| Title |
A phase I dose-escalation study of a biosimilar trastuzumab in Chinese metastasis breast cancer patients
|
|---|---|
| Published in |
SpringerPlus, December 2015
|
| DOI | 10.1186/s40064-015-1603-5 |
| Pubmed ID | |
| Authors |
Xinna Zhou, Jing Yu, Wenmiao Wang, Guohong Song, Xiaoli Wang, Jun Ren, Lijun Di, Xinghe Wang |
| Abstract |
Trastuzumab has been widely used among the breast cancer patients with human epidermal growth factor receptor 2 (HER2) overexpression. The genetically engineered trastuzumab traded as Cipterbin® was developed in China since 2003. We have disclosed the phase I clinical trial data of safety, pharmacokinetic profile (PK) in patients with metastasis breast cancer. Subjects identified as HER2 strong positive received single intravenously doses of 100, 250 or 500 mg Cipterbin® in dose-escalation manner. The safety evaluations were recorded and plasma concentration profiles for the drug were analyzed. 27 Chinese metastatic breast cancer patients were enrolled in this study. Patients in each group of different dosage were well-tolerated. The most frequently drug-related adverse events were fever (59.3 %), transaminase increased (22.2 %), chills (18.5 %) and arrhythmia (18.5 %). Only one patient with severe adverse event was observed in 250 mg group revealing brachycardia. PK profile analysis showed that sera steady concentration could be reached in dose-proportional manner, except volume of distribution (Vd) and clearance (CL), which reached peak values at 250 mg administration cohort. This genetically engineered HER2-target antibody had demonstrated the accepted safety with well-tolerated. |
X Demographics
The data shown below were collected from the profile of 1 X user who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 36 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 36 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 8 | 22% |
| Student > Master | 2 | 6% |
| Student > Doctoral Student | 1 | 3% |
| Student > Bachelor | 1 | 3% |
| Student > Ph. D. Student | 1 | 3% |
| Other | 3 | 8% |
| Unknown | 20 | 56% |
| Readers by discipline | Count | As % |
|---|---|---|
| Pharmacology, Toxicology and Pharmaceutical Science | 5 | 14% |
| Medicine and Dentistry | 4 | 11% |
| Agricultural and Biological Sciences | 2 | 6% |
| Psychology | 2 | 6% |
| Economics, Econometrics and Finance | 1 | 3% |
| Other | 2 | 6% |
| Unknown | 20 | 56% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 25 December 2015.
All research outputs
#20,299,108
of 22,836,570 outputs
Outputs from SpringerPlus
#1,459
of 1,849 outputs
Outputs of similar age
#327,731
of 390,618 outputs
Outputs of similar age from SpringerPlus
#133
of 197 outputs
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