King's Technology Evaluation Centre, School of Biomedical Engineering and Imaging Sciences, King's College London, London, UK.
King's Technology Evaluation Centre, School of Biomedical Engineering and Imaging Sciences, King's College London, London, UK.
Lancet Oncol. 2021 Jan;22(1):98-106. doi: 10.1016/S1470-2045(20)30537-4.
Stereotactic ablative body radiotherapy (SABR) is increasingly being used to treat oligometastatic cancers, but high-level evidence to provide a basis for policy making is scarce. Additional evidence from a real-world setting is required. We present the results of a national study of patients with extracranial oligometastases undergoing SABR, representing the largest dataset, to our knowledge, on outcomes in this population so far.
In 2015, National Health Service (NHS) England launched a Commissioning through Evaluation scheme that funded a prospective, registry-based, single-arm, observational, evaluation study of patients with solid cancer and extracranial oligometastases treated with SABR. Prescribed doses ranged from 24-60 Gy administered in three to eight fractions. The study was done at 17 NHS radiotherapy centres in England. Patients were eligible for the scheme if aged 18 years or older with confirmed primary carcinoma (excluding haematological malignancies), one to three extracranial metastatic lesions, a disease-free interval from primary tumour development to metastases of longer than 6 months (with the exception of synchronous colorectal liver metastases), a WHO performance status of 2 or lower, and a life expectancy of at least 6 months. The primary outcome was overall survival at 1 year and 2 years from the start of SABR treatment. The study is now completed.
Between June 15, 2015, and Jan 30, 2019, 1422 patients were recruited from 17 hospitals in England. The median age of the patients was 69 years (IQR 62-76), and the most common primary tumour was prostate cancer (406 [28·6%] patients). Median follow-up was 13 months (IQR 6-23). Overall survival was 92·3% (95% CI 90·5-93·9) at 1 year and 79·2% (76·0-82·1) at 2 years. The most common grade 3 adverse event was fatigue (28 [2·0%] of 1422 patients) and the most common serious (grade 4) event was increased liver enzymes (nine [0·6%]). Notreatment-related deaths were reported.
In patients with extracranial oligometastatic cancer, use of SABR was associated with high overall survival and low toxicity. 'The study findings complement existing evidence from a randomised, phase 2 trial, and represent high-level, real-world evidence supporting the use of SABR in this patient cohort, with a phase 3 randomised, controlled trial to confirm these findings underway. Based on the selection criteria in this study, SABR was commissioned by NHS England in March, 2020, as a treatment option for patients with oligometastatic disease.
NHS England Commissioning through Evaluation scheme.
立体定向消融体放射治疗（SABR）越来越多地被用于治疗寡转移癌症，但提供决策依据的高级别证据却很少。需要来自真实环境的额外证据。我们报告了一项针对接受颅外寡转移 SABR 治疗的患者的全国性研究结果，这是迄今为止针对该人群的最大数据集，提供了迄今为止在该人群中的结果。
2015 年，英国国民保健制度（NHS）推出了一项通过评估进行委托的计划，该计划资助了一项针对接受 SABR 治疗的实体癌和颅外寡转移患者的前瞻性、基于登记、单臂、观察性、评估性研究。规定剂量范围为 24-60Gy，分 3-8 次给予。该研究在英格兰的 17 个 NHS 放射治疗中心进行。如果患者年龄在 18 岁或以上，患有经证实的原发性癌（不包括血液恶性肿瘤）、一到三个颅外转移灶、从原发性肿瘤发展到转移灶的无疾病间隔期超过 6 个月（结直肠癌肝同步转移除外）、世界卫生组织表现状态为 2 或更低，并且预期寿命至少 6 个月，则有资格参加该计划。主要结局是从 SABR 治疗开始后 1 年和 2 年的总生存率。该研究现已完成。
2015 年 6 月 15 日至 2019 年 1 月 30 日，从英格兰的 17 家医院招募了 1422 名患者。患者的中位年龄为 69 岁（IQR 62-76），最常见的原发性肿瘤是前列腺癌（406 [28.6%]名患者）。中位随访时间为 13 个月（IQR 6-23）。1 年时的总生存率为 92.3%（95%CI 90.5-93.9），2 年时为 79.2%（76.0-82.1）。最常见的 3 级不良事件是疲劳（1422 名患者中有 28 名，2.0%），最常见的严重（4 级）事件是肝酶升高（9 名，0.6%）。没有报告与治疗相关的死亡。
在患有颅外寡转移癌的患者中，使用 SABR 与高总体生存率和低毒性相关。“研究结果补充了来自一项随机、2 期试验的现有证据，并代表了支持在这一患者群体中使用 SABR 的高级别真实世界证据，目前正在进行一项 3 期随机对照试验来证实这些发现。根据本研究的入选标准，NHS 英格兰于 2020 年 3 月委托 SABR 作为寡转移疾病患者的治疗选择。
NHS 英格兰通过评估进行委托计划。
