Department of Radiation Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio.
Department of Radiation Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio.
Int J Radiat Oncol Biol Phys. 2021 Oct 1;111(2):436-442. doi: 10.1016/j.ijrobp.2021.05.116. Epub 2021 May 26.
To review 10 years of using single-fraction lung stereotactic body radiation therapy (SF-SBRT) for medically inoperable peripheral early-stage lung cancer.
An institutional review board-approved prospective lung SBRT data registry was surveyed until the end of December 2019 for all patients receiving SF-SBRT with minimum 6-month follow-up. Doses used were either 34 Gy or 30 Gy. Outcomes of interest included rates of local failure and overall survival (OS), as well as treatment-related toxicity graded per Common Terminology Criteria for Adverse Events version 3.0.
A total of 229 patients met the study criteria. Patient characteristics included female sex (55%); median age, 74.6 years (range, 47-94); and median Karnofsky Performance Status 80 (range, 50-100). Tumor characteristics included median diameter, 1.6 cm (range, 0.7-4.1); median positron emission tomography standardized uptake value maximum 6.1 (range, 0.8-24.3); and 63.6% of patients biopsied. SF-SBRT dose was 34 Gy in 72.1% cases and 30 Gy in 27.9%, with patient and tumor characteristics balanced between cohorts. Overall median follow-up times for 30 Gy and 34 Gy were 36.7 and 17.2 months, respectively (P < .0001). At analysis, 55.9% patients were alive. Two (0.9%) patients developed grade 3 toxicities, and none had grade 4/5 toxicities. Grades 1 to 2 pneumonitis and chest wall toxicity were seen in 7% and 12.7% patients, respectively. Median overall survival was 44.1 months. Rates of 2-year local, nodal, and distant failure were 7.3%, 9.4%, and 12.2%, respectively. There were no significant differences in outcomes by dose.
This is the largest institutional series to date reporting on SF-SBRT outcomes for medically inoperable peripheral early-stage lung cancer and the first to report on a decade's experience in implementing this schedule. Outcomes from this analysis are comparable to published results from 2 randomized trials and validate the use of this schedule in routine practice. In the absence of phase 3 trials, this study should encourage increased use of SF-SBRT for inoperable tumors.
回顾 10 年来对不能手术的外周早期肺癌患者采用单次分割立体定向体部放疗（SF-SBRT）的结果。
本研究对机构审查委员会批准的前瞻性肺 SBRT 数据登记进行了调查，直至 2019 年 12 月底，对所有接受 SF-SBRT 治疗且随访时间至少为 6 个月的患者进行调查。使用的剂量为 34 Gy 或 30 Gy。我们关注的结果包括局部失败和总生存率（OS）的发生率，以及根据不良事件常用术语标准 3.0 分级的治疗相关毒性。
共有 229 名患者符合研究标准。患者特征包括女性（55%）；中位年龄 74.6 岁（范围 47-94 岁）；中位卡氏功能状态评分 80（范围 50-100）。肿瘤特征包括中位直径 1.6 cm（范围 0.7-4.1）；最大正电子发射断层扫描标准化摄取值中位数 6.1（范围 0.8-24.3）；有 63.6%的患者进行了活检。SF-SBRT 剂量 34 Gy 占 72.1%，30 Gy 占 27.9%，两组患者和肿瘤特征均衡。30 Gy 和 34 Gy 的中位随访时间分别为 36.7 和 17.2 个月（P<0.0001）。分析时，55.9%的患者存活。2 例（0.9%）患者发生 3 级毒性，无 4/5 级毒性。分别有 7%和 12.7%的患者出现 1-2 级肺炎和胸壁毒性。中位总生存期为 44.1 个月。2 年局部、淋巴结和远处失败的发生率分别为 7.3%、9.4%和 12.2%。剂量间无显著差异。
这是目前为止关于不能手术的外周早期肺癌 SF-SBRT 结果的最大机构系列研究，也是第一个报告实施该方案 10 年经验的研究。本分析的结果与两项随机试验的已发表结果相当，并验证了该方案在常规实践中的应用。在缺乏 3 期试验的情况下，这项研究应鼓励更多地使用 SF-SBRT 治疗不能手术的肿瘤。
