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oai:recercat.cat:2445/1252492025-12-05T13:12:42Zcom_2072_1057col_2072_478798col_2072_478916col_2072_478917

Randomized Phase Iii Study Comparing Paclitaxel-bleomycin, Etoposide, And Cisplatin (bep) To Standard Bep In Intermediate-prognosis Germ-cell Cancer: Intergroup Study Eortc 30983 Wit, Ronald de Skoneczna, Iwona Daugaard, Gedske Santis, Maria de Garin, August Aass, Nina Witjes, J. Alfred Albers, Peter White, Jeffery D. Germà Lluch, José Ramón Marreaud, Sandrine Collette, Laurence Metàstasi Quimioteràpia Metastasis Chemotherapy Purpose: To compare the efficacy of four cycles of paclitaxel-bleomycin, etoposide, and cisplatin (T-BEP) to four cycles of bleomycin, etoposide, and cisplatin (BEP) in previously untreated patients with intermediate-prognosis germ-cell cancer (GCC). Patients and Methods: Patients were randomly assigned to receive either T-BEP or standard BEP. Patients assigned to the T-BEP group received paclitaxel 175 mg/m(2) in a 3-hour infusion. Patients who were administered T-BEP received primary granulocyte colony-stimulating factor (G-CSF) prophylaxis. The study was designed as a randomized open-label phase II/III study. To show a 10% improvement in 3-year progression-free survival (PFS), the study aimed to recruit 498 patients but closed with 337 patients as a result of slow accrual. Results: Accrual was from November 1998 to April 2009. A total of 169 patients were administered BEP, and 168 patients were administered T-BEP. Thirteen patients in both arms were ineligible, mainly as a result of a good prognosis of GCC (eight patients administered BEP; six patients administered T-BEP) or a poor prognosis of GCC (one patient administered BEP; four patients administered T-BEP). PFS at 3 years (intent to treat) was 79.4% in the T-BEP group versus 71.1% in the BEP group (hazard ratio [HR], 0.73; CI, 0.47 to 1.13; P [log-rank test] = 0.153). PFS at 3 years in all eligible patients was 82.7% versus 70.1%, respectively (HR, 0.60; CI: 0.37 to 0.97) and was statistically significant (P = 0.03). Overall survival was not statistically different. Conclusion: T-BEP administered with G-CSF seems to be a safe and effective treatment regimen for patients with intermediate-prognosis GCC. However, the study recruited a smaller-than-planned number of patients and included 7.7% ineligible patients. The primary analysis of the trial could not demonstrate statistical superiority of T-BEP for PFS. When ineligible patients were excluded, the analysis of all eligible patients demonstrated a 12% superior 3-year PFS with T-BEP, which was statistically significant. J Clin Oncol 30: 792-799. (C) 2012 by American Society of Clinical Oncology 2018-10-10T11:41:33Z 2018-10-10T11:41:33Z 2012-03-10 2018-07-24T12:55:35Z info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Reproducció del document publicat a: https://doi.org/10.1200/JCO.2011.37.0171 Journal of Clinical Oncology, 2012, vol. 30, num. 8, p. 792-799 https://doi.org/10.1200/JCO.2011.37.0171 (c) American Society of Clinical Oncology, 2012 info:eu-repo/semantics/openAccess American Society of Clinical Oncology Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))