The study of Jinyouli selected for presentation at ASCO

The American Society of Clinical Oncology (ASCO) plenary session is one of the world's most influential platforms for academic exchanges in oncology.

The ASCO Annual Meeting 2022 focused on breast cancer studies, presenting numbers of new advances in breast cancer treatment. A randomized, controlled clinical study of Jinyouli (PEGylated recombinant human granulocyte colony-stimulating factor injection [PEG-rhG-CSF]) in the prevention of febrile neutropenia in patients with breast cancer, led by Professor Geng Cuizhi, Executive Vice President of Hebei Cancer Institute and Vice President of the Fourth Hospital of Hebei Medical University, was selected for presentation at this year's ASCO meeting.

01

Background

This study aimed to evaluate the incidence of febrile neutropenia (FN) in breast cancer patients administered PEGylated recombinant human granulocyte colony-stimulating factor injection (PEG-rhG-CSF) as primary prophylaxis 48h or 24h after chemotherapy.

02

Method

This clinical study was a multicenter, open-label, randomized trial that included patients with stage I-III invasive breast cancer who would receive 4 cycles of adjuvant EC (epirubicin in combination with cyclophosphamide) chemotherapy.

At the end of each chemotherapy cycle, the patients were randomized at a ratio of 1:1 to receive PEG-rhG-CSF as prophylaxis 48h (48h group) or 24h (24h group) after chemotherapy. The primary endpoint was the incidence of FN. The secondary endpoints included the incidence of grade 3/4 neutropenia, chemotherapy dose reduction, delay in chemotherapy due to neutropenia, antibiotic administration, pain (bone, muscle, or joint), and relative dose intensity (RDI) of chemotherapy.

03

Results

Preliminary results included 197 patients, with 96 in the 48h group and 101 in the 24h group. 78.1% of patients in the 48h group and 73.3% of patients in the 24h group completed 4 cycles of chemotherapy.

The incidence of FN was 2.1% and 4.0% in the 48h group and 24h group, respectively. FN occurred in the first two cycles in the 48h group and only in the first cycle in the 24h group. The incidence of grade 3/4 neutropenia was 27.1% in the 48h group while 51.5% in the 24h group. There was no delay in chemotherapy due to neutropenia in either group. The incidence of neutropenia resulting in chemotherapy dose reduction was 2.1% in the 48h group and 1.0% in the 24h group. Two patients (2.1%) in the 48h group and 4 patients (4.0%) in the 24h group received antibiotics. The mean RDI for each chemotherapy cycle was 91.3% in the 48h group and 91.5% in the 24h group. The incidence of pain (bone, muscle, or joint) in all grades was 25.0% in the 48h group and 20.8% in the 24h group. For pain of grade 3 or higher, one patient (1.0%) in the 48h group had bone pain, and one patient (1.0%) in the 24h group had muscle pain.

04

Conclusions

Preliminary results have shown similar efficacy of PEG-rhG-CSF administered 48h or 24h post-chemotherapy as primary prophylaxis of FN in breast cancer patients receiving EC chemotherapy.

This study fills the gap in studies of PEG-rhG-CSF administered d2 (24h) versus d3 (48h) post-chemotherapy in Chinese breast cancer patients, providing significant medical guidance on clinical dosing practices.