Abiraterone and Increased Survival in Metastatic Prostate Cancer
In this study, abiraterone acetate inhibited androgen synthesis and prolonged survival by 4 months among men with castration-resistant prostate cancer that had progressed with docetaxel chemotherapy. For the past 70 years, depleting or blocking the action of androgens has been the standard of care f...
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| Published in | The New England journal of medicine Vol. 364; no. 21; pp. 1995 - 2005 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Waltham, MA
Massachusetts Medical Society
26.05.2011
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| Subjects | |
| Online Access | Get full text |
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| Abstract | In this study, abiraterone acetate inhibited androgen synthesis and prolonged survival by 4 months among men with castration-resistant prostate cancer that had progressed with docetaxel chemotherapy.
For the past 70 years, depleting or blocking the action of androgens has been the standard of care for men with advanced prostate cancer.
1
Androgen deprivation results in a decrease in the concentration of prostate-specific antigen (PSA) as well as tumor regression and relief of symptoms in most patients, but the response to treatment is not durable in patients with advanced cancer, and with time, PSA concentrations increase, indicating reactivated androgen-receptor signaling and a transition to a castration-resistant state that is invariably fatal.
2
Many endocrine therapies have been evaluated in these patients, but none have prolonged survival.
3
Three nonhormonal systemic . . . |
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| AbstractList | Biosynthesis of extragonadal androgen may contribute to the progression of castration-resistant prostate cancer. We evaluated whether abiraterone acetate, an inhibitor of androgen biosynthesis, prolongs overall survival among patients with metastatic castration-resistant prostate cancer who have received chemotherapy.BACKGROUNDBiosynthesis of extragonadal androgen may contribute to the progression of castration-resistant prostate cancer. We evaluated whether abiraterone acetate, an inhibitor of androgen biosynthesis, prolongs overall survival among patients with metastatic castration-resistant prostate cancer who have received chemotherapy.We randomly assigned, in a 2:1 ratio, 1195 patients who had previously received docetaxel to receive 5 mg of prednisone twice daily with either 1000 mg of abiraterone acetate (797 patients) or placebo (398 patients). The primary end point was overall survival. The secondary end points included time to prostate-specific antigen (PSA) progression (elevation in the PSA level according to prespecified criteria), progression-free survival according to radiologic findings based on prespecified criteria, and the PSA response rate.METHODSWe randomly assigned, in a 2:1 ratio, 1195 patients who had previously received docetaxel to receive 5 mg of prednisone twice daily with either 1000 mg of abiraterone acetate (797 patients) or placebo (398 patients). The primary end point was overall survival. The secondary end points included time to prostate-specific antigen (PSA) progression (elevation in the PSA level according to prespecified criteria), progression-free survival according to radiologic findings based on prespecified criteria, and the PSA response rate.After a median follow-up of 12.8 months, overall survival was longer in the abiraterone acetate-prednisone group than in the placebo-prednisone group (14.8 months vs. 10.9 months; hazard ratio, 0.65; 95% confidence interval, 0.54 to 0.77; P<0.001). Data were unblinded at the interim analysis, since these results exceeded the preplanned criteria for study termination. All secondary end points, including time to PSA progression (10.2 vs. 6.6 months; P<0.001), progression-free survival (5.6 months vs. 3.6 months; P<0.001), and PSA response rate (29% vs. 6%, P<0.001), favored the treatment group. Mineralocorticoid-related adverse events, including fluid retention, hypertension, and hypokalemia, were more frequently reported in the abiraterone acetate-prednisone group than in the placebo-prednisone group.RESULTSAfter a median follow-up of 12.8 months, overall survival was longer in the abiraterone acetate-prednisone group than in the placebo-prednisone group (14.8 months vs. 10.9 months; hazard ratio, 0.65; 95% confidence interval, 0.54 to 0.77; P<0.001). Data were unblinded at the interim analysis, since these results exceeded the preplanned criteria for study termination. All secondary end points, including time to PSA progression (10.2 vs. 6.6 months; P<0.001), progression-free survival (5.6 months vs. 3.6 months; P<0.001), and PSA response rate (29% vs. 6%, P<0.001), favored the treatment group. Mineralocorticoid-related adverse events, including fluid retention, hypertension, and hypokalemia, were more frequently reported in the abiraterone acetate-prednisone group than in the placebo-prednisone group.The inhibition of androgen biosynthesis by abiraterone acetate prolonged overall survival among patients with metastatic castration-resistant prostate cancer who previously received chemotherapy. (Funded by Cougar Biotechnology; COU-AA-301 ClinicalTrials.gov number, NCT00638690.).CONCLUSIONSThe inhibition of androgen biosynthesis by abiraterone acetate prolonged overall survival among patients with metastatic castration-resistant prostate cancer who previously received chemotherapy. (Funded by Cougar Biotechnology; COU-AA-301 ClinicalTrials.gov number, NCT00638690.). Biosynthesis of extragonadal androgen may contribute to the progression of castration-resistant prostate cancer. We evaluated whether abiraterone acetate, an inhibitor of androgen biosynthesis, prolongs overall survival among patients with metastatic castration-resistant prostate cancer who have received chemotherapy. We randomly assigned, in a 2:1 ratio, 1195 patients who had previously received docetaxel to receive 5 mg of prednisone twice daily with either 1000 mg of abiraterone acetate (797 patients) or placebo (398 patients). The primary end point was overall survival. The secondary end points included time to prostate-specific antigen (PSA) progression (elevation in the PSA level according to prespecified criteria), progression-free survival according to radiologic findings based on prespecified criteria, and the PSA response rate. After a median follow-up of 12.8 months, overall survival was longer in the abiraterone acetate-prednisone group than in the placebo-prednisone group (14.8 months vs. 10.9 months; hazard ratio, 0.65; 95% confidence interval, 0.54 to 0.77; P<0.001). Data were unblinded at the interim analysis, since these results exceeded the preplanned criteria for study termination. All secondary end points, including time to PSA progression (10.2 vs. 6.6 months; P<0.001), progression-free survival (5.6 months vs. 3.6 months; P<0.001), and PSA response rate (29% vs. 6%, P<0.001), favored the treatment group. Mineralocorticoid-related adverse events, including fluid retention, hypertension, and hypokalemia, were more frequently reported in the abiraterone acetate-prednisone group than in the placebo-prednisone group. The inhibition of androgen biosynthesis by abiraterone acetate prolonged overall survival among patients with metastatic castration-resistant prostate cancer who previously received chemotherapy. (Funded by Cougar Biotechnology; COU-AA-301 ClinicalTrials.gov number, NCT00638690.). BackgroundBiosynthesis of extragonadal androgen may contribute to the progression of castration-resistant prostate cancer. We evaluated whether abiraterone acetate, an inhibitor of androgen biosynthesis, prolongs overall survival among patients with metastatic castration-resistant prostate cancer who have received chemotherapy.MethodsWe randomly assigned, in a 2:1 ratio, 1195 patients who had previously received docetaxel to receive 5 mg of prednisone twice daily with either 1000 mg of abiraterone acetate (797 patients) or placebo (398 patients). The primary end point was overall survival. The secondary end points included time to prostate-specific antigen (PSA) progression (elevation in the PSA level according to prespecified criteria), progression-free survival according to radiologic findings based on prespecified criteria, and the PSA response rate.ResultsAfter a median follow-up of 12.8 months, overall survival was longer in the abiraterone acetate–prednisone group than in the placebo–prednisone group (14.8 months vs. 10.9 months; hazard ratio, 0.65; 95% confidence interval, 0.54 to 0.77; P<0.001). Data were unblinded at the interim analysis, since these results exceeded the preplanned criteria for study termination. All secondary end points, including time to PSA progression (10.2 vs. 6.6 months; P<0.001), progression-free survival (5.6 months vs. 3.6 months; P<0.001), and PSA response rate (29% vs. 6%, P<0.001), favored the treatment group. Mineralocorticoid-related adverse events, including fluid retention, hypertension, and hypokalemia, were more frequently reported in the abiraterone acetate–prednisone group than in the placebo–prednisone group.ConclusionsThe inhibition of androgen biosynthesis by abiraterone acetate prolonged overall survival among patients with metastatic castration-resistant prostate cancer who previously received chemotherapy. (Funded by Cougar Biotechnology; COU-AA-301 ClinicalTrials.gov number, NCT00638690.) In this study, abiraterone acetate inhibited androgen synthesis and prolonged survival by 4 months among men with castration-resistant prostate cancer that had progressed with docetaxel chemotherapy. For the past 70 years, depleting or blocking the action of androgens has been the standard of care for men with advanced prostate cancer. 1 Androgen deprivation results in a decrease in the concentration of prostate-specific antigen (PSA) as well as tumor regression and relief of symptoms in most patients, but the response to treatment is not durable in patients with advanced cancer, and with time, PSA concentrations increase, indicating reactivated androgen-receptor signaling and a transition to a castration-resistant state that is invariably fatal. 2 Many endocrine therapies have been evaluated in these patients, but none have prolonged survival. 3 Three nonhormonal systemic . . . |
| Author | Jones, Robert J Chi, Kim N Mainwaring, Paul Saleh, Mansoor Chu, Luis Bianchini, Diletta Molina, Arturo Staffurth, John N Patterson, Helen Chieffo, Nicole de Bono, Johann S Scholz, Mark Ryan, Charles J Goodman, Oscar B Kheoh, Thian Ellard, Susan L Fizazi, Karim Cheng, Tina Scher, Howard I Saad, Fred Hutson, Thomas E Efstathiou, Eleni North, Scott Flaig, Thomas W Loriot, Yohann Harland, Stephen Sternberg, Cora N Logothetis, Christopher J Hainsworth, John D Fléchon, Aude Haqq, Christopher M Zivi, Andrea |
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| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24185881$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/21612468$$D View this record in MEDLINE/PubMed |
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| CODEN | NEJMAG |
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| ContentType | Journal Article |
| Contributor | Waxman, J Glasgow, A Breathnach, O Lara, P Alam, M Hoskin Galsky, M Schöffski, P Denmeade, S McDermott, R Protheroe, A Carney, J Parnis, F Messina, C Assikis, V Bellmunt, J Lynch, R Van Hazel, G Villa, E Conte, P Durkan, G Germa Lluch, J Bird, B Hahn, N Algeri, R Suttmann, H Janku, F Deshpande, H Rottey, S Krakowski, I Oudard, S Brown, M Rajan, R Joly, F Zanetta, S Berry, W Elliot, T Stöckle, M Mulders, P Marx, G Koletsky, A Clingan, P Burke, J Werbrouck, P Cosgriff, T Janetschek, G Boni, C Gabrail, N Inglis, P O'Reilly, S Van Aelst, F Abadie, S Davis, I Wenczl, M Appelman, L Gore, I de Souza, P Kelly, W Jancewicz, M Chu, L Wood, L Arrowsmith, E Ng, S Nottage, M James, N Costello, A Schrijvers, D Wirth, M McCaffrey, J Salamon, C Kaplan, R Marberger, M Underhill, C Nott, L Renard, V Sautois, B Luyten, D Wynendaele, W Cohen, N Dakhil, S Ferrari, A Ernst, S Michels, J Klotz, L Baron, A Curti, B Duran, I Horvath, L O'Sullivan, J Machiels, J Hotte, S Wong, S Hamid, O Rolland, F Miller, K Harris, J George, D Loidl, W Pfister, D Crane, E |
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| Copyright | Copyright © 2011 Massachusetts Medical Society. All rights reserved. 2015 INIST-CNRS Copyright © 2011 Massachusetts Medical Society. 2011 |
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| Keywords | Urinary system disease Prostate disease Abiraterone Antiandrogen Antihormone Malignant tumor Metastasis Survival Medicine Advanced stage Metastatic Male genital diseases Prostate cancer Cancer |
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| Snippet | In this study, abiraterone acetate inhibited androgen synthesis and prolonged survival by 4 months among men with castration-resistant prostate cancer that had... Biosynthesis of extragonadal androgen may contribute to the progression of castration-resistant prostate cancer. We evaluated whether abiraterone acetate, an... BackgroundBiosynthesis of extragonadal androgen may contribute to the progression of castration-resistant prostate cancer. We evaluated whether abiraterone... |
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| StartPage | 1995 |
| SubjectTerms | Acetic acid Aged Androgen Antagonists - adverse effects Androgen Antagonists - therapeutic use Androgens Androgens - biosynthesis Androstenes Androstenols - adverse effects Androstenols - therapeutic use Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences Biosynthesis Biotechnology Cancer therapies Castration Chemotherapy Disease Progression Double-Blind Method Fatigue - chemically induced Fees & charges General aspects Gynecology. Andrology. Obstetrics Humans Hypertension Hypokalemia Kaplan-Meier Estimate Laboratories Male Male genital diseases Medical research Medical sciences Metastases Middle Aged Neoplasm Metastasis Nephrology. Urinary tract diseases Oncology Pain Patients Prednisone Prednisone - therapeutic use Prostate cancer Prostate-specific antigen Prostatic Neoplasms - drug therapy Prostatic Neoplasms - mortality Prostatic Neoplasms - pathology Steroid 17-alpha-Hydroxylase - antagonists & inhibitors Survival Survival Analysis Treatment Outcome Tumors Tumors of the urinary system Urinary tract. Prostate gland |
| Title | Abiraterone and Increased Survival in Metastatic Prostate Cancer |
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