Quality of life in the CHISEL randomized trial of stereotactic ablative radiotherapy (SABR) versus standard radiotherapy for stage I non-small cell lung cancer (Trans-Tasman Radiation Oncology Group 09.02)

Abstract

Background: In the randomized phase III trial of SABR versus standard radiotherapy for stage I NSCLC (CHISEL TROG09.02), we demonstrated superior progression free and overall survival for patients randomized to SABR. Here we report comparisons in quality of life (QoL) between the two treatment arms. Methods: Patients with biopsy proven stage I NSCLC confirmed by FDG PET/CT were randomized (2 to 1) to SABR (54 Gy in 3 fractions or 48 Gy in 4 fractions) or standard radiotherapy (66 Gy in 33 fractions or 50 Gy in 20 fractions). The primary endpoint was local progression free survival, with overall survival and QoL secondary endpoints. QoL was measured with the EORTC QLQ C30 and LC13 scales, before treatment, then at 1 and 3 months after treatment, then at 3 monthly intervals until 2 years and then at 6 monthly intervals. The area under the QoL ‐ time curve (AUC) until 31/2 years was estimated for each arm and differences between arms calculated using a linear mixed effects model with the appropriate linear contrast applied. Scores were standardised to be on a scale from 0 to 100. Results: 101 patients were randomized, 35 to standard radiotherapy and 66 to SABR. Local failure and overall survival favoured patients randomized to SABR, with hazard ratios of 0.32 (95% CI 0.13, 0.77, P = 0.008) and 0.53 (95% CI 0.30, 0.94, P = 0.027) respectively. For global health status measured with the QLQ C30, the difference in the mean AUC was 5.46 favouring the SABR arm (95% CI ‐3.6, 14.5). Similarly, there were no significant differences in functional or symptom scales, including fatigue (mean AUC difference 0.83, 95% CI‐8.0, 9.7), pain (‐3.60, 95% CI ‐13.4, 6.2) dyspnea (‐6.2, 95% CI ‐16.8, 4.4) or cough (‐7.68, 95% CI ‐19.7, 4.4) ‐ for all these symptom scales, negative values represent lesser symptoms in the SABR arm. Conclusions: In spite of substantial differences in treatment duration and intensity between the two arms, there were no differences in any of the QoL measures, providing further support for SABR as the standard of care in this patient group.