Abstract 909P
Background
Neutropenia is a common complication of chemotherapy, which will lead to the delay or reduction of chemotherapy and affect the therapeutic effect. Mecapegfilgramtim (code name HHPG-19K), the novel long-acting rhG-CSF, has been developed. This study was evaluated the efficacy and safety of HHPG-19K for reducing neutropenia compared with un-prevention.
Methods
This was a randomized, controlled non-inferiority study. A total of 151 lymphoma patients who were eligible for chemotherapy were randomly assigned into two groups, which received HHPG-19K fixed dosage of 6 mg or un-prevention in the first cycle of chemotherapy. The primary endpoint was the duration of grade≥3 neutropenia in cycle 1, incidence of grade≥3 neutropenia, and febrile neutropenia (FN). The safety profile was also evaluated.
Results
The adjusted mean duration of grade>1 neutropenia was 5 days in HHPG-19K fixed dosage of 6 mg group and 7 days in the un-prevention group (P<0.01). There was difference between the two groups in the incidence of grade≥3 neutropenia (P<0.01). There were 10 patients (12.82%) in HHPG-19K fixed dosage of 6 mg/kg group, 15 patients (20.55%) in un-prevention group experienced grade≥3 neutropenia. Compared with un-prevention group, the incidence of grade 4 neutropenia was significantly lower in patients treated with HHPG-19K fixed dosage of 6 mg/kg (7.69% vs 15.07%). For the incidence of FN, there were 5 patients (6.41%) in HHPG-19K fixed dosage of 6 mg/kg group, 11 patients (15.07%) in un-prevention group experienced FN (P<0.05). For safety profile, HHPG-19K group were all well-tolerated. The frequent AEs were ostalgia (13.70 vs 6.41%), fever (24.66% vs 11.54%), nausea (21.92% vs 1.28%), emesis (16.44% vs 1.28%), weakness (9.59% vs 2.56%) and others (19.18% vs 10.26%) during the chemotherapy, which were inferior to the un-prevention group (P<0.01). The frequent AEs were ostalgia (6.41 vs 13.70%), fever (11.54% vs 24.66%), nausea (1.28% vs 21.92%), emesis (1.28% vs 16.44%), weakness (2.56% vs 9.59%) and others (10.26% vs 19.18%) during the chemotherapy, which were inferior to the un-prevention group (P<0.01). No unexpected AE was observed.
Conclusions
This study provided new evidence for HHPG-19K, which would be a new alternative clinical practice for prophylaxis of chemotherapy induced neutropenia.
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.