Single-Fraction vs Multifraction Stereotactic Ablative Body Radiotherapy for Pulmonary Oligometastases (SAFRON II) The Trans Tasman Radiation Oncology Group 13.01 Phase 2 Randomized Clinical Trial
Single-Fraction vs Multifraction Stereotactic Ablative Body Radiotherapy for Pulmonary Oligometastases (SAFRON II) The Trans Tasman Radiation Oncology Group 13.01 Phase 2 Randomized Clinical Trial
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DOI：
10.1001/jamaoncol.2021.2939
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发表时间：
2021-08-29
期刊：
影响因子：
28.4
通讯作者：
Neeson, Paul
中科院分区：
文献类型：
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作者：
Siva, Shankar;Bressel, Mathias;Neeson, Paul
重要的是缺乏随机临床试验的证据来指导立体定向消融体放射治疗（SABR）在肺寡转移患者中的最佳方法。目的评估单次或多次SABR是否更有效地治疗肺寡转移患者。设计，设置和参与者这个多中心，非盲，在澳大利亚和新西兰的13个中心的90例患者中进行的II期随机临床试验，招募了1 - 3例肺寡转移灶小于或等于5 cm的患者，这些患者来自远离中心气道的任何非血液学恶性肿瘤，东部肿瘤协作组体能状态为0或1，所有原发性和胸外疾病均通过局部治疗得到控制。入组时间为2015年1月1日至2018年12月31日，患者随访时间至少为2 years. Interventions单次28戈伊（单次组）或4次12戈伊（多次组），每次寡转移。主要结局和指标主要结局是SABR 1年内发生的3级或更高级别的治疗相关不良事件（AE）。次要结果是无局部失败，总生存率，无病生存率和患者报告的结果（MD安德森症状量表-肺癌和EuroQol 5维视觉模拟量表）。平均（SD）年龄为66.6 [11.6]岁; 58例（64%）为男性。中位随访时间为36.5个月（四分位距，24.8 - 43.9个月）。1年时，单次治疗组中与治疗相关的3级或以上AE数量为2例（5%; 80% CI，1%-13%），多次治疗组中为1例（3%; 80% CI，0%-10%），两组间未观察到显著差异。多分割组发生1例5级不良事件，多分割组与单分割组无局部失效率无显著差异（风险比[HR]，0.5; 95% CI，0.2 - 1.3; P = 0.13），总生存期（HR，1.5; 95% CI，0.6 - 3.7; P =.44）或无病生存期（HR，1.0; 95% CI，0.6 - 1.6; P>.99）。在患者报告的outcome.Conclusions和相关性在这项随机临床试验中，没有手臂表现出优越的安全性，疗效，或症状负担的证据，但是，单馏分SABR是更有效地提供。因此，根据所有终点的最可接受结局特征评估，可以选择单次SABR升级至未来研究。
IMPORTANCE Evidence is lacking from randomized clinical trials to guide the optimal approach for stereotactic ablative body radiotherapy (SABR) in patients with pulmonary oligometastases.OBJECTIVE To assess whether single-fraction or multifraction SABR is more effective for the treatment of patients with pulmonary oligometastases.DESIGN, SETTING, AND PARTICIPANTS This multicenter, unblinded, phase 2 randomized clinical trial of 90 patients across 13 centers in Australia and New Zealand enrolled patients with 1 to 3 lung oligometastases less than or equal to 5 cmfrom any nonhematologic malignant tumors located away from the central airways, Eastern Cooperative Oncology Group performance status 0 or 1, and all primary and extrathoracic disease controlled with local therapy. Enrollment was from January 1, 2015, to December 31, 2018, with a minimum patient follow-up of 2 years.INTERVENTIONS Single fraction of 28 Gy (single-fraction arm) or 4 fractions of 12 Gy (multifraction arm) to each oligometastasis.MAIN OUTCOMES AND MEASURES The main outcomewas grade 3 or higher treatment-related adverse events (AEs) occurring within 1 year of SABR. Secondary outcomes were freedom from local failure, overall survival, disease-free survival, and patient-reported outcomes (MD Anderson Symptom Inventory-Lung Cancer and EuroQol 5-dimension visual analog scale).RESULTS Ninety participants were randomized, of whom 87 were treated for 133 pulmonary oligometastases. The mean (SD) age was 66.6 [11.6] years; 58 (64%) were male. Median follow-up was 36.5 months (interquartile range, 24.8-43.9 months). The numbers of grade 3 or higher AEs related to treatment at 1 year were 2 (5%; 80% CI, 1%-13%) in the single-fraction arm and 1 (3%; 80% CI, 0%-10%) in the multifraction arm, with no significant difference observed between arms. One grade 5 AE occurred in the multifraction arm. No significant differences were found between the multifraction arm and single-fraction arm for freedom from local failure (hazard ratio [HR], 0.5; 95% CI, 0.2-1.3; P =.13), overall survival (HR, 1.5; 95% CI, 0.6-3.7; P =.44), or disease-free survival (HR, 1.0; 95% CI, 0.6-1.6; P >.99). There were no significant differences observed in patient-reported outcomes.CONCLUSIONS AND RELEVANCE In this randomized clinical trial, neither arm demonstrated evidence of superior safety, efficacy, or symptom burden; however, single-fraction SABR is more efficient to deliver. Therefore, single-fraction SABR, as assessed by the most acceptable outcome profile from all end points, could be chosen to escalate to future studies.