2100P - An exploratory study of the efficacy and safety of hetrombopag in the treatment of thrombocytopenia induced by concurrent or sequential chemoradiotherapy

Background

Chemoradiotherapy is still a basic treatment for cancer, even in the era of immunotherapy and targeted therapy. Chemoradiotherapy could cause bone marrow damage. A study published in ECIM/ICIM confirmed that hetrombopag significantly improved outcomes in patients with chemotherapy-induced thrombocytopenia (CIT), exhibiting good safety. However, the efficacy in concurrent or sequential chemoradiotherapy remains unclear. We conducted a clinical trial to explore the efficacy and safety of hetrombopag (a TPO-RA) in treating thrombocytopenia induced by concurrent or sequential chemoradiotherapy.

Methods

This prospective trial enrolled patients with thrombocytopenia induced by concurrent or sequential chemoradiotherapy. The study comprised two cohorts: cohort 1 (PLT≥30×10⁹/L and <50×10⁹/L) treated with hetrombopag combined with IL-11, and cohort 2 (PLT≥50×10⁹/L and ≤75×10⁹/L) treated with hetrombopag alone. Main inclusion criteria included: ≥18 years, platelet count ≥30×10⁹/L and ≤75×10⁹/L. The primary endpoint was the proportion of patients with PLT ≥75×10⁹/L, while secondary endpoints included the proportion and median time of PLT ≥100×10⁹/L, and safety.

Results

A total of 14 patients (5 in the combination group and 9 in the single group) were enrolled from March 2022 to May 2023. The hetrombopag response rate (PLT ≥75×10⁹/L) was 80% (n=4/5) in cohort 1 and 100% (n=9/9) in cohort 2. The proportion of PLT ≥100×10⁹/L was 60% (n=3/5) in cohort 1 and 77.8% (n=7/9) in cohort 2, and the median time was 8.3 days in cohort 1 and 8.8 days in cohort 2, respectively. Adverse events (AEs) were grade 1-2 and occurred only in the single group, including rash (1, 11.1%), nausea and vomiting (1, 11.1%), with no grade 3 or 4 adverse events.

Conclusions

Hetrombopag was safe and effective for patients with thrombocytopenia induced by concurrent or sequential chemoradiotherapy.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding

Disclosure

All authors have declared no conflicts of interest.