局限期小细胞肺癌同步加量与常规分割调强放疗的Ⅲ期随机对照研究中期分析

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...

Simultaneous integrated boost vs. routine IMRT in limited-stage small-cell lung cancer:an open-label,non-inferiority,randomized, phase 3 trial

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.