该试验检查了 ≤5 个寡进展部位的患者是否能从标准护理 (SOC) 全身治疗中添加立体定向消融放射治疗 (SABR) 中获益。我们招募了 1-5 个转移瘤在全身治疗中进展的患者，并按类型分层后全身治疗（细胞毒性与非细胞毒性），在持续 SOC 治疗与 SABR 之间以 1:2 随机分配，用于所有进展性病变加 SOC。该试验最初仅限于非小细胞肺癌，但后来扩大到包括所有非血液恶性肿瘤，以实现应计目标。主要终点是无进展生存期（PFS）。次要终点包括总生存期 (OS)、病变控制、生活质量、不良事件 (AE) 和随机化后全身治疗的持续时间。 8 个加拿大机构招募了 90 名患有 127 个寡进展转移的患者，其中 59 名随机接受 SABR 和31 至 SOC。中位年龄为 67 岁，其中 39 名 (43%) 为女性。最常见的原发部位是肺（44%）、泌尿生殖系统（23%）和乳腺（13%）。 SOC 组的方案依从性不佳，11 名患者 (35%) 要么接受高剂量/消融治疗（与试验方案冲突），要么退出研究。中位随访时间为 31 个月。两组之间的 PFS 没有差异（SABR 组的中位 PFS 为 8.4 个月，SOC 组为 4.3 个月，但曲线交叉和 2 年 PFS 分别为 9% 和 24%，p=0.91）。中位 OS 分别为 31.2 个月和 27.4 个月 (p=0.22)。 SABR 的病灶控制效果更好（分别为 70% 和 38%，p=0.0015）。有 2 例 (3.4%) 3 级 AE 归因于 SABR，没有 4/5 级 AE。SABR 耐受性良好，病变控制良好，但没有改善 PFS 或 OS。这项研究的进展很困难，而且结果可能受到 SOC 臂不愿意放弃消融治疗的影响。 (NCT02756793)。版权所有 © 2024。由 Elsevier Inc. 出版。

This trial examined if patients with ≤5 sites of oligoprogression benefit from the addition of stereotactic ablative radiotherapy (SABR) to standard of care (SOC) systemic therapy.We enrolled patients with 1-5 metastases progressing on systemic therapy, and after stratifying by type of systemic therapy (cytotoxic vs. non-cytotoxic), randomized 1:2 between continued SOC treatment vs. SABR to all progressing lesions plus SOC. The trial was initially limited to non-small cell lung cancer but was expanded to include all non-hematologic malignancies to meet accrual goals. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), lesional control, quality of life, adverse events (AEs), and duration of systemic therapy post-randomization.Ninety patients with 127 oligoprogressive metastases were enrolled across 8 Canadian institutions, with 59 randomized to SABR and 31 to SOC. Median age was 67 years and 39 (43%) were female. The most common primary sites were lung (44%), genitourinary (23%) and breast (13%). Protocol adherence in the SOC arm was suboptimal, with 11 patients (35%) either receiving high-dose/ablative therapies (conflicting with trial protocol) or withdrawing from the study. Median follow-up was 31 months. There was no difference in PFS between arms (median PFS 8.4 months in the SABR arm vs. 4.3 months in the SOC arm but curves cross and 2-year PFS was 9% vs. 24% respectively, p=0.91). Median OS was 31.2 months vs. 27.4 months, respectively (p=0.22). Lesional control was superior with SABR (70% vs. 38% respectively, p=0.0015). There were 2 (3.4%) grade 3 and no grade 4/5 AEs attributable to SABR.SABR was well-tolerated with superior lesional control but did not improve PFS or OS. Accrual to this study was difficult, and the results may have been impacted by an unwillingness to forgo ablative treatments on the SOC arm. (NCT02756793).Copyright © 2024. Published by Elsevier Inc.