This analysis estimated the overall survival, treatment patterns and economic burden of elderly metastatic triple-negative breast cancer patients. Materials & methods: Patients (≥66 years) with metastatic triple-negative breast cancer were identified from the SEER-Medicare database. Treatment patterns were defined in terms of first, second and third or more regimens. Healthcare resource use and costs were reported over the follow-up period and over the treatment duration of each regimen. Results: A total of 51% of patients did not receive chemotherapy. Taxanes were most commonly used. Median survival was 7 months. The mean cumulative (per patient per month
This study assessed the net health benefits of treatment with nivolumab versus everolimus among patients with advanced renal cell carcinoma by assessing the quality (ie, patient preferences) and quantity of survival (ie, time spent with significant toxicities, in progression, or before progression and without significant toxicities). Nivolumab resulted in a 3.3-month quality-adjusted survival gain versus everolimus that was statistically significant and clearly clinically meaningful. Background: This analysis compared quality-adjusted time without symptoms of disease progression or toxicity (Q-TWiST) between nivolumab and everolimus among previously treated patients with advanced renal cell carcinoma enrolled in the phase III CheckMate 025 trial (NCT01668784). Materials and Methods: At 45-month follow-up, overall survival (OS) was partitioned into 3 health states: TWiST, time with grade ! 3 toxicity (TOX), and time after progression (REL). Mean Q-TWiST was determined by multiplying each state's duration with its utility (TWiST, 1.0; TOX, 0.5; REL, 0.5). Relative Q-TWiST gains (calculated as Q-TWiST difference divided by everolimus OS) of ! 10% were predefined as clinically important. Immuno-oncology-specific sensitivity analyses considered 4 alternative progression definitions: Tumor size increase ! 25% from nadir; treatment discontinuation; ! 2-point reduction from baseline in Functional Assessment of Cancer Therapy-Kidney Symptom Index Disease-Related Symptoms scores; and a composite definition. A scenario incorporating grade ! 2 toxicities was tested. Results: Compared with everolimus, nivolumab was associated with a significant Q-TWiST improvement of 3.3 months (P < .001). In all sensitivity analyses, nivolumab was associated with Q-TWiST gains (relative gain %) ranging from 3.3 months (14.4%) to 4.8 months (20.9%). Conclusions: Nivolumab is associated with a statistically significant and clinically meaningful gain in qualityadjusted OS versus everolimus among previously treated patients with advanced renal cell carcinoma.
Inadequate MDD care was associated with a higher risk of adverse CVD events. These findings reveal a significant unmet clinical need in patients with post-MI or post-stroke MDD that may impact CVD outcomes.
BackgroundThis study examined the psychometric properties of version 2 of the SF-12 Health Survey (SF-12v2) among adults with hemophilia in the United States.MethodsThis study employed a cross-sectional design using web-based and paper-based self-administered surveys. Hemophilia patients were recruited using an online panel and at a hemophilia treatment clinic. The psychometric properties of the SF-12v2 were assessed in terms of construct validity, internal consistency reliability, and presence of floor and ceiling effects.ResultsA total of 218 adults with hemophilia completed the survey, with most recruited via the online panel (78%). Confirmatory factor analysis using the WLSMV estimator in Mplus supported a two-factor model for the SF-12v2 where the physical functioning, role physical, bodily pain, and general health items loaded onto a latent physical factor (LPF) and the role emotional, mental health, social functioning, and vitality items loaded onto a latent mental factor (LMF). Model fit statistics for the two-factor model were: Chi-square [df] = 172.778 [48]; CFI = 0.972; TLI = 0.962; RMSEA [90% CI] = 0.109 [0.092–0.127]; WRMR = 0.947. Correlated residuals for items belonging to similar domains were estimated and there was a significant correlation between LPF and LMF. All standardized factor loadings were strong and statistically significant, indicating adequate convergent validity. Item-to-other scale correlations were lower than item-to-hypothesized scale correlations suggesting good item discriminant validity. Model testing revealed that LPF and LMF were not perfectly correlated, suggesting adequate construct discriminant validity. Increasing levels of symptom severity were associated with significant decreases in physical component summary (PCS) and mental component summary (MCS) scores, supporting known-groups validity. Internal consistency reliability was satisfactory, with Cronbach’s alpha of 0.848 for the LPF and 0.785 for the LMF items. Finally, none of the participants received the least or maximum possible PCS or MCS score, indicating the absence of floor and ceiling effects.ConclusionsOverall, the SF-12v2 was found to have adequate psychometric validity in our sample of adults with hemophilia. These results add to the growing evidence of psychometric validity of the SF-12v2 in different patient populations including hemophilia.
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