PURPOSE: There is limited evidence on quality-of-life (QoL) outcomes of stereotactic body radiation therapy (SBRT) compared with conventionally hypofractionated radiation therapy (CHRT) in patients with medically inoperable stage I (≤5 cm) non-small cell lung cancer (NSCLC).
METHODS AND MATERIALS: This phase 3 randomized trial was conducted across 16 Canadian centers, enrolling patients with medically inoperable stage I (≤5 cm) NSCLC. Participants were randomized in a 2:1 ratio to receive SBRT or CHRT. QoL was assessed over 2 years postrandomization using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and the lung cancer-specific module 13 (LC-13), evaluating physical, symptom, functional, and social well-being. Differences in QoL between treatment groups at 2 weeks and 2 years were analyzed using linear mixed models, adjusting for baseline scores and stratification variables.
RESULTS: Of the 233 patients, 154 received SBRT and 79 received CHRT. At 2 weeks, model estimated mean global health scores were higher in the SBRT group (68.93 vs 64.93), with an estimated mean difference of 4.00 (95% CI 3.12, 4.89, P < .01). At 24 months, global health scores were 59.96 for SBRT and 62.88 for CHRT, with a difference of -2.92, 95% CI: -3.73, -2.11, P < .01). Mean LC-13 symptom scores at 2 weeks were 15.70 for SBRT and 17.11 for CHRT, with a difference of -1.41 (95% CI: -1.87, -0.95, P < .01). Mean difference in LC-13 at 24 months was 0.14 (95% CI: -0.29, 0.57, P = .69).
CONCLUSIONS: SBRT offers modest benefit in acute QoL and similar benefit in long-term QoL compared with CHRT in patients with inoperable stage I NSCLC.