Quality of life in the CHISEL randomized trial of stereotactic ablative radiotherapy (SABR) versus standard radiotherapy for stage I non-small cel...

Date 25 November 2018
Event ESMO Asia 2018 Congress
Session Mini Oral - Thoracic cancers
Topics Radiation Oncology
Presenter David Ball
Citation Annals of Oncology (2018) 29 (suppl_9): ix139-ix142. 10.1093/annonc/mdy445
Authors D. Ball1, G..T. Mai2, S. Vinod3, S. Babington4, J. Ruben5, T. Kron6, B. Chesson7, A. Herschtal8, M. Vanevski8, A. Rezo9, C. Elder10, M. Skala11, A. Wirth1, G. Wheeler1, A. Lim12, M. Shaw1, P. Schofield13, L. Irving14, B. Solomon15
  • 1Radiation Oncology, Peter MacCallum Cancer Center, 3000 - Melbourne/AU
  • 2Radiation Oncology, Princess Alexandra Hospital, 4102 - Woolloongabba/AU
  • 3Radiation Oncology, Liverpool Hospital, 2170 - Liverpool/AU
  • 4Radiation Oncology, Christchurch Hospital, 8011 - Christchurch/NZ
  • 5Radiation Oncology, Alfred Hospital, 3004 - Melbourne/AU
  • 6Physical Sciences, Peter MacCallum Cancer Center, 3000 - Melbourne/AU
  • 7Radiation Therapy, Peter MacCallum Cancer Center, 3000 - Melbourne/AU
  • 8Biostatistics And Clinical Trials, Peter MacCallum Cancer Center, 3000 - Melbourne/AU
  • 9Radiation Oncology, Canberra Hospital, 2605 - Canberra/AU
  • 10Radiation Oncology, Auckland City Hospital, 1023 - Auckland/NZ
  • 11Radiation Oncology, Royal Hobart Hospital, 7000 - Hobart/AU
  • 12Radiation Oncology, Austin Hospital, 3084 - Heidelberg/AU
  • 13Cancer Experiences, Peter MacCallum Cancer Center, 3000 - Melbourne/AU
  • 14Respiratory Medicine, Royal Melbourne Hospital, 3050 - Parkville/AU
  • 15Medical Oncology, Peter MacCallum Cancer Center, 3000 - Melbourne/AU

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 3½ 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.

Editorial acknowledgement

Clinical trial identification

NCT01014130.

Legal entity responsible for the study

Trans Tasman Radiation Oncology Group.

Funding

The Radiation and Optometry Section of the Australian Government Department of Health with the assistance of Cancer Australia; The Cancer Society of New Zealand; and The Cancer Research Trust, New Zealand.

Disclosure

All authors have declared no conflicts of interest.