Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligometastatic Cancers: Long-Term Results of the SABR-COMET Phase II Randomized Trial
Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligometastatic Cancers: Long-Term Results of the SABR-COMET Phase II Randomized Trial
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DOI：
10.1200/jco.20.00818
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发表时间：
2020-09-01
影响因子：
45.3
通讯作者：
Senan, Suresh
中科院分区：
文献类型：
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作者：
Palma, David A.;Olson, Robert;Senan, Suresh
目的：低转移范式假设，如果所有的疾病部位都可以切除，那么有限数量转移的患者可能实现长期的疾病控制，甚至治愈。然而，长期的随机数据测试这种范式是缺乏的。方法：我们招募了1-5例原发性恶性肿瘤和转移灶的患者，所有转移灶均可接受立体定向消融放疗（SABR）。我们根据转移的数量进行分层（1-3 vs 4-5），并在姑息标准治疗（SOC）治疗（第1组）和SOC + SABR（第2组）之间按1:2的比例进行随机化。我们采用随机II期筛选设计，主要终点为总生存期（OS）， a为。20（其中P < .20为阳性试验）。次要终点包括无进展生存期（PFS）、毒性和生活质量（QOL）。在此，我们介绍了该试验的长期结果。结果2012年至2016年，99名患者被随机分配到10个国际中心。最常见的原发肿瘤类型为乳腺（n = 18）、肺（n = 18）、结直肠（n = 18）和前列腺（n = 16）。中位随访时间为51个月。1组5年OS率为17.7% (95% CI, 6% - 34%)， 2组为42.3% （95% CI, 28% - 56%；分层log-rank P= 0.006）。第1组的5年PFS率未达到（3.2%,95% CI，最后一位患者4年时为0% - 14%），第2组为17.3% （95% CI, 8% - 30%， P=.001）。没有新的2-5级不良事件，两组间生活质量无差异。结论随着随访时间的延长，SABR对OS的影响比最初的分析更大，并且随着时间的推移持续。没有新的安全信号，SABR对QOL没有不利影响。(C)美国临床肿瘤学会2020
PURPOSE The oligometastatic paradigm hypothesizes that patients with a limited number of metastases may achieve long-term disease control, or even cure, if all sites of disease can be ablated. However, long-term randomized data that test this paradigm are lacking.METHODS We enrolled patients with a controlled primary malignancy and 1-5 metastatic lesions, with all metastases amenable to stereotactic ablative radiotherapy (SABR). We stratified by the number of metastases (1-3 v 4-5) and randomized in a 1:2 ratio between palliative standard-of-care (SOC) treatments (arm 1) and SOC plus SABR (arm 2). We used a randomized phase II screening design with a primary end point of overall survival (OS), using an a of .20 (wherein P < .20 indicates a positive trial). Secondary end points included progression-free survival (PFS), toxicity, and quality of life (QOL). Herein, we present long-term outcomes from the trial.RESULTS Between 2012 and 2016, 99 patients were randomly assigned at 10 centers internationally. The most common primary tumor types were breast (n = 18), lung (n = 18), colorectal (n = 18), and prostate (n = 16). Median follow-up was 51 months. The 5-year OS rate was 17.7% in arm 1 (95% CI, 6% to 34%) versus 42.3% in arm 2 (95% CI, 28% to 56%; stratified log-rank P=.006). The 5-year PFS rate was not reached in arm 1 (3.2%; 95% CI, 0% to 14% at 4 years with last patient censored) and 17.3% in arm 2 (95% CI, 8% to 30%; P=.001). There were no new grade 2-5 adverse events and no differences in QOL between arms.CONCLUSION With extended follow-up, the impact of SABR on OS was larger in magnitude than in the initial analysis and durable over time. There were no new safety signals, and SABR had no detrimental impact on QOL. (C) 2020 by American Society of Clinical Oncology