Aliihsan Gemici1, Fahir Ozkalemkas2, Mehmet Hilmi Dogu3, Atakan Tekinalp4, Inci Alacacioglu5, Tekin Guney6, Idris Ince7, Ayfer Geduk8, Gulsum Akgun Cagliyan9, Senem Maral10, Istemi Serin11, Eren Gunduz12, Volkan Karakus13, Huseyin Saffet Bekoz14, Rafet Eren15, Ibrahim Ethem Pinar2, Ahmet Kursad Gunes6, Fatma Deniz Sargın14, Omur Gokmen Sevindik14. 1. Department of Hematology, Medipol University, Istanbul, Turkey. Electronic address: inci.alacaciogl@deu.edu.tr. 2. Department of Hematology, Uludağ University, Bursa, Turkey. 3. Department of Hematology, Istinye University, Istanbul, Turkey. 4. Department of Hematology, Necmettin Erbakan University, Konya, Turkey. 5. Department of Hematology, Dokuz Eylul University, Izmir, Turkey. 6. Department of Hematology, University of Medical Sciences, Ankara City Hospital, Ankara, Turkey. 7. Division of Hematology, Dr. Ersin Arslan Training and Research Hospital, Gaziantep, Turkey. 8. Department of Hematology, Kocaeli University, Kocaeli, Turkey. 9. Department of Hematology, Pamukkale University, Denizli, Turkey. 10. Division of Hematology, Diskapi Training and Research Hospital, Ankara, Turkey. 11. Division of Hematology, Istanbul Training and Research Hospital, Istanbul, Turkey. 12. Department of Hematology, Osman Gazi University, Eskisehir, Turkey. 13. Department of Hematology, Alaaddin Keykubat University, Alanya, Turkey. 14. Department of Hematology, Medipol University, Istanbul, Turkey. 15. Division of Hematology, Bozyaka Training and Research Hospital, Izmir, Turkey.
Abstract
INTRODUCTION: Venetoclax is a selective B-cell lymphoma 2 (BCL2) inhibitor, which is approved to treat elderly patients with newly diagnosed acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) in combination with either low-dose cytarabine (ARA-C) or hypomethylating agents. We aimed to collect and share data among the efficacy and safety of venetoclax both as a monotherapy or in combination with other drugs used to treat high-risk MDS or AML. MATERIALS AND METHODS: A total of 60 patients with a median age of 67 (30-83) years from 14 different centers were included in the final analysis. Thirty (50%) of the patients were women; 6 (10%) of the 60 patients were diagnosed with high-risk MDS and the remaining were diagnosed with AML. RESULTS: The best objective response rate (complete remission [CR], complete remission with incomplete hematological recovery (CRi), morphological leukemia-free state [MLFS], partial response [PR]) was 35% in the entire cohort. Best responses achieved during venetoclax per patient number were as follows: 7 CR, 1 CRi, 8 MLFS, 5 PR, and stable disease. Median overall survival achieved with venetoclax was 5 months in patients who relapsed and not achieved in patients who were initially treated with venetoclax. Nearly all patients (86.7%) had experienced a grade 2 or more hematologic toxicity. Some 36.7% of these patients had received granulocyte colony stimulating factor (GCSF) support. Infection, mainly pneumonia (26.7%), was the leading nonhematologic toxicity, and fatigue, diarrhea, and skin reactions were the others reported. CONCLUSION: Our real-life data support the use of venetoclax in patients with both newly diagnosed and relapsed high-risk MDS and AML.
INTRODUCTION: Venetoclax is a selective B-cell lymphoma 2 (BCL2) inhibitor, which is approved to treat elderly patients with newly diagnosed acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) in combination with either low-dose cytarabine (ARA-C) or hypomethylating agents. We aimed to collect and share data among the efficacy and safety of venetoclax both as a monotherapy or in combination with other drugs used to treat high-risk MDS or AML. MATERIALS AND METHODS: A total of 60 patients with a median age of 67 (30-83) years from 14 different centers were included in the final analysis. Thirty (50%) of the patients were women; 6 (10%) of the 60 patients were diagnosed with high-risk MDS and the remaining were diagnosed with AML. RESULTS: The best objective response rate (complete remission [CR], complete remission with incomplete hematological recovery (CRi), morphological leukemia-free state [MLFS], partial response [PR]) was 35% in the entire cohort. Best responses achieved during venetoclax per patient number were as follows: 7 CR, 1 CRi, 8 MLFS, 5 PR, and stable disease. Median overall survival achieved with venetoclax was 5 months in patients who relapsed and not achieved in patients who were initially treated with venetoclax. Nearly all patients (86.7%) had experienced a grade 2 or more hematologic toxicity. Some 36.7% of these patients had received granulocyte colony stimulating factor (GCSF) support. Infection, mainly pneumonia (26.7%), was the leading nonhematologic toxicity, and fatigue, diarrhea, and skin reactions were the others reported. CONCLUSION: Our real-life data support the use of venetoclax in patients with both newly diagnosed and relapsed high-risk MDS and AML.