Intensive induction chemotherapy with C-BOP/BEP for intermediate- and poor-risk metastatic germ cell tumours (EORTC trial 30948)
| Autor: | O. Koriakine, P.H.M. de Mulder, G. Kaiser, Alan Horwich, B. Paluchowska, A. van Oosterom, Sophie D. Fosså, R. de Wit, Laurence Collette, L. de Prijck |
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| Přispěvatelé: | Medical Oncology |
| Rok vydání: | 2005 |
| Předmět: |
Oncology
Male Cancer Research medicine.medical_treatment cisplatin etoposide Carboplatin chemistry.chemical_compound 0302 clinical medicine Antineoplastic Combined Chemotherapy Protocols Clinical Studies Neoplasm Metastasis Etoposide Ovarian Neoplasms 0303 health sciences Middle Aged Neoplasms Germ Cell and Embryonal Prognosis 3. Good health Treatment Outcome 030220 oncology & carcinogenesis Disease Progression Female medicine.drug Adult Vincristine medicine.medical_specialty Adolescent Risk Assessment vincristine 03 medical and health sciences Bleomycin Testicular Neoplasms Interventional oncology [UMCN 1.5] Internal medicine medicine Humans Survival rate Survival analysis 030304 developmental biology Cisplatin Chemotherapy business.industry Induction chemotherapy Survival Analysis Surgery chemistry intermediate and poor prognosis metastatic germ cell tumours business |
| Zdroj: | British Journal of Cancer British Journal of Cancer, 93(11), 1209-1214. Nature Publishing Group British Journal of Cancer, 93, 1209-14 British Journal of Cancer, 93, 11, pp. 1209-14 |
| ISSN: | 1532-1827 0007-0920 |
| DOI: | 10.1038/sj.bjc.6602830 |
| Popis: | Item does not contain fulltext New chemotherapy regimens are continuously explored in patients with high-risk malignant germ cell tumours (MGCTs). This multicentre phase II trial assessed the efficacy and toxicity of C-BOP/BEP chemotherapy in intermediate and poor prognosis MGCT (IGCCCG criteria). C-BOP/BEP treatment consisted of cycles of cisplatin, vincristine, bleomycin and carboplatin, followed by one cycle of vincristine and bleomycin and three cycles of BEP (bleomycon, etoposide, cisplatin). The trial was designed to demonstrate a 1-year progression-free survival rate of 80%, that is, to exclude a 1-year rate of 70% or less, with a one-sided significance level of 5%. Secondary end points included toxicity, overall survival and the postchemotherapy complete response rate. In total, 16 European hospitals entered 66 eligible patients (intermediate prognosis group: 37; poor prognosis group: 29). A total of 45 patients (68.2%, 95% confidence interval (95% CI): 56.9-79.4%) achieved a complete response (intermediate prognosis: 30; poor prognosis: 15). After a median observation time of 40.4 months (range: 13.7-66.3), the 1-year progression-free survival rate was 81.8% 95% CI: 72.5-91.1%). The 2-year overall survival was 84.5% (95% CI: 75.6-93.3%). In all, 51 patients experienced at least one episode of WHO grade 3/4 leucopenia, and at least one event of grade 3/4 thrombocytopenia occurred in 30 patients. There was no toxic death. With an 82% 1-year progression-free survival and a lower limit of the 95% CI above 70%, the efficacy of C-BOP/BEP is comparable to that of published alternative chemotherapy schedules in high-risk MGCT patients. The treatment's toxicity is manageable in a multicentre setting. In poor prognosis patients, C-BOP/BEP should be compared to standard chemotherapy of four cycles of BEP. |
| Databáze: | OpenAIRE |
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