同步放化疗联合热疗与同步放化疗治疗局部晚期宫颈癌的有效性和安全性比较

Efficacy and safety of chemoradiotherapy plus intensive hyperthermia versus chemoradiotherapy alone in patients with locally advanced cervical cancer

目的:比较后程密集热疗联合放化疗对比单独放化疗在局部晚期宫颈癌治疗中的安全性和有效性。方法:本研究收集了自2012年3月至2019年7月经我院治疗的局部晚期宫颈癌患者62例。其中32例患者接受了标准放化疗联合后程密集盆腔深部热疗,剩余30例患者接受了标准放化疗。两组放化疗方案一致:盆腔外照射(50 Gy/25 f)+腔内放疗(A点剂量30 Gy/5 f)+同期紫杉醇联合铂类(TP)方案全身化疗。主要研究终点是完全缓解率和5年局部无复发生存率。次要研究终点是客观缓解率、5年无病生存率、5年总生存率和安全性。结果:统计学检查显示两组患者的基线特征是平衡的。研究结果显示热放化疗组的客观缓解率、5年无病生存率和5年总生存率均优于单独放化疗组(93.8%vs 90.0%,P=0.588;62.1%vs 47.4%,P=0.212;71.9%vs 58.8%,P=0.316),尽管没有达到统计学差异。然而,热放化疗组的完全缓解率显著优于标准放化疗组(78.1%vs 53.3%,P=0.039)。热放化疗组的5年局部无进展生存率也显著高于标准放化疗组(72.9%vs 51.2%,P=0.048)。至于毒副反应,患者能够很好地耐受热放化疗。而且,相比单独放化疗,热放化疗有减轻中性粒细胞缺乏,恶心和乏力等毒副作用的趋势,且未增加额外的急性或者晚期毒副反应。结论:后程密集热疗联合同步放化疗对比单独同步放化疗显著提高了局部晚期宫颈癌患者的完全缓解率和5年局部无复发生存率。

Objective:To compare the efficacy and safety of chemoradiotherapy plus late-course intensive hyperthermia versus chemoradiotherapy alone in patients with locally advanced cervical cancer(LACC).Methods:62 patients with LACC,who received either standard chemoradiotherapy plus late-course intensive whole pelvic deep hyperthermia(32 patients)or chemoradiotherapy alone(30 patients)were reviewed in our hospital from March 2012 to July 2019.The schedule of chemoradiotherapy between the two groups was comparable:Whole pelvic external beam radiotherapy(50 Gy/25 f)+intracavitary brachtherapy(Dose of point A:30 Gy/5 f)+systemic chemotherapy of Taxane with platinum.The primary endpoints were complete response rate(CRR)and 5-year local relapse-free survival(LRFS).The secondary endpoints were objective response rate(ORR),5-year disease-free survival(DFS),5-year overall survival(OS)and safety profiles.Results:Patient baseline characteristics were balanced statistically for both groups.The results showed that the 5-year ORR,DFS and OS in the chemoradiotherapy plus hyperthermia group were better than those in the CRT group respectively(93.8%vs 90.0%,P=0.588;62.1%vs 47.4%,P=0.212;71.9%vs 58.8%,P=0.316),although not statistically significant.However,CR was significantly superior in patients treated with chemoradiotherapy plus hyperthermia to that in patients treated with chemoradiotherapy alone(78.1%vs 53.3%,P=0.039).Additionally,the LRFS in the group of chemoradiotherapy plus hyperthermia was significantly better than that in the group of chemoradiotherapy alone(72.9%vs 51.2%,P=0.048).As to toxicities,chemoradiotherapy combined with hyperthermia was well tolerated.Furthermore,the patients treated with chemoradiotherapy plus hypertherapy had a trend toward better safety with less neutropenia,fatigue and nausea and caused no additional acute or long-term toxicity compared with the patients treated with chemoradiotherapy alone.Conclusion:Late-course intensive hyperthermia in combination with chemoradiotherapy significantly improved the CR rate and 5-year LRFS in patients with LACC compared with hyperthermia alone.