高风险前列腺癌中的螺旋疗法与三维保形辐射疗法：3期随机对照试验
Helical Tomotherapy Versus 3-Dimensional Conformal Radiation Therapy in High-Risk Prostate Cancer: A Phase 3 Randomized Controlled Trial
影响因子:6.50000
分区:医学1区 Top / 肿瘤学2区 核医学2区
发表日期:2024 Dec 01
作者:
Soumyajit Roy, Robert MacRae, Scott Grimes, Julia Malone, Michael Lock, Prateek Mehra, Scott C Morgan, Shawn Malone
摘要
我们提出了一项3阶段随机对照试验的长期结果，该试验将螺旋疗法与三维保形放射疗法（3D-CRT）进行了比较，以治疗高危前列腺癌。使用3D-CRT或Helical Tomotherapy，将高风险前列腺癌的患者随机分配以接受激进放射治疗（RT）。在这两个臂中，患者在前列腺和骨盆淋巴结的23个部分中接受了46 Gy的初始剂量，随后在16个馏分中增加了32 Gy的前列腺。将RT与3年的辅助雄激素剥夺结合使用。主要终点是直肠毒性的晚期（> 90天> 90天。中位随访时间为161个月。总体而言，在3D-CRT ARM中，直肠晚期晚期毒性的患者比例为8.3％（95％CI，3.1-19.1； n = 5），在Tomothapy ARM中的比例为11.1％（95％CI，5.0-22.2; n = 7），无显着臂间差异（P = .83）。在3D-CRT ARM中，晚期≥2级生殖器毒性的患者比例没有显着差异（p = .17）：10.0％（95％CI，4.1-21.2）和20.6％（95％CI，11.9-33.0）在Tomother Appary手臂中。两组之间生化进展或死亡的危险没有显着差异（体疗法组的危险比：0.72; 95％CI，0.46-1.15; p = .17）。在这一3阶段试验，≥2级直肠毒性的总体发生率很低，并且在2臂之间没有显着差异。没有明显的证据表明，在接受疗法治疗的患者中，无生化进展生存率得到了改善。考虑到由于样本量有限和事件率较低而导致的II型错误的可能性，应解释这些发现。
Abstract
We present long-term outcomes from a phase 3 randomized controlled trial that compared helical tomotherapy with 3-dimensional conformal radiation therapy (3D-CRT) in the treatment of high-risk prostate cancer.Newly diagnosed patients with high-risk prostate cancer were randomly allocated to receive radical radiation therapy (RT) 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 an additional boost to the prostate of 32 Gy in 16 fractions. RT 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. The median follow-up was 161 months. Overall, the proportion of patients with grade ≥ 2 late rectal toxicity was 8.3% (95% CI, 3.1-19.1; n = 5) in the 3D-CRT arm and 11.1% (95% CI, 5.0-22.2; n = 7) in the tomotherapy arm with no significant between-arm difference (P = .83). There was no significant difference (P = .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 2 groups (hazard ratio for the tomotherapy arm: 0.72; 95% CI, 0.46-1.15; P = .17).In this phase 3 trial, the overall incidence of grade ≥ 2 rectal toxicity was low and was not significantly different between the 2 arms. There was no 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.