Randomized and dose-escalation trials of recombinant human serum albumin /granulocyte colony-stimulating factor in patients with breast cancer receiving anthracycline-containing chemotherapy.
机构：[1]Department of Medical Oncology, National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 17 Panjiayuan Nanli, Chaoyang District, Beijing 100021, China.[2]Department of Breast Cancer Medical Oncology, Hunan Cancer Hospital, Changsha, Hunan, China.[3]Department of General Surgery, Xi’an Tangdu Hospital, Xi’an, Shanxi, China.[4]Department of Oncology, Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China.[5]Department of Breast Cancer and Lymphoma, The Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China.[6]Department of Internal Medicine, Linyi Tumor Hospital, Linyi, Shandong, China.[7]Department of Oncology, The Fourth Affiliated Hospital of Guangxi Medical University, Liuzhou, Guangxi, China.[8]Department of Breast Surgery, National Clinical Research Center for Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.[9]Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.[10]Department of Breast Surgery, Sichuan Province Tumor Hospital, Chengdu, Sichuan, China.四川省肿瘤医院[11]Department of Medical Oncology, The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China.[12]Department of Medical Oncology, Central Hospital of Xuzhou, the Cancer Institute of Southeast University, Xuzhou, Jiangsu, China.[13]First Department of Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.河北医科大学第四医院[14]Department of Medical Oncology, Nantong Tumor Hospital, Nantong, Jiangsu, China.[15]Department of Tumor, Yunnan First People’s Hospital, Kunming, Yunnan, China.云南省第一人民医院
To evaluate the efficacy and safety of recombinant human serum albumin /granulocyte colony-stimulating factor (rHSA/G-CSF) in breast cancer following receipt of cytotoxic agents.
The phase 1b trial assessed the pharmacokinetics, pharmacodynamics, and safety of dose-escalation, ranging from rHSA/G-CSF 1800 μg, 2100 μg, and 2400 μg. Randomized controlled phase 2b trial was further conducted to ensure the comparative efficacy and safety of rHSA/G-CSF 2400 μg and rhG-CSF 5 μg/kg. In multicenter, randomized, open-label, parallel, phase 2 study, participants treated with anthracycline-containing chemotherapy were assigned in a ratio 1:1:1 to receive double delivery of rHSA/G-CSF 1200 μg, 1500 μg, and continuous rhG-CSF 5 μg/kg.
Between December 16, 2014, to July 23, 2018, a total of 320 patients were enrolled, including 25 individuals in phase 1b trial, 80 patients in phase 2b trial, and 215 participants in phase 2 study. The mean duration of agranulocytosis during the first chemotherapeutic intermission was observed as 1.14 ± 1.35 days in rHSA/G-CSF 1500 μg, which was comparable with that of 1.07 ± 0.97 days obtained in rhG-CSF control (P = 0.71). Safety profiles were assessed to be acceptable ranging from rHSA/G-CSF 1800 μg to 2400 μg, while the double delivery of HSA/G-CSF 2400 μg failed to meet the noninferiority in comparison with rhG-CSF.
The prospective randomized controlled trials demonstrated that rHSA/G-CSF was efficacious and well-tolerated with an approachable frequency and expense of application for prophylactic management of agranulocytosis. The double delivery of rHSA/G-CSF 1500 μg in comparisons with paralleling G-CSF preparations is warranted in the phase 3 trial.
ClinicalTrials.gov identifiers: NCT02465801 (11/17/2014), NCT03246009 (08/08/2017), NCT03251768 (08/07/2017).
第一作者机构：[1]Department of Medical Oncology, National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 17 Panjiayuan Nanli, Chaoyang District, Beijing 100021, China.
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推荐引用方式(GB/T 7714)：
Shanshan Chen,Yiqun Han,Quchang Ouyang,et al.Randomized and dose-escalation trials of recombinant human serum albumin /granulocyte colony-stimulating factor in patients with breast cancer receiving anthracycline-containing chemotherapy.[J].BMC CANCER.2021,21(1):doi:10.1186/s12885-021-08093-z.
APA：
Shanshan Chen,Yiqun Han,Quchang Ouyang,Jianguo Lu,Qingyuan Zhang...&Binghe Xu.(2021).Randomized and dose-escalation trials of recombinant human serum albumin /granulocyte colony-stimulating factor in patients with breast cancer receiving anthracycline-containing chemotherapy..BMC CANCER,21,(1)
MLA：
Shanshan Chen,et al."Randomized and dose-escalation trials of recombinant human serum albumin /granulocyte colony-stimulating factor in patients with breast cancer receiving anthracycline-containing chemotherapy.".BMC CANCER 21..1(2021)
