Background: Past studies have indicated a potential racial disparity in Multiple Myeloma (MM) survival between black and white patients (Costa et al., 2017; Marinac et al., 2020), an issue compounded by minority underrepresentation in clinical trials (Ailawadhi et al., 2018). To better understand how racial disparities affect both MM survival and access to treatment, we performed an analysis of pooled clinical trial (CT) and Real-World EMR Data (RWD). Methods: Eligible Phase II and III open-label MM clinical trials were identified from the Medidata Enterprise Data Store, which comprises over 22,000 historical clinical trials, for de-identified aggregate analyses. De-identified Oncology RWD was sourced from the Guardian Research Network of integrated delivery systems from 2016 to 2020. Baseline characteristics were analyzed in both cohorts. Race was categorized as black, white, or other. Overall Survival (OS) was assessed using Kaplan-Meier analysis. In the RWD, therapy utilization was assessed by race. Results: The RWD contained 5871 patients, with 17.5% black, 78.3% white, and 4.2% other race. Median age in years at diagnosis was 69 for blacks, 72 for whites, and 70 for other races. The gender breakdown was 54.2% female in blacks, 46.0% in whites, 45.9% in those of other races respectively. Median number of prior regimens was 2, with no differences between racial groups. The CT data contained 851 patients, with 1.4% black, 93.5% white, and 5.1% other race. Median age in years at diagnosis was 62 for blacks, 58 for whites, and 55 for other races. The gender breakdown was 33.3% female in blacks, 43.5% in whites, and 46.7% in those of other races respectively. Median number of prior regimens was 5, with no differences between racial groups. There was no statistically significant difference in OS between racial groups in either dataset. In the CT data with median follow-up of 7.8 years, survival from date of diagnosis to last visit or date of death was 25% for blacks and 18% for whites. Currently, in the RWD, 3-year survival comparing blacks to whites is 85% to 83%. The proportion of treated RWD patients appears to be similar between black and white patient groups, with 56% of white and 53% of black patients receiving 1st line therapy, and 33% and 31% receiving 2nd line therapy, respectively. Among newer therapy modalities, white patients had a higher utilization of targeted antibody agent daratumumab (8.7% utilization among whites, 5.2% in blacks, p<0.001), and although not statistically different, proteasome inhibitor carfilzomib use was also higher among whites compared to blacks (6.5% versus 5.5%). Mono daratumumab and ixazomib were used as 1st-line therapy in white patients, while these agents were administered in combination with other treatments in black patients. Adjusting for age and novel therapy use, there was also a suggestion that treatment initiation after diagnosis occurred earlier in whites than blacks (median 1.1 years vs. 1.6 years, p=0.3). Conclusions: Though there were no demonstrated differences in survival between racial groups in either dataset, the RWD suggested differences in treatment utilization, with underutilization of novel therapies like proteasome inhibitors and targeted antibody therapy and later treatment initiation in blacks. Previous studies (Fiala et al., 2017) have noted similar trends, which suggest that therapeutic advances may not be equitably available to all racial groups. This observation could not be replicated in CT data, but merits further exploration. Despite black patients making up 17.5% of patients in the RWD, a racial distribution consistent with published literature (Rosenberg et al., 2015), black patients made up only 1.3% of patients in the CT data. Furthermore, in the CT data, the median age of black patients was older than that of the white and other race groups (62 years compared to 58 and 55, respectively). This observation is magnified by evidence in both the RWD and other datasets (Fillmore et al., 2019) that shows a younger age of onset in black MM patients. Given the strong correlation between age and poorer outcomes in MM (Ludwig et al.,2008), it is possible that these clinical trials are not capturing a representative black patient population, and results may not be generalizable to other groups. Recruitment of black patients should remain a priority in clinical studies in order to effectively assess racial disparities in MM treatment access and survival. Disclosures Rusli: Acorn AI by Medidata, a Dassault Systemes Company: Current Employment, Current equity holder in publicly-traded company. Diao:Acorn AI by Medidata, a Dassault Systemes Company: Current Employment. Liu:Acorn AI by Medidata, a Dassault Systemes Company: Current Employment. Kelkar:Acorn AI by Medidata, a Dassault Systemes Company: Current Employment. Ensign:Acorn AI by Medidata, a Dassault Systemes Company: Current Employment, Current equity holder in publicly-traded company. Watson:Guardian Research Network, Inc.: Current Employment. Galaznik:Acorn AI by Medidata, a Dassault Systemes Company: Current Employment, Current equity holder in publicly-traded company.
e19501 Background: Management of acute leukemia is often complicated by acute venous thromboembolism (VTE) and bleeding. However, it is unknown which risk factors contribute to these VTE and bleeding events, how they impact survival, or whether they warrant VTE prophylaxis. Methods: A retrospective study was conducted at the University of Florida Health Shands Hospital System. The study included patients aged 18 or older with acute leukemia who received induction chemotherapy between January 2000 and December 2011. Bleeding was defined as clinically significant non-major bleeding and major bleeding per the International Society on Thrombosis and Haemostasis guidelines. VTE was defined as pulmonary embolism, deep vein thrombosis of the upper or lower extremities, or visceral vein thrombosis. Results: Of the 250 patients with acute leukemia, 65 had VTE, 60 had bleeding, and 152 had no significant VTE or bleeding. There were 27 patients with both VTE and bleeding. There were no significant differences in demographics or disease types between these three groups. There was a total of 77 VTE events and 72 bleeding events. We performed a logistic regression analysis in a mixed model to identify risk factors for VTE and bleeding, considering leukemia type, presence of infection, chemotherapy, number of comorbidities, VTE prophylaxis, and transplant as covariates. Presence of infection and number of comorbidities were significantly associated with VTE (p = 0.0094 and 0.0009, respectively). We did not find any significant risk factor associated with bleeding. Kaplan-Meier survival analysis showed a non-significant difference in survival between the non-VTE, non-bleed group and the VTE group (Logrank test, p = 0.52). In contrast, survival in the non-VTE, non-bleed group was significantly higher than the bleed group (Logrank test, p = 0.0006). The table demonstrates higher two-year survival in the non-VTE, non-bleed group (68.7%) compared to the VTE and bleed groups (54.4% and 30.3%, respectively). Conclusions: Acute leukemia patients without VTE or bleeding had significantly higher duration of survival than patients with bleeding. Patients with acute leukemia and presence of infection or multiple comorbidities may warrant greater consideration of VTE prophylaxis. [Table: see text]
Background: Cytomegalovirus (CMV) infection has been associated with venous thromboembolism (VTE) and acute coronary syndromes (ACS). Methods: A retrospective study was conducted within the OSF HealthCare System in Peoria, Illinois. The objectives were to determine the incidence of acute VTE and ACS within one year of CMV testing. The “study group” included patients with positive CMV IgM or positive CMV Polymerase Chain Reaction (PCR). The “seropositive control” group included patients with positive CMV IgG and negative IgM. The “seronegative control” group included patients with negative CMV IgG and IgM, or negative PCR. Results: Within one year of CMV infection, 38 of 379 patients (10.0%) developed VTE in the study group compared to 41 of 1334 patients (3.1%) in the seropositive control and 37 of 1249 (3.0%) in the seronegative control. Adjusting for age and gender, both control groups were less likely to have VTE than the study group within one year (Seropositive Control: OR = 0.3, 95% CI 0.2-0.5, p <0.0001; Seronegative Control: OR = 0.4, 95% CI 0.2-0.6, p <0.0001). ACS was more likely to occur in the study group, with incidence of 7.7% compared to 4.7% (p <0.0001) in the seropositive control and 1.9% (p <0.0001) in the seronegative control. Adjusting for age and gender, the seronegative control was less likely to develop ACS than the study group within one year (OR = 0.4, 95% CI 0.2-0.7, p = 0.003). Conclusions: This retrospective study demonstrates that CMV infection may be a significant risk factor for VTE and ACS.
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