我们介绍了一项 III 期随机对照试验的长期结果，该试验比较了螺旋断层放射治疗与三维适形放射治疗 (3D-CRT) 在治疗高危前列腺癌 (PCa) 中的作用。新诊断的高危 PCa 患者为随机分配接受 3D-CRT 或螺旋断层放射治疗的根治性放射治疗。在两组中，患者的前列腺和盆腔淋巴结分 23 次接受 46 Gy 的初始剂量，随后分 16 次对前列腺进行 32 Gy 的额外加强剂量。放射治疗与 3 年辅助雄激素剥夺相结合。主要终点是晚期（自 RT 开始后 > 90 天）直肠毒性。总体而言，123 名患者被随机分配到 3D-CRT (n=60) 或断层放射治疗 (n=63) 组。中位随访时间为 161 个月。总体而言，3D-CRT 组中出现≥2 级晚期直肠毒性的患者比例为 8.3%（95% CI：3.1 至 19.1；n=5），而 3D-CRT 组中这一比例为 11.1%（95% CI：5.0 至 22.2；n=7） ）在断层放射治疗组中没有显着的组间差异（p = 0.83）。晚期≥2级泌尿生殖毒性患者的比例没有显着差异（p=0.17）：3D-CRT组为10.0%（95% CI：4.1-21.2），3D-CRT组为20.6%（95% CI：11.9-21.2）。 33.0）在断层放射治疗臂中。两组之间生化进展或死亡的风险没有显着差异（断层放疗组的 HR：0.72；95% CI：0.46-1.15，p=0.17）。在这项 III 期试验中， ≥2 直肠毒性较低，并且两组之间没有显着差异。没有显着证据表明接受断层放疗治疗的患者的生化无进展生存期有所改善。解释这些发现时应考虑到由于样本量有限和事件发生率低而导致 II 类错误的可能性。NCT00326638.版权所有 © 2024。由 Elsevier Inc. 出版。

We present long-term outcomes from a phase III randomized controlled trial that compared helical tomotherapy with three-dimensional conformal radiotherapy (3D-CRT) in the treatment of high-risk prostate cancer (PCa).Newly diagnosed patients with high-risk PCa were randomly allocated to receive radical radiotherapy using 3D-CRT or helical tomotherapy. In both arms, patients received an initial dose of 46 Gy in 23 fractions to the prostate and pelvic lymph nodes followed by additional boost to the prostate of 32 Gy in 16 fractions. Radiotherapy was combined with 3 years of adjuvant androgen deprivation. The primary endpoint was late (>90 days since RT initiation) rectal toxicity.Overall,123 patients were randomly assigned to either the 3D-CRT (n=60) or tomotherapy (n=63) arms. Median follow-up was 161 months. Overall, the proportion of patients with grade ≥2 late rectal toxicity was 8.3% (95% CI: 3.1 to 19.1; n=5) in the 3D-CRT arm and 11.1% (95% CI: 5.0 to 22.2; n=7) in the tomotherapy arm with no significant between-arm difference (p=0.83). There was no significant difference (p=0.17) in the proportion of patients with late grade ≥2 genitourinary toxicity:10.0% (95% CI: 4.1-21.2) in the 3D-CRT arm and 20.6% (95% CI: 11.9-33.0) in the tomotherapy arm. There was no significant difference in the hazard of biochemical progression or death between the two groups (HR for the tomotherapy arm: 0.72; 95% CI: 0.46-1.15, p=0.17).In this phase III trial, the overall incidence of grade ≥2 rectal toxicity was low and was not significantly different between the two arms. There was non-significant evidence of improved biochemical progression-free survival in patients treated with tomotherapy. These findings should be interpreted considering the possibility of type II errors due to limited sample size and low event rates.NCT00326638.Copyright © 2024. Published by Elsevier Inc.