Shaikh M Parvez, Alite Fiori, Wu Meng-Jia, Solanki Abhishek A, Harkenrider Matthew M
Department of Radiation Oncology, Stritch School of Medicine.
Research Methodology, School of Education, Loyola University-Chicago, Chicago, IL.
Am J Clin Oncol. 2018 Aug;41(8):730-738. doi: 10.1097/COC.0000000000000358.
To conduct a meta-analysis of the randomized controlled trials (RCTs) comparing adjuvant radiotherapy (ART) to wait-and-see (WS) strategy in pathologic T3 or margin-positive prostate cancer.
A comprehensive EMBASE, MEDLINE, http://www.clinicaltrails.gov, and Cochrane Library search for RCTs of ART versus WS was done. Results were synthesized for metastasis-free, biochemical progression-free, clinical progression-free, hormone-free, and overall survival as well as gastrointestinal (GI) and genitourinary (GU) toxicities. Either random-effects model or fixed-effects model were used based on the test of heterogeneity.
Three RCTs (EORTC22911, SWOG8794, ARO96-02/AUO-AP09/95) were identified with 1737 patients. ART resulted in greater biochemical progression-free survival (hazard ratio [HR]=0.48, P<0.00001) including benefit in all subsets, greater clinical progression-free survival (HR=0.73, P=0.0003) including benefit in subsets with margin-positive or seminal vesicle invasion and, greater hormone-free survival (HR=0.64, 95% confidence interval, 0.51-0.80, P=0.0001). Ten-year metastasis-free survival was significantly improved with ART (odds ratio=0.77, P=0.02). There was no survival benefit (HR=0.97; P=0.89). With ART compared with WS, there was significantly increased toxicity of any grade (50% vs. 38.6%), grade 2 or greater GU toxicity (17.1% vs. 10.3%), grade 2 or greater GI toxicity (2.5% vs. 1.1%), urinary stricture rates (11.1% vs. 5.7%) and, urinary incontinence (6.9% vs. 2.7%).
Ten-year metastasis-free survival is significantly improved with ART compared with WS. Biochemical progression-free, clinical progression-free, and hormone-free survival were also improved with ART. Grade 2 or higher GI and GU toxicities were greater in ART. Therefore, ART should be offered to patients with these high-risk features.
对比较辅助放疗（ART）与等待观察（WS）策略用于病理T3期或切缘阳性前列腺癌的随机对照试验（RCT）进行荟萃分析。
全面检索了EMBASE、MEDLINE、http://www.clinicaltrails.gov和Cochrane图书馆中关于ART与WS的RCT。综合分析了无转移生存期、无生化进展生存期、无临床进展生存期、无激素生存期和总生存期，以及胃肠道（GI）和泌尿生殖系统（GU）毒性。根据异质性检验采用随机效应模型或固定效应模型。
共纳入3项RCT（EORTC22911、SWOG8794、ARO96 - 02/AUO - AP09/95），涉及1737例患者。ART可提高无生化进展生存期（风险比[HR]=0.48，P<0.00001），在所有亚组中均有获益；提高无临床进展生存期（HR=0.73，P=0.0003），在切缘阳性或精囊侵犯亚组中也有获益；提高无激素生存期（HR=0.64，95%置信区间，0.51 - 0.80，P=0.0001）。ART可显著提高10年无转移生存期（优势比=0.77，P=0.02）。未观察到生存获益（HR=0.97；P=0.89）。与WS相比，ART组任何级别的毒性显著增加（50%对38.6%），2级或更高级别的GU毒性增加（17.1%对10.3%），2级或更高级别的GI毒性增加（2.5%对1.1%），尿道狭窄发生率增加（11.1%对5.7%），尿失禁发生率增加（6.9%对2.7%）。
与WS相比，ART可显著提高10年无转移生存期。ART还可改善无生化进展生存期、无临床进展生存期和无激素生存期。ART组2级或更高等级的GI和GU毒性更大。因此，应将ART应用于具有这些高危特征的患者。
