胸段食管鳞癌根治性放化疗IFI和ENI前瞻性多中心随机对照临床研究

目的 比较胸段食管鳞癌根治性放化疗采用IFI和ENI照射的不良反应、失败模式和长期生存。方法 符合入组条件胸段食管鳞癌采用随机数字表法分为IFI或ENI组。主要观察终点为急性放化疗不良反应,次要观察终点为失败模式、PFS和OS。Kaplan-Meier法计算生存率,Logrank法检验差异。结果 2012—2016年9个试验中心共筛选食管鳞癌患者 228例,最终可分析的患者ENI组 101例,IFI组 104例。IFI组≥2级急性放射性食管炎和放射性肺炎的发生率明显低于ENI组(P=0.018,0.027)。ENI组和IFI组在总失败率、局部区域失败率、远处转移率、野内和野外淋巴结复发率等均相近(P=0.401、0.561、0.510、0.561、0.681)。ENI组与和IFI组1、2、3、4年OS率和中位OS期分别为84.1%、57.3%、39.4%、31.6%和28个月与83.6%、62.1%、44.5%、31.5%和32个月(P=0.654);1、2、3年PFS率和中位PFS期分别为71.9%、42.3%、32.7%和20个月与70.1%、45.0%、35.9%和22个月(P=0.885)。结论 与ENI相比,胸段食管鳞癌采用IFI照射可减少急性放射性食管炎和肺炎发生率,而不会降低局部-区域淋巴结和肿瘤控制率及远期生存。临床试验注册 临床试验注册中心,注册号:NCT01551589。

Involved field irradiation (IFI) versus elective nodal irradiation (ENI) in combination with concurrent chemotherapy for esophageal thoracic squamous cell cancer:a prospective,randomized,multicenter,controlled study

Objective This study was conducted to evaluate treatment-related toxicities,the patterns of failure,overall survival (OS) and progression-free survival (PFS) by comparing IFI with ENI in combination with chemotherapy. Methods Eligible patients were treated with concurrent chemoradiotherapy and randomized into either an IFI or ENI arm. The primary end points wereacute treatment-related toxicities. The secondary end points were patterns of failure,OS and PFS. Kaplan-Meier survival rate of the method for calculating the Logrank test difference method. Results Between April 2012 and October 2016,a total of 228 patients were enrolled from nine centers in china. Grade≥3,Grade≥2 radiation esophagitis and pneumonitis in the IFI arm were significantly lower than that of the ENI arm (P=0.018,0.027).No significant differences were observed in overall failure rates,loco-regional failure,distant failure rates,in-field and out-field lymph node failure between the two arms (P=0.401,0.561,0.510,0.561,0.681).The 1-,2-,3-,4-yearand median OS in the ENI arm and IFI arm were 84.1%,57.3%,39.4%,31.6%,28 months and 83.6%,62.1%,44.5%,31.5%,32 months (P=0.654),respectively. The 1-,2-,3-yearand median PFS in the ENI arm and IFI arm were 71.9%,42.3%,32.7%,20 months and 70.1%,45.0%,35.9%,22 months (P=0.885),respectively. Conclusions Compared to ENI,IFI resulted in decreased radiation pneumonitis and esophagitis without sacrificing loco-regional lymph nodal control,PFS and OS in thoracic ESCC.Clinical Trial Registry Chinese Clinical trail registry,registration number:NCT01551589.