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1.
J Thromb Thrombolysis ; 57(2): 293-301, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37932590

ABSTRACT

Direct oral anticoagulants (DOACs) for venous thromboembolism (VTE) treatment are of interest in oncology due to ease of administration and lack of need for therapeutic monitoring compared to other anticoagulants. Data supporting their use in patients with hematologic malignancies post-hematopoietic stem cell transplant (HCT) are limited. The purpose of the study is to characterize DOAC use in HCT patients. This multicenter, retrospective cohort analysis included allogeneic and autologous HCT recipients. The primary outcome was major bleeding. Secondary outcomes included clinically relevant non-major bleeding (CRNMB)/minor bleeding and VTE recurrence. Of 126 patients, 91 (72.2%) patients received an autologous HCT, and 35 (27.8%) patients received an allo-HCT. No major bleeding occurred in either transplant recipient groups. In autologous HCT recipients, CRNMB/minor bleeding occurred in four (4.4%) patients and VTE recurrence occurred in one (1.1%) patient. For allogeneic HCT recipients, CRNMB/minor bleeding occurred in five (14.3%) patients and VTE recurrence occurred in two (5.7%) patients. For patients that experienced a CRNMB, five (100%) of the allogeneic HCT and two (50%) of the autologous HCT recipients were thrombocytopenic at the time of bleeding. Only 38.5% of patients who experienced a drug-drug interaction requiring DOAC dose adjustment received the appropriate dose adjustment. DOACs were associated with low rates of recurrent VTE and no major bleeding events, similar to published data on DOAC use in the general cancer patient population. This suggests that DOACs may be safe therapeutic options with proactive management of drug interactions and careful monitoring for bleeding events, especially in the allogeneic HCT population where minor bleeding rates were slightly higher.


Subject(s)
Hematopoietic Stem Cell Transplantation , Venous Thromboembolism , Adult , Humans , Venous Thromboembolism/etiology , Venous Thromboembolism/chemically induced , Retrospective Studies , Transplant Recipients , Anticoagulants/adverse effects , Hemorrhage/chemically induced , Hemorrhage/drug therapy , Administration, Oral , Hematopoietic Stem Cell Transplantation/adverse effects
2.
Support Care Cancer ; 31(4): 224, 2023 Mar 21.
Article in English | MEDLINE | ID: mdl-36941508

ABSTRACT

PURPOSE: Venetoclax combined with a hypomethylating agent (HMA) has become the standard of care for elderly/unfit patients with newly diagnosed acute myeloid leukemia (AML). This study is aimed at characterizing the impact of an interdisciplinary team on the length of stay (LOS) of patients with newly diagnosed AML receiving venetoclax with an HMA. METHODS: This retrospective observational study included patients with AML who received HMA with venetoclax as an initial treatment between December 2015 and July 2021. The primary outcome was the median LOS during induction stratified by HMA. Secondary outcomes included barriers to hospital discharge, incidence of tumor lysis syndrome (TLS), response rates, and utilization of the institution's prescription assistance program (PAP). RESULTS: Seventy-eight patients were included in our analysis: 51 received azacitidine/venetoclax, and 27 received decitabine/venetoclax. The median LOS from therapy initiation was eight days (range 7-38) for the azacitidine group and six days (range 5-26) for the decitabine group. The most common barriers to discharge were transfusion dependence (33 patients, 42.3%) and insurance coverage (12 patients, 15.4%). Twelve patients (15.3%) had tumor lysis syndrome during hospital admission, and 20 (25.6%) were readmitted during induction. Twenty-three patients (29.5%) required financial assistance for AML care, and a pharmacy-led PAP generated approximately $342,646 in cost savings. CONCLUSION: The utilization of an interdisciplinary AML team to target early hospital discharge proved to be safe and effective and led to a reduction in costs for the health system. Future research may identify select patients who may be suitable for earlier discharge or outpatient induction.


Subject(s)
Leukemia, Myeloid, Acute , Tumor Lysis Syndrome , Humans , Aged , Decitabine/pharmacology , Decitabine/therapeutic use , Treatment Outcome , Tumor Lysis Syndrome/etiology , Patient Discharge , Induction Chemotherapy , Azacitidine/therapeutic use , Leukemia, Myeloid, Acute/pathology , Patient Care Team , Antineoplastic Combined Chemotherapy Protocols/adverse effects
3.
J Oncol Pharm Pract ; 29(7): 1715-1724, 2023 Oct.
Article in English | MEDLINE | ID: mdl-36731514

ABSTRACT

BACKGROUND: For patients with multiple myeloma (MM) who have undergone autologous stem cell transplant (auto-SCT), the immunomodulatory agent lenalidomide is a first-line option for maintenance therapy. Because longer durations of lenalidomide maintenance are associated with improved survival, identifying strategies to avoid premature cessation of maintenance is an important priority in the post-transplant setting. OBJECTIVES: The primary objective of this analysis was to identify specific clinical predictors of lenalidomide treatment duration that could guide optimal medication management. Key secondary objectives included predictors of intolerable toxicity, rationale for lenalidomide dose reduction/discontinuation, and characterization of dose adjustments. STUDY DESIGN: This retrospective, multi-center cohort study included adults with MM who underwent auto-SCT and initiated maintenance lenalidomide between 01/01/2012 and 02/28/2021. Variables assessed as potential predictors of maintenance duration or intolerable toxicity included age, body mass index (BMI), Eastern Cooperative Oncology Group (ECOG) performance status at time of auto-SCT, renal function, initial lenalidomide dose, use of combination maintenance therapy, and cytogenetic risk category. RESULTS: Among 299 patients included, the median age at time of auto-SCT was 62 years (range 30-77). The majority of patients had standard-risk cytogenetics (64%) and an ECOG performance status of 0 or 1 (72%). In the overall population, the median duration of maintenance was 1.3 years (range 0.3-8.6 years). The median initial dose of lenalidomide was 10 mg daily (range 2.5-25 mg). During the study period, 35% of patients had a dose reduction due to toxicity, 21% stopped lenalidomide due to disease progression, and 19% stopped due to toxicity. Multivariate linear regression analyses did not identify any significant predictors of lenalidomide duration or discontinuation due to intolerable toxicity. The most frequently reported toxicities leading to discontinuation were cytopenias, rash, and fatigue. CONCLUSION: This analysis did not identify any significant risk factors to predict the duration of lenalidomide maintenance or discontinuation for toxicity following auto-SCT in patients with MM. While limited by the retrospective design and relatively small sample size, our findings suggest that a priori lenalidomide dose reductions based on patient co-morbidities or performance status may not substantially affect the duration of lenalidomide maintenance.


Subject(s)
Hematopoietic Stem Cell Transplantation , Multiple Myeloma , Adult , Humans , Middle Aged , Aged , Multiple Myeloma/drug therapy , Lenalidomide/therapeutic use , Retrospective Studies , Cohort Studies , Disease-Free Survival , Transplantation, Autologous , Stem Cell Transplantation , Hematopoietic Stem Cell Transplantation/adverse effects , Antineoplastic Combined Chemotherapy Protocols/therapeutic use
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