Avatrombopag for the treatment of thrombocytopenia induced by chemotherapy in patients with solid tumors: A multicenter, open-label, single-arm trial

Yayun Cui, Yifu He, Changlu Hu, Congyin Tu, Jin Huang, Xiaofeng Zhu, Chunbao Zang, Kaiyang Ding, Bihong Zhan, Yufei Zhao, Liting Qian, Yayun Cui, Yifu He, Changlu Hu, Congyin Tu, Jin Huang, Xiaofeng Zhu, Chunbao Zang, Kaiyang Ding, Bihong Zhan, Yufei Zhao, Liting Qian

Abstract

Objective: To explore the effect and safety of avatrombopag for chemotherapy-induced thrombocytopenia (CIT). Methods: This multicenter, open-label, single-arm trial enrolled CIT patients in eight centers from October 2020 to April 2021. The participants received avatrombopag tablets 60 mg once a day for 5-10 days. The main endpoint was the proportion of patients with platelet count ≥100×109/L or increased by ≥ 50×109/L or increased by ≥ 100% in the cycle after the start of treatment. Results: Seventy-four participants were enrolled with a mean age of 59.8 ± 11.62.2% were males. The cumulative effective rate (any criteria) was 70.3% at 4 weeks. 42 (56.8%) achieved platelet count ≥100×109/L, 44 (59.5%) increased by ≥ 50×109/L, and 27 (36.5%) increase by ≥ 100% from baseline. The duration of grade III and IV platelet reduction was 4.2 ± 5.3 days. The time of PLT recovery to ≥75×109/L was 9.4 ± 6.6 days. The time of PLT recovery to ≥100×109/L was 10.2 ± 6.4 days. The platelet count nadir was 57.9 ± 45.3×109/L. The most common adverse events were nausea (8.1%), fatigue (5.4%), and abdominal pain (1.4%). There were no cases of fever, headache, or peripheral edema. Conclusion: Although it was a single-arm trial without a control group, the application of avatrombopag in patients with CIT can increase the platelet count of the patients compared with baseline. Avatrombopag is safe and tolerable. Clinical Trial Registration: https://ichgcp.net/clinical-trials-registry/NCT04609891?term=04609891&draw=2&rank=1, identifier [NCT04609891].

Keywords: adverse event; agonist; chemotherapy; receptors; thrombocytopenia; thrombopoietin.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 Cui, He, Hu, Tu, Huang, Zhu, Zang, Ding, Zhan, Zhao and Qian.

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