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DC Field | Value | Language |
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dc.contributor.author | Wit, Ronald de | - |
dc.contributor.author | Skoneczna, Iwona | - |
dc.contributor.author | Daugaard, Gedske | - |
dc.contributor.author | Santis, Maria De | - |
dc.contributor.author | Garin, August | - |
dc.contributor.author | Aass, Nina | - |
dc.contributor.author | Witjes, J. Alfred | - |
dc.contributor.author | Albers, Peter | - |
dc.contributor.author | White, Jeffery D. | - |
dc.contributor.author | Germà Lluch, José Ramón | - |
dc.contributor.author | Marreaud, Sandrine | - |
dc.contributor.author | Collette, Laurence | - |
dc.date.accessioned | 2018-10-10T11:41:33Z | - |
dc.date.available | 2018-10-10T11:41:33Z | - |
dc.date.issued | 2012-03-10 | - |
dc.identifier.uri | http://hdl.handle.net/2445/125249 | - |
dc.description.abstract | 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 | - |
dc.format.extent | 8 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | American Society of Clinical Oncology | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1200/JCO.2011.37.0171 | - |
dc.relation.ispartof | Journal of Clinical Oncology, 2012, vol. 30, num. 8, p. 792-799 | - |
dc.relation.uri | https://doi.org/10.1200/JCO.2011.37.0171 | - |
dc.rights | (c) American Society of Clinical Oncology, 2012 | - |
dc.source | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) | - |
dc.subject.classification | Metàstasi | - |
dc.subject.classification | Quimioteràpia | - |
dc.subject.other | Metastasis | - |
dc.subject.other | Chemotherapy | - |
dc.title | Randomized Phase Iii Study Comparing Paclitaxel-bleomycin, Etoposide, And Cisplatin (bep) To Standard Bep In Intermediate-prognosis Germ-cell Cancer: Intergroup Study Eortc 30983 | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.date.updated | 2018-07-24T12:55:35Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 22271474 | - |
Appears in Collections: | Articles publicats en revistes (Ciències Clíniques) Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
Files in This Item:
File | Description | Size | Format | |
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de WitR.pdf | 157.35 kB | Adobe PDF | View/Open |
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