Department of Radiotherapy Oncology, Ghent University Hospital, Ghent, Belgium.
Department of Radiotherapy Oncology, Ghent University Hospital, Ghent, Belgium.
Int J Radiat Oncol Biol Phys. 2018 Mar 15;100(4):866-870. doi: 10.1016/j.ijrobp.2017.12.016. Epub 2017 Dec 19.
Hypofractionated radiation therapy (HFRT) for localized prostate cancer is safe and effective. The question that remains is which hypofractionation schedule to implement. We compared 2 different HFRT regimens in the present study.
From June 2013 to July 2016, 160 patients with prostate cancer were randomly assigned (1:1), within this single-center phase III trial, to 56 Gy (16 fractions of 3.5 Gy; arm A) or 67 Gy (25 fractions of 2.68 Gy; arm B). Randomization was performed using computer-generated permuted blocks, stratified by previous transurethral resection of the prostate and the presence of a dominant intraprostatic lesion. Treatment allocation was not masked, and the clinicians were not blinded. The primary endpoint was acute gastrointestinal (GI) toxicity, assessed using the Common Terminology Criteria for Adverse Events, version 4.0, and Radiation Therapy Oncology Group toxicity scale. An interim analysis of acute toxicity was planned at 160 patients to prove the safety of both treatment regimens. If ≥22 of 72 patients had grade ≥2 GI toxicity, the study arm would be rejected. The study is registered at ClinicalTrials.gov (NCT01921803).
In arm A, 20 patients (26%) and 1 patient (1%) developed acute grade 2 and grade 3 GI toxicity. In arm B, 16 patients (20%) reported acute grade 2 GI toxicity. In arm A, 42 (55%) and 5 (6%) patients developed acute grade 2 and grade 3 urinary toxicity. In arm B, 40 (49%) and 7 (9%) patients reported acute grade 2 and grade 3 urinary toxicity. Toxicity peaked during radiation therapy and resolved in the months after radiation therapy.
With acute grade ≥2 GI toxicity reported in 21 of 77 patients in arm A and 16 of 82 patients in arm B, both treatment arms can be considered safe.
局部前列腺癌的短程放疗（HFRT）既安全又有效。但仍存在一个问题，即选择哪种短程放疗方案。本研究比较了两种不同的 HFRT 方案。
在这项单中心 III 期试验中，2013 年 6 月至 2016 年 7 月，160 例前列腺癌患者被随机分配（1:1），分别接受 56 Gy（16 次，每次 3.5 Gy；A 组）或 67 Gy（25 次，每次 2.68 Gy；B 组）。采用计算机生成的随机化区组，按经尿道前列腺切除术和前列腺内优势病灶的存在进行分层。随机分组不设盲，治疗方案不设盲。主要终点是急性胃肠道（GI）毒性，采用不良事件通用术语标准，版本 4.0 和放射治疗肿瘤学组毒性量表进行评估。计划在 160 例患者中进行急性毒性的中期分析，以证明两种治疗方案的安全性。如果 72 例患者中≥22 例出现≥2 级 GI 毒性，则拒绝该研究方案。该研究在 ClinicalTrials.gov 注册（NCT01921803）。
在 A 组中，20 例（26%）和 1 例（1%）患者发生急性 2 级和 3 级 GI 毒性。在 B 组中，16 例（20%）患者报告急性 2 级 GI 毒性。在 A 组中，42 例（55%）和 5 例（6%）患者发生急性 2 级和 3 级尿毒性。在 B 组中，40 例（49%）和 7 例（9%）患者报告急性 2 级和 3 级尿毒性。毒性在放疗期间达到高峰，并在放疗后几个月内消退。
A 组 77 例患者中有 21 例（21%）和 B 组 82 例患者中有 16 例（19%）报告有急性≥2 级 GI 毒性，因此两种治疗方案均被认为是安全的。
