Efficacy and safety of Romiplostim N01 for grades II to IV cancer therapy induced thrombocytopenia in a real world observational study

To assess the clinical efficacy and safety of Romiplostim N01 for moderate-to-severe Cancer Therapy-Induced Thrombocytopenia (Grade II–IV, CTIT) in a real-world study. In this retrospective analysis, a total of ten patients with a current diagnosis of CTIT were enrolled from the Department of Thoracic Oncology at the Second Affiliated Hospital of Zunyi Medical University, who received treatments from April 2024 to August 2024. All subjects were aged over 18 years, with a diagnosis of CTIT and subjected to platelet elevation with Romiplostim N01. The mean platelet count (PLT) for these patients before Romiplostim N01 administration was 28.8 × 10⁹/L. The median time to platelet recovery to 75 × 10⁹/L was 6 days, with a range of 5–13 days, and the median time to reach 100 × 10⁹/L was 7 days, the range being 5–16 days. After treatment, 70% of patients (7/10) reached a PLT count ≥ 100 × 10⁹/L; 60% of them reached this threshold within 14 days. Response rates were 40% at 7 days and 60% at 14 days. In the small exploratory cohort, Romiplostim N01 tentatively increased platelet counts in patients with grade II–IV CTIT, with no treatment-related serious adverse events reported.