Long-Term Results of NRG Oncology RTOG 0617: Standard- Versus High-Dose Chemoradiotherapy With or Without Cetuximab for Unresectable Stage III Non-Small-Cell Lung Cancer
Long-Term Results of NRG Oncology RTOG 0617: Standard- Versus High-Dose Chemoradiotherapy With or Without Cetuximab for Unresectable Stage III Non-Small-Cell Lung Cancer
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DOI：
10.1200/jco.19.01162
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发表时间：
2020-03-01
影响因子：
45.3
通讯作者：
Choy, Hak
中科院分区：
文献类型：
--
作者：
Bradley, Jeffrey D.;Hu, Chen;Choy, Hak
PURPOS ERTOG 0617与标准剂量（SD; 60戈伊）与高剂量（房屋署;方法采用2 × 2析因设计，以放疗剂量为1因素，西妥昔单抗为2因素，观察西妥昔单抗对Ⅲ期非小细胞肺癌（NSCLC）的疗效。主要终点为总生存期（OS）。结果中位随访时间为5.1年。SD组中有3例5级不良事件（AE），HD组中有9例。SD组中有3.2%和5.0%的患者发生治疗相关的≥ 3级吞咽困难和食管炎，HD组中分别为12.1%和17.4%（P = 0.0005和<0.0001）。肺毒性无差异，≥ 3级AE分别为20.6%和19.3%。SD和HD组的中位OS分别为28.7和20.3个月（P = 0.0072），5年OS和无进展生存期（PFS）率分别为32.1%和23%以及18.3%和13%（P = 0.055）。多变量分析中与OS改善相关的因素包括标准放射剂量、肿瘤位置、机构累积体积、食管炎/吞咽困难、计划靶体积和心脏V5。西妥昔单抗的使用不会带来生存益处，但会增加毒性。在具有较高H评分的患者中，先前的获益信号不再明显。SD组治疗完成后1个月内的进展率为4.6%。为了比较的目的，由此产生的2年OS和PFS率，允许脱落率分别为59.6%和30.7%，在SD arms.CONCLUSION 60-戈伊的放射剂量与同步化疗应保持标准的治疗，OS率是在文献中报道的最高的III期NSCLC。西妥昔单抗对OS没有影响。对照组的2年OS率与PACIFIC试验相似。(C)2019年美国临床肿瘤学会
PURPOS ERTOG 0617 compared standard-dose (SD; 60 Gy) versus high-dose (HD; 74 Gy) radiation with concurrent chemotherapy and determined the efficacy of cetuximab for stage III non-small-cell lung cancer (NSCLC).METHODS The study used a 2 x 2 factorial design with radiation dose as 1 factor and cetuximab as the other, with a primary end point of overall survival (OS).RESULTS Median follow-up was 5.1 years. There were 3 grade 5 adverse events (AEs) in the SD arm and 9 in the HD arm. Treatment-related grade >= 3 dysphagia and esophagitis occurred in 3.2% and 5.0% of patients in the SD arm v 12.1% and 17.4% in the HD arm, respectively (P = .0005 and < .0001). There was no difference in pulmonary toxicity, with grade >= 3 AEs in 20.6% and 19.3%. Median OS was 28.7 v 20.3 months (P = .0072) in the SD and HD arms, respectively, 5-year OS and progression-free survival (PFS) rates were 32.1% and 23% and 18.3% and 13% (P = .055), respectively. Factors associated with improved OS on multivariable analysis were standard radiation dose, tumor location, institution accrual volume, esophagitis/dysphagia, planning target volume and heart V5. The use of cetuximab conferred no survival benefit at the expense of increased toxicity. The prior signal of benefit in patients with higher H scores was no longer apparent. The progression rate within 1 month of treatment completion in the SD arm was 4.6%. For comparison purposes, the resultant 2-year OS and PFS rates allowing for that dropout rate were 59.6% and 30.7%, respectively, in the SD arms.CONCLUSION A 60-Gy radiation dose with concurrent chemotherapy should remain the standard of care, with the OS rate being among the highest reported in the literature for stage III NSCLC. Cetuximab had no effect on OS. The 2-year OS rates in the control arm are similar to the PACIFIC trial. (C) 2019 by American Society of Clinical Oncology