Prostate high dose-rate brachytherapy as monotherapy for prostate cancer: Late toxicity and patient reported outcomes from a randomized phase II clinical trial

被引:19
作者
Corkum, Mark [1 ]
Loblaw, Andrew [1 ]
Hasan, Yaser [1 ]
Chung, Hans T. [1 ]
Tseng, Chia-Lin [1 ]
McGuffin, Merrylee [1 ]
Cheung, Patrick [1 ]
Szumacher, Ewa [1 ]
Liu, Stanley [1 ]
Chu, William [1 ]
Zhang, Liying [1 ]
Mamedov, Alexandre [1 ]
Morton, Gerard [1 ]
机构
[1] Univ Toronto, Sunnybrook Odette Canc Ctr, Toronto, ON, Canada
关键词
HDR; Monotherapy; Randomized trial; Late toxicity; EPIC;
D O I
10.1016/j.radonc.2020.12.021
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Background and Purpose: Long-term toxicity of high dose-rate brachytherapy as monotherapy for prostate cancer is not well defined. We report late toxicity and health related quality of life (HRQOL) changes from a randomized phase II clinical trial of two different fractionation schemes. Materials and Methods: Eligible patients had NCCN low or intermediate risk prostate cancer. 170 patients were randomized to receive either a single 19 Gy or two-fractions of 13.5 Gy one week apart. Toxicity was measured using Common Terminology for Adverse Events (CTCAE) v4.0, and HRQOL was measured using the Expanded Prostate Index Composite (EPIC). Results: Median follow-up was 63 months. The 5-year cumulative incidence of Grade 2 or higher genitourinary (GU) and gastrointestinal (GI) toxicity was 62% and 12% in the single-fraction arm, and 47% and 9% in the two-fraction arm, respectively. Grade 3 GU toxicity was only seen in the single fraction arm with a cumulative incidence of 2%. The 5-year prevalence of Grade 2 GU toxicity was 29% and 21%, in the single- and two-fraction arms, respectively, with Grade 2 GI toxicity of 1% and 2%. Beyond the first year, no significant differences in mean urinary HRQOL were seen compared to baseline in the two-fraction arm, in contrast to the single-fraction arm where a decline in urinary HRQOL was seen at 4 and 5 years. Sexual HRQOL was significantly reduced in both treatment arms at all timepoints, with no changes in the bowel domain. Conclusions: HDR monotherapy is well tolerated with minimal impact on HRQOL. (C) 2020 Elsevier B.V. All rights reserved.
引用
收藏
页码:160 / 165
页数:6
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