Division of Radiation Oncology, European Institute of Oncology IRCCS, Milan, Italy; Department of Oncology and Hemato-oncology, University of Milan, Milan, Italy.
National Centre of Healthcare Research and Pharmacoepidemiology, University of Milano-Bicocca, Milan, Italy; Unit of Biostatistics, Epidemiology and Public Health, Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy.
Radiother Oncol. 2024 Jun;195:110264. doi: 10.1016/j.radonc.2024.110264. Epub 2024 Mar 30.
High-level evidence on hypofractionated proton therapy (PT) for localized and locally advanced prostate cancer (PCa) patients is currently missing. The aim of this study is to provide a systematic literature review to compare the toxicity and effectiveness of curative radiotherapy with photon therapy (XRT) or PT in PCa.
PubMed, Embase, and the Cochrane Library databases were systematically searched up to April 2022. Men with a diagnosis of PCa who underwent curative hypofractionated RT treatment (PT or XRT) were included. Risk of grade (G) ≥ 2 acute and late genitourinary (GU) OR gastrointestinal (GI) toxicity were the primary outcomes of interest. Secondary outcomes were five-year biochemical relapse-free survival (b-RFS), clinical relapse-free, distant metastasis-free, and prostate cancer-specific survival. Heterogeneity between study-specific estimates was assessed using Chi-square statistics and measured with the I2 index (heterogeneity measure across studies).
A total of 230 studies matched inclusion criteria and, due to overlapped populations, 160 were included in the present analysis. Significant lower rates of G ≥ 2 acute GI incidence (2 % vs 7 %) and improved 5-year biochemical relapse-free survival (95 % vs 91 %) were observed in the PT arm compared to XRT. PT benefits in 5-year biochemical relapse-free survival were maintained for the moderate hypofractionated arm (p-value 0.0122) and among patients in intermediate and low-risk classes (p-values < 0.0001 and 0.0368, respectively). No statistically relevant differences were found for the other considered outcomes.
The present study supports that PT is safe and effective for localized PCa treatment, however, more data from RCTs are needed to draw solid evidence in this setting and further effort must be made to identify the patient subgroups that could benefit the most from PT.
目前缺乏关于局部和局部晚期前列腺癌（PCa）患者的质子治疗（PT）的高级别证据。本研究旨在提供系统的文献综述，以比较光子治疗（XRT）或 PT 治疗 PCa 的毒性和疗效。
系统检索了 PubMed、Embase 和 Cochrane 图书馆数据库，截至 2022 年 4 月。纳入接受根治性低分割 RT 治疗（PT 或 XRT）的 PCa 男性患者。主要结局为≥2 级急性和晚期泌尿生殖系统（GU）或胃肠道（GI）毒性的发生率。次要结局为 5 年生化无复发生存率（b-RFS）、临床无复发生存率、远处转移无复发生存率和前列腺癌特异性生存率。使用卡方检验和 I2 指数（研究间异质性度量）评估研究特异性估计值之间的异质性。
共检索到 230 项符合纳入标准的研究，由于人群重叠，本分析纳入了 160 项研究。与 XRT 相比，PT 组急性 GI 发生率≥2 级的发生率显著降低（2%比 7%），5 年生化无复发生存率提高（95%比 91%）。对于中度低分割 PT 组（p 值=0.0122）和中低危患者（p 值分别<0.0001 和 0.0368），PT 在 5 年生化无复发生存率方面的获益得以维持。对于其他考虑的结局，未发现统计学上的显著差异。
本研究支持 PT 是治疗局限性 PCa 的安全有效的方法，然而，需要更多 RCT 数据来在此背景下得出确凿的证据，并且必须进一步努力确定最能从 PT 中获益的患者亚组。
