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Long-term outcomes with intensive induction chemotherapy (carboplatin, bleomycin, vincristine and cisplatin/bleomycin, etoposide and cisplatin) and standard bleomycin, etoposide and cisplatin in poor prognosis germ cell tumours: A randomised phase II trial (ISRCTN53643604)

European Journal of Cancer Feb 24, 2020

Cafferty FH, et al. - Given standard BEP (bleomycin, etoposide and cisplatin) chemotherapy results in death in up to 50% of men with poor prognosis, non-seminoma germ cell tumours (GCTs), and response targets were met by an intensive regimen, CBOP/BEP (carboplatin, bleomycin, vincristine and cisplatin/BEP), in a randomised, phase II trial (74% complete response or partial response marker negative, 90% confidence interval (CI) 61%–85%), so, researchers evaluated long-term results as well as late toxicity related to CBOP/BEP. Overall 89 patients with poor prognosis extracranial GCT were randomly assigned to 4xBEP or CBOP/BEP (2xCBOP, 2xBO, 3xBEP with 15,000iu of bleomycin). For CBOP/BEP and for BEP, the 3-year progression-free survival (PFS) was estimated to be 55.7% and 38.7%, respectively. The estimated 3-year overall survival (OS) was 65.0% and 58.5%, respectively. Stabilizing chemotherapy was found to be related to poorer PFS, whereas unfavourable marker drop, in 60 (70%) patients, was not. The observed outcomes for CBOP/BEP were promising, although not powered for PFS. The influence on OS was less clear (and will be affected by subsequent therapy).
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