Key Points Vitamin D deficiency is a predictor for poor overall survival in patients with multiple myeloma, even after adjusting for age and stage. This difference is only observed in white patients, not African Americans, even under a lower threshold for deficiency.
Direct oral anticoagulants (DOACs) are increasingly used for stroke prevention in atrial fibrillation and treatment and prevention of venous thromboembolism. They are also associated with bleeding risk. Existing literature suggests that prothrombin complex concentrate (PCC) administration may help control bleeding due to factor Xa inhibitors (FXaI). To determine the hemostatic efficacy of PCC in patients with major bleeding due to FXaI, we performed a retrospective chart review of 50 patients who presented with FXaI associated major bleeding that required urgent hemostatic management. Hemostatic assessment was performed using ISTH and ANNEXA-4 criteria. Twenty patients presented with intracranial hemorrhage (ICH), 20 had gastrointestinal bleeding, 3 had visceral bleeding, 3 had genitourinary bleeding, and 4 had miscellaneous types of bleeding. Fifty-six percent (28/50) had effective hemostasis using ISTH criteria and 84% (42/50) achieved effective hemostasis by ANNEXA-4 criteria. Hemostatic efficacy was similar by both tools for ICH (75% each). However, there was a major difference between ISTH and ANNEXA-4 hemostatic efficacy assessments for GI bleeding (45% and 95%, respectively). When comparing rivaroxaban and apixaban, there was no significant difference in effective hemostasis using either criteria, time to hemostasis, thromboembolic events, or patient mortality. Five (10%) patients had thromboembolic events within seven days of PCC administration, and the 30-day mortality rate was 14% (7/50). Our study shows similar efficacy, thromboembolic events, and mortality associated with PCC compared to andexanet alfa using ANNEXA-4 criteria, suggesting that PCC may be a viable alternative.
81 Background: Bisphosphonates, including zoledronic acid (Zometa), decrease skeletal-related events in breast cancer patients with bone metastasis but are also associated with side effects and utilization costs. Data from a randomized trial supporting 12-week versus 4-week dosing of Zometa was released in July 2016 and officially published in January 2017. We examined the practice pattern of Zometa dosing over time in our practice to determine compliance and develop interventions for improvement. Methods: We conducted a retrospective chart review on all breast cancer patients treated at Parkland Health and Hospital System oncology clinic to identify patients who were initiated on Zometa for bone metastasis between June 2015 and September 2019. The initially prescribed dosing frequencies were assessed for time periods before and after the Zometa dosing data was made available. The prescribing patterns were also compared between teaching and non-teaching clinics. An educational review of the guidelines was presented to providers in all clinics in March 2020 to improve compliance. Results: In the year prior to July 2016, of the 27 patients who started Zometa, only 1 (4%) was on every 12-week dosing. In the six months after release of the data, 29% (6/21 patients) were placed on 12-week Zometa dosing. Between January 2019 and September 2019, 52% of patients were started on the recommended 12-week dosing interval. These patterns were consistent between teaching and non-teaching clinics. Conclusions: We found that the variability in Zometa prescribing patterns persisted despite updated national guidelines and multiple studies supporting 12-week dosing intervals. In addition to educational interventions, we plan to implement electronic interventions to improve rates of compliance with the goal of 80% adherence by September 2020. Improved adherence will likely lead to a reduction in potential complications from treatment as well as infusion costs (estimated $482.81 saved per patient annually).
Background: A number of studies have reported elevated incidence of 25-OH-vitamin D deficiency among patients with multiple myeloma (MM). Several studies have found association between vitamin D levels and factors associated with survival, including ISS stage at diagnosis. However, the impact of vitamin D deficiency on MM prognosis is not entirely clear. Also, in general, both the incidence and the impact of vitamin D deficiency differ substantially by race. Here, we investigate the impact of vitamin D deficiency on prognosis in a large and racially heterogenous patient population with MM in the Veterans Affairs (VA) system. Methods: We used the VA's nationwide Corporate Data Warehouse to identify patients diagnosed with symptomatic MM from 1999 to 2017. Various demographic and laboratory data was collected including age, race, 25-OH-vitamin D levels, and ISS stage at diagnosis as well as survival outcome data. Details of therapies received was also available which indicted similar access to all newer agents approved for myeloma for both African American (AA) and Caucasian patients. Results: We identified 15,717 patients diagnosed with MM (3353 AA and 9070 Caucasian), of whom 6675 had vitamin D measurements within 2 months of diagnosis (1959 AA and 4398 Caucasian). Median serum vitamin D levels were significantly lower among AA patients (21.8 ng/mL) than Caucasians (28.6 ng/mL; p<0.0001). No difference in median vitamin D levels was observed across ISS stage at diagnosis (p=0.7575), but a significant positive correlation (ρ=0.166; p<0.0001) was found between vitamin D levels and age at diagnosis. We evaluated the ability of serum vitamin D level to predict overall survival (OS) in patients with MM using a cut-off of 20ng/mL. Patients with vitamin D deficiency (<20ng/mL) had a significantly worse prognosis than patients with normal levels (≥20ng/mL) (Fig 1A). Specifically, median OS was 3.10 years (95% CI 2.73-3.52) for patients with vitamin D deficiency, compared to 3.91 years (95% CI 3.59-4.38) for patients with normal serum vitamin D. Univariate Cox proportional hazard analysis also showed that vitamin D deficiency is a significant predictor of OS after MM diagnosis (HR 1.24; P=0.0021), and vitamin D deficiency remained an independent predictor of OS under multivariate analysis in which adjustments were made for race, age, and stage at diagnosis (HR 1.28; P=0.0385). The analyses were repeated for AA and Caucasian patients separately. Among AA patients, serum vitamin D was not a significant predictor of OS in univariate (P=0.5096) or multivariate analysis (P=0.6923), while it was still a strong predictor among Caucasian patients in both univariate (HR 1.38; P=0.0006) and multivariate analysis (HR 1.45; P=0.0048). Median OS is 3.54 years (95% CI 2.99-5.52; n=255) for AA patients with vitamin D deficiency and 3.95 years (3.25-5.35; n=296) with normal levels. Among Caucasians, median OS is 2.71 years (2.18-3.47; n=273) for deficient and 3.87 years (3.59-4.42; n=885) for normal. Kaplan-Meier plots (Fig. 1B and 1C) illustrate the observed OS curves for the two subgroups. Since levels of vitamin D were lower in AA patients, a lower cut-off of 10 ng/mL was also tested. Even using this lower cutoff, vitamin D deficiency was not a statistically significant predictor of OS in univariate (HR 1.33; P=0.0781) or multivariate analysis (HR 1.09; P=0.7039), though the number of AA patients with vitamin D <10 ng/ML is small (n=73). Conclusions: Vitamin D deficiency is a significant predictor of survival among patients diagnosed with MM, even after accounting for race, age, and ISS stage. However, this relationship is only observed in Caucasian patients and not observed among AA patients. Studies are ongoing to evaluate impact of Vitamin D deficiency of disease presentation including bone disease as well as genetic characteristics. This investigation highlights the need to assess the underlying biological mechanism responsible for the observed impact of vitamin D deficiency across race in MM. Figure 1. Figure 1. Disclosures Yellapragada: Novartis: Employment; Celgene: Research Funding; Takeda: Research Funding. Munshi:OncoPep: Other: Board of director.
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