Quality of life after pulmonary stereotactic fractionated radiotherapy (SBRT): Results of the phase II STRIPE trial.

• Prospective data on QoL after pulmonary SBRT of patients with small lung nodules. • Long-term preservation of QoL after pulmonary SBRT. • First trial revealing QoL-benefit for lung-SBRT patients with low initial QoL-score. • Long-term QoL-benefit for frail patients encourages lung-SBRT in such patients. • For lung-SBRT 3X12.5 Gy to 60% isodose is efficient and well tolerated. 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. [ABSTRACT FROM AUTHOR]