Department of Radiation Oncology, University of Toronto, Toronto, Canada; Princess Margaret Cancer Centre, University Health Network, Toronto, Canada.
Department of Radiation Oncology, University of Toronto, Toronto, Canada; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.
Int J Radiat Oncol Biol Phys. 2024 May 1;119(1):100-109. doi: 10.1016/j.ijrobp.2023.11.006. Epub 2023 Nov 17.
The aim of this work is to report on the results of a phase 2 randomized trial of moderately hypofractionated (MH) versus conventionally fractionated (CF) radiation therapy to the prostate with elective nodal irradiation.
This was a single-center, prospective, phase 2 randomized study. Patients with high-risk disease (cT3, prostate-specific antigen level >20 ng/mL, or Gleason score 8-10) were eligible. Patients were randomized to either MH using a simultaneous integrated boost (68 Gy in 25 fractions to prostate; 48 Gy to pelvis) or CF (46 Gy in 23 fractions with a sequential boost to the prostate of 32 Gy in 16 fractions), with long-term androgen deprivation therapy. The primary endpoint was grade ≥2 acute gastrointestinal (GI) and genitourinary (GU) toxicity (Common Terminology Criteria for Adverse Events version 3.0). Secondary endpoints included late GI and GU toxicity, quality of life, and oncologic outcomes.
One-hundred eighty patients were enrolled; 90 were randomized to and received MH and 90 to CF. The median follow-up was 67.4 months. Seventy-five patients (41.7%) experienced a grade ≥2 acute GI and/or GU toxicity, including 34 (37.8%) in the MH and 41 (45.6%) in the CF arms, respectively (P = .29). Late grade ≥2 GI (P = .07) and GU (P = .25) toxicity was not significantly different between arms; however, late grade ≥3 GI toxicity was worse in the MH group (P = .01). There were no statistically significant quality-of-life differences between the 2 treatments. There were no statistically significant differences observed in cumulative incidence of biochemical failure (P = .71) or distant metastasis (P = .31) and overall survival (P = .46).
MH to the prostate and pelvis with androgen deprivation therapy for men with high-risk localized prostate cancer was not significantly different than CF with regard to acute toxicity, quality of life, and oncologic efficacy. However, late grade ≥3 GI toxicity was more common in the MH arm.
本研究旨在报告前列腺中度适形放疗（MH）与常规适形放疗（CF）联合选择性淋巴结照射治疗高危前列腺癌的 2 期随机临床试验结果。
这是一项单中心前瞻性 2 期随机研究。高危疾病（cT3、前列腺特异性抗原水平>20ng/mL 或 Gleason 评分 8-10）患者符合条件。患者被随机分为 MH 组（前列腺采用同步整合boost，68Gy/25 次；骨盆 48Gy）或 CF 组（前列腺 46Gy/23 次，序贯 boost 32Gy/16 次），同时长期接受雄激素剥夺治疗。主要终点为≥2 级急性胃肠道（GI）和泌尿生殖系统（GU）毒性（不良事件通用术语标准 3.0 版）。次要终点包括晚期 GI 和 GU 毒性、生活质量和肿瘤学结局。
共纳入 180 例患者，90 例接受 MH，90 例接受 CF。中位随访时间为 67.4 个月。75 例（41.7%）发生≥2 级急性 GI 和/或 GU 毒性，MH 组 34 例（37.8%），CF 组 41 例（45.6%），两组无统计学差异（P=0.29）。两组晚期≥2 级 GI（P=0.07）和 GU 毒性（P=0.25）无显著差异；然而，MH 组晚期≥3 级 GI 毒性更严重（P=0.01）。两种治疗方法在生活质量方面无统计学差异。生化失败（P=0.71）、远处转移（P=0.31）和总生存（P=0.46）的累积发生率无统计学差异。
对于高危局限性前列腺癌患者，与 CF 相比，MH 联合前列腺和骨盆雄激素剥夺治疗在急性毒性、生活质量和肿瘤学疗效方面无显著差异。然而，MH 组更常见晚期≥3 级 GI 毒性。
