立体定向消融放疗治疗少进展期癌症:随机 II 期 STOP 试验结果。

IF 6.4 1区 医学 Q1 ONCOLOGY
Devin Schellenberg, Zsolt Gabos, Adele Duimering, Brock Debenham, Alysa Fairchild, Fleur Huang, Lindsay S Rowe, Diane Severin, Meredith E Giuliani, Andrea Bezjak, Benjamin H Lok, Srinivas Raman, Peter Chung, Yizhou Zhao, Clement K Ho, Michael Lock, Alexander V Louie, Shilo Lefresne, Hannah Carolan, Mitchell Liu, Vivian Yau, Allison Ye, Robert A Olson, Benjamin Mou, Islam G Mohamed, David W Petrik, Maryam Dosani, Howard Pai, Boris Valev, Stewart Gaede, Andrew Warner, David A Palma
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引用次数: 0

摘要

目的:本试验研究了在标准治疗(SOC)的基础上增加立体定向消融放疗(SABR)是否会使少于5个部位转移的患者受益:我们招募了1-5例经全身治疗仍有进展的转移灶患者,按照全身治疗类型(细胞毒性与非细胞毒性)进行分层后,以1:2的比例在继续SOC治疗与对所有进展病灶进行SABR加SOC治疗之间进行随机分组。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,以达到预期目标。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)以及随机化后系统治疗的持续时间:加拿大8家医疗机构共招募了90名患有127个少进展转移灶的患者,其中59人随机接受SABR治疗,31人接受SOC治疗。中位年龄为 67 岁,女性 39 人(占 43%)。最常见的原发部位是肺(44%)、泌尿生殖系统(23%)和乳腺(13%)。SOC治疗组的方案依从性不佳,有11名患者(35%)接受了高剂量/烧蚀疗法(与试验方案相冲突)或退出了研究。中位随访时间为 31 个月。两组间的 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的病变控制率更高(分别为70%对38%,P=0.0015)。SABR共导致2例(3.4%)3级AE,无4/5级AE:结论:SABR耐受性良好,病变控制效果显著,但并未改善PFS或OS。这项研究的招募工作十分困难,结果可能会受到不愿意放弃SOC臂消融治疗的影响(NCT02756793)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Stereotactic Ablative Radiation for Oligoprogressive Cancers: Results of the Randomized Phase 2 STOP Trial.

Purpose: This trial examined if patients with ≤5 sites of oligoprogression benefit from the addition of SABR to standard of care (SOC) systemic therapy.

Methods and materials: 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.

Results: 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.

Conclusions: 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).

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来源期刊
CiteScore
11.00
自引率
7.10%
发文量
2538
审稿时长
6.6 weeks
期刊介绍: International Journal of Radiation Oncology • Biology • Physics (IJROBP), known in the field as the Red Journal, publishes original laboratory and clinical investigations related to radiation oncology, radiation biology, medical physics, and both education and health policy as it relates to the field. This journal has a particular interest in original contributions of the following types: prospective clinical trials, outcomes research, and large database interrogation. In addition, it seeks reports of high-impact innovations in single or combined modality treatment, tumor sensitization, normal tissue protection (including both precision avoidance and pharmacologic means), brachytherapy, particle irradiation, and cancer imaging. Technical advances related to dosimetry and conformal radiation treatment planning are of interest, as are basic science studies investigating tumor physiology and the molecular biology underlying cancer and normal tissue radiation response.
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