| 胡 晓,周昌明.局限期小细胞肺癌高剂量常规分割胸部放疗疗效分析：CALGB 30610 (Alliance)/RTOG 0538研究解读[J].肿瘤学杂志,2023,29(4):339-344. |
| 局限期小细胞肺癌高剂量常规分割胸部放疗疗效分析：CALGB 30610 (Alliance)/RTOG 0538研究解读 |
| Efficacy of High-Dose Conventional Fractionated Chest Radiotherapy for Limited-Stage Small-Cell Lung Cancer： Interpretation of CALGB 30610(Alliance)/RTOG 0538 Study |
| 投稿时间：2023-04-13 |
| DOI：10.11735/j.issn.1671-170X.2023.04.B014 |
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| 中文关键词: 局限期小细胞肺癌 胸部放疗 放疗剂量 临床研究 |
| 英文关键词:limited-stage small-cell lung cancer thoracic radiotherapy radiotherapy dose clinical study |
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| 中文摘要: |
| 摘 要：CALGB 30610 (Alliance)/RTOG 0538（NCT00632853）是一项随机、Ⅲ期临床试验，对比了3种不同的胸部放疗剂量-分割模式在局限期小细胞肺癌（small-cell lung cancer ，SCLC）中的疗效：超分割放疗45 Gy/30 F、2 F/d，常规分割放疗70 Gy/35 F、1 F/d以及61.2 Gy/34 F后程同步加量放疗模式（前16次为1.8 Gy/F、1 F/d，后18 F为1.8 Gy/F、2 F/d）。放疗与第一或第二疗程化疗同步开始，化疗共4个疗程。研究主要终点是意向性治疗人群的总生存。研究于2008年3月15日至2019年12月1日在美国、以色列、韩国、波多黎各的934个中心开展。研究分两个阶段：第一阶段随机入组3种放疗模式中的一种，在中期分析后，61.2 Gy后程同步加量放疗组因4例（5.7%）患者出现4度呼吸困难而被终止。研究第二阶段招募的患者，随机进入超分割放疗或常规分割放疗模式，最终超分割放疗组纳入患者313例，常规分割放疗组纳入患者325例。中位随访时间4.7年，超分割放疗组和常规分割放疗组中位生存时间分别为28.5个月和30.1个月，5年总生存率分别为29%和32%（HR=0.94，95%CI：0.76～1.17，P=0.594）。超分割放疗组治疗完成率高于常规分割放疗组（放疗完成率：92% vs 79%，化疗完成率：80% vs 72%）。两种放疗模式耐受性可，两组不良反应发生率相似。超分割放疗仍然是局限期SCLC胸部放疗可选择的标准模式，该研究为高剂量常规分割放疗的应用提供了迄今为止最可靠的研究证据。 |
| 英文摘要: |
| Abstract： CALGB 30610(Alliance)/RTOG 0538(NCT00632853) is a randomized， phase Ⅲ clinical trial comparing the efficacy of three different dose-fractionation patterns of thoracic radiotherapy in limited-stage small-cell lung cancer(SCLC)： hyperfractionated radiotherapy with 45 Gy/30 fractions， twice-daily， conventional fractionated radiotherapy with 70 Gy/35 fractions once-daily， or 61.2Gy concomitant boost(1.8 Gy/dose， 1 fraction/day for the first 16 fractions and 1.8 Gy， 2 fractions/day for the rest 18 fractions)， starting simultaneously with either the first or second(of four in total) chemotherapy cycles. The primary endpoint of the study was overall survival in the intention-to-treat population. Patients were recruited at 934 centers in the United States， Israel， South Korea， and Puerto Rico from March 15， 2008 to December 1， 2019. The study was divided into two phases： in the first phase， eligible patients were randomized to one of the three radiotherapy modalities， following a planned interim analysis， the 61.2 Gy arm was discontinued due to degree 4 dyspnea in 4 patients(5.7%). Patients recruited in the second phase of the study were randomized to hyperfractionated radiotherapy or conventional-fractionated radiotherapy modalities. Finally， 313 patients were included in the hyperfractionated radiotherapy arm and 325 patients were included in the conventional-fractionated radiotherapy arm. The median follow-up time was 4.7 years， and the median survival time was 28.5 months and 30.1 months in the hyperfractionated and conventional-fractionated arms， respectively； with 5-year overall survival rates of 29% and 32%， respectively(HR=0.94， 95%CI：0.76～1.17， P=0.594). Treatment completion rates were higher in hyperfractionated radiotherapy arm than those in the conventional-fractionated radiotherapy arm(radiotherapy completion rate： 92% vs 79%， chemotherapy completion rate： 80% vs 72%). Both radiotherapy modalities were well tolerated， and the incidence of adverse events was similar in both groups. Hyperfractionated radiotherapy remains the standard modality for thoracic radiotherapy in limited-stage SCLC， and this study provides the most robust evidence to date for the use of high-dose conventional-fractionated radiotherapy. |
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