Quality-of-life results of an EORTC phase III randomized trial of adjuvant whole-brain radiotherapy versus observation after radiosurgery or surgical resection of one to three cerebral metastases of solid tumors.

Abstract

9036 Background: This study aimed to evaluate the effects of adjuvant whole brain radiotherapy (WBR) compared to no further radiotherapy after local treatment of a limited number of brain metastases in patients with stable solid tumor. We present the Health Related Quality of Life (HRQOL) results. Methods: HRQOL (EORTC QOL-C30 and BN-20) was a secondary endpoint in the trial. Out of 359, 317 patients (88.3% compliance) had baseline HRQOL assessments. Compliance was a challenge in this population: at month 6 some 51% of patients completed a HRQOL measure and at year one 45.1%. Therefore the analysis focuses on only the first year post baseline. The primary HRQOL endpoint was global QoL; secondary HRQOL endpoints were Cognitive, Physical, Emotional, Role Functioning and Fatigue. Sensitivity analyses were planned and undertaken for all scales. Statistical significance required p≤0.05 and clinical relevance ≥10 pt difference. Results: Over the year studied, there were no significant differences in the primary endpoint, global HRQOL (p<0.12). Patients who underwent WBR had a lower physical functioning score (p = 0.0325) and a deteriorated cognitive function (p = 0.006). However, the difference in physical function was clinically relevant only at week 8 and that in cognitive function only at year one. No differences between the treatments were found for role (p>0.1) or emotional functioning (p>0.1) or fatigue (p = 0.077). Exploratory analysis of several other HRQOL scales suggested worse scores for the WBR group, but these differences were not clinically relevant (<10 pt) and were not sustained in time for most other scales. Explorations also suggested that the detriment was generally greater in patients who had WBRT after radio surgery than after surgical removal of the brain metastases. Conclusions: In summary, patients who underwent WBR suffered from worse HRQOL levels, but very few differences were observed or reached the level of clinical or statistical significance. No significant financial relationships to disclose.