Long-term Follow-up on NRG Oncology RTOG 0915 (NCCTG N0927): A Randomized Phase 2 Study Comparing 2 Stereotactic Body Radiation Therapy Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung Cancer
Long-term Follow-up on NRG Oncology RTOG 0915 (NCCTG N0927): A Randomized Phase 2 Study Comparing 2 Stereotactic Body Radiation Therapy Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung Cancer
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DOI：
10.1016/j.ijrobp.2018.11.051
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发表时间：
2019-04-01
影响因子：
7
通讯作者：
Bradley, Jeffrey D.
中科院分区：
文献类型：
--
作者：
Videtic, Gregory M.;Paulus, Rebecca;Bradley, Jeffrey D.
目的：研究RTOG 0915/NCCTG N0927的长期疗效，RTOG 0915/NCCTG N0927是一项随机肺立体定向放射治疗试验，每次34 Gy，每次4次，每次48 Gy。方法和材料：这是一项医学上不能手术的非小细胞肺癌患者的2期多中心研究，活检证实外周T1或T2 N0M0肿瘤，1年毒性率作为主要终点，选择的失败和生存结局作为次要终点。这项研究于2009年9月开始，2011年3月结束。最终数据分析截止到2018年5月17日。结果：94例累积患者中有84例符合分析条件：第1组39例，第2组45例。所有患者的中位随访时间为4.0年，分析时存活的患者为6.0年。第1组3级及以上毒性发生率为2.6%，第2组为11.1%。34 Gy和48 Gy的中位生存时间（年）分别为4.1和4.6。34 Gy和48 Gy的5年预后（95%可信区间）分别为10.6%（3.3%-23.1%）和6.8%（1.7%-16.9%）的原发性肿瘤失败率；总生存率为29.6% (16.2%-44.4%)vs 41.1% (26.6%-55.1%)；无进展生存率分别为19.1%（8.5%-33.0%）和33.3%（20.2%-47.0%）。34 Gy组中有6例（37.5%）患者发生远端衰竭，48 Gy组中有7例（41.2%）患者发生远端衰竭。结论：两组均未见晚期毒性增加。5年原发性肿瘤控制率各组相似。每组的中位生存时间为4年，表明疗效相似，有待更大的研究来适当地检测生存差异。(C) 2018爱思唯尔公司版权所有。
Purpose: To present long-term results of RTOG 0915/NCCTG N0927, a randomized lung stereotactic body radiation therapy trial of 34 Gy in 1 fraction versus 48 Gy in 4 fractions.Methods and Materials: This was a phase 2 multicenter study of patients with medically inoperable non-small cell lung cancer with biopsy-proven peripheral T1 or T2 N0M0 tumors, with 1-year toxicity rates as the primary endpoint and selected failure and survival outcomes as secondary endpoints. The study opened in September 2009 and closed in March 2011. Final data were analyzed through May 17, 2018.Results: Eighty-four of 94 patients accrued were eligible for analysis: 39 in arm 1 and 45 in arm 2. Median follow-up time was 4.0 years for all patients and 6.0 years for those alive at analysis. Rates of grade 3 and higher toxicity were 2.6% in arm 1 and 11.1% in arm 2. Median survival times (in years) for 34 Gy and 48 Gy were 4.1 versus 4.6, respectively. Five-year outcomes (95% confidence interval) for 34 Gy and 48 Gy were a primary tumor failure rate of 10.6% (3.3%-23.1%) versus 6.8% (1.7%-16.9%); overall survival of 29.6% (16.2%-44.4%) versus 41.1% (26.6%-55.1%); and progression-free survival of 19.1% (8.5%-33.0%) versus 33.3% (20.2%-47.0%). Distant failure as the sole failure or a component of first failure occurred in 6 patients (37.5%) in the 34 Gy arm and in 7 (41.2%) in the 48 Gy arm.Conclusions: No excess in late-appearing toxicity was seen in either arm. Primary tumor control rates at 5 years were similar by arm. A median survival time of 4 years for each arm suggests similar efficacy, pending any larger studies appropriately powered to detect survival differences. (C) 2018 Elsevier Inc. All rights reserved.