Romiplostim-N01 for cancer therapy-induced thrombocytopenia: A propensity score-matched cohort study

Cancer therapy-induced thrombocytopenia (CTIT) is a common complication in patients with solid tumors during their cancer treatment. The sole therapeutic agents approved for this indication are recombinant human interleukin-11 (rhIL-11) or recombinant human thrombopoietin (rhTPO). Romiplostim-N01 is a novel thrombopoietic agent launched in China in 2024, which has demonstrated preliminary therapeutic efficacy in the management of CTIT. This retrospective study compared romiplostim-N01 with rhIL-11 or rhTPO for CTIT management. Ninety-two matched consecutive patients with grade ≥2 CTIT (platelet [PLT] count < 75 × 10 9 /L) were grouped into either the romiplostim-N01 group or the rhIL-11/rhTPO group. The primary endpoint was the proportion of treatment-marked responders, defined as patients who reached a PLT count of ≥100 × 10 9 /L and at least 30 × 10 9 /L higher than the pretreatment baseline within 7 days of treatment. Propensity score matching and a multivariate logistic regression model were used to estimate the treatment effects of the 2 drugs on CTIT. The 7-day marked response rate was significantly higher in the romiplostim-N01 group compared with the control group (58.7% vs 28.3%, P < .05), whereas the 14-day overall response rate was comparable between the 2 groups (89.1% vs 89.1%, P > .05). The median duration of chemotherapy delay was significantly shorter in the romiplostim-N01 group compared with the rhIL-11/rhTPO group (5.5 vs 9.5 days, P < .001). Multivariate regression analysis confirmed that romiplostim-N01 was independently associated with an elevation in PLT count. These findings position romiplostim-N01 as a favorable alternative to rhIL-11 or rhTPO in CTIT, given its enhanced early PLT response and reduced risk of chemotherapy disruption.