Cited by 665Prostate Cancer Diagnosis and TreatmentProstate Cancer Treatment and ResearchBreast Cancer Treatment Studies

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Radiation with or without Antiandrogen Therapy in Recurrent Prostate Cancer

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Shipley, William U., Seiferheld, Wendy, Lukka, Himanshu R., Major, Pierre P., Heney, Niall M., Grignon, David J., Sartor, Oliver, Patel, Maltibehn P., Bahary, Jean-Paul, Zietman, Anthony L., Pisansky, Thomas M., Zeitzer, Kenneth L., Lawton, Colleen A.F., Feng, Felix Y., Lovett, Richard D., Balogh, Alexander G., Souhami, Luis, Rosenthal, Seth A., Kerlin, Kevin J., Dignam, James J., Pugh, Stephanie L., Sandler, Howard M.·2017·New England Journal of Medicine

DOI 10.1056/nejmoa1607529PMC PMC5444881

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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 .).

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Authors: Shipley, W. U., Seiferheld, W., Lukka, H. R., Major, P. P., Heney, N. M., Grignon, D. J., Sartor, O., Patel, M. P., Bahary, J.-P., Zietman, A. L., Pisansky, T. M., Zeitzer, K. L., Lawton, C. A. F., Feng, F. Y., Lovett, R. D., Balogh, A. G., Souhami, L., Rosenthal, S. A., Kerlin, K. J., Dignam, J. J., Pugh, S. L., & Sandler, H. M.
Affiliations: Cedars-Sinai Medical Center (US)
Tulane University (US)
ORCID: Shipley, William U.
Major, Pierre P.
Grignon, David J.
Sartor, Oliver
Bahary, Jean-Paul
Zietman, Anthony L.
Pisansky, Thomas M.
Zeitzer, Kenneth L.
Feng, Felix Y.
Rosenthal, Seth A.
Dignam, James J.
Pugh, Stephanie L.
Sandler, Howard M.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2017-02-02
Volume: 376
Issue: 5
Pages: 417-428
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1607529
PMC: PMC5444881
OpenAlex: W2585109238
Cited by: 663
References: 29
Citations by year: 2026: 32 · 2025: 54 · 2024: 65 · 2023: 50 · 2022: 63 · 2021: 84 · 2020: 81 · 2019: 86 · 2018: 78 · 2017: 68
FWCI: 70.79
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
Funders: National Cancer Institute (UG1CA189867, U10CA180868, U10CA180801, U10CA021661, U10CA180822)
Topics: Health Sciences › Medicine › Urology › Prostate Cancer Diagnosis and Treatment
Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Prostate Cancer Treatment and Research
Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
Keywords: recurrent prostate cancer, salvage radiotherapy, antiandrogen therapy, bicalutamide, prostate-specific antigen, radical prostatectomy, overall survival, metastatic prostate cancer, gynecomastia, androgen deprivation therapy, lymph node dissection, long-term follow-up
MeSH terms: Aged, Aged, 80 and over, Androgen Antagonists, Anilides, Combined Modality Therapy, Double-Blind Method, Follow-Up Studies, Gynecomastia, Humans, Male, Middle Aged, Neoplasm Metastasis, Neoplasm Recurrence, Local, Neoplasm Staging, Nitriles, Prostatectomy, Prostatic Neoplasms, Radiotherapy, Tosyl Compounds, Incidence, Survival Rate, Kaplan-Meier Estimate

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