每日与每周前列腺癌图像引导放射治疗比较：3 期多中心随机试验。
Daily Versus Weekly Prostate Cancer Image Guided Radiation Therapy: Phase 3 Multicenter Randomized Trial.
机构信息
Department of Radiotherapy, Centre Eugène Marquis, LTSI INSERM 1099, Rennes, France.
Department of Biostatistics, Gustave-Roussy Institute, Villejuif, France; CESP, Faculté de médecine, Université Paris-Sud, Faculté de médecine, UVSQ, INSERM, Université Paris-Saclay, Villejuif, France.
出版信息
Int J Radiat Oncol Biol Phys. 2018 Dec 1;102(5):1420-1429. doi: 10.1016/j.ijrobp.2018.07.2006. Epub 2018 Jul 31.
PURPOSE
The optimal frequency of prostate cancer image guided radiation therapy (IGRT) has not yet been clearly identified. This study sought to compare the safety and efficacy of daily versus weekly IGRT.
MATERIALS AND METHODS
This phase 3 randomized trial recruited patients with N0 localized prostate cancer. The total IGRT doses in the prostate ranged from 70 Gy to 80 Gy, sparing the lymph nodes. Patients were randomly assigned (1:1) to 2 prostate IGRT frequency groups: daily and weekly (ie, on days 1, 2, and 3 and then weekly). The primary outcome was 5-year recurrence-free survival. Secondary outcomes included overall survival and toxicity. Post hoc analyses included biochemical progression-free interval, clinical progression-free interval, and other cancer-free interval.
RESULTS
Between June 2007 and November 2012, 470 men from 21 centers were randomized into the 2 groups. Median follow-up was 4.1 years. There was no statistically significant difference in recurrence-free survival between the groups (hazard ratio [HR] = 0.81; P = .330). Overall survival was worse in the daily group than in the weekly group (HR = 2.12 [95% confidence interval (CI), 1.03-4.37]; P = .042). Acute rectal bleeding (grade ≥1) was significantly lower in the daily group (6%) (n = 14) than in the weekly group (11%) (n = 26) (P = .014). Late rectal toxicity (grade ≥1) was significantly lower in the daily group (HR = 0.71 [95% CI, 0.53-0.96]; P = .027). Biochemical progression-free interval (HR = 0.45 [95% CI, 0.25 - 0.80]; P = .007) and clinical progression-free interval (HR = 0.50 [95% CI, 0.24-1.02]; P = .057) were better in the daily group, whereas other cancer-free interval was worse in the daily group (HR = 2.21 [95% CI, 1.10-4.44]; P = .026).
CONCLUSIONS
Compared with weekly control, daily IGRT control in prostate cancer significantly improves biochemical progression-free and clinical progression-free interval, and rectal toxicity.
目的
前列腺癌图像引导放疗（IGRT）的最佳频率尚未明确。本研究旨在比较每日和每周 IGRT 的安全性和疗效。
材料与方法
本 3 期随机试验招募了 N0 局限性前列腺癌患者。前列腺的总 IGRT 剂量为 70-80Gy，不包括淋巴结。患者按 1:1 随机分为 2 个前列腺 IGRT 频率组：每日和每周（即第 1、2 和 3 天，然后每周）。主要结局为 5 年无复发生存率。次要结局包括总生存率和毒性。事后分析包括生化无进展间隔、临床无进展间隔和其他无癌症间隔。
结果
2007 年 6 月至 2012 年 11 月，21 个中心的 470 名男性被随机分为 2 组。中位随访时间为 4.1 年。两组无复发生存率无统计学差异（风险比[HR] = 0.81；P =.330）。每周组的总生存率优于每日组（HR = 2.12 [95%置信区间（CI），1.03-4.37]；P =.042）。每日组（6%）（n = 14）的急性直肠出血（≥1 级）明显低于每周组（11%）（n = 26）（P =.014）。每日组的晚期直肠毒性（≥1 级）明显低于每周组（HR = 0.71 [95% CI，0.53-0.96]；P =.027）。生化无进展间隔（HR = 0.45 [95% CI，0.25-0.80]；P =.007）和临床无进展间隔（HR = 0.50 [95% CI，0.24-1.02]；P =.057）在每日组更好，而其他无癌症间隔在每日组更差（HR = 2.21 [95% CI，1.10-4.44]；P =.026）。
结论
与每周对照相比，前列腺癌每日 IGRT 对照显著改善生化无进展和临床无进展间隔以及直肠毒性。
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