局限期小细胞肺癌的大剂量每日一次胸部放射治疗:CALGB 30610 (Alliance)/RTOG 0538

SCI 2 February 2023

High-Dose Once-Daily Thoracic Radiotherapy in Limited-Stage Small-Cell Lung Cancer: CALGB 30610 (Alliance)/RTOG 0538

(J Clin Oncol;IF:50.717)

Bogart J, Wang X, Masters G, Gao J, Komaki R, Gaspar LE et al. High-Dose Once-Daily Thoracic Radiotherapy in Limited-Stage Small-Cell Lung Cancer: CALGB 30610 (Alliance)/RTOG 0538. J Clin Oncol 2023:Jco2201359.

CORRESPONDING AUTHOR：Jeffrey Bogart, MD, Department of Radiation OncoloGy, State University of New York, Upstate Medical University, 750 East Adams St, Syracuse, NY 13210; e-mail: Bogartj@upstate.edu.

PURPOSE 目的  

Although level 1 evidence supports 45-Gy twice-daily radiotherapy as standard for limited-stage smallcell lung cancer, most patients receive higher-dose once-daily regimens in clinical practice. Whether increasing radiotherapy dose improves outcomes remains to be prospectively demonstrated.

尽管1级证据支持45 GY每日两次放疗作为局限期小细胞肺癌的标准，但在临床实践中，大多数患者接受更高剂量的每日一次方案。增加放疗剂量是否能改善预后仍有待前瞻性证明。

METHODS 方法  

This phase III trial, CALGB 30610/RTOG 0538 (ClinicalTrials.gov identifier: NCT00632853), was conducted in two stages. In the first stage, patients with limited-stage disease were randomly assigned to receive 45-Gy twice-daily, 70-Gy once-daily, or 61.2-Gy concomitant-boost radiotherapy, starting with either the first or second (of four total) chemotherapy cycles. In the second stage, allocation to the 61.2-Gy arm was discontinued following planned interim toxicity analysis, and the study continued with two remaining arms. The primary end point was overall survival (OS) in the intention-to-treat population.

该III期试验CALGB 30610/RTOG 0538 (ClinicalTrials.gov:NCT00632853)分两个阶段进行。在第一阶段，局限期疾病患者被随机分配接受45 Gy每日两次、70 Gy每日一次或61.2 Gy的同步加量放疗，从第一个或第二个(总共四个)化疗周期开始。在第二阶段，61.2 Gy组的分配在中期毒性分析后停止，其余两个组的研究继续进行。主要终点为意向治疗人群的总生存期(OS)。

RESULTS 结果

Trial accrual opened on March 15, 2008, and closed on December 1, 2019. All patients randomly assigned to 45-Gy twice-daily (n=313) or 70-Gy once-daily radiotherapy (n=325) are included in this analysis. After a median follow-up of 4.7 years, OS was not improved on the once-daily arm (hazard ratio for death, 0.94; 95% CI, 0.76 to 1.17; P =.594). Median survival is 28.5 months for twice-daily treatment, and 30.1 months for once-daily treatment, with 5-year OS of 29% and 32%, respectively. Treatment was tolerable, and the frequency of severe adverse events, including esophageal and pulmonary toxicity, was similar on both arms.

该研究于2008年3月15日开始，2019年12月1日结束。所有随机分配接受45Gy每日两次放疗(n=313)或70Gy每日一次放疗(n=325)的患者均纳入本分析。中位随访4.7年后，每天一次组的OS没有改善(死亡危险比，0.94;95% CI, 0.76 ~ 1.17;p=.594)。每日两次治疗的中位生存期为28.5个月，每日一次治疗的中位生存期为30.1个月，5年OS分别为29%和32%。该治疗是可耐受的，严重不良事件(包括食管和肺毒性)的频率在两组中相似。

CONCLUSION 结论  

Although 45-Gy twice-daily radiotherapy remains the standard of care, this study provides the most robust information available to help guide the choice of thoracic radiotherapy regimen for patients with limitedstage small-cell lung cancer.

尽管每天两次45 Gy的放射治疗仍然是标准的治疗，但这项研究提供了最可靠的信息来帮助指导局限期小细胞肺癌患者选择胸部放射治疗方案。