Exploring optimal administration timing of pegylated recombinant human granulocyte colony-stimulating factor for chemotherapy-induced neutropenia in early breast cancer treated with pharmorubicin and endoxan: a prospective randomized controlled clinical trial.

Xiaofeng Huang, Wenjie Shi, Ye Wang, Xinyu Wan, Jinzhi He, Yinggang Xu, Lu Xu, Xiaoming Zha, Jue Wang, Rui Chen, Weiwei Zhang, Jin Liu, Lifeng Huang

Journal: BMC cancer 2024;24(1):1387

PMID: 39533204

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Abstract

BACKGROUND

Pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) is a treatment for preventing febrile neutropenia (FN) in patients with early breast cancer. However, the optimal injection timing of PEG-rhG-CSF after chemotherapy is obscure. The trial was designed to explore the best administration timing of PEG-rhG-CSF when breast cancer patients could benefit most.

METHODS

Patients with early breast cancer were randomly assigned to receive a preventive injection on the 7th or 3rd day following chemotherapy. The experimental group (n = 80) received PEG-rhG-CSF treatment on day 7 after chemotherapy, whereas the control group (n = 80) received it on day 3. The occurrence of grades 3-4 neutropenia and FN in the first cycle was the primary endpoint. The secondary endpoint was the frequency of PEG-rhG-CSF dose reduction.

RESULTS

In comparison to the control group, the experimental group exhibited higher white blood cell count (WBC) and absolute neutrophil count (ANC) on the 9th and 13th days following chemotherapy (P < 0.05). Additionally, the incidence of grade 3-4 neutropenia was significantly lower in the experimental group (P = 0.038). Furthermore, a greater proportion of patients in the experimental group met the criteria for reducing the PEG-rhG-CSF dose compared to the control group (69.74% vs. 35.06%, P < 0.001).

CONCLUSIONS

In comparison with PEG-rhG-CSF injection on day 3 after chemotherapy, the incidence of grade 3-4 myelosuppression is lower, and the safety is more manageable after the injection on day 7. This approach potentially allows for a wider adoption of PEG-rhG-CSF dose reduction, leading to a consequential decrease in overall medical costs for patients.

TRIAL REGISTRATION

Clinical Trials: NCT04477616. Registered July 16, 2020.

Address: Department of Thyroid and Breast Surgery, The Affiliated Suqian First People's Hospital of Nanjing Medical University, Suqian, 223800, China.; Department of Breast Disease, The First Affiliated Hospital of Nanjing Medical University, No.300 Guangzhou Road, Nanjing, 210000, China.; Department of Breast Disease, The First Affiliated Hospital of Nanjing Medical University, No.300 Guangzhou Road, Nanjing, 210000, China.; Collaborative Innovation Center for Cancer Personalized Medicine, Nanjing Medical University, Nanjing, 210000, China.; Clinical Medicine Research Institution, The First Affiliated Hospital of Nanjing Medical University, No.300 Guangzhou Road, Nanjing, 210000, China.; Department of Clinical nutrition, The First Affiliated Hospital of Nanjing Medical University, No.300 Guangzhou Road, Nanjing, 210000, China. [email protected].; Department of Breast Disease, The First Affiliated Hospital of Nanjing Medical University, No.300 Guangzhou Road, Nanjing, 210000, China. [email protected].; Collaborative Innovation Center for Cancer Personalized Medicine, Nanjing Medical University, Nanjing, 210000, China. [email protected].

DOI: 10.1186/s12885-024-13156-y

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https://assays.cancer.gov/CPTAC-1496

MeSH Terms: Humans, Female, Breast Neoplasms, Granulocyte Colony-Stimulating Factor, Middle Aged, Polyethylene Glycols, Recombinant Proteins, Adult, Prospective Studies, Antineoplastic Combined Chemotherapy Protocols, Chemotherapy-Induced Febrile Neutropenia, Drug Administration Schedule, Aged, Neutropenia