Title |
A phase II study of afatinib (BIBW 2992), an irreversible ErbB family blocker, in patients with HER2-positive metastatic breast cancer progressing after trastuzumab
|
---|---|
Published in |
Breast Cancer Research and Treatment, March 2012
|
DOI | 10.1007/s10549-012-2003-y |
Pubmed ID | |
Authors |
Nancy U. Lin, Eric P. Winer, Duncan Wheatley, Lisa A. Carey, Stephen Houston, David Mendelson, Pamela Munster, Laurie Frakes, Steve Kelly, Agustin A. Garcia, Susan Cleator, Martina Uttenreuther-Fischer, Hilary Jones, Sven Wind, Richard Vinisko, Tamas Hickish |
Abstract |
Afatinib is an oral, ErbB family blocker, which covalently binds and irreversibly blocks all kinase-competent ErbB family members. This phase II, open-label, single-arm study explored afatinib activity in human epidermal growth factor receptor 2 (HER2)-positive breast cancer patients progressing after trastuzumab treatment. Patients had stage IIIB/IV HER2-positive metastatic breast cancer, with progression following trastuzumab or trastuzumab intolerance and an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Patients received 50 mg afatinib once-daily until disease progression. Primary endpoint was objective response rate (Response Evaluation Criteria in Solid Tumors 1.0), with tumor assessments every 8 weeks. Forty-one patients were treated. Patients had received a median of three prior chemotherapy lines (range, 0-15) and 68.3% had received trastuzumab for >1 year. Four patients (10% of 41 treated; 11% of evaluable patients) had partial response. Fifteen patients (37% of 41) had stable disease as best response and 19 (46% of 41) achieved clinical benefit. Median progression-free survival was 15.1 weeks (95% confidence interval [CI]: 8.1-16.7); median overall survival was 61.0 weeks (95% CI: 56.7-not evaluable). Most frequent common terminology criteria for adverse events grade 3 treatment-related adverse events were diarrhea (24.4%) and rash (9.8%). Afatinib monotherapy was associated with promising clinical activity in extensively pretreated HER2-positive breast cancer patients who had progressed following trastuzumab treatment. |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
United Kingdom | 1 | <1% |
United States | 1 | <1% |
France | 1 | <1% |
Unknown | 105 | 97% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 24 | 22% |
Student > Ph. D. Student | 18 | 17% |
Student > Master | 14 | 13% |
Other | 9 | 8% |
Student > Postgraduate | 7 | 6% |
Other | 16 | 15% |
Unknown | 20 | 19% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 32 | 30% |
Agricultural and Biological Sciences | 19 | 18% |
Biochemistry, Genetics and Molecular Biology | 10 | 9% |
Pharmacology, Toxicology and Pharmaceutical Science | 9 | 8% |
Economics, Econometrics and Finance | 4 | 4% |
Other | 14 | 13% |
Unknown | 20 | 19% |