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前列腺癌选择性淋巴结超分割放射治疗:四项前瞻性临床试验的安全性和疗效。

Elective nodal ultra hypofractionated radiation for prostate cancer: Safety and efficacy from four prospective clinical trials.

机构信息

Odette Cancer Centre, Sunnybrook Health Sciences Centre, Canada.

Odette Cancer Centre, Sunnybrook Health Sciences Centre, Canada; Department of Radiation Oncology, University of Toronto, Canada.

出版信息

Radiother Oncol. 2021 Oct;163:159-164. doi: 10.1016/j.radonc.2021.08.017. Epub 2021 Sep 4.

DOI:10.1016/j.radonc.2021.08.017
PMID:34487764
Abstract

BACKGROUND AND PURPOSE

The role of elective nodal irradiation (ENI) in localized prostate cancer (PCa) is controversial. With increasing use of SBRT to the prostate, data is needed regarding the safety and efficacy of ENI using ultra-hypofractionated radiation (UHRT).

MATERIALS AND METHODS

Between 2013-2020, 4 prospective clinical trials of intermediate or high-risk PCa receiving dose-escalated RT to the prostate (via HDR brachytherapy or SBRT boost) and ENI using UHRT (25 Gy in 5 weekly fractions) were conducted. Primary endpoints included acute genitourinary and gastrointestinal toxicities (CTCAE v3.0/4.0), and secondary endpoints included late genitourinary and gastrointestinal toxicities, patient-reported quality of life (EPIC) and biochemical failure (Phoenix definition).

RESULTS

One-hundred sixty-five patients were enrolled, of whom 98 (59%) had high-risk disease. ADT was used in 141 (85%). Median follow-up was 38 months (IQR 10-63). The worst acute genitourinary and gastrointestinal toxicities respectively were 48% and 7.5% for grade 2, and 2.7% and 0% for grade 3. Cumulative incidence of late grade 2+ genitourinary and gastrointestinal toxicities at 36 months were 58% and 11.3% and for late grade 3+ toxicities were 1% and 0%, respectively. No grade 4+ acute or late toxicities were observed. Bowel and sexual toxicity significantly worsened up to 1-year compared to baseline. Over time, urinary (p < 0.0001), bowel (p = 0.0018) and sexual (p < 0.0001) scores significantly improved. The 3-year biochemical recurrence-free survival was 98%.

CONCLUSION

ENI using UHRT is associated with low incidence of grade 3+ toxicity, while grade 1-2 acute genitourinary and gastrointestinal toxicity is common. Randomized phase 3 trials are needed.

摘要

背景与目的

在局限性前列腺癌(PCa)中,选择性淋巴结照射(ENI)的作用存在争议。随着前列腺 SBRT 的应用日益增多,需要了解使用超分割放疗(UHRT)进行 ENI 的安全性和有效性。

材料与方法

2013 年至 2020 年,共进行了 4 项针对接受前列腺高剂量放疗(通过 HDR 近距离治疗或 SBRT 加量)并采用 UHRT(25Gy,每周 5 次)进行 ENI 的中高危 PCa 的前瞻性临床试验。主要终点包括急性泌尿生殖和胃肠道毒性(CTCAE v3.0/4.0),次要终点包括晚期泌尿生殖和胃肠道毒性、患者报告的生活质量(EPIC)和生化失败(Phoenix 定义)。

结果

共纳入 165 例患者,其中 98 例(59%)患有高危疾病。141 例(85%)使用 ADT。中位随访时间为 38 个月(IQR 10-63)。最严重的急性泌尿生殖和胃肠道毒性分别为 48%和 7.5%为 2 级,2.7%和 0%为 3 级。36 个月时晚期 2+级泌尿生殖和胃肠道毒性的累积发生率分别为 58%和 11.3%,晚期 3+级毒性的发生率分别为 1%和 0%。未观察到 4+级急性或晚期毒性。与基线相比,肠道和性功能毒性在 1 年内明显恶化。随着时间的推移,尿(p<0.0001)、肠(p=0.0018)和性功能(p<0.0001)评分均显著改善。3 年生化无复发生存率为 98%。

结论

采用 UHRT 的 ENI 导致 3 级以上毒性的发生率较低,而 1-2 级急性泌尿生殖和胃肠道毒性较常见。需要进行随机的 3 期临床试验。

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