ABSTRACT
Aim ASPEN is a randomized, open-label, Phase III study comparing zanubrutinib and ibrutinib in patients with Waldenström macroglobulinemia (WM). Materials & methods: Patient-reported outcomes were exploratory end points assessed using the EORTC QLQ-C30 and EQ-5D-5L VAS scores. Results: Overall, 201 patients (102 zanubrutinib; 99 ibrutinib) were enrolled. Clinically meaningful differences were observed in diarrhea and nausea/vomiting in both the intent-to-treat population and in patients attaining very good partial response (VGPR) in earlier cycles of treatment, as well as in long-term physical functioning and fatigue in patients achieving VGPR. Conclusion: Treatment with zanubrutinib was associated with greater improvements in health-related quality of life compared with ibrutinib in patients with WM and MYD88 mutations.Clinical Trial Registration: NCT03053440 (ClinicalTrials.gov).
Patient quality of life is importantWhat is this article about? This article talks about a study called the ASPEN trial, which compares two medicines used for treating a rare blood cancer that doctors call Waldenström macroglobulinemia. The medicines are called zanubrutinib (ZAN) and ibrutinib (IBR). They work in the same way, by blocking a protein called Bruton tyrosine kinase. When patients take medicines for an illness, it is important to learn about their physical, social, emotional and mental well-being (quality of life). In this study, we asked patients to fill out questionnaires about their well-being before starting the study treatment for their blood cancer, and again a few times while taking the medication, to see if there were any changes.What were the results of the study? There were two groups of patients. One group took ZAN and the other took IBR. The patients could not choose which medicine they were going to take. Results from both groups of patients were compared. Patients taking ZAN did not feel worse or better about their diarrhea and sickness, but those taking IBR said these symptoms had become worse. Both medicines improved how patients were feeling. However, improvement in tiredness and physical ability was larger in patients taking ZAN than those on IBR, especially for the patients whose cancer was getting better.What do the results mean? For patients with a rare blood cancer in this study, those taking ZAN had a better quality of life than those taking IBR.
ABSTRACT
BACKGROUND: Few ocular trauma studies have addressed mortality outcomes. We sought to determine characteristics of mortality-related ocular trauma admissions and compared them with non-fatal injuries. METHODS: A retrospective study was conducted using de-identified data of patients admitted with major trauma from the National Trauma Data Bank (2008-2014). Patients with ocular injury were identified using ICD- 9CM codes. Demographics, intention and mechanism, types of ocular and head injuries, and injury severity were documented. Mortality was determined using post-admission disposition. Statistical analysis using student t-test, chi-square, and odds ratios (OR) calculations were performed with STATA-17 software. Significance was set at P < 0.05. RESULTS: Of 316,485 patients admitted with ocular trauma, 12,233 (3.86%) were mortality related. Expired patients were older than survivors: mean (SD) of 50.1(25.5) vs. 41.5(22.8) years. White (OR = 1.32; P < 0.001), ≥ 65years old (OR = 2.25; P < 0.001), and male (OR = 1.05; P = 0.029) patients were most likely to expire than their counterparts. Common mechanisms of injury in survivors were falls (25.3%), motor vehicle traffic-occupant, MVTO (21.8%) and struck by/against (18.1%) and for fatal injuries, falls (29.7%), MVTO (21.9%) and firearms (11.5%). Traumatic brain injury (TBI) was documented in 88.2% of mortality-related admissions. Very severe injury severity scores (ISS > 24) (OR = 19.19; P < 0.001) and severe Glasgow Coma Score (GCS < 8) (OR = 19.22; P < 0.001) were most associated with mortality than survival. Firearms were most associated with very severe ISS (OR = 3.73; P < 0.001), severe GCS (OR = 4.68; P < 0.001) and mortality (OR = 5.21; P < 0.001) than other mechanisms. Patients with cut/pierce injuries had the greatest odds of survival (OR = 13.48; P < 0.001). Optic nerve/visual pathways injuries (3.1%) had the highest association with very severe ISS (OR = 2.51; P < 0.001), severe GCS (OR = 3.64; P < 0.001) and mortality (OR = 2.58; P < 0.001) than other ocular injuries. Black patients with very severe ISS (OR = 32.14; P < 0.001) and severe GCS (OR = 31.89; P < 0.001) were more likely to expire than other race/ethnicities with similar injury severity. CONCLUSIONS: Mortality-related admissions were older, male, and mostly of White race than ocular trauma admissions of survivors. Firearms were the deadliest mechanism. TBI was commonly associated and patients with optic nerve/pathway injuries, very severe ISS and severe GCS had higher mortality rates. Characteristics and demographic variations identified in this study may be useful in developing focused measures aimed at preventing trauma-related deaths.