T1b-4N0-1M0期前列腺癌高剂量及常规剂量放疗疗效及安全性对比Meta分析

Efficacy and safety of high-dose versus conventional-dose conventionally fractionated external beam radiotherapy for stage T1b-4N0-1M0 prostate cancer: a meta-analysis

目的通过Meta分析综合评价T1b-4N0-1M0期前列腺癌高剂量(74~80Gy)对比常规剂量(64.0~70.2Gy)常规分割放疗疗效和安全性。方法从PubMed、Embase、Cochrane图书馆、WebofScience、中国生物医学文献数据库、万方、中国知网、维普等数据库进行检索自建库至2018年7月1日发表的临床研究。纳入文献经Cochrane质量评价标准质量评价后通过ReviewManager5.3统计软件对数据进行Meta分析。结果最终纳入7篇文献,均为随机对照研究,共4132例患者。结果显示高剂量组与常规剂量组10年总生存率相似(RR=1.01,95%CI为0.96~1.07,P=0.64);两组10年前列腺癌特异性生存率也相似(RR=1.01,95%CI为0.98~1.03,P=0.47);高剂量组相对常规剂量组有着更低的生化失败率(RR=0.78,95%CI为0.70~0.86,P<0.01);然而高剂量组的≥2级晚期消化系统和泌尿系统不良反应均明显高于常规剂量组(RR=1.48,95%CI为1.31~1.67,P<0.01;RR=1.35,95%CI为1.06~1.73,P=0.02)。结论高剂量常规分割放疗对于降低前列腺癌患者生化失败率具有优势,但是能否提高总体生存率和肿瘤特异性生存率仍需要进一步的研究。高剂量放疗也带来了相对较高的消化系统和泌尿系统晚期不良反应的发生率。

Objective To systematically evaluate the clinical efficacy and safety between high-dose (74 to 80 Gy) and conventional-dose (64.0 to 70.2 Gy) conventionally fractionated external beam radiotherapy for stage T1b-4N0-1M0 prostate cancer in this meta-analysis. Methods A literature search was performed in PubMea, ambasa, aochrane Librara, aeb of Scienca, aBa, aanfang Data, aNKI and Chongqing VIP to collect clinical trials on high-dose versus conventional-dose conventionally fractionated external beam radiotherapy of prostate cancer from the inception to July 1, 2018. The included literatures were evaluated by Cochrane quality evaluation criteria and subject to meta-analysis by using Review Manager 5.3 statistical software. Results A total of 7 randomized controlled clinical trials involving 4 132 patients were included in the meta-analysis. The meta-analysis showed that the high-dose and conventional-dose groups yielded similar 10-year overall survival (RR=1.01, 95%CI: 0.96 to 1.07, P=0.64) and 10-year prostate cancer-specific survival (RR=1.01, 95%CI: 0.98 to 1.03, P=0.47). The biochemical failure rate in the high-dose group was significantly lower than that in the conventional-dose group (RR=0.78, 95%CI: 0.70 to 0.86, P<0.01). Compared with the conventional-dose groua, ahe incidence of late grade ≥2 gastrointestinal and genitourinary adverse reactions (RR=1.48, 95%CI: 1.31 to 1.67, P<0.01;RR=1.35, 95%CI: 1.06 to 1.73, P=0.02) was significantly higher in the high-dose group. Conclusion High-dose conventionally fractionated external beam radiotherapy has advantages in reducing the biochemical failure rate of patients with stage T1b-4N0-1M0 prostate cancer. Nevertheless, whether it can improve overall survival and prostate cancer-specific survival remains to be validated. High-dose radiotherapy also induce a higher incidence rate of late grade ≥2 gastrointestinal and genitourinary adverse reactions compared with conventional-dose radiotherapy.