Stereotactic ablative radiotherapy versus standard of care palliative treatment in patients with oligometastatic cancers (SABR-COMET): a randomised, phase 2, open-label trial
Stereotactic ablative radiotherapy versus standard of care palliative treatment in patients with oligometastatic cancers (SABR-COMET): a randomised, phase 2, open-label trial
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DOI：
10.1016/s0140-6736(18)32487-5
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发表时间：
2019-05-18
期刊：
影响因子：
168.9
通讯作者：
Senan, Suresh
中科院分区：
文献类型：
--
作者：
Palma, David A.;Olson, Robert;Senan, Suresh
背景：寡转移模型表明，如果所有病灶都被根除，一些转移灶数量有限的患者可能会治愈。支持这一范式的随机对照试验证据很少。我们的目的是评估立体定向消融放射治疗（SABR）对生存率，肿瘤学结局，毒性和生活质量的患者与控制原发肿瘤和1至5 oligometastatic lesions.Methods这个随机，开放标签2期研究在加拿大，荷兰，苏格兰和澳大利亚的10家医院完成。年龄在18岁或18岁以上、原发性肿瘤得到控制、有1 - 5处转移性病灶、东部肿瘤协作组评分为0-1、预期寿命至少为6个月的患者有资格入选。在按转移灶数量（1-3 vs 4-5）分层后，我们将患者（1：2）随机分配至仅接受姑息性标准治疗（对照组）或所有转移灶接受标准治疗加SABR（SABR组），使用计算机生成的随机化列表，排列区组9个。患者和医生均未对治疗分配设盲。主要终点是总生存期。我们采用随机2期筛选设计，双侧a为0.20（其中p
Background The oligometastatic paradigm suggests that some patients with a limited number of metastases might be cured if all lesions are eradicated. Evidence from randomised controlled trials to support this paradigm is scarce. We aimed to assess the effect of stereotactic ablative radiotherapy (SABR) on survival, oncological outcomes, toxicity, and quality of life in patients with a controlled primary tumour and one to five oligometastatic lesions.Methods This randomised, open-label phase 2 study was done at 10 hospitals in Canada, the Netherlands, Scotland, and Australia. Patients aged 18 or older with a controlled primary tumour and one to five metastatic lesions, Eastern Cooperative Oncology Group score of 0-1, and a life expectancy of at least 6 months were eligible. After stratifying by the number of metastases (1-3 vs 4-5), we randomly assigned patients (1:2) to receive either palliative standard of care treatments alone (control group), or standard of care plus SABR to all metastatic lesions (SABR group), using a computer-generated randomisation list with permuted blocks of nine. Neither patients nor physicians were masked to treatment allocation. The primary endpoint was overall survival. We used a randomised phase 2 screening design with a two-sided a of 0.20 (wherein p