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EVERAL RANDOMIZED STUDIES [1][2][3][4][5] have documented a prolongation in overall survival, prostate cancer-specific survival, or both when androgen suppression therapy (AST) is combined with external beam radiation therapy (RT) compared with RT alone in the management of unfavorable localized and locally advanced prostate cancer. Therefore, in men with these stages of disease, RT and AST have become a standard of care.However, evidence from pooled analyses of randomized studies 6 as well as large patient cohort studies 7,8 suggests that AST administration is associated with an increased risk of fatal 6 and nonfatal 7,8 cardiovascular events in men of advanced age. A possible explanation for this association is that as men age, they often acquire comorbid illnesses and these comorbidities may increase the negative effects of specific anticancer treatments such as AST. As a result, it is possible that the survival benefit observed when AST is added to RT may vary among specific subsets of patients defined by their comorbid illness profile.In this study, we first report the results of the long-term follow-up of a randomized study of 6 months of AST and RT vs RT alone. The results of shorterterm follow-up, ie, at 4.5 years, have been previously reported. 5 In addition, we performed an analysis of overall survival in subgroups defined by their level of comorbidity at the time of randomization and evaluated whether an interaction existed between the level of comorbidity and treatment group with respect to time to all-cause mortality. METHODSPatient Population and Treatment At academic (Dana-Farber Cancer Institute, Brigham and Women's Hospital, and Beth Israel Deaconess Medical Center) and community-based (St Anne's Hospital, Metrowest Medical Center, and Suburban Oncology Center) medical centers in Massachusetts,

BACKGROUNDTo the authors' knowledge, consensus is lacking regarding the relative long‐term efficacy of radical prostatectomy (RP) versus conventional‐dose external beam radiation therapy (RT) in the treatment of patients with clinically localized prostate carcinoma.METHODSA retrospective cohort study of 2635 men treated with RP (n = 2254) or conventional‐dose RT (n = 381) between 1988–2000 was performed. The primary endpoint was prostate specific antigen (PSA) survival stratified by treatment received and high‐risk, intermediate‐risk, or low‐risk group based on the serum PSA level, biopsy Gleason score, 1992 American Joint Commission on Cancer clinical tumor category, and percent positive prostate biopsies.RESULTSEstimates of 8‐year PSA survival (95% confidence interval [95% CI]) for low‐risk patients (T1c,T2a, a PSA level ≤ 10 ng/mL, and a Gleason score ≤ 6) were 88% (95% CI, 85, 90) versus 78% (95% CI, 72, 83) for RP versus patients treated with RT, respectively. Eight‐year estimates of PSA survival also favored RP for intermediate‐risk patients (T2b or Gleason score 7 or a PSA level > 10 and ≤ 20 ng/mL) with < 34% positive prostate biopsies, being 79% (95% CI, 73, 85) versus 65% (95% CI, 58, 72), respectively. Estimates of PSA survival in high‐risk (T2c or PSA level > 20 ng/mL or Gleason score ≥ 8) and intermediate‐risk patients with at least 34% positive prostate biopsies initially favored RT, but were not significantly different after 8 years.CONCLUSIONSIntermediate‐risk and low‐risk patients with a low biopsy tumor volume who were treated with RP appeared to fare significantly better compared with patients who were treated using conventional‐dose RT. Intermediate‐risk and high‐risk patients with a high biopsy tumor volume who were treated with RP or RT had long‐term estimates of PSA survival that were not found to be significantly different. [See editorials on pages 211–4 and 215–8, this issue. Cancer 2002;95:281–6. © 2002 American Cancer Society.DOI 10.1002/cncr.10657