| Article Title: |
Short-term androgen deprivation and radiotherapy for locally advanced prostate cancer: Results from the Trans-Tasman Radiation Oncology Group 96.01 randomised controlled trial. Denham JW, Steigler A, Lamb DS, Joseph D, Mameghan H, Turner S, Matthews J, Franklin I, Atkinson C, North J, Poulsen M, Christie D, Spry NA, Tai K-H, Wynne C, Duchesne G, Kovacev O, D'Este C, Trans-Tasman Radiation Oncology Group, Newcastle Mater Hospital, Newcastle, New South Wales, Australia |
| Abstract: |
Background: Androgen deprivation is an established treatment regimen for disseminated prostate cancer; however, its role in patients with localised cancer is less clear. We did a large randomised controlled trial to determine whether 3 months or 6 months of androgen deprivation given before and during radiotherapy improves outcomes for patients with locally advanced prostate cancer. Methods: 818 men with locally advanced prostate cancer were randomly assigned to: no androgen deprivation (ie, radiotherapy alone: 66 Gy in 33 fractions of 2 Gy per day over 6.5-7.0 weeks to the prostate and seminal vesicles); 3 months' androgen deprivation with 3.6 mg goserelin given subcutaneously every month and 250 mg flutamide given orally three times a day starting 2 months before radiotherapy (same regimen as control group); or 6 months' androgen deprivation, with the same regimen, starting 5 months before radiotherapy (same regimen as control group). Primary endpoints were time to local failure and prostate-cancer-specific survival; secondary endpoints were distant failure, disease-free survival, and freedom from salvage treatment. Analyses were done by intention to treat. Findings: 802 (98%) patients were eligible for analysis. Median follow-up was 5.9 years (range 0.1-8.5). Compared with patients assigned no androgen deprivation, those assigned 3 months' treatment had significantly improved local failure (hazard ratio [HR] 0.56 [95% CI 0.39-0.79], p = 0.001), biochemical failure-free survival (0.70 [0.56-0.88], p = 0.002), disease-free survival (0.65 [0.52-0.80], p = 0.0001), and freedom from salvage treatment (0.73 [0.56-0.96], p = 0.025). 6 months' androgen deprivation significantly improved local failure (0.42 [0.28-0.62], p < 0.0001), biochemical failure-free survival (0.58 [0.46-0.74], p < 0.0001), disease-free survival (0.56 [0.45-0.69], p < 0.0001), freedom from salvage treatment (0.53 [0.40-0.71], p < 0.0001), distant failure (0.67 [0.45-0.99], p = 0.046) and prostate-cancer-specific survival (0.56 [0.32-0.98], p = 0.04) compared with no androgen deprivation. Interpretation: 6 months' androgen deprivation given before and during radiotherapy improves the outlook of patients with locally advanced prostate cancer. Further follow-up is needed to estimate precisely the size of survival benefits. Increased radiation doses and additional periods of androgen deprivation might lead to further benefit. © 2006 Elsevier Inc. All rights reserved. |
