title: Effect of Long-Term Hormonal Therapy (vs Short-Term Hormonal Therapy): A Secondary Analysis of Intermediate-Risk Prostate Cancer Patients Treated on NRG Oncology RTOG 9202.
abstract: NRG Oncology RTOG 9202 was a randomized trial testing long-term adjuvant androgen deprivation (LTAD) versus initial androgen deprivation only (STAD) with external beam radiation therapy (RT) in mostly high-risk and some intermediate-risk prostate cancer patients. RTOG 9408 found an overall survival (OS) advantage in patients with cT1b-T2b disease and prostate-specific antigen (PSA) <20 ng/mL, with benefit observed mostly among intermediate-risk patients. It was still unknown whether intermediate-risk patients would experience an additional survival benefit with LTAD; thus, we performed a secondary analysis to explore whether LTAD had any incremental benefit beyond STAD among the intermediate-risk subset of RTOG 9202. The study endpoints were OS, disease-specific survival (DSS), and PSA failure (PSAF).
  
  
  
  An analysis was performed for all patients enrolled in RTOG 9202 defined as intermediate-risk (cT2 disease, PSA<10 ng/mL, and Gleason score = 7 or cT2 disease, PSA 10-20 ng/mL, and Gleason score <7). This review yielded 133 patients: 74 (STAD) and 59 (LTAD). The Kaplan-Meier method was used to estimate OS; the cumulative incidence approach was used to estimate DSS and PSAF. A 2-sided test was used, with significance level defined to be .05.
  
  
  
  With over 11 years of median follow-up, 39 STAD patients were alive and 33 LTAD patients were alive. There was no difference in OS (10-year estimates, 61% STAD vs 65% LTAD; P=.53), DSS (10-year DSS, 96% vs 97%; P=.72), or PSAF (10-year PSAF, 53% vs 55%; P=.99) between groups.
  
  
  
  LTAD did not confer a benefit in terms of OS, DSS, or PSAF rates in the intermediate-risk subset in this study. Whereas the subset was relatively small, treatment assignment was randomly applied, and a trend in favor of LTAD would have been of interest. Given the small number of disease-specific deaths observed and lack of benefit with respect to our endpoints, this secondary analysis does not suggest that exploration of longer hormonal therapy is worth testing in the intermediate-risk prostate cancer subset.
authors.affiliation: Cedars-Sinai Medical Center, Los Angeles, California. Electronic address: amin.mirhadi@cshs.org.
authors.forename: Amin J
authors.initials: AJ
authors.lastname: Mirhadi
authors.affiliation: NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.
authors.forename: Qiang
authors.initials: Q
authors.lastname: Zhang
authors.affiliation: Fox Chase Cancer Center, Philadelphia, Pennsylvania.
authors.forename: Gerald E
authors.initials: GE
authors.lastname: Hanks
authors.affiliation: NYU Medical Center, New York, New York.
authors.forename: Herbert
authors.initials: H
authors.lastname: Lepor
authors.affiliation: Indiana University, Indianapolis, Indiana.
authors.forename: David J
authors.initials: DJ
authors.lastname: Grignon
authors.affiliation: Northeast Radiation Oncology Center, Dunmore, Pennsylvania.
authors.forename: Christopher A
authors.initials: CA
authors.lastname: Peters
authors.affiliation: Sutter General Hospital, Sacramento, California.
authors.forename: Seth A
authors.initials: SA
authors.lastname: Rosenthal
authors.affiliation: Albert Einstein Medical Center, Philadelphia, Pennsylvania.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Zeitzer
authors.affiliation: London Regional Cancer Program, London, Ontario, Canada.
authors.forename: John S
authors.initials: JS
authors.lastname: Radwan
authors.affiliation: Medical College of Wisconsin, Milwaukee, Wisconsin.
authors.forename: Colleen
authors.initials: C
authors.lastname: Lawton
authors.affiliation: Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Matthew B
authors.initials: MB
authors.lastname: Parliament
authors.affiliation: Cedars-Sinai Medical Center, Los Angeles, California.
authors.forename: Robert S
authors.initials: RS
authors.lastname: Reznik
authors.affiliation: Cedars-Sinai Medical Center, Los Angeles, California.
authors.forename: Howard M
authors.initials: HM
authors.lastname: Sandler
mesh_terms: D000230:Adenocarcinoma; D000368:Aged; D000369:Aged, 80 and over; D000726:Androgen Antagonists / Q000627:therapeutic use*; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D003131:Combined Modality Therapy / Q000379:methods; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000097:blood* / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D020266:Radiotherapy, Conformal; D012189:Retrospective Studies; D012306:Risk; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000726:Androgen Antagonists; D018931:Antineoplastic Agents, Hormonal; D017430:Prostate-Specific Antigen