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.

中文翻译：

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图像引导中度大分割放射治疗局限性前列腺癌：一项多中心回顾性研究 (IPOPROMISE)

背景

根据随机前瞻性试验的结果，中度大分割放疗是治愈局限性前列腺癌 (PCa) 患者的一种治疗选择，但临床上对相对较短的随访时间和现实世界的结果存在担忧缺乏基于尖端技术的毒性。本研究的目的是展示大型多中心系列的长期结果。

材料和方法

我们回顾性评估了 2007 年至 2020 年间在 16 个中心接受每日体积图像引导大分割放疗的 1325 名 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 比例风险回归模型来研究临床变量与每种生存类型之间的关联。

结果

随访结束时，11 名患者死于 PCa。癌症特异性生存率 (CSS) 和生化无复发生存率 (b-RFS) 的 15 年值分别为 98.5% (95%CI 97.3–99.6%) 和 85.5% (95%CI 81.9–89.4%) 。多变量分析表明，基线 PSA、格里森评分和雄激素剥夺疗法的使用是所有结果的重要变量。 ≥2级的急性胃肠道（GI）和泌尿生殖（GU）毒性分别为7.0%和16.98%。 15 年晚期 ≥ 2 级 GI 和 GU 毒性分别为 5% (95%CI 4–6%) 和 6% (95%CI 4–8%)。

结论

这项关于治疗局部 PCa 的尖端技术的多中心研究的实际长期结果表明，15 年无生化生存率高达 85.5%，并且 ≥ G3 晚期 GU 和 GI 毒性的发生率非常低（分别为 1.6% 和 0.9%），强化了现有已发表试验的结果。