PGY2 Hematology/Oncology Pharmacy Resident Hospital of the University of Pennsylvania Philadelphia, Pennsylvania, United States
Poster Abstract:
Background: Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative treatment option for patients with certain hematologic malignancies. However, graft-versus-host disease (GVHD) remains a significant complication of allo-HSCT and can contribute to post-transplant morbidity and mortality. Ruxolitinib is a selective inhibitor of Janus associated kinases (JAK1 and JAK2) that has shown promising results in treatment of steroid-refractory acute and chronic GVHD. Maintenance therapy using tyrosine kinase inhibitors (TKIs) after allo-HSCT can prevent disease recurrence and improve long-term outcomes. Due to the efficacy of ruxolitinib in GVHD treatment and the potential benefits of TKI maintenance therapy, many patients may require treatment with both agents to simultaneously control GVHD and prevent disease relapse. However, there is limited data surrounding the efficacy and safety of combining these medications after allo-HSCT.
Objectives: This study aims to assess the safety and tolerability of using ruxolitinib for GVHD treatment in patients receiving TKIs as maintenance therapy after allogeneic transplant to optimize treatment outcomes and minimize potential risks. The primary outcome is the incidence of hematologic toxicities, including neutropenia, thrombocytopenia, and anemia. Secondary outcomes include overall survival at 1 and 2 years, the rates and reasons for treatment discontinuation, dose-reductions, and interruptions.
Methods: This is a retrospective chart review of adult patients post-allo-HSCT receiving either ruxolitinib, a TKI, or both agents concurrently. Patients with relapsed primary malignancy or receiving additional systemic chemotherapy agents will be excluded. Data regarding patient demographics, treatment-related factors, and outcomes will be collected from the electronic medical record (EMR) from January 2015 through July 2023. Hematologic toxicities will be assessed by toxicity grade at nadir, using the Common Terminology Criteria for Adverse Effects (CTCAE) grading scale. Overall survival will be defined as the time from transplant day zero to death from any cause or last follow up. Incidence of hematologic toxicity between groups will be analyzed using a Fisher’s Exact test, overall survival will be analyzed using the Kaplan-Meier Method, and descriptive statistics will be utilized for all other endpoints.
Results: Results pending at this time.
Conclusion: Results pending at this time.
References (must also be included in final poster): 1. Hamilton BK. Current approaches to prevent and treat GVHD after allogeneic stem cell transplantation. Hematology Am Soc Hematol Educ Program. 2018;2018(1):228-235. doi:10.1182/asheducation-2018.1.228 2. Zeiser R, von Bubnoff N, Butler J, et al. Ruxolitinib for Glucocorticoid-Refractory Acute Graft-versus-Host Disease. N Engl J Med. 2020;382(19):1800-1810. doi:10.1056/NEJMoa1917635 3. Zeiser R, Polverelli N, Ram R, et al. Ruxolitinib for Glucocorticoid-Refractory Chronic Graft-versus-Host Disease. N Engl J Med. 2021;385(3):228-238. doi:10.1056/NEJMoa2033122 4. DeFilipp Z, Chen YB. How I treat with maintenance therapy after allogeneic HCT. Blood. 2023;141(1):39-48. doi:10.1182/blood.2021012412 5. Giebel S, Czyz A, Ottmann O, Baron F, Brissot E, Ciceri F, et al. Use of tyrosine kinase inhibitors to prevent relapse after allogeneic hematopoietic stem cell transplantation for patients with Philadelphia chromosome-positive acute lymphoblastic leukemia: A position statement of the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplantation. Cancer. 2016;122:2941–51. doi:10.1002/cncr.30130 6. Saini N, Marin D, Ledesma C, et al. Impact of TKIs post-allogeneic hematopoietic cell transplantation in Philadelphia chromosome-positive ALL. Blood. 2020;136(15):1786-1789. doi:10.1182/blood.2019004685 7. Common terminology criteria for adverse events (CTCAE) v5.0. November 27, 2017. Accessed October 3, 2023. https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcae_v5_quick_reference_5x7.pdf.
