Department of Radiation Oncology, Iridium Netwerk, Wilrijk (Antwerp), Belgium; Translational Cancer Research Unit (TCRU), Center for Oncological Research (CORE), University of Antwerp, Edegem (Antwerp), Belgium.
Department of Radiation Oncology, Iridium Netwerk, Wilrijk (Antwerp), Belgium; Translational Cancer Research Unit (TCRU), Center for Oncological Research (CORE), University of Antwerp, Edegem (Antwerp), Belgium.
Int J Radiat Oncol Biol Phys. 2021 Apr 1;109(5):1195-1205. doi: 10.1016/j.ijrobp.2020.11.066. Epub 2020 Dec 8.
Increasing evidence suggests that patients with a limited number of metastases benefit from SABR to all lesions. However, the optimal dose and fractionation remain unknown. This is particularly true for bone and lymph node metastases. Therefore, a prospective, single-center, dose-escalation trial was initiated.
Dose-Escalation trial of STereotactic ablative body RadiOtherapY for non-spine bone and lymph node metastases (DESTROY) was an open-label phase 1 trial evaluating SABR to nonspine bone and lymph node lesions in patients with up to 3 metastases. Patients with European Cooperative Oncology Group performance status ≤1, an estimated life expectancy of at least 6 months, and histologically confirmed nonhematological malignancy were eligible. Three SABR fractionation regimens, ie, 5 fractions of 7.0 Gy versus 3 fractions of 10.0 Gy versus a single fraction of 20.0 Gy, were applied in 3 consecutive patient cohorts. The rate of ≥grade 3 toxicity, scored according to the Common Toxicity Criteria for Adverse Events v. 4.03, up to 6 months after SABR, was the primary endpoint. The trial was registered on clinicaltrials.gov (NCT03486431).
Between July 2017 and December 2018, 90 patients were enrolled. In total 101 metastases were treated. No ≥grade 3 toxicity was observed in any of the enrolled patients (95% CI 0.0%-12.3% for the first cohort with 28 analyzable patients; 95% CI 0.0%-11.6% for the second and third cohort with 30 analyzable patients each). Treatment-related grade 2 toxicities occurred in 4 out of 30 versus 2 out of 30 versus 2 out of 30 patients for the 5, 3 and 1 fraction schedule, respectively. Actuarial local control rate at 12 months was 94.5%.
All 3 treatment schedules were feasible and effective with remarkably low toxicity rates and high local control rates. From a patient and resource point of view, the single-fraction schedule is undoubtedly most convenient.
越来越多的证据表明，转移灶数量有限的患者从所有病变的立体定向消融放疗（SABR）中获益。然而，最佳剂量和分割方式仍不清楚。这在骨转移和淋巴结转移中尤其如此。因此，启动了一项前瞻性、单中心、剂量递增试验。
非脊柱骨和淋巴结转移的立体定向消融体放射治疗剂量递增试验（DESTROY）是一项开放标签的 1 期试验，评估了 SABR 治疗最多 3 个转移灶的非脊柱骨和淋巴结病变患者。符合条件的患者为欧洲癌症研究和治疗组织表现状态≤1、预计生存期至少 6 个月且组织学证实为非血液恶性肿瘤。应用了 3 种 SABR 分割方案，即 5 次 7.0 Gy 与 3 次 10.0 Gy 与单次 20.0 Gy，分别在 3 个连续的患者队列中进行。SABR 后 6 个月内≥3 级毒性（根据通用不良事件毒性标准 4.03 评分）的发生率是主要终点。该试验在 clinicaltrials.gov 上注册（NCT03486431）。
2017 年 7 月至 2018 年 12 月，共纳入 90 例患者，共治疗 101 个转移灶。任何纳入患者均未观察到≥3 级毒性（第 1 队列 28 例可分析患者的 95%CI 为 0.0%-12.3%；第 2 队列和第 3 队列各 30 例可分析患者的 95%CI 分别为 0.0%-11.6%）。5、3 和 1 分次方案中，各有 4 例、30 例和 30 例患者发生与治疗相关的 2 级毒性。12 个月时的局部控制率为 94.5%。
所有 3 种治疗方案均可行且有效，毒性反应率低，局部控制率高。从患者和资源的角度来看，单次分割方案无疑是最方便的。
