一项评估GB-K02培非格司亭生物类似药用于预防乳腺癌化疗所致中性粒细胞减少症的3期试验。
完整摘要 · 中文译文
化疗引起的中性粒细胞减少症（CIN）在全球范围内构成沉重的疾病负担。尽管培非格司亭（一种长效粒细胞集落刺激因子）已在预防CIN方面显示出疗效，但在中国尚不可及。这是首项在中国评估培非格司亭生物类似药的临床研究。这项多中心、随机、双盲、平行对照、3期等效性研究旨在评估GB-K02（一种培非格司亭生物类似药）在250例乳腺癌患者中预防CIN的有效性和安全性。主要疗效终点为化疗第1周期中4级中性粒细胞减少的持续时间（DG4N）。GB-K02组与培非格司亭组第1周期的DG4N（LSMean ± SE）分别为0.58 ± 0.13天和0.80 ± 0.13天（p = 0.2139）。在4个化疗周期中，两组在其他疗效终点和安全性方面也相似。总体而言，GB-K02显示出与培非格司亭适当的等效性，可能为中国预防CIN提供一种选择。
完整摘要 · 英文原文
Chemotherapy-induced neutropenia (CIN) constitutes a substantial disease burden globally. Although pegfilgrastim (a long-acting granulocyte-colony stimulating factor) has demonstrated efficacy in preventing CIN, it is not yet available in China. This is the first clinical study to evaluate a pegfilgrastim biosimilar in China. This multicenter, randomized, double-blind, parallel-controlled, phase 3 equivalence study aims to evaluate the efficacy and safety of GB-K02 (a pegfilgrastim biosimilar) in preventing CIN among 250 patients with breast cancer. The primary efficacy endpoint was the duration of grade 4 neutropenia (DG4N) in cycle 1 of chemotherapy. The DG4N (LSMean ± SE) in cycle 1 was 0.58 ± 0.13 days versus 0.80 ± 0.13 days (p = 0.2139) for the GB-K02 group and the pegfilgrastim group, respectively. Other efficacy endpoints and safety were also similar between the two groups in 4 cycles of chemotherapy. Overall, GB-K02 demonstrated proper equivalence to pegfilgrastim and might offer an option in preventing CIN in China.