Clinical efficacy and safety of romiplostim N01 in the treatment of cancer therapy induced thrombocytopenia

XU Haiyuan; JI Zhangyi; XU Yan

doi:10.3969/j.issn.1009-0460.2025.05.012

Abstract：Objective To evaluate the clinical efficacy and safety of romiplostim N01 in patients with cancer therapy induced thrombocytopenia(CTIT).Methods A total of 46 patients with CTIT treated with romiplostim N01 in Kunshan First People's Hospital from July 2024 to January 2025 were retrospectively analyzed.The baseline platelet count was lower than 50×109/L,and the initial dose of romiplostim N01 was 3-5 μg/kg,once a week,subcutaneously injected,and the dose was increased by 1-2 μg/kg per week according to the platelet count level,the maximum dose was 10 μg/kg.The blood routine was reviewed every other day.There was drug withdraw when platelet count restored to more than 75×109/L and increased more than 30×109/L from baseline.Platelet counts,bleeding and related adverse reactions were recorded before and within 21 days after treatment.Results Forty-six patients with CTIT were treated with romiplostim N01,with 38 cases complete reponse(CR),4 cases partial response(PR),3 cases mild response(MR)and 1 case no change(NC).The total objective response rate(ORR)was 91.3%(42/46).The response rates in the first-line treatment group and in the second-line treatment group were similar(94.1%vs.90.0%),which had no statistically significant difference(P>0.05).The duration of platelet<50×109/L,recovery time to 75×109/L and time to 100×109/L in the first-line treatment group were shorter than those in the second-line treatment group,and the differences were statistically significant(P<0.05).Overall adverse reactions were mild,mainly manifested as mild to moderate muscle and joint pain,headache,dizziness and insomnia.Conclusion Romiplostim N01 is effective for CTIT,and only once a week.It is also effective for patients who have failed treatment with rhTPO,rhIL-11,first-generation TPO-RA.Adverse reactions is mild and no risk of thrombosis increased.Romiplostim N01 can be recommended as a first-line treatment for patients with grade 3 or higher CTIT,or as a salvage treatment for patients who have failed treatment with other drugs.