Neurocognitive, Symptom, and Health- Related Quality of Life Outcomes of a Randomized Trial of Bevacizumab for Newly Diagnosed Glioblastoma (NRG/RTOG 0825).

Background Results of NRG Oncology RTOG 0825 reported adding bevacizumab to standard chemoradiation did not significantly improve survival endpoints and resulted in greater decline in neurocognitive function (NCF) and patient reported outcomes (PRO) over time in bevacizumab treated patients. The present report provides additional results of patient centered outcomes over time and their prognostic association with survival endpoints. Methods NCF tests, MD Anderson Symptom Inventory brain tumor module (MDASI-BT), and European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire with brain-cancer module (QLQ-C30/BN20) were completed in a subset of progression-free patients at baseline and longitudinally. The prognostic value of baseline and early changes in NCF and PROs and differences between treatments from baseline to follow-up assessments was evaluated. Results 508 randomized patients participated. Baseline/early changes in NCF and PROs were prognostic for OS and PFS. No between arm differences in time to deterioration was found. At week 6, patients treated with bevacizumab evidenced greater improvement on NCF tests of executive function and the MDASI-BT Cognitive Function scale, but simultaneously reported greater decline on the EORTC Cognitive Function Scale. At later time points (week 22, 34, and 46), patients treated with bevacizumab had greater worsening on NCF tests as well as PRO measures of cognitive, communication, social function, motor symptoms, general symptoms and interference. Conclusion The collection of patient centered clinical outcome assessments in this phase III trial revealed greater deterioration in NCF, symptoms and QOL in patients treated with bevacizumab. Baseline and early change in NCF and PROs were prognostic for survival endpoints.