Medical oncology
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Randomized Controlled Trial Multicenter Study
An open-label, randomized, multicenter dose-finding study of once-per-cycle pegfilgrastim versus daily filgrastim in Chinese breast cancer patients receiving TAC chemotherapy.
A chemotherapy regimen of docetaxel, doxorubicin and cyclophosphamide (TAC) has been accepted as a standard care because of their superior clinical benefit in early-stage breast cancer patients, but with a higher risk of neutropenia. Pegfilgrastim is a once-per-cycle therapy for prophylactic neutrophil support and neutropenia prevention. There was still a lack of direct evidences for finding an optimal fixed dose of pegfilgrastim in Chinese breast cancer patients receiving TAC regimen. ⋯ The results for febrile neutropenia, time to neutrophil recovery and neutrophil profile were also not significantly different between arms. The safety profiles of pegfilgrastim and filgrastim were similar. A single dose of 100 µg/kg once-per-cycle administration of pegfilgrastim provided neutrophil support and a safety profile comparable to daily subcutaneous injections of filgrastim in Chinese breast cancer patients receiving TAC chemotherapy.