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| Content Provider | World Health Organization (WHO)-Global Index Medicus |
|---|---|
| Author | Zhao, Qiong Shentu, Jianzhong Xu, Nong Zhou, Jianya Yang, Guangdie Yao, Yinan Tan, Fenlai Liu, Dongyang Wang, Yingxiang Zhou, Jianying |
| Description | Country affiliation: China Author Affiliation: Zhao Q ( Department of Respiratory Disease, The First Affiliated Hospital, Zhejiang University, School of Medicine, No. 79, Qingchun Road, Hangzhou, Zhejiang, China.) |
| Abstract | PURPOSE: The goal of this study was to assess the safety and tolerability of icotinib hydrochloride (BPI-2009H), a new selective epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), and to explore its pharmacokinetics (PK) and clinical activity in patients with advanced solid tumors, mainly those with non-small-cell lung cancer (NSCLC) after the failure of the prior platinum-based chemotherapy. EXPERIMENTAL DESIGN: Different doses of oral icotinib were administered once every 8 h (Q8H) for a 28-continuous-day cycle until disease progression and or undue toxicity was observed. PK studies of subjects' blood were performed during cycle one (day 1 through 28). Patients aged ≥18 and ≤70 years with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 and adequate organ functions eligible for the study. Tumor responses were assessed by Response Evaluation Criteria in Solid Tumors (RECIST). K-ras and EGFR mutations in the extracted DNA of fourteen specimens were examined using PCR-based direct sequencing assay. RESULTS: Thirty-six patients were enrolled in the study. PK analysis demonstrated that the mean elimination half-life of icotinib was 6 h, and the T(max) was around 2 h. The steady-state concentration of icotinib administered at a dose of 125 mg once every 8 h (Q8H) was significantly higher than that achieved by a dose of 100mg Q8H. The most frequent treatment-related adverse events (TRAEs) were an acne-like (folliculitis) rash (16/36, 44.4%), diarrhea (8/36, 22.2%) and a decrease in white blood cells (4/36, 11.1%). The maximum-tolerated dose (MTD) was not reached. Among 33 patients with NSCLC, 7 patients exhibited a partial response, 7 showed stable disease at the 24 weeks. Among 14 patients undergoing DNA sequence for K-ras and EGFR mutations, 3 with K-ras mutation presented 2 stable disease (SD) and 1 partial response (PR), 5 with EGFR exon 19 or 21 mutation 2 PR and 3 SD within 4 weeks. CONCLUSIONS: Oral icotinib was generally well tolerated, with manageable and reversible adverse events (AEs) and showed positive clinical anti-tumor activities in patients with advanced NSCLC. The recommended dose for phase II/III studies with icotinib is 125 mg or 150 mg Q8H. |
| File Format | HTM / HTML |
| ISSN | 01695002 |
| Issue Number | 2 |
| Volume Number | 73 |
| e-ISSN | 18728332 |
| Journal | Lung Cancer |
| Language | English |
| Publisher | Elsevier |
| Publisher Date | 2011-08-01 |
| Publisher Place | Ireland |
| Access Restriction | One Nation One Subscription (ONOS) |
| Subject Keyword | Discipline Oncology Antineoplastic Agents Therapeutic Use Carcinoma, Non-small-cell Lung Drug Therapy Crown Ethers Lung Neoplasms Quinazolines Receptor, Epidermal Growth Factor Antagonists & Inhibitors Administration, Oral Adult Aged Adverse Effects Blood Female Folliculitis Chemically Induced Humans Male Maximum Tolerated Dose Middle Aged Proto-oncogene Proteins P21(ras) Genetics Treatment Outcome Clinical Trial, Phase I Journal Article |
| Content Type | Text |
| Resource Type | Article |
| Subject | Pulmonary and Respiratory Medicine Cancer Research Oncology |
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