1.
Randomized and dose-escalation trials of recombinant human serum albumin /granulocyte colony-stimulating factor in patients with breast cancer receiving anthracycline-containing chemotherapy
Chen S, Han Y, Ouyang Q, Lu J, Zhang Q, Yang S, Wang J, Huang H, Liu H, Shao Z, et al
BMC cancer. 2021;21(1):341
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).
2.
Efficacy of romiplostim in the treatment of ITP in children: a meta-analysis
Li H, Yang H, Liu WJ
European Review for Medical and Pharmacological Sciences. 2018;22((18)):6162-6169.
Abstract
OBJECTIVE We aimed to analyze the efficacy and safety of romiplostim in the treatment of primary immune thrombocytopenia (ITP) in children. MATERIALS AND METHODS PubMed, the Cochrane Database of Systematic Reviews, the Cochrane Central Register of Controlled Trials, Chinese biomedical literature database (CBM), Chinese Journal Full Text Database (CNKI), Wanfang and VIP database were searched. The bibliography was screened according to the inclusion and exclusion criteria and the target literature was selected. The data were extracted, and the quality of included literature was evaluated. RevMan 5.3 software was used to carry out the meta-analysis. The rate of effective, adverse and bleeding events was collected, and meta-analysis was performed. RESULTS 3 out of 43 papers met the inclusion criteria. Meta-analysis showed that there was a statistical significance in effective rate and median time to platelet rise to response criteria of in romiplostim group, RR=5.05, [95% CI (2.21, 11.53), p<0.01] and RR=9.67, [95% CI (1.89, 49.46), p<0.01]. Similar results occurred in the rate of adverse event and serious adverse event, [RR=0.95, 95% CI (0.69,1.31), p>0.05] and [RR=1.65, 95% CI (0.53,5.31), p>0.05]; bleeding event of the two groups was similar [RR=1.27, 95% CI (0.92,1.75), p>0.05]. CONCLUSIONS On the aspect of treating ITP, romiplostim is more effective and safer than placebo.