聚乙二醇化重组人粒细胞集落刺激因子预防乳腺癌和非小细胞肺癌患者化疗所致中性粒细胞减少症的多中心、随机、对照、Ⅲ期临床研究
[A multicenter, randomized, controlled, phase Ⅲ clinical study of PEG-rhG-CSF for preventing chemotherapy-induced neutropenia in patients with breast cancer and non-small cell lung cancer].
作者信息
Xu Binghe, Tian Fuguo, Yu Jingrui, Song Yanqiu, Shi Jianhua, Zhang Baihong, Zhang Yanjun, Yuan Zhiping, Wu Qiong, Zhang Qingyuan, Nan Kejun, Sun Qiang, Li Weilian, Hu Jianbing, Bi Jingwang, Meng Chun, Dai Hong, Jiang Hongchuan, Yue Shun, Cao Bangwei, Sun Yuping, Wang Shu, Tong Zhongsheng, Shen Peng, Wu Gang, Tang Lili, Deng Yongchuan, Jia Liqun, Shen Kunwei, Zhuang Wu, Xie Xiaodong, Wu Youhua, Chen Lin
机构信息
Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, Beijing 100021, China.
Department of Breast Surgery, Shanxi Province Cancer Center, Taiyuan 030013, China.
出版信息
Zhonghua Zhong Liu Za Zhi. 2016 Jan;38(1):23-7. doi: 10.3760/cma.j.issn.0253-3766.2016.01.005.
OBJECTIVE
To explore the safety and efficacy of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) in preventing chemotherapy-induced neutropenia in patients with breast cancer and non-small cell lung cancer (NSCLC), and to provide the basis for clinical application.
METHODS
According to the principle of open-label, randomized, parallel-group controlled clinical trial, all patients were randomized by 1∶1∶1 into three groups to receive PEG-rhG-CSF 100 μg/kg, PEG-rhG-CSF 6 mg, or rhG-CSF 5 μg/kg, respectively. The patients with breast cancer received two chemotherapy cycles, and the NSCLC patients received 1-2 cycles of chemotherapy according to their condition. All patients were treated with the combination chemotherapy of TAC (docetaxel+ epirubicin+ cyclophosphamide) or TA (docetaxel+ epirubicin), or the chemotherapy of docetaxel combined with carboplatin, with a 21 day cycle.
RESULTS
The duration of grade 3-4 neutropenia in the PEG-rhG-CSF 100 μg/kg and PEG-rhG-CSF 6 mg groups were similar with that in the rhG-CSF 5 μg/kg group (P>0.05 for all). The incidence rate of grade 3-4 neutropenia in the PEG-rhG-CSF 100 μg/kg group, PEG-rhG-CSF 6 mg group, and G-CSF 5 μg/kg group were 69.7%, 68.4%, and 69.5%, respectively, with a non-significant difference among the three groups (P=0.963). The incidence rate of febrile neutropenia in the PEG-rhG-CSF 100 μg/kg group, PEG-rhG-CSF 6 mg group and G-CSF 5 μg/kg group were 6.1%, 6.4%, and 5.5%, respectively, showing no significant difference among them (P=0.935). The incidence rate of adverse events in the PEG-rhG-CSF 100 μg/kg group, PEG-rhG-CSF 6 mg group and G-CSF 5 μg / kg group were 6.7%, 4.1%, and 5.5%, respectively, showing a non-significant difference among them (P=0.581).
CONCLUSIONS
In patients with breast cancer and non-small cell lung cancer (NSCLC) undergoing TAC/TA chemotherapy, a single 100 μg/kg injection or a single fixed 6 mg dose of PEG-rhG-CSF at 48 hours after chemotherapy show definite therapeutic effect with a low incidence of adverse events and mild adverse reactions. Compared with the continuous daily injection of rhG-CSF 5 μg/kg/d, a single 100 μg/kg injection or a single fixed 6 mg dose of PEG-rhG-CSF has similar effect and is more advantageous in preventing chemotherapy-induced neutropenia.
目的
探讨聚乙二醇化重组人粒细胞集落刺激因子（PEG-rhG-CSF）预防乳腺癌和非小细胞肺癌（NSCLC）患者化疗所致中性粒细胞减少的安全性和有效性，为临床应用提供依据。
方法
按照开放标签、随机、平行组对照临床试验原则，将所有患者按1∶1∶1随机分为三组，分别接受PEG-rhG-CSF 100 μg/kg、PEG-rhG-CSF 6 mg或rhG-CSF 5 μg/kg治疗。乳腺癌患者接受两个化疗周期，NSCLC患者根据病情接受1-2个化疗周期。所有患者均采用TAC（多西他赛+表柔比星+环磷酰胺）或TA（多西他赛+表柔比星）联合化疗，或多西他赛联合卡铂化疗，每21天为一个周期。
结果
PEG-rhG-CSF 100 μg/kg组和PEG-rhG-CSF 6 mg组3-4级中性粒细胞减少持续时间与rhG-CSF 5 μg/kg组相似（均P>0.05）。PEG-rhG-CSF 100 μg/kg组、PEG-rhG-CSF 6 mg组和G-CSF 5 μg/kg组3-4级中性粒细胞减少发生率分别为69.7%、68.4%和69.5%，三组间差异无统计学意义（P=0.963）。PEG-rhG-CSF 100 μg/kg组、PEG-rhG-CSF 6 mg组和G-CSF 5 μg/kg组发热性中性粒细胞减少发生率分别为6.1%、6.4%和5.5%，差异无统计学意义（P=0.935）。PEG-rhG-CSF 100 μg/kg组、PEG-rhG-CSF 6 mg组和G-CSF 5 μg/kg组不良事件发生率分别为6.7%、4.1%和5.5%，差异无统计学意义（P=0.581）。
结论
在接受TAC/TA化疗的乳腺癌和非小细胞肺癌（NSCLC）患者中，化疗后48小时单次注射100 μg/kg或单次固定剂量6 mg的PEG-rhG-CSF具有确切疗效，不良事件发生率低，不良反应轻微。与每日连续注射rhG-CSF 5 μg/kg/d相比），单次注射100 μg/kg或单次固定剂量6 mg的PEG-rhG-CSF预防化疗所致中性粒细胞减少效果相似且更具优势。
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