| Added by | mollevi |
|---|---|
| Last modified by | celine.gongora |
| Group name | EquipeCG |
| Item Type | Journal Article |
| Title | Randomized, placebo-controlled, phase III trial of sunitinib plus prednisone versus prednisone alone in progressive, metastatic, castration-resistant prostate cancer |
| Creator | Michaelson et al. |
| Author | M. D. Michaelson |
| Author | S. Oudard |
| Author | Y. C. Ou |
| Author | L. Sengelov |
| Author | F. Saad |
| Author | N. Houede |
| Author | P. Ostler |
| Author | A. Stenzl |
| Author | G. Daugaard |
| Author | R. Jones |
| Author | F. Laestadius |
| Author | A. Ullen |
| Author | A. Bahl |
| Author | D. Castellano |
| Author | J. Gschwend |
| Author | T. Maurina |
| Author | E. Chow Maneval |
| Author | S. L. Wang |
| Author | M. J. Lechuga |
| Author | J. Paolini |
| Author | I. Chen |
| Abstract | 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. |
| Publication | J Clin Oncol |
| Volume | 32 |
| Pages | 76-82 |
| Date | Jan 10 2014 |
| Journal Abbr | Journal of clinical oncology : official journal of the American Society of Clinical Oncology |
| DOI | 10.1200/JCO.2012.48.5268 |
| ISSN | 1527-7755 (Electronic) 0732-183X (Linking) |
| Tags | Adult, Aged, Aged, 80 and over, Anemia/chemically induced, Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use, Asthenia/chemically induced, clinic, Disease Progression, Disease-Free Survival, Double-Blind Method, Drug Administration Schedule, Drug Resistance, Neoplasm, Fatigue/chemically induced, Humans, Indoles/administration & dosage/adverse effects, Kaplan-Meier Estimate, Lymphopenia/chemically induced, Male, Middle Aged, Neoplasm Metastasis, Orchiectomy, pfizer, Prednisone/administration & dosage/adverse effects/*therapeutic use, Prostatic Neoplasms/*drug therapy/pathology, Pyrroles/administration & dosage/adverse effects, Taxoids/therapeutic use, Treatment Outcome |
| Date Added | 2018/07/20 - 10:05:58 |
| Date Modified | 2019/10/24 - 17:21:07 |
| Notes and Attachments | (Note) (Note) 24323035 (Attachment) |
Institut de Recherche en Cancérologie de
