螺旋CT同步放疗与三维适形放疗（3D-CRT）在高风险前列腺癌中的对比：一项第3阶段随机对照试验
Helical Tomotherapy Versus 3-Dimensional Conformal Radiation Therapy in High-Risk Prostate Cancer: A Phase 3 Randomized Controlled Trial
DOI 原文链接
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影响因子:6.5
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
DOI:
10.1016/j.ijrobp.2024.05.032
摘要
我们报告一项第3阶段随机对照试验的长期结果，该试验比较了螺旋CT同步放疗（tomotherapy）与三维适形放疗（3D-CRT）在高风险前列腺癌治疗中的效果。新诊断的高风险前列腺癌患者被随机分配接受3D-CRT或螺旋CT同步放疗的根治性放疗（RT）。两组患者均接受初始剂量46 Gy，分23次照射至前列腺及盆腔淋巴结，随后对前列腺进行32 Gy的增剂，分16次照射。RT结合为期3年的辅助雄激素剥夺治疗（ADT）。主要观察指标为晚期（RT起始后 >90天）直肠毒性。共123名患者随机分配到两组：3D-CRT组60人，螺旋CT同步放疗组63人。随访中位时间为161个月。两组中，≥2级晚期直肠毒性比例分别为8.3%（95% CI，3.1-19.1；5例）和11.1%（95% CI，5.0-22.2；7例），差异无统计学意义（P = .83）。两组中，≥2级晚期泌尿生殖系统毒性的比例也无显著差异：3D-CRT组为10.0%（95% CI，4.1-21.2），螺旋CT组为20.6%（95% CI，11.9-33.0），差异无统计学意义（P = .17）。两组在生化无进展或死亡的危险比方面也无显著差异（螺旋CT组的风险比：0.72；95% CI，0.46-1.15；P = .17）。本次第3阶段试验显示，两组中≥2级直肠毒性发生率低，差异不显著。也未观察到螺旋CT同步放疗在生化无进展存活期方面的明显优势。应考虑样本量有限和事件发生率低的可能性，谨慎解读本研究结果。
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.