title: Adjuvant bleomycin, vincristine and cisplatin (BOP) for high-risk stage I non-seminomatous germ cell tumours: a prospective trial (MRC TE17).
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.
authors.affiliation: Academic Radiotherapy, Institute of Cancer Research and Royal Marsden Hospital, Sutton, Surrey SM2 5PT, UK. David.Dearnaley@icr.ac.uk
authors.forename: D P
authors.initials: DP
authors.lastname: Dearnaley
authors.forename: S D
authors.initials: SD
authors.lastname: Fossa
authors.forename: S B
authors.initials: SB
authors.lastname: Kaye
authors.forename: M H
authors.initials: MH
authors.lastname: Cullen
authors.forename: S J
authors.initials: SJ
authors.lastname: Harland
authors.forename: M P J
authors.initials: MP
authors.lastname: Sokal
authors.forename: J D
authors.initials: JD
authors.lastname: Graham
authors.forename: J T
authors.initials: JT
authors.lastname: Roberts
authors.forename: G M
authors.initials: GM
authors.lastname: Mead
authors.forename: M V
authors.initials: MV
authors.lastname: Williams
authors.forename: P A
authors.initials: PA
authors.lastname: Cook
authors.forename: S P
authors.initials: SP
authors.lastname: Stenning
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D001761:Bleomycin / Q000008:administration & dosage; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D018237:Germinoma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D006801:Humans; D008297:Male; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D009919:Orchiectomy; D010865:Pilot Projects; D011446:Prospective Studies; D011788:Quality of Life; D013736:Testicular Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D018675:Toxicity Tests; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D001761:Bleomycin; D014750:Vincristine; D002945:Cisplatin