Cancer Management and Research (Jul 2021)

Efficacy of Venetoclax Combined with Decitabine-Based Treatment for Heavily Pre-Treated Relapsed or Refractory AML Patients in a Real-World Setting

  • Tong J,
  • Zhao N,
  • Hu X,
  • Yao W,
  • Cheng Y,
  • Zhou L,
  • Liu H,
  • Geng L,
  • Sun Z,
  • Zheng C

Journal volume & issue
Vol. Volume 13
pp. 5613 – 5621

Abstract

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Juan Tong, Na Zhao, Xing Hu, Wen Yao, Yaxin Cheng, Li Zhou, Huilan Liu, Liangquan Geng, Zimin Sun, Changcheng Zheng Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, People’s Republic of ChinaCorrespondence: Changcheng ZhengDepartment of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Lujiang Road No. 17, Hefei, 230001, People’s Republic of ChinaTel +86-551-62284476Fax +86-551-62284476Email [email protected]: We report the efficacy and safety of venetoclax plus decitabine-based treatment in heavily pre-treated relapsed or refractory acute myeloid leukaemia (RR-AML) in a real-world setting.Patients and Methods: There were 22 patients in this study and the median age was 47.5 (12– 84) years old, including 11 males and 11 females. Among them, 8 patients were relapsed AML including 2 patients relapsed after HSCT and 14 patients with primary refractory AML including 4 secondary AML. The median number of cycles of previous chemotherapy was 4 (range, 2– 10).Results: After a course of venetoclax plus decitabine-based treatment, 9 patients achieved complete remission (CR) and 1 patient achieved complete remission with incomplete haematological recovery (CRi). The overall response rate (ORR) was 45.5% and the CR rate was 40.9%, and the median time to reach CR/CRi was 21 (13– 46) days. Four of the 10 CR/CRi patients relapsed again, and the median time of relapse was 5 (1.0– 24) months. The one-year overall survival rate was 31.8%, and the median survival time was 6 months (95% CI, 1– 9 months). The one-year overall survival rate of 10 CR/CRi patients was 59.1%, and the 12 NR patients was 10.4% (p=0.001). Nausea and vomiting occurred in 11 patients (50.0%). All patients had grade IV neutropenia and IV thrombocytopenia (100%). Pneumonia occurred in 14 patients (63.6%) and septicaemia occurred in 2 patients (9.0%). The cause of death in all patients was primary disease progression, and no patients died due to the side effects.Conclusion: The efficacy of venetoclax plus decitabine-based treatment in the real-world treatment of heavily pre-treated RR-AML is similar to that in clinical trials, and the side effects are controllable.Keywords: venetoclax, hypomethylating agents, acute myeloid leukaemia

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