BMC cancer · 2026
Real-world effectiveness of mecapegfilgrastim for prophylaxis in patients with breast cancer receiving 2-weekly and 3-weekly chemotherapy in China.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Shi Yanxia, Fu Peifen, Wang Yongsheng, Li Yongqing, Yao Yumin, Li Huiping, Yu Zhiyong, Song Lihua, Zhang Guifang, Ren Zhangxia, Cheng Gang, Ding Lifang, Yang Jun, Zhang Jing, Bie Jun, Yuan Chao, Wang Zhanggui, Xu Ruihua, Ma Jun
Аннотация
BACKGROUND: Breast cancer patients receiving myelosuppressive chemotherapy are at high risk of febrile neutropenia (FN). Long-acting G-CSFs are recommended for FN prevention, but evidence for mecapegfilgrastim in the dose-dense setting remains limited.
METHODS: This multicenter, prospective, observational, real-world study was conducted at 43 centers in China. Patients with breast cancer who received 2-weekly or 3-weekly chemotherapy with mecapegfilgrastim (6 mg) as prophylaxis for chemotherapy-induced neutropenia were enrolled. The primary outcome was the incidence of FN, defined as an oral temperature of > 38.3 °C or two consecutive readings of > 38.0 °C for 2 h and an absolute neutrophil count (ANC) of < 0.5 × 109/l, or expected to fall below 0.5 × 109/L. The secondary outcomes included severe neutropenia and adverse events (AEs).
RESULTS: Between June 2019 and March 2022, a total of 757 patients were enrolled. After 1:2 propensity score matching, 36 patients were included in the 2-weekly group and 71 patients were included in the 3-weekly group. In the first cycle, FN, grade 3/4 neutropenia, and grade 4 neutropenia occurred in 0 (0%; 95% CI, 0.0-9.6%), 9 (25.0%; 95% CI, 13.8-41.1%), and 4 (11.1%; 95% CI, 4.4-25.3%) patients in the 2-weekly group, and in 2 (2.8%; 95% CI, 0.8-9.7%), 11 (15.5%; 95% CI, 8.9-25.7%), and 5 (7.0%; 95% CI, 3.0-15.4%) patients in the 3-weekly group. Across all cycles, the corresponding incidences were observed in 0 (0.0%), 11 (30.6%), and 5 (13.9%) patients in the 2-weekly group, and 2 (2.8%), 14 (19.7%) and 7 (9.9%) patients in the 3-weekly group. Dose hold (≥ 5 days) occurred in 7 patients (19.4%) in the 2-weekly group and 5 patients (7.0%) in the 3-weekly group. The incidence of grade 3/4 treatment-emergent adverse events (TEAEs) was 26.7% in the 2-weekly and 33.3% in the 3-weekly groups. No patients had serious AEs in either group. No treatment-related deaths were reported.
CONCLUSION: Mecapegfilgrastim was associated with a low incidence of FN and manageable safety profiles in patients with breast cancer receiving 3-weekly or 2-weekly chemotherapy. Nevertheless, further studies with larger sample sizes are warranted to confirm these findings.
METHODS: This multicenter, prospective, observational, real-world study was conducted at 43 centers in China. Patients with breast cancer who received 2-weekly or 3-weekly chemotherapy with mecapegfilgrastim (6 mg) as prophylaxis for chemotherapy-induced neutropenia were enrolled. The primary outcome was the incidence of FN, defined as an oral temperature of > 38.3 °C or two consecutive readings of > 38.0 °C for 2 h and an absolute neutrophil count (ANC) of < 0.5 × 109/l, or expected to fall below 0.5 × 109/L. The secondary outcomes included severe neutropenia and adverse events (AEs).
RESULTS: Between June 2019 and March 2022, a total of 757 patients were enrolled. After 1:2 propensity score matching, 36 patients were included in the 2-weekly group and 71 patients were included in the 3-weekly group. In the first cycle, FN, grade 3/4 neutropenia, and grade 4 neutropenia occurred in 0 (0%; 95% CI, 0.0-9.6%), 9 (25.0%; 95% CI, 13.8-41.1%), and 4 (11.1%; 95% CI, 4.4-25.3%) patients in the 2-weekly group, and in 2 (2.8%; 95% CI, 0.8-9.7%), 11 (15.5%; 95% CI, 8.9-25.7%), and 5 (7.0%; 95% CI, 3.0-15.4%) patients in the 3-weekly group. Across all cycles, the corresponding incidences were observed in 0 (0.0%), 11 (30.6%), and 5 (13.9%) patients in the 2-weekly group, and 2 (2.8%), 14 (19.7%) and 7 (9.9%) patients in the 3-weekly group. Dose hold (≥ 5 days) occurred in 7 patients (19.4%) in the 2-weekly group and 5 patients (7.0%) in the 3-weekly group. The incidence of grade 3/4 treatment-emergent adverse events (TEAEs) was 26.7% in the 2-weekly and 33.3% in the 3-weekly groups. No patients had serious AEs in either group. No treatment-related deaths were reported.
CONCLUSION: Mecapegfilgrastim was associated with a low incidence of FN and manageable safety profiles in patients with breast cancer receiving 3-weekly or 2-weekly chemotherapy. Nevertheless, further studies with larger sample sizes are warranted to confirm these findings.