Department of Radiation Oncology, Medical Center, Faculty of Medicine, University of Freiburg, Germany; Department of Radiation Oncology, Kliniken Maria Hilf GmbH Mönchengladbach, Germany.
Department of Radiation Oncology, Medical Center, Faculty of Medicine, University of Freiburg, Germany; German Cancer Consortium (DKTK) Partner Site Freiburg, Germany; German Cancer Research Center (DKFZ), Heidelberg, Germany.
Radiother Oncol. 2020 Jul;148:82-88. doi: 10.1016/j.radonc.2020.03.018. Epub 2020 Apr 6.
Preserving health related quality of life (HRQOL) plays an important role in considering stereotactic body fractionated radiotherapy (SBRT). The prospective monocenter phase II STRIPE trial investigated long-term HRQOL after SBRT, efficacy and toxicity.
Patients with ≤2 pulmonary lesions ≤5 cm were treated with 4DPET/CT-based SBRT (3 × 12.5 Gy or risk-adapted 5 × 7 Gy, to 60% isodose). Follow up (FU) was performed 2 and 7 weeks after SBRT, then 3-monthly for 2 years with assessment of response (primary endpoint: 2-year cumulative incidence of local progression (LP); secondary endpoints: local progression free survival (LPFS), overall survival (OS) and toxicity (CTCAE)). Impact of predefined patient and treatment related factors on HRQOL (EORTC QLQ-C30 and EORTC QLQ-LC13) was evaluated.
Between 02/2011 and 11/2014, 100 patients were given SBRT for 56 NSCLC and 44 pulmonary metastases (M1). Long-term FU overall revealed stable Quality of Life (QoL)/Global health status (GHS), functions-scores and symptoms. For QoL/GHS, patients with low (<median) initial QoL/GHS-Score revealed significantly stronger improvement than those with good QoL/GHS-scores (p < 0.001). Probability for LP, LPFS and OS 2 years after SBRT was 8.1% (NSCLC: 7.3%, M1:9.2%), 53.3% (NSCLC: 50.7%, M1: 56.0%) and 62.2% (NSCLC: 57.2%, M1: 68.4%). ≥G3-Toxicity was <4%, but ≥G3 dyspnea was 6% at baseline and 14.5% 2 years after SBRT.
These prospective data on representative pulmonary SBRT patients confirm stable preservation of HRQOL after SBRT and demonstrate a QoL/GHS-benefit for patients with low initial QoL/GHS-scores, the regimen of 3 × 12.5 Gy SBRT being efficient and well tolerated. This result may inform shared decision making when discussing SBRT for frail patients.
维持健康相关生活质量（HRQOL）在考虑立体定向体部分割放疗（SBRT）中起着重要作用。前瞻性单中心 II 期 STRIPE 试验研究了 SBRT 后的长期 HRQOL、疗效和毒性。
≤2 个≤5cm 的肺病变患者接受 4DPET/CT 引导的 SBRT（3×12.5Gy 或风险适应性 5×7Gy，至 60%等剂量）。SBRT 后 2 周和 7 周进行随访（FU），然后每 3 个月进行 2 年，评估反应（主要终点：2 年累积局部进展率（LP）；次要终点：局部无进展生存期（LPFS）、总生存期（OS）和毒性（CTCAE））。评估了预设的患者和治疗相关因素对 HRQOL（EORTC QLQ-C30 和 EORTC QLQ-LC13）的影响。
2011 年 2 月至 2014 年 11 月，100 例患者接受了 56 例 NSCLC 和 44 例肺转移瘤（M1）的 SBRT。长期 FU 总体显示稳定的生活质量（QoL）/全球健康状况（GHS）、功能评分和症状。对于 QoL/GHS，初始 QoL/GHS 评分较低（<中位数）的患者比 QoL/GHS 评分良好的患者改善更明显（p<0.001）。SBRT 后 2 年 LP、LPFS 和 OS 的概率分别为 8.1%（NSCLC：7.3%，M1：9.2%）、53.3%（NSCLC：50.7%，M1：56.0%）和 62.2%（NSCLC：57.2%，M1：68.4%）。≥G3 毒性<4%，但基线时有≥G3 呼吸困难 6%，SBRT 后 2 年有 14.5%。
这些关于代表性肺部 SBRT 患者的前瞻性数据证实，SBRT 后 HRQOL 稳定，3×12.5Gy SBRT 方案有效且耐受性良好，为初始 QoL/GHS 评分较低的患者带来了 QoL/GHS 获益。该结果可能为讨论 SBRT 治疗体弱患者时的共同决策提供信息。
