Schellenberg Devin, Gabos Zsolt, Duimering Adele, Debenham Brock, Fairchild Alysa, Huang Fleur, Rowe Lindsay S, Severin Diane, Giuliani Meredith E, Bezjak Andrea, Lok Benjamin H, Raman Srinivas, Chung Peter, Zhao Yizhou, Ho Clement K, Lock Michael, Louie Alexander V, Lefresne Shilo, Carolan Hannah, Liu Mitchell, Yau Vivian, Ye Allison, Olson Robert A, Mou Benjamin, Mohamed Islam G, Petrik David W, Dosani Maryam, Pai Howard, Valev Boris, Gaede Stewart, Warner Andrew, Palma David A
Department of Radiation Oncology, BC Cancer - Surrey, Surrey, British Columbia, Canada.
University of Alberta, Edmonton, Alberta, Canada.
Int J Radiat Oncol Biol Phys. 2025 Jan 1;121(1):28-38. doi: 10.1016/j.ijrobp.2024.08.031. Epub 2024 Aug 19.
This trial examined if patients with ≤5 sites of oligoprogression benefit from the addition of SABR to standard of care (SOC) systemic therapy.
We enrolled patients with 1 to 5 metastases progressing on systemic therapy, and after stratifying by type of systemic therapy (cytotoxic vs noncytotoxic), randomized 1:2 between continued SOC treatment versus SABR to all progressing lesions plus SOC. The trial was initially limited to non-small cell lung cancer but was expanded to include all nonhematologic 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, and duration of systemic therapy postrandomization.
Ninety patients with 127 oligoprogressive metastases were enrolled across 8 Canadian institutions, with 59 randomized to SABR and 31 to SOC. The median age was 67 years, and 39 (43%) were women. 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. The 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 = .91). The median OS was 31.2 months versus 27.4 months, respectively (P = .22). Lesional control was superior with SABR (70% vs 38%, respectively; P = .0015). There were 2 (3.4%) grade 3 and no grade 4/5 adverse events 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).
本试验旨在研究寡进展部位≤5个的患者在标准治疗（SOC）全身治疗基础上加用立体定向体部放疗（SABR）是否有益。
我们纳入了在全身治疗过程中出现1至5个转移灶进展的患者，并根据全身治疗类型（细胞毒性治疗与非细胞毒性治疗）进行分层，然后按照1:2的比例将患者随机分为继续接受SOC治疗组与对所有进展病灶进行SABR联合SOC治疗组。该试验最初仅限于非小细胞肺癌，但为了达到入组目标扩展至包括所有非血液系统恶性肿瘤。主要终点为无进展生存期（PFS）。次要终点包括总生存期（OS）、病灶控制、生活质量、不良事件以及随机分组后全身治疗的持续时间。
8家加拿大机构共纳入了90例有127个寡进展转移灶的患者，其中59例随机分配至SABR组，31例分配至SOC组。中位年龄为67岁，39例（43%）为女性。最常见的原发部位为肺（44%）、泌尿生殖系统（23%）和乳腺（13%）。SOC组的方案依从性欠佳，有11例患者（35%）接受了高剂量/消融治疗（与试验方案冲突）或退出研究。中位随访时间为31个月。两组之间的PFS无差异（SABR组的中位PFS为8.4个月，SOC组为4.3个月，但曲线交叉，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组的病灶控制情况更佳（分别为70%和38%；P = 0.0015）。有2例（3.4%）3级不良事件可归因于SABR，无4/5级不良事件。
SABR耐受性良好，病灶控制效果更佳，但未改善PFS或OS。本研究的入组困难重重，结果可能受到SOC组不愿放弃消融治疗的影响。（NCT02756793）
