Journal of Clinical Oncology, Vol 15, 1837-1843, Copyright © 1997 by American Society of Clinical Oncology
Importance of bleomycin in combination chemotherapy for good-prognosis testicular nonseminoma: a randomized study of the European Organization for Research and Treatment of Cancer Genitourinary Tract Cancer Cooperative Group
R de Wit, G Stoter, SB Kaye, DT Sleijfer, WG Jones, WW ten Bokkel Huinink, LA Rea, L Collette and R Sylvester
Department of Medical Oncology, Rotterdam Cancer Institute and University Hospital, The Netherlands. eyk@onch.azr.nl
PURPOSE: This prospective randomized trial was designed to compare the
efficacy of etoposide plus cisplatin (EP) versus bleomycin, etoposide, and
cisplatin (BEP) chemotherapy in patients with good-prognosis metastatic
nonseminomatous testicular cancer. PATIENTS AND METHODS: Four hundred
nineteen patients with good-prognosis nonseminomatous testicular cancer
were randomized to receive four cycles of cisplatin 20 mg/m2 on days 1 to 5
plus etoposide 120 mg/m2 on days 1, 3, and 5 with or without bleomycin 30
mg weekly. RESULTS: Of 395 eligible patients, 169 of 195 patients allocated
to EP (87%) and 189 of 200 patients allocated to BEP (95%) achieved a
complete response with chemotherapy alone or after postchemotherapy
surgery. These results are significantly different (P = .0075). After a
median follow-up duration of 7.3 years, eight patients (4%) on each
treatment arm relapsed. In view of the low number of unfavorable treatment
outcomes (11%), no significant differences were detected in time to
progression (P = .136) and survival (P = .262). Both the acute and late
pulmonary toxicity and neurotoxicity were significantly greater in patients
who received BEP, whereas Raynaud's phenomenon occurred exclusively in
patients who received BEP (P < .001). Two patients treated with BEP died
of bleomycin pulmonary toxicity. CONCLUSION: BEP is the most effective
combination regimen in the treatment of disseminated nonseminomatous germ
cell cancer. In this particular BEP regimen with etoposide at a dose of 360
mg/m2 per cycle, even in good-prognosis patients, bleomycin cannot be
deleted without compromising treatment efficacy, but its use is associated
with more toxicity (particularly pulmonary) and efforts to reduce this
merit further exploration.
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