An open-label, randomized, multicenter dose-finding study of once-per-cycle pegfilgrastim versus daily filgrastim in Chinese breast cancer patients receiving TAC chemotherapy

摘要

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. An open-label, randomized, phase II study was designed to compare the effects of pegfilgrastim with filgrastim. Eighteen centers in China enrolled 171 eligible female breast cancer patients with cycles of TAC chemotherapy treatment, randomized into four arms, received a single subcutaneous injection of pegfilgrastim (60, 100 or 120 mu g/kg) per chemotherapy cycle or daily subcutaneous injections of filgrastim 5 mu g/kg 24 h after chemotherapy. Efficacy and safety were analyzed. In ITT population, the mean duration of grade 3+ neutropenia (neutrophil count <1.0 x 10(9)/l) was 2.09, 1.53 and 1.73 days in patients who received pegfilgrastim 60, 100 and 120 mu g/kg/cycle, respectively, and 1.69 days in patients who received 5 mu g/kg/day filgrastim (P = 0.043). The incidence of grade 3+ neutropenia was 76, 83 and 74 % for doses of pegfilgrastim and 90 % for filgrastim (P = 0.409). 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 mu g/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.