Concurrent radiotherapy and chemotherapy, as the main treatment scheme for gynecological tumors, can improve the prognosis of patients, while its high-intensity treatment will lead to bone marrow suppression, among which severe thrombocytopenia (CTIT) will lead to the reduction of chemotherapy dose and the delay of treatment, which will affect its curative effect. Hetrombopag is a new oral active small molecule thrombopoietin receptor agonist (TPO-RA).At present, it has shown the effect of promoting platelets and good safety in patients with persistent CTIT. The purpose of this study is to explore the single-arm, prospective and exploratory clinical study on the efficacy and safety of heterpopopa ethanolamine tablets in the treatment of thrombocytopenia caused by concurrent radiotherapy and chemotherapy of gynecological tumors.
In this prospective study, we observed the effect of heterpopa ethanolamine tablets on thrombocytopenia (CTIT) in gynecological tumor patients. Divided into two doses, 75x109/L<PLT<100x109/L, 5mg/d, po; 25×109<PLT<75×109/L，7.5mg/d，PO。 The main observation result is that the effective rate of heterpopa (PLT recovered to ≥100x109/L after treatment, or increased at least 50x109/L compared with the baseline, or at least doubled the baseline).
In this study, 23 patients were included for analysis, with a median age of 57 years, a median weight of 56kg and an ECOG score of 0-1. The median value of baseline PLT is 76×109/L.The effective rate of hertripopal: among the 23 subjects, the PLT increased to ≥ 100×109/L(15 cases, 65%) within 7 days, or at least increased by 50×109/L(7 cases, 30%) or at least doubled (1 case, 4%) compared with the baseline. The subjects who achieved the effective treatment of heterpopal within 14 days, that is, the PLT increased to ≥ 100×109/L(21 cases, 91%), or increased at least 50×109/L(12 cases, 52%) compared with the baseline or at least doubled the baseline (5 cases, 22%).