AN ANTICIPATED CHEMOTHERAPY INTENSIFICATION FAILURE IN TESTICULAR CANCER

J Clin Oncol. 2012 Jan 23. [Epub ahead of print]

Randomized Phase III Study Comparing Paclitaxel-Bleomycin, Etoposide, and Cisplatin (BEP) to Standard BEP in Intermediate-Prognosis Germ-Cell Cancer: Intergroup Study EORTC 30983.

de Wit R, Skoneczna I, Daugaard G, De Santis M, Garin A, Aass N, Witjes AJ, Albers P, White JD, Germa-Lluch JR, Marreaud S, Collette L.

Source

Ronald de Wit, Erasmus University Medical Center and Daniel den Hoed Cancer Center, Rotterdam; Alfred J. Witjes, Radboud University Hospital, Nijmegen, the Netherlands; Iwona Skoneczna, Marie Sklodowska-Curie Memorial Cancer Center, Warsaw, Poland; Gedske Daugaard, Rigshospital, Copenhagen, Denmark; Maria De Santis, Ludwig Boltzmann-Institute for Applied Cancer Research Vienna and Applied Cancer Research-Institution for Translational Research Vienna/Kaiser Franz Josef-Spital, Vienna, Austria; August Garin, Cancer Research Center, Moscow, Russia; Nina Aass, Oslo University Hospital and University of Oslo, Oslo, Norway; Peter Albers, Heinrich-Heine-University, Dusseldorf, Germany; Jeffery D. White, Glasgow-Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom; José R. Germa-Lluch, Bellvitge Institute for Biomedical Research, Institut Catala d'Oncologia, Barcelona, Spain; and Sandrine Marreaud and Laurence Collette, European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.

Abstract

PURPOSETo 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 METHODSPatients 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: 0.37 to 0.97) and was statistically significant (P = 0.03). Overall survival was not statistically different. CONCLUSIONT-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.