Randomized, placebo-controlled, phase III trial of sunitinib plus prednisone versus prednisone alone in progressive, metastatic, castration-resistant prostate cancer.
| Autor: | Michaelson MD; M. Dror Michaelson, Massachusetts General Hospital Cancer Center, Boston, MA; Stephane Oudard, George Pompidou European Hospital, Rene Descartes University, Paris; Nadine Houede, Institut Bergonie, Bordeaux; Tristan Maurina, CHU de Besançon, Hôpital Jean Minjoz, Besançon, France; Yen-Chuan Ou, Taichung Veterans General Hospital, Taichung, Taiwan; Lisa Sengeløv, Herlev Hospital, Herlev; Gedske Daugaard, Rigshospitalet, Copenhagen, Denmark; Fred Saad, University of Montreal, Montreal, Canada; Peter Ostler, Mount Vernon Hospital, Northwood, Middlesex; Robert Jones, Beatson West of Scotland Cancer Centre, Glasgow; Amit Bahl, Bristol Haematology and Oncology Centre, Bristol, UK; Arnulf Stenzl, Eberhard-Karls-University Medical School, Tübingen; Juergen Gschwend, Technical University of Munich, Munich, Germany; Fredrik Laestadius and Anders Ullèn, Karolinska University Hospital, Stockholm, Sweden; Daniel Castellano, I_12 Research Institute, University Hospital 12 de Octubre, Madrid, Spain; Edna Chow Maneval, Shaw-Ling Wang, and Isan Chen, Pfizer Oncology, La Jolla, CA; and Maria Jose Lechuga and Jolanda Paolini, Pfizer Oncology, Milan, Italy., Oudard S, Ou YC, Sengeløv L, Saad F, Houede N, Ostler P, Stenzl A, Daugaard G, Jones R, Laestadius F, Ullèn A, Bahl A, Castellano D, Gschwend J, Maurina T, Chow Maneval E, Wang SL, Lechuga MJ, Paolini J, Chen I |
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| Jazyk: | angličtina |
| Zdroj: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2014 Jan 10; Vol. 32 (2), pp. 76-82. Date of Electronic Publication: 2013 Dec 09. |
| DOI: | 10.1200/JCO.2012.48.5268 |
| Abstrakt: | Purpose: We evaluated angiogenesis-targeted sunitinib therapy in a randomized, double-blind trial of metastatic castration-resistant prostate cancer (mCRPC). Patients and Methods: Men with progressive mCRPC after docetaxel-based chemotherapy were randomly assigned 2:1 to receive sunitinib 37.5 mg/d continuously or placebo. Patients also received oral prednisone 5 mg twice daily. The primary end point was overall survival (OS); secondary end points included progression-free survival (PFS). Two interim analyses were planned. Results: Overall, 873 patients were randomly assigned to receive sunitinib (n = 584) or placebo (n = 289). The independent data monitoring committee stopped the study for futility after the second interim analysis. After a median overall follow-up of 8.7 months, median OS was 13.1 months and 11.8 months for sunitinib and placebo, respectively (hazard ratio [HR], 0.914; 95% CI, 0.762 to 1.097; stratified log-rank test, P = .168). PFS was significantly improved in the sunitinib arm (median 5.6 v 4.1 months; HR, 0.725; 95% CI, 0.591 to 0.890; stratified log-rank test, P < .001). Toxicity and rates of discontinuations because of adverse events (AEs; 27% v 7%) were greater with sunitinib than placebo. The most common treatment-related grade 3/4 AEs were fatigue (9% v 1%), asthenia (8% v 2%), and hand-foot syndrome (7% v 0%). Frequent treatment-emergent grade 3/4 hematologic abnormalities were lymphopenia (20% v 11%), anemia (9% v 8%), and neutropenia (6% v < 1%). Conclusion: The addition of sunitinib to prednisone did not improve OS compared with placebo in docetaxel-refractory mCRPC. The role of antiangiogenic therapy in mCRPC remains investigational. |
| Databáze: | MEDLINE |
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