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立体定向消融治疗（SABR）最多5个寡转移的毒性
Treatment With Stereotactic Ablative Radiotherapy for Up to 5 Oligometastases in Patients With Cancer Primary Toxic Effect Results of the Non randomized Phase 2 SABR-5 Clinical Trial
重要性
在标志性的SABR-COMET试验发表后，人们开始关注立体定向消融体放射治疗（SABR）治疗寡转移瘤的高级别毒性效应。
目的
在基于人群的省级癌症项目的大型队列中记录SABR治疗的毒性效应。
设计、设置与参与者
2016年11月至2020年7月，不列颠哥伦比亚省所有6个癌症中心的381名患者，在这项单臂、2期试验中接受了SABR治疗寡转移或寡进展疾病。在此期间，仅在不列颠哥伦比亚省的试验中，患者才有资格在这些环境中接受SABR治疗；因此，与之前发布的SABR系列相比，该分析基于人群，产生的选择偏差最小。
干预
立体定向消融体放疗最多可治疗5个转移灶。
主要结果与方法
与SABR相关的2、3、4和5级毒性反应率。
发现
在381名参与者（122名女性[32%]）中，平均（标准差；范围）年龄为68（11.1；30-97）岁，中位（范围）随访时间为25（1-54）个月。最常见的组织学发现是前列腺癌（123[32%]）、结直肠癌（63[17%]），乳腺癌（42[11%]）和肺癌（33[9%]）。SABR治疗部位的数量为1个（263[69%]）、2个（82[22%]）和3个或更多（36[10%]）。SABR最常见的部位是肺（188[34%]）、非脊柱骨（136[25%]）、脊柱（85[16%]），淋巴结（78[14%]）、肝脏（29[5%]）和肾上腺（15[3]）。与SABR相关的2级、3级、4级和5级毒性反应的发生率（基于每位患者的最高毒性作用）分别为14.2%；（95% CI, 10.7%-17.7%）、4.2%（95% CI, 2.2%-6.2%）、0%和0.3%（95% CI, 0%-0.8%）。根据Kaplan-Meier分析，在第2年与SABR相关的2级或更高级别毒性反应的累积发生率为8%，而3级或更高级毒性反应的累计发生率为4%。
结论与意义
这项单臂、2期临床试验发现，在这项以基于人群的研究中，3级或以上SABR毒性反应的发生率低于5%。此外，2级或更高毒性反应的发生率（18.6%）低于先前公布的SABR-COMET（29%）。这些结果表明，SABR治疗寡转移瘤具有可接受的毒性反应率，并可能支持进一步纳入随机第3阶段临床试验。
Treatment With Stereotactic Ablative Radiotherapy for Up to 5 Oligometastases in Patients With Cancer Primary Toxic Effect Results of the Non randomized Phase 2 SABR-5 Clinical Trial
Olson R, Jiang W, Liu M, Bergman A, Schellenberg D, Mou B, Alexander A, Carolan H, Hsu F, Miller S, Atrchian S, Chan E, Ho C, Mohamed I, Lin A, Berrang T, Bang A, Chng N, Matthews Q, Baker S, Huang V, Mestrovic A, Hyde D, Lund C, Pai H, Valev B, Lefresene S, Tyldesley S. Treatment With Stereotactic Ablative Radiotherapy for Up to 5 Oligometastases in Patients With Cancer: Primary Toxic Effect Results of the Nonrandomized Phase 2 SABR-5 Clinical Trial. JAMA Oncol. 2022 Sep 29.
Robert Olson, MD, MSc,University of British Columbia, Associate Head, Research, Department of Surgery, University of British Columbia, Radiation Oncology and Developmental Radiotherapeutics, University of British Columbia
OBJECTIVE
To document toxic effects of treatment with SABR in a large cohort from a population-based, provincial cancer program.
DESIGN, SETTING, AND PARTICIPANTS
From November 2016 to July 2020, 381patients across all 6 cancer centers in British Columbia were treated in this single-arm, phase 2 trial of treatment with SABR for patients with oligometastatic or oligo progressive disease. During this period, patients were only eligible to receive treatment with SABR in these settings in trials within British Columbia; therefore, this analysis is population based, with resultant minimal selection bias compared with previously published SABR series.
INTERVENTIONS
Stereotactic ablative body radiotherapy to up to 5 metastases.
MAIN OUTCOMES AND MEASURES
Rate of grade 2,3,4, and 5 toxic effects associated with SABR.
FINDINGS
Among 381 participants (122 women [32%]), the mean (SD; range) age was 68 (11.1;30-97) years, and the median (range) follow-up was 25(1-54) months. The most common histological findings were prostate cancer (123[32%]),colorectal cancer(63[17%]), breast cancer (42[11%]),and lung cancer (33[9%]).The number of SABR-treated sites were 1 (263[69%]),2 (82[22%]),and 3 or more (36[10%]).The most common sites of SABR were lung (188[34%]),nonspine bone (136[25%]),spine (85[16%]),lymph nodes (78[14%]), liver (29[5%]),and adrenal (15[3%]).Rates of grade 2,3,4,and 5 toxic effects associated with SABR (based on the highest-grade toxic effect per patient) were 14.2%;(95% CI, 10.7%-17.7%),4.2% (95% CI,2.2%-6.2%),0%,and 0.3% (95% CI,0%-0.8%),respectively. The cumulative incidence of grade 2 or higher toxic effects associated with SABR at year 2 by Kaplan-Meier analysis was8%, and for grade 3 or higher, 4%.
CONCLUSIONS AND RELEVANCE
This single-arm, phase 2 clinical trial found that the incidence of grade 3 or higher SABR toxic effects in this population-based study was less than 5%. Furthermore, the rates of grade 2 or higher toxic effects (18.6%) were lower than previously published for SABR-COMET (29%).These results suggest that SABR treatment for oligometastases has acceptable rates of toxic effects and potentially support further enrollment in randomized phase 3 clinical trials.
IMPORTANCE
After the publication of the landmark SABR-COMET trial, concerns arose regarding high-grade toxic effects of treatment with stereotactic ablative body radiotherapy (SABR) for oligometastases.
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