방사선의학 웹진

바로가기  >

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 .).

Comment in

Improved Therapy for PSA Recurrence after Prostatectomy. [N Engl J Med. 2017]​ 

Author information

Shipley WU1, Seiferheld W1, Lukka HR1, Major PP1, Heney NM1, Grignon DJ1, Sartor O1, Patel MP1, Bahary JP1, Zietman AL1, Pisansky TM1, Zeitzer KL1, Lawton CA1, Feng FY1, Lovett RD1, Balogh AG1, Souhami L1, Rosenthal SA1, Kerlin KJ1, Dignam JJ1, Pugh SL1, Sandler HM1; NRG Oncology RTOG.

1 From Massachusetts General Hospital and Harvard Medical School, Boston (W.U.S., N.M.H., A.L.Z.); NRG Oncology Statistics and Data Management Center (W.S., J.J.D., S.L.P.) and Einstein Medical Center (K.L.Z.), Philadelphia; Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON (H.R.L., P.P.M., M.P.P.), Hospital Notre-Dame du Centre Hospitalier de l'Université de Montréal (J.-P.B.) and McGill University Health Centre (L.S.), Montreal, and Tom Baker Cancer Centre, Calgary, AB (A.G.B.) - all in Canada; Indiana University, Indianapolis (D.J.G.); Tulane University, New Orleans (O.S.); Mayo Clinic, Rochester, MN (T.M.P.); Medical College of Wisconsin, Milwaukee (C.A.F.L.); University of Michigan, Ann Arbor (F.Y.F.); University of Vermont Medical Center, Burlington (R.D.L.); Radiation Oncology Center, Sacramento (S.A.R.), and Cedars-Sinai Medical Center, Los Angeles (H.M.S.) - both in California; Wayne Radiation Oncology, Goldsboro, NC (K.J.K.); and the University of Chicago, Chicago (J.J.D.).