Qu, Xuanlu

Abstract Background EuroQoL EQ-5D-5L is a commonly used measure of health-related quality of life in clinical trials given the use of its index score as a measure of health utilities. It is unclear whether EQ-5D-5L is sensitive to changes in neurocognitive function and progression that occur following brain radiation. This study sought to evaluate the sensitivity of EQ-5D-5L in reflecting these changes. Methods A secondary analysis of NRG Oncology CC001 was performed. Mean EQ-5D-5L index and visual analog scale (VAS) score changes from baseline between groups of patients stratified by neurocognitive function and intracranial progression status were assessed. MD Anderson Symptom Inventory for brain tumor (MDASI-BT) symptom and interference items were also analyzed between groups. Results EQ-5D-5L mean index and VAS score changes between patients who had cognitive failure and those who had preserved cognition showed no statistically significant differences at any timepoint. In contrast, VAS changes at 4 months (1.61 vs -5.13, P = .05) and 6 months (8.17 vs −0.14, P = .04) were significantly improved in the patients who survived without intracranial progression. MDASI-BT cognitive factor scores were improved in the cohort of patients with preserved neurocognitive function at 2 months (1.68 vs 2.08, P = .05) and 4 months (1.35 vs 1.83, P = .04). MDASI-BT symptom interference was significantly associated with intracranial progression at 4 months, but not with neurocognitive status. Conclusion EQ-5D-5L index and VAS scores were not sensitive to neurocognitive changes that patients experienced, but VAS scores were sensitive to progression. This study challenges the routine use of EQ-5D as a quality of life metric in brain metastases clinical trials that are focused on preventing neurocognitive dysfunction. Trial Registration NCT# 02360215.

Objectives: Radiotherapy for soft-tissue sarcoma (STS) has been shown to reduce local recurrence, but without clear improvement in survival. We conducted a meta-analysis to study the association between radiotherapy and survival in patients undergoing surgery for STS. Methods: A systematic review was conducted from PubMed, EMBASE, Web of Science, and Cochrane databases. Our population of interest consisted of adults with primary extremity, chest wall, trunk, or back STS. Our metameters were either an odds or hazard ratio for mortality. A bias score was generated for each study based on margin status and grade. Results: Of 1044 studies, 30 met inclusion criteria for final analysis. The pooled odds ratio in patients receiving radiation was 0.94 (95% confidence interval [CI], 0.78-1.14). The pooled estimate of the hazards ratio in patients receiving radiation was 0.87 (95% CI, 0.73-1.03) overall and 0.65 (95% CI, 0.52-0.82) for studies judged to be at low risk of bias. Significant publication bias was not seen. Conclusions: High-quality studies reporting adjusted hazard ratios are associated with improved survival in patients receiving radiotherapy for STS. Studies in which odds ratios are calculated from event data and those that do not report adjusted outcomes do not show the same association, likely due to confounding by indication.