109 Background: Treatment options for mCSPC patients include adding novel hormonal therapy (NHT) with/without docetaxel (DOC) to androgen deprivation therapy (ADT). Uptake of these agents has been slow, and safety concerns may contribute to therapeutic inertia. This study aims to understand the RW occurrence of prespecified AEs among pts with mCSPC in the US. Methods: Claims from the PharMetrics Plus database (IQVIA, Durham, NC) were used to retrospectively estimate the proportion of pts with AEs among those with mCSPC from Jan 2014 through Jun 2021. Common AEs (≥10%) specified in FDA labels of treatments of interest or clinical trials ≥2% more prevalent than ADT alone were included in the study. Results of four clinically important AEs (fatigue, hot flash, sexual function and gastrointestinal [GI] AEs) are reported here. The proportions of pts with each of these AEs at specific timepoints plus 95% confidence intervals (CI) were estimated from cumulative hazard plots. Results were adjusted using inverse probability of treatment weighting across ADT alone, ADT+ nonsteroidal antiandrogen (NSAA), ADT+DOC and ADT+NHT. Results: The mean age of the overall study population (N=4145) was 66 years. At baseline, common sites of metastasis were bone only (n=1886, 45.5%) and node only (n=1237, 29.8%); the most common medications used were for pain (n=2182, 52.6%) and corticosteroids (n=1213, 29.3%). The reference group for all comparisons of AEs was ADT alone. For the entire study period, GI AEs and fatigue were significantly higher only in the ADT+DOC group ( P<0.001). Hot flash was higher in ADT+NHT ( P=0.05) and the ADT+DOC groups ( P<0.001). No statistically significant differences in sexual function AEs in the groups was noted. The table shows the proportions of pts with specified AEs. Conclusions: In this large RW study, all groups, including ADT alone, showed an increase in AE reporting over time. Most AE rates with ADT+NHT were comparable to ADT alone and ADT+NSAA, while ADT+DOC showed an increase in GI AEs, fatigue and hot flash. [Table: see text]
e19002 Background: Treatment for acute myeloid leukemia (AML) includes intensive chemotherapy and/or hematopoietic stem cell transplant, and patients usually require extended hospital stays and absence from work. Caregivers may also take workplace absence to provide care during and after treatment. As data on the indirect burden of AML are underreported, we aimed to understand the impact of work absenteeism (ABS) and disability days among patients with AML and caregivers. Methods: This non-interventional, retrospective analysis of healthcare claims data was conducted using MarketScan Databases containing ABS data. Two cohorts were analyzed: patients newly diagnosed with AML between January 1, 2009 and December 1, 2019 (index period), and caregivers with an adult family member newly diagnosed with AML during the index period. All participants were full-time employees, aged 18–64 years, and had ≥12 months of continuous enrollment prior to index date and ≥30 days of continuous enrollment after index date. The index date was the date of first AML diagnosis for patients, or the date of the linked family member’s first AML diagnosis for caregivers. Participants were followed for ≥30 days up to 3 years, until the end of continuous enrollment, end of database eligibility, or end of the study period. Participants who were pregnant or in families with > 1 member with AML were excluded. Days of work loss and associated wage loss were calculated for each work loss type: ABS, short-term disability (STD), and long-term disability (LTD). Results: This analysis included 1,037 patients with AML and 781 caregivers. From baseline to follow-up (FU) period, the proportion of patients reporting ABS numerically decreased from 72.8% to 62.7% (p = 0.054), and changes in ABS days per patient per month (PPPM) (2.21– 2.10, p = 0.735) or ABS-related wage loss PPPM ($562–$511, p = 0.516) were not statistically significant. However, the proportion of patients reporting STD and LTD significantly increased (24.6%–50.0%, p < 0.001, and 4.0%–20.0%, p < 0.001, respectively). The number of days PPPM lost due to STD and LTD significantly increased (0.85–4.94, p < 0.001, and 0.24–1.40, p < 0.001), as did STD- and LTD-related wage loss PPPM ($203–$1194, p < 0.001, and $57–$330, p < 0.001). Among caregivers, the proportion reporting ABS and ABS days PPPM were similar between baseline and FU periods (83.2%–83.9%, p = 0.871, and 2.41–2.64, p = 0.315). The proportion of caregivers with STD claims significantly increased (5.4%–11.8%, p < 0.001), and days PPPM lost due to STD and associated wage loss PPPM numerically increased (0.15–0.25, p = 0.057 and $38–$60, p = 0.087). Conclusions: Following AML diagnosis, the proportion of patients with STD and LTD leave increased significantly, while absenteeism did not change significantly. Days of STD leave also increased among caregivers. Future research is needed to determine how work loss varies by AML treatment type and/or sequencing.
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