摘要
目的对比同步加量模式和常规分割模式在局限期小细胞肺癌的疗效、预后及不良反应,为同步加量放射治疗技术在局限期小细胞肺癌中的应用提供证据。方法通过开放标签的随机对照非劣Ⅲ期研究,在中国医学科学院肿瘤医院入组经细胞学或组织学证实的局限期小细胞肺癌患者,随机分配至同步加量组(PGTV 60.2 Gy分28次,2.15 Gy/次;PTV 50.4 Gy分28次,1.8 Gy/次)和常规分割组(PTV 60 Gy分30次,2 Gy/次)。主要终点为2年无进展生存(PFS),次要终点为2年局部区域控制,2年总生存(OS),放疗相关的不良反应。结果2017年2月—2019年7月入组患者231例,其中216例患者随访时间超过2年或已死亡,常规分割组106例,同步加量组110例。常规分割组对比同步加量组的2年PFS率为45.2%∶38.2%(HR=1.22,95%CI为0.87~1.72,P=0.2),2年无局部区域复发生存(LRFS)为68.7%∶69.9%(HR=0.98,95%CI为0.62~1.56,P=1.0)。多因素分析显示,2组患者中,早放疗在PFS、OS、LRFS均显著优于晚放疗(HR=1.69,95%CI为1.18~2.41,P=0.003;HR=1.72,95%CI为1.09~2.70,P=0.018;HR=1.66,95%CI为1.01~2.73,P=0.046)。肿瘤分期是OS的影响因素(Ⅲ期相比于Ⅰ-Ⅱ期,HR=3.64,95%CI为1.15~11.57,P=0.028)。两组患者的3级以上不良反应无统计差异:放射性肺炎4.7%∶2.7%(P=0.44),放射性食管炎3.8%∶1.8%(P=0.51),骨髓抑制21.7%∶15.4%(P=0.83)。结论局限期小细胞肺癌接受同步加量放疗的疗效不劣于常规分割放疗,其中早放疗可改善预后。两组的放疗相关的不良反应两者相似。
Objective Simultaneous integrated boost radiation technique in limited-stage small cell lung cancer is lack of evidence.This prospective study aims to evaluate whether the simultaneous integrated boost is as efficacious and safe as conventional fractionated radiotherapy.Methods Patients diagnosed with treatment-naiveand confirmed limited-stage SCLC were eligible.Participants were randomly assigned(1:1)to receive simultaneous integrated boost radiotherapy(PGTV 60.2Gy/2.15Gy/28F,PTV 50.4Gy/1.8Gy/28F)or conventional fractionated radiotherapy(PTV 60Gy/2Gy/30F).The primary endpoint was 2-year progression-free survival,and the secondary endpoints were 2-year overall survival,2-year local-regional recurrence-free survival and toxicity.Results Between February 2017 and July 2019,231 patients were enrolled.We analyzed 216 patients whose follow-up time was more than 2 years or who had died,among whom 106 patients in the conventional fractionated radiotherapy group and 110 patients in the simultaneous integrated boost radiotherapy group.The median follow-up time was 37 months(95%CI:35.2-38.7).The 2-year progression-free survival rates were 45.2%vs.38.2%(HR=1.22,95%CI:0.87-1.72,P=0.2).The 2-year overall survival rates were 73.5%vs.60.9%(HR=1.35,95%CI:0.90-2.04,P=0.14).The 2-year local-regional recurrence-free survival rates were 68.7%vs.69.9%(HR=0.98,95%CI:0.62-1.56,P=1.0).Multivariate analysis showed that early radiotherapy yielded better 2-year progression-free survival,overall survival and local-regional recurrence-free survival than delayed radiotherapy in two groups(HR=1.69,95%CI:1.18-2.41,P=0.003;HR=1.72,95%CI:1.09-2.70,P=0.018;HR=1.66,95%CI:1.01-2.73,P=0.046).Tumor staging was an influencing factor of overall survival(stage Ⅲ vs.stage Ⅰ-Ⅱ,HR=3.64,95%CI:1.15-11.57,P=0.028).The most common grade 3–4 adverse events were myelosuppression(21.7%vs.15.4%,P=0.83),radiation pneumonitis(4.7%vs.2.7%,P=0.44)and radiation esophagitis(3.8%vs.1.8%,P=0.51).Conclusions Simultaneous integrated boost radiotherapy yields equivalent efficacy and toxicities to conventional fractionated radiotherapy for limited-stage small cell lung cancer.Early radiotherapy can enhance clinical prognosis.
作者
占天佑
张涛
周宗玫
颜文彬
翟医蕊
邓垒
王文卿
毕楠
王健仰
王鑫
刘文扬
肖泽芬
冯勤付
陈东福
吕纪马
惠周光
梁军
王绿化
Zhan Tianyou;Zhang Tao;Zhou Zongmei;Yan Wenbin;Zhai Yirui;Deng Lei;Wang Wenqing;Bi Nan;Wang Jianyang;Wang Xin;Liu Wenyang;Xiao Zefen;Feng Qinfu;Chen Dongfu;Lyu Jima;Hui Zhouguang;Liang Jun;Wang Lyuhua(Department of Radiation Oncology,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China)
出处
《中华放射肿瘤学杂志》
CSCD
北大核心
2022年第5期425-430,共6页
Chinese Journal of Radiation Oncology
基金
北京希望马拉松专项基金资助(LC2019A03)。
关键词
肺肿瘤
前瞻性研究
同步加量放疗
疗效
Lung tumor
Prospective study
Simultaneous integrated boost radiotherapy
Efficacy
