1. Adding Short-Term Androgen Deprivation Therapy to Radiation Therapy in Men With Localized Prostate Cancer: Long-Term Update of the NRG/RTOG 9408 Randomized Clinical Trial.
- Author
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Jones, Christopher U, Jones, Christopher U, Pugh, Stephanie L, Sandler, Howard M, Chetner, Michael P, Amin, Mahul B, Bruner, Deborah W, Zietman, Anthony L, Den, Robert B, Leibenhaut, Mark H, Longo, John M, Bahary, Jean-Paul, Rosenthal, Seth A, Souhami, Luis, Michalski, Jeff M, Hartford, Alan C, Amin, Pradip P, Roach, Mack, Yee, Don, Efstathiou, Jason A, Rodgers, Joseph P, Feng, Felix Y, Shipley, William U, Jones, Christopher U, Jones, Christopher U, Pugh, Stephanie L, Sandler, Howard M, Chetner, Michael P, Amin, Mahul B, Bruner, Deborah W, Zietman, Anthony L, Den, Robert B, Leibenhaut, Mark H, Longo, John M, Bahary, Jean-Paul, Rosenthal, Seth A, Souhami, Luis, Michalski, Jeff M, Hartford, Alan C, Amin, Pradip P, Roach, Mack, Yee, Don, Efstathiou, Jason A, Rodgers, Joseph P, Feng, Felix Y, and Shipley, William U
- Abstract
PurposeFor men with localized prostate cancer, NRG Oncology/Radiation Therapy Oncology Group (RTOG) 9408 demonstrated that adding short-term androgen deprivation therapy (ADT) to radiation therapy (RT) improved the primary endpoint of overall survival (OS) and improved disease-specific mortality (DSM), biochemical failure (BF), local progression, and freedom from distant metastases (DM). This study was performed to determine whether the short-term ADT continued to improve OS, DSM, BF, and freedom from DM with longer follow-up.Methods and materialsFrom 1994 to 2001, NRG/RTOG 9408 randomized 2028 men from 212 North American institutions with T1b-T2b, N0 prostate adenocarcinoma and prostate-specific antigen (PSA) ≤20ng/mL to RT alone or RT plus short-term ADT. Patients were stratified by PSA, tumor grade, and surgical versus clinical nodal staging. ADT was flutamide with either goserelin or leuprolide for 4 months. Prostate RT (66.6 Gy) was started after 2 months. OS was calculated at the date of death from any cause or at last follow-up. Secondary endpoints were DSM, BF, local progression, and DM. Acute and late toxic effects were assessed using RTOG toxicity scales.ResultsMedian follow-up in surviving patients was 14.8 years (range, 0.16-21.98). The 10-year and 18-year OS was 56% and 23%, respectively, with RT alone versus 63% and 23% with combined therapy (HR 0.94; 95% confidence interval [CI], 0.85-1.05; P = .94). The hazards were not proportional (P = .003). Estimated restricted mean survival time at 18 years was 11.8 years (95% CI, 11.4-12.1) with combined therapy versus 11.3 years with RT alone (95% CI, 10.9-11.6; P = .05). The 10-year and 18-year DSM was 7% and 14%, respectively, with RT alone versus 3% and 8% with combined therapy (HR 0.56; 95% CI, 0.41-0.75; P < .01). DM and BF favored combined therapy at 18 years. Rates of late grade ≥3 hepatic, gastrointestinal, and genitourinary toxicity were ≤1%, 3%, and 8%, respectively
- Published
- 2022