Androgen Suppression Combined with Elective Nodal and Dose Escalated Radiation Therapy (the ASCENDE-RT Trial): An Analysis of Survival Endpoints for a Randomized Trial Comparing a Low-Dose-Rate Brachytherapy Boost to a Dose-Escalated External Beam Boost for High- and Intermediate-risk Prostate Cancer

作者：Morris, W. James^*; Tyldesley, Scott; Rodda, Sree; Halperin, Ross; Pai, Howard; McKenzie, Michael; Duncan, Graeme; Morton, Gerard; Hamm, Jeremy; Murray, Nevin

来源：International Journal of Radiation Oncology, Biology, Physics, 2017, 98(2): 275-285.

DOI：10.1016/j.ijrobp.2016.11.026

• INTENSITY-MODULATED RADIOTHERAPY
• RADICAL PROSTATECTOMY
• FAILURE
• OUTCOMES
• DISEASE
• ANTIGEN
• IRRADIATION
• PATTERNS

Purpose: To report the primary endpoint of biochemical progression-free survival (bPFS) and secondary survival endpoints from ASCENDE-RT, a randomized trial comparing 2 methods of dose escalation for intermediate-and high-risk prostate cancer. @@@ Methods and Materials: ASCENDE-RTenrolled 398men, with amedian age of 68 years; 69% (n = 276) had high-risk disease. After stratification by risk group, the subjects were randomized to a standard arm with 12 months of androgen deprivation therapy, pelvic irradiation to 46 Gy, followed by a dose-escalated external beamradiation therapy (DE-EBRT) boost to 78 Gy, or an experimental arm that substituted a low-dose-rate prostate brachytherapy (LDR-PB) boost. Of the 398 trial subjects, 200 were assigned to DE-EBRT boost and 198 to LDR-PB boost. The median follow-up was 6.5 years. @@@ Results: In an intent-to-treat analysis, men randomized to DE-EBRTwere twice as likely to experience biochemical failure (multivariable analysis [MVA] hazard ratio [HR] 2.04; P= .004). The 5-, 7-, and 9-year Kaplan-Meier b-PFS estimates were 89%, 86%, and 83% for the LDR-PB boost versus 84%, 75%, and 62% for the DE-EBRT boost (log-rank P<.001). The LDR-PB boost benefited both intermediate- and high-risk patients. Because the b-PFS curves for the treatment arms diverge sharply after 4 years, the relative advantage of the LDR-PB should increase with longer follow-up. OnMVA, the only variables correlated with reduced overall survival were age (MVA HR 1.06/y; P = .004) and biochemical failure (MVA HR 6.30; P<.001). Although biochemical failure was associated with increased mortality and randomization to DE-EBRT doubled the rate of biochemical failure, no significant overall survival difference was observed between the treatment arms (MVA HR 1.13; P= .62). @@@ Conclusions: Compared with 78 Gy EBRT, men randomized to the LDR-PB boost were twice as likely to be free of biochemical failure at amedian follow-up of 6.5 years.

• 出版日期2017-6-1