Sanguineti Giuseppe, Arcidiacono Fabio, Landoni Valeria, Saracino Bianca Maria, Farneti Alessia, Arcangeli Stefano, Petrongari Maria Grazia, Gomellini Sara, Strigari Lidia, Arcangeli Giorgio
Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome, Italy.
Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome, Italy.
Int J Radiat Oncol Biol Phys. 2016 Oct 1;96(2):304-312. doi: 10.1016/j.ijrobp.2016.05.017. Epub 2016 May 25.
To assess the macroscopic hematuria rates within a single-institution randomized phase 3 trial comparing dose-escalated, conventionally fractionated radiation therapy (CFRT) and moderately hypofractionated radiation therapy (MHRT) for localized prostate cancer.
Patients with intermediate- to high-risk localized prostate cancer were treated with conformal RT and short-course androgen deprivation. Both the prostate and the entire seminal vesicles were treated to 80 Gy in 40 fractions over 8 weeks (CFRT) or 62 Gy in 20 fractions over 5 weeks (MHRT). The endpoint of the present study was the development of any episode or grade of macroscopic hematuria. The median follow-up period was 93 months (range 6-143).
Macroscopic hematuria was reported by 25 of 168 patients (14.9%). The actuarial estimate of hematuria at 8 years was 17.0% (95% confidence interval [CI] 10.7%-23.3%). The number of patients with hematuria was 6 and 19 in the CFRT and MHRT arms, respectively, for an actuarial 8-year estimate of 9.7% and 24.3%, respectively (hazard ratio 3.468, 95% CI 1.385-8.684; P=.008). Overall, 8 of 25 patients were found to have biopsy-proven urothelial carcinoma (3 in the CFRT arm and 5 in the MHRT arm; P=.27). Thus, the 8-year actuarial incidence of macroscopic hematuria (after censoring urothelial cancer-related episodes) was 4.1% and 18.2% after CFRT and MHRT, respectively (hazard ratio 4.961, 95% CI 1.426-17.263; P=.012). The results were confirmed by multivariate analysis after accounting for several patient-, treatment-, and tumor-related covariates.
MHRT was associated with a statistically significant increased risk of macroscopic hematuria compared with CFRT.
在一项单机构随机3期试验中，评估剂量递增的传统分割放射治疗（CFRT）与中度低分割放射治疗（MHRT）用于局部前列腺癌时的肉眼血尿发生率。
中高危局部前列腺癌患者接受适形放疗和短程雄激素剥夺治疗。前列腺和整个精囊在8周内分40次给予80 Gy（CFRT）或在5周内分20次给予62 Gy（MHRT）。本研究的终点是任何程度或级别的肉眼血尿的发生情况。中位随访期为93个月（范围6 - 143个月）。
168例患者中有25例报告了肉眼血尿（14.9%）。8年时肉眼血尿的精算估计值为17.0%（95%置信区间[CI] 10.7% - 23.3%）。CFRT组和MHRT组肉眼血尿患者分别为6例和19例，8年精算估计值分别为9.7%和24.3%（风险比3.468，95% CI 1.385 - 8.684；P = 0.008）。总体而言，25例患者中有8例经活检证实为尿路上皮癌（CFRT组3例，MHRT组5例；P = 0.27）。因此，CFRT和MHRT后8年肉眼血尿的精算发生率（剔除与尿路上皮癌相关的事件后）分别为4.1%和18.2%（风险比4.961，95% CI 1.426 - 17.263；P = 0.012）。在考虑了几个与患者、治疗和肿瘤相关的协变量后，多因素分析证实了该结果。
与CFRT相比，MHRT与肉眼血尿的统计学显著风险增加相关。
