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Title: | Importance of bleomycin in combination chemotherapy for good prognosis testicular non-seminoma: a randomized study of the EORTC Genitourinary Tract Cancer Cooperative Group | Authors: | de Wit, R. Stoter, G. Kaye, S.B. Steijffer, D.Th. Jones, W.G. ten Bokkel Huinink, W.W. Rea, L.A. Collette, L. SYLVESTER, Richard |
Issue Date: | 1997 | Source: | Journal of clinical oncology, 15(5). p. 1837-1843 | Abstract: | 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. | Document URI: | http://hdl.handle.net/1942/5521 | Link to publication/dataset: | http://jco.ascopubs.org/cgi/content/abstract/15/5/1837 | Type: | Journal Contribution |
Appears in Collections: | Research publications |
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