一项开放标签、多中心的研究，评估重组粒细胞集落刺激因子在预防乳腺癌患者中性粒细胞减少症相关并发症中的安全性、耐受性和疗效。

An open-label multicenter safety, tolerability, and efficacy study of recombinant granulocyte colony-stimulating factor in the prevention of neutropenic complications in breast cancer patients.

机构信息

Institute of Physiology and Pharmacology, Medical Academy, Lithuanian University of Health Science, A. Mickevičiaus 9, 44307 Kaunas, Lithuania.

出版信息

Medicina (Kaunas). 2011;47(8):428-33. Epub 2011 Nov 18.

PMID:22123557

Abstract

UNLABELLED

The primary objective of this open-label, two chemotherapy arm, phase 4 study was to evaluate the safety and efficacy of newly developed recombinant granulocyte colony-stimulating factor (rG-CSF) used to prevent neutropenia-related complications in patients with metastatic breast cancer treated with docetaxel (75 mg/m(2)) and doxorubicin (50 mg/m(2)) or docetaxel (100 mg/m(2)) alone.

MATERIAL AND METHODS

A total of 50 patients who were treated with a maximum of 6 cycles of either docetaxel-doxorubicin (36 patients) or docetaxel alone (14 patients) every 21 days were recruited from 3 centers in Lithuania. All the patients received study medication rG-CSF at a dosage of 5 μg/kg per day (Sicor Biotech UAB, Teva Group) from day 2 of each cycle and continued for minimum 5 days or until absolute neutrophil count reached ≥1.5×10(9)/L.

RESULTS

A total of 611 adverse events were reported. Most of them were related to myelotoxic chemotherapy. Two patients withdrew due to adverse events (neuropathy and bone pain). One patient died possibly because of pulmonary thromboembolism. The most frequently reported adverse events related to study drug in the docetaxel-doxorubicin and docetaxel groups were leukocytosis (22% and 21%, respectively), bone pain (19% and 21%, respectively), and headache (8% and 14%, respectively). The incidence of grade 4 neutropenia in both the groups was 47% and 29%, respectively, in all cycles and 42% and 21%, respectively, in cycle 1. The incidence of febrile neutropenia was 8% in cycle 1 and 14% across all cycles. The mean duration of febrile neutropenia was 2.1 days (SD, 1.9) in cycle 1 and 2.14 days (SD 2.0) across all cycles in both the treatment groups.

CONCLUSION

This study provide data that the study drug rG-CSF has the expected safety and could be an efficacious medication to decrease the risk of febrile neutropenia and related complications of myelosuppressive chemotherapy in patients with metastatic breast cancer.

摘要

目的

本开放性、两化疗臂、四期研究的主要目的是评估新开发的重组粒细胞集落刺激因子（rG-CSF）在预防转移性乳腺癌患者中性粒细胞减少相关并发症中的安全性和疗效，这些患者接受多西紫杉醇（75mg/m(2)）和阿霉素（50mg/m(2)）或多西紫杉醇（100mg/m(2)）单药治疗。

材料和方法

共招募了来自立陶宛 3 个中心的 50 名患者，他们最多接受了 6 个周期的治疗，每个周期 21 天，方案为多西紫杉醇-阿霉素（36 名患者）或多西紫杉醇单药（14 名患者）。所有患者从每个周期的第 2 天开始接受研究药物 rG-CSF，剂量为 5μg/kg/天（Sicor Biotech UAB，Teva Group），持续至少 5 天或直至中性粒细胞绝对计数达到≥1.5×10(9)/L。

结果

共报告了 611 例不良事件。大多数与骨髓抑制化疗有关。两名患者因不良事件（神经病变和骨痛）退出研究。一名患者可能因肺血栓栓塞而死亡。在多西紫杉醇-阿霉素和多西紫杉醇组中，与研究药物相关的最常报告的不良事件是白细胞增多（分别为 22%和 21%）、骨痛（分别为 19%和 21%）和头痛（分别为 8%和 14%）。两组所有周期中性粒细胞减少 4 级的发生率分别为 47%和 29%，第 1 周期分别为 42%和 21%。第 1 周期发热性中性粒细胞减少的发生率为 8%，所有周期的发生率为 14%。两组第 1 周期发热性中性粒细胞减少的平均持续时间为 2.1 天（标准差为 1.9），所有周期的平均持续时间为 2.14 天（标准差为 2.0）。