Authors: | Dickler, M. N.; Cobleigh, M. A.; Miller, K. D.; Klein, P. M.; Winer, E. P. |
Article Title: | Efficacy and safety of erlotinib in patients with locally advanced or metastatic breast cancer |
Abstract: | Purpose To evaluate the efficacy and safety of erlotinib in advanced breast cancer. Experimental design Multicenter, phase II study of erlotinib (150 mg orally daily). Cohort 1: progression after anthracyclines, taxanes, and capecitabine (n = 47). Cohort 2: progression after >1 chemotherapy for advanced-stage disease (n = 22). Primary endpoint was response rate (World Health Organization criteria). Secondary endpoints were safety, time to progression, and survival. Results One patient in each cohort (n = 2, 3.0%) had a partial response. Response duration was 17 weeks for the Cohort 1 patient and 32 weeks for the Cohort 2 patient. Median time to progression was 43 days for Cohort 1 (range 1-204) and 43 days for Cohort 2 (range 25-419). Common adverse events were diarrhea, rash, dry skin, asthenia, nausea, anorexia. Conclusion Erlotinib had minimal activity in unselected previously treated women with advanced breast cancer. Predictive factors are needed to identify breast cancer patients who may derive benefit from erlotinib treatment. © 2008 Springer Science+Business Media, LLC. |
Keywords: | adult; cancer survival; controlled study; human tissue; treatment response; aged; aged, 80 and over; middle aged; major clinical study; clinical trial; erlotinib; fluorouracil; advanced cancer; cancer growth; diarrhea; drug dose reduction; drug efficacy; drug safety; patient selection; capecitabine; anorexia; metastasis; controlled clinical trial; phase 2 clinical trial; cohort studies; breast cancer; nausea; randomized controlled trial; vomiting; antineoplastic combined chemotherapy protocols; cohort analysis; receptor, epidermal growth factor; breast neoplasms; asthenia; dyspnea; pruritus; rash; protein kinase inhibitors; disease progression; multicenter study; acne; neoplasm metastasis; taxoids; taxane derivative; anthracycline derivative; epidermal growth factor receptor (egfr/her1); metastatic breast cancer; dry eye; dry skin; anthracyclines; deoxycytidine; quinazolines |
Journal Title: | Breast Cancer Research and Treatment |
Volume: | 115 |
Issue: | 1 |
ISSN: | 0167-6806 |
Publisher: | Springer |
Date Published: | 2009-05-01 |
Start Page: | 115 |
End Page: | 121 |
Language: | English |
DOI: | 10.1007/s10549-008-0055-9 |
PUBMED: | 18496750 |
PROVIDER: | scopus |
DOI/URL: | |
Notes: | --- - "Cited By (since 1996): 9" - "Export Date: 30 November 2010" - "CODEN: BCTRD" - "Source: Scopus" |