage
  • Chemotherapy, Adjuvant
  • Cisplatin / administration & dosage
  • Germinoma / drug therapy*
  • Germinoma / pathology
  • Germinoma / surgery
  • Humans
  • Male
  • Neoplasm Recurrence, Local
  • Neoplasm Staging
  • Orchiectomy
  • Pilot Projects
  • Prospective Studies
  • Quality of Life
  • Testicular Neoplasms / drug therapy*
  • Testicular Neoplasms / pathology
  • Testicular Neoplasms / surgery
  • Toxicity Tests
  • Treatment Outcome
  • Vincristine / administration & dosage

Substances

  • Bleomycin
  • Vincristine
  • Cisplatin

Supplementary concepts

  • COB protocol