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A Thrombopoietin Receptor Agonist for Chemotherapy-Induced Thrombocytopenia?
Thrombopoietin receptor agonists (TPO-RAs) are approved for use in patients with immune thrombocytopenia, aplastic anemia, and cirrhotic thrombocytopenia in need of procedures. These agents have also been studied in patients with chemotherapy-associated thrombocytopenia, which can result in the need for platelet transfusions, chemotherapy dose reductions, and chemotherapy treatment delays.
Now, investigators have conducted an industry-funded, randomized, double-blind, placebo-controlled, phase III study to evaluate the efficacy of the TPO-RA avatrombopag in 122 patients with chemotherapy-induced thrombocytopenia (<50×109 cells/L) and nonhematological malignancies (ovarian, bladder, or lung cancer). Patients were assigned (2:1) to receive avatrombopag (60 mg daily 5 days prior to chemotherapy and 5 days after administration) or placebo.
In the intention-to-treat analysis, the proportion of patients without the need for platelet transfusion, chemotherapy dose reduction, or delay in chemotherapy treatment (the primary endpoint) was similar with avatrombopag or placebo (70% and 73%, respectively). The durations of severe thrombocytopenia, rates of platelet transfusion, and chemotherapy treatment delays were also similar in each group, as was the low rate of thromboembolic events (2% and 3%).
This phase III study, the first to evaluate a TPO-RA for the management of chemotherapy-induced thrombocytopenia, did not demonstrate any benefit from administering avatrombopag before and after chemotherapy. The investigators suspected that the lack of benefit was related to a higher-than-expected rate of spontaneous platelet recovery in the placebo group. They also suggested that the results could have been affected by the exclusion from the study of patients with prior chemotherapy-associated thrombocytopenia. Although TPO-RAs are safe enough, a lack of statistical efficacy limits their use in patients with chemotherapy-associated thrombocytopenia.
Al-Samkari H et al.
Title: Avatrombopag for chemotherapy-induced thrombocytopenia in patients with non-haematological malignancies: An international, randomised, double-blind, placebo-controlled, phase 3 trial.
Source: Lancet Haematol 2022 Mar ; [e-pub]. (Abstract/FREE Full Text)