TROG 13.01 SAFERON II 单次与多次分割立体定向消融放疗治疗肺寡转移瘤随机试验的长期结果

SCI

28 May 2023

Long-Term Outcomes of TROG 13.01 SAFRON II Randomized Trial of Single- Versus Multifraction Stereotactic Ablative Body Radiotherapy for Pulmonary Oligometastases

(Journal of Clinical Oncology, IF: 50.717)

Shankar Siva, Pitchaya Sakyanun, Tao Mai, Wenchang Wong, Adeline Lim, Joanna Ludbrook, Catherine Bettington, Angela Rezo,; David Pryor, Nicholas Hardcastle, Tomas Kron, Braden Higgs, Hien Le, Marketa Skala, Suki Gill, Thomas Eade, Raef Awad, Giuseppe Sasso, Shalini Vinod, Rebecca Montgomery, David Ball, and Mathias Bressel,

CORRESPONDENCE TO: shankar.siva@petermac.orrg

Abstract 摘要

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.

临床试验通常包括在不同时间成熟的多个终点。初始报告通常基于主要终点，因此初始报告可能会在关键计划的共同主要或次要分析尚不明确时发布。临床试验更新栏目为部分已经在JCO或其他期刊发表的研究的额外结果的公布提供了机会，通常这些研究的主要终点已经报告。

In a randomized phase II clinical trial, the Trans Tasman Radiation Oncology Group compared single- versus multifraction stereotactic ablative body radiotherapy (SABR) in 90 patients with 133 oligometastases to the lung. The study found no differences in safety, efficacy, systemic immunogenicity, or survival between arms, with single-fraction SABR picked as the winner on the basis of cost-effectiveness. In this article, we report the final updated survival outcome analysis. The protocol mandated no concurrent or post-therapy systemic therapy until progression. Modified disease-free survival (mDFS) was defined as any progression not addressable by local therapy, or death. At a median follow-up of 5.4 years, the 3- and 5-year estimates for overall survival (OS) were 70% (95% CI, 59 to 78) and 51% (95% CI, 39 to 61). There were no significant differences between the multi- and single-fraction arms for OS (hazard ratio [HR], 1.1 [95% CI, 0.6 to 2.0]; P = .81). The 3- and 5-year estimates for disease free survival were 24% (95% CI, 16 to 33) and 20% (95% CI, 13 to 29), with no differences between arms (HR, 1.0 [95% CI, 0.6 to 1.6]; P = .92). The 3- and 5-year estimates for mDFS were 39% (95% CI, 29 to 49) and 34% (95% CI, 24 to 44), with no differences between arms (HR, 1.0 [95% CI, 0.6 to 1.8]; P = .90). In this patient population, where patients receive SABR in lieu of systemic therapy, one-in-three patients are alive without disease in the long term. There were no differences in outcomes by fractionation schedule.

在一项随机II期临床试验中，跨塔斯曼放射肿瘤学协会比较了90名肺部寡转移瘤患者的单次和多次分割立体定向消融放射治疗（SABR）。该研究发现，在安全性、有效性、系统免疫原性或存活率方面，两组之间没有差异，根据成本效益，单次SABR被选为赢家。在这篇文章中，我们报告了最终更新的生存结果分析。该方案要求在疾病进展之前不进行同期或治疗后的系统治疗。改良无病生存期（mDFS）被定义为任何无法通过局部治疗解决的进展，或死亡。在中位随访时间为5.4年时，总生存率（OS）的3年和5年估计值分别为70%（95%CI，59至78）和51%（95%CI，39至61）。多次分割放疗组或单次放疗组的OS之间没有显著差异（危险比[HR]，1.1[95%CI，0.6至2.0]；P = 0.81）。无病生存期的3年和5年估计值分别为24%（95%CI，16至33）和20%（95%CI，13至29），两组之间无差异（HR，1.0[95%CI，0.6至1.6]；P = .92）。mDFS的3年和5年估计值分别为39%（95%CI，29至49）和34%（95%CI，24至44），两组间无差异（HR 1.0[95%CI，0.6至1.8]；P = .70）。在这一患者群体中，患者接受SABR而非全身治疗，三分之一的患者长期无疾病存活。分级方案的结果没有差异。

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