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图像引导的中度低分割放射治疗局限性前列腺癌:多中心回顾性研究(IPOPROMISE)。

Image-guided moderately hypofractionated radiotherapy for localized prostate cancer: a multicentric retrospective study (IPOPROMISE).

机构信息

Radiation Oncology Section, Department of Medicine and Surgery, University of Perugia and Perugia General Hospital, Perugia, Italy.

Radiation Oncology Department, San Giovanni Addolorata Hospital, Rome, Italy.

出版信息

Radiol Med. 2024 Apr;129(4):643-652. doi: 10.1007/s11547-024-01782-2. Epub 2024 Feb 19.

Abstract

BACKGROUND

Moderate hypofractionated radiotherapy is a treatment option for the cure of localized prostate cancer (PCa) patients based on the results of randomized prospective trials, but there is a clinical concern about the relatively short length of follow-up, and real-world results on outcome and toxicity based on cutting-edge techniques are lacking. The objective of this study is to present the long-term results of a large multicentric series.

MATERIALS AND METHODS

We retrospectively evaluated 1325 PCa patients treated with daily volumetric image-guided hypofractionated radiotherapy between 2007 and 2020 in 16 Centers. For survival endpoints, we used Kaplan-Meier survival curves and fitted univariate and multivariable Cox's proportional hazards regression models to study the association between the clinical variables and each survival type.

RESULTS

At the end of the follow-up, 11 patients died from PCa. The 15-year values of cancer-specific survival (CSS) and biochemical relapse-free survival (b-RFS) were 98.5% (95%CI 97.3-99.6%) and 85.5% (95%CI 81.9-89.4%), respectively. The multivariate analysis showed that baseline PSA, Gleason score, and the use of androgen deprivation therapy were significant variables for all the outcomes. Acute gastrointestinal (GI) and genitourinary (GU) toxicities of grade ≥ 2 were 7.0% and 16.98%, respectively. The 15-year late grade ≥ 2 GI and GU toxicities were 5% (95%CI 4-6%) and 6% (95%CI 4-8%), respectively.

CONCLUSION

Real-world long-term results of this multicentric study on cutting-edge techniques for the cure of localized PCa demonstrated an excellent biochemical-free survival rate of 85.5% at 15 years, and very low rates of ≥ G3 late GU and GI toxicity (1.6% and 0.9% respectively), strengthening the results of the available published trials.

摘要

背景

基于随机前瞻性试验的结果,中度适形分割放疗是治疗局限性前列腺癌(PCa)患者的一种治疗选择,但由于随访时间相对较短,临床上存在一定的担忧,并且缺乏基于先进技术的实际结果和毒性。本研究的目的是介绍一项大型多中心系列研究的长期结果。

材料和方法

我们回顾性评估了 2007 年至 2020 年期间在 16 个中心接受每日容积图像引导适形分割放疗的 1325 例 PCa 患者。对于生存终点,我们使用 Kaplan-Meier 生存曲线,并拟合单变量和多变量 Cox 比例风险回归模型,以研究临床变量与每种生存类型之间的关系。

结果

在随访结束时,有 11 例患者死于 PCa。15 年时癌症特异性生存(CSS)和生化无复发生存(b-RFS)的数值分别为 98.5%(95%CI 97.3-99.6%)和 85.5%(95%CI 81.9-89.4%)。多变量分析显示,基线 PSA、Gleason 评分和雄激素剥夺治疗的使用是所有结果的重要变量。急性胃肠道(GI)和泌尿生殖系统(GU)毒性≥2 级的发生率分别为 7.0%和 16.98%。15 年时,迟发性 GI 和 GU 毒性≥2 级的发生率分别为 5%(95%CI 4-6%)和 6%(95%CI 4-8%)。

结论

这项针对局限性 PCa 治疗的尖端技术的多中心真实世界长期研究结果显示,15 年时生化无复发生存率为 85.5%,GU 和 GI 晚期≥3 级毒性发生率非常低(分别为 1.6%和 0.9%),这进一步证实了现有已发表试验的结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/10c9/11021246/5e9a22735609/11547_2024_1782_Fig1_HTML.jpg

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