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Randomized and dose-escalation trials of recombinant human serum albumin /granulocyte colony-stimulating factor in patients with breast cancer receiving anthracycline-containing chemotherapy

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. Department of Breast Cancer Medical Oncology, Hunan Cancer Hospital, Changsha, Hunan, China. Department of General Surgery, Xi'an Tangdu Hospital, Xi'an, Shanxi, China. Department of Oncology, Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China. Department of Breast Cancer and Lymphoma, The Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China. Department of Internal Medicine, Linyi Tumor Hospital, Linyi, Shandong, China. Department of Oncology, The Fourth Affiliated Hospital of Guangxi Medical University, Liuzhou, Guangxi, China. Department of Breast Surgery, National Clinical Research Center for Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China. Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China. Department of Breast Surgery, Sichuan Province Tumor Hospital, Chengdu, Sichuan, China. Department of Medical Oncology, The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China. Department of Medical Oncology, Central Hospital of Xuzhou, the Cancer Institute of Southeast University, Xuzhou, Jiangsu, China. First Department of Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China. Department of Medical Oncology, Nantong Tumor Hospital, Nantong, Jiangsu, China. Department of Tumor, Yunnan First People's Hospital, Kunming, Yunnan, China. 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. wangjiayu8778@sina.com. 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. xubingheBM@163.com.

BMC cancer. 2021;21(1):341
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Abstract
BACKGROUND 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. METHODS 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. RESULTS 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. CONCLUSION 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. TRIAL REGISTRATION ClinicalTrials.gov identifiers: NCT02465801 (11/17/2014), NCT03246009 (08/08/2017), NCT03251768 (08/07/2017).
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Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine