Health-Related Quality of Life in a Randomized Phase III Study of Bevacizumab, @entity2903 , and Radiotherapy in Newly Diagnosed XXXX .

@entity1 @entity5 @entity2903 @entity2904 @entity463
PURPOSE: As @entity463 progresses, @entity1 experience a decline in health-related quality of life (HRQoL). Delaying this decline is an important treatment goal. In newly diagnosed @entity463 , progression-free survival was prolonged when bevacizumab was added to radiotherapy plus @entity2903 (RT/ @entity2904 ) versus placebo plus RT/ @entity2904 (phase III AVAglio study; hazard ratio, 0.64; 95% CI, 0.55 to 0.74; P < .001). To ensure that addition of bevacizumab to standard-of-care therapy was not associated with HRQoL detriment, HRQoL assessment was a secondary objective. @entity1 AND METHODS: @entity1 completed European Organisation for Research and Treatment of @entity5 Quality of Life Questionnaires C30 and BN20 at each @entity5 assessment (Appendix Table A1, online only). Raw scores were converted to a 100-point scale and mean changes from baseline scores were evaluated (stable: < 10-point change; clinically relevant deterioration/improvement: >=  10-point change). Deterioration-free survival was the time to deterioration/progression/death; time to deterioration was the time to deterioration/death. RESULTS: Most evaluable @entity1 who had not progressed (> 74%) completed all HRQoL assessments for at least 1 year of treatment, and almost all completed at least one HRQoL assessment at baseline (98.3% and 97.6%, bevacizumab and placebo arms, respectively). Mean changes from baseline did not reach a clinically relevant difference between arms for most items. HRQoL declined at progression in both arms. The addition of bevacizumab to RT/ @entity2904 resulted in statistically longer (P < .001) deterioration-free survival across all items. Time to deterioration was not statistically longer in the placebo plus RT/ @entity2904 arm (v bevacizumab) for any HRQoL item. CONCLUSION: The addition of bevacizumab to standard-of-care treatment for newly diagnosed @entity463 had no impact on HRQoL during the progression-free period.
