Title |
Radiation with or without Antiandrogen Therapy in Recurrent Prostate Cancer
|
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Published in |
New England Journal of Medicine, February 2017
|
DOI | 10.1056/nejmoa1607529 |
Pubmed ID | |
Authors |
William U Shipley, Wendy Seiferheld, Himanshu R Lukka, Pierre P Major, Niall M Heney, David J Grignon, Oliver Sartor, Maltibehn P Patel, Jean-Paul Bahary, Anthony L Zietman, Thomas M Pisansky, Kenneth L Zeitzer, Colleen A F Lawton, Felix Y Feng, Richard D Lovett, Alexander G Balogh, Luis Souhami, Seth A Rosenthal, Kevin J Kerlin, James J Dignam, Stephanie L Pugh, Howard M Sandler |
Abstract |
Background Salvage radiation therapy is often necessary in men who have undergone radical prostatectomy and have evidence of prostate-cancer recurrence signaled by a persistently or recurrently elevated prostate-specific antigen (PSA) level. Whether antiandrogen therapy with radiation therapy will further improve cancer control and prolong overall survival is unknown. Methods In a double-blind, placebo-controlled trial conducted from 1998 through 2003, we assigned 760 eligible patients who had undergone prostatectomy with a lymphadenectomy and had disease, as assessed on pathological testing, with a tumor stage of T2 (confined to the prostate but with a positive surgical margin) or T3 (with histologic extension beyond the prostatic capsule), no nodal involvement, and a detectable PSA level of 0.2 to 4.0 ng per milliliter to undergo radiation therapy and receive either antiandrogen therapy (24 months of bicalutamide at a dose of 150 mg daily) or daily placebo tablets during and after radiation therapy. The primary end point was the rate of overall survival. Results The median follow-up among the surviving patients was 13 years. The actuarial rate of overall survival at 12 years was 76.3% in the bicalutamide group, as compared with 71.3% in the placebo group (hazard ratio for death, 0.77; 95% confidence interval, 0.59 to 0.99; P=0.04). The 12-year incidence of death from prostate cancer, as assessed by means of central review, was 5.8% in the bicalutamide group, as compared with 13.4% in the placebo group (P<0.001). The cumulative incidence of metastatic prostate cancer at 12 years was 14.5% in the bicalutamide group, as compared with 23.0% in the placebo group (P=0.005). The incidence of late adverse events associated with radiation therapy was similar in the two groups. Gynecomastia was recorded in 69.7% of the patients in the bicalutamide group, as compared with 10.9% of those in the placebo group (P<0.001). Conclusions The addition of 24 months of antiandrogen therapy with daily bicalutamide to salvage radiation therapy resulted in significantly higher rates of long-term overall survival and lower incidences of metastatic prostate cancer and death from prostate cancer than radiation therapy plus placebo. (Funded by the National Cancer Institute and AstraZeneca; RTOG 9601 ClinicalTrials.gov number, NCT00002874 .). |
X Demographics
Geographical breakdown
Country | Count | As % |
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United States | 76 | 30% |
Spain | 18 | 7% |
Brazil | 16 | 6% |
Canada | 11 | 4% |
United Kingdom | 11 | 4% |
France | 6 | 2% |
Turkey | 5 | 2% |
Mexico | 5 | 2% |
Australia | 5 | 2% |
Other | 29 | 12% |
Unknown | 68 | 27% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 144 | 58% |
Scientists | 63 | 25% |
Practitioners (doctors, other healthcare professionals) | 38 | 15% |
Science communicators (journalists, bloggers, editors) | 5 | 2% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Germany | 2 | <1% |
Netherlands | 1 | <1% |
Chile | 1 | <1% |
Korea, Republic of | 1 | <1% |
Brazil | 1 | <1% |
Canada | 1 | <1% |
United States | 1 | <1% |
Unknown | 492 | 98% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 103 | 21% |
Other | 64 | 13% |
Student > Postgraduate | 44 | 9% |
Student > Doctoral Student | 40 | 8% |
Student > Bachelor | 39 | 8% |
Other | 111 | 22% |
Unknown | 99 | 20% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 280 | 56% |
Biochemistry, Genetics and Molecular Biology | 23 | 5% |
Agricultural and Biological Sciences | 17 | 3% |
Nursing and Health Professions | 7 | 1% |
Engineering | 7 | 1% |
Other | 33 | 7% |
Unknown | 133 | 27% |