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Pollack A , Walker G , Horwitz EM , Price R , Feigenberg S , Konski AA , Stoyanova R , Movsas B , Greenberg RE , Uzzo RG , Ma C , Buyyounouski MK
Randomized trial of hypofractionated external-beam radiotherapy for prostate cancer
J Clin Oncol. 2013 Nov 1;31(31) :3860-8
PMID: 24101042    PMCID: PMC 3805927   
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Abstract
PURPOSE: To determine if escalated radiation dose using hypofractionation significantly reduces biochemical and/or clinical disease failure (BCDF) in men treated primarily for prostate cancer. PATIENTS AND METHODS: Between June 2002 and May 2006, men with favorable- to high-risk prostate cancer were randomly allocated to receive 76 Gy in 38 fractions at 2.0 Gy per fraction (conventional fractionation intensity-modulated radiation therapy [CIMRT]) versus 70.2 Gy in 26 fractions at 2.7 Gy per fraction (hypofractionated IMRT [HIMRT]); the latter was estimated to be equivalent to 84.4 Gy in 2.0 Gy fractions. High-risk patients received long-term androgen deprivation therapy (ADT), and some intermediate-risk patients received short-term ADT. The primary end point was the cumulative incidence of BCDF. Secondarily, toxicity was assessed. RESULTS: There were 303 assessable patients with a median follow-up of 68.4 months. No significant differences were seen between the treatment arms in terms of the distribution of patients by clinicopathologic or treatment-related (ADT use and length) factors. The 5-year rates of BCDF were 21.4% (95% CI, 14.8% to 28.7%) for CIMRT and 23.3% (95% CI, 16.4% to 31.0%) for HIMRT (P = .745). There were no statistically significant differences in late toxicity between the arms; however, in subgroup analysis, patients with compromised urinary function before enrollment had significantly worse urinary function after HIMRT. CONCLUSION: The hypofractionation regimen did not result in a significant reduction in BCDF; however, it is delivered in 2.5 fewer weeks. Men with compromised urinary function before treatment may not be ideal candidates for this approach.
Notes
Pollack, Alan Walker, Gail Horwitz, Eric M Price, Robert Feigenberg, Steven Konski, Andre A Stoyanova, Radka Movsas, Benjamin Greenberg, Richard E Uzzo, Robert G Ma, Charlie Buyyounouski, Mark K United States Journal of clinical oncology : official journal of the American Society of Clinical Oncology J Clin Oncol. 2013 Nov 1;31(31):3860-8. doi: 10.1200/JCO.2013.51.1972. Epub 2013 Oct 7.