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Title: | Phase II study of single-agent bosutinib, a Src/Abl tyrosine kinase inhibitor, in patients with locally advanced or metastatic breast cancer pretreated with chemotherapy |
Authors: | Campone, Mario Bondarenko, Igor N. Brincat, Stephen Hotko, Y. S. Münster, Pamela N. Chmielowska, Ewa Fumoleau, Pierre Ward, Robyn L. Bardy-Bouxin, Nathalie Leip, Eric Turnbull, Kathleen W. Zacharchuk, Charles M. Epstein, Richard John |
Keywords: | Breast -- Cancer -- Case studies Breast -- Cancer -- Treatment Metastasis Protein-tyrosine kinase -- Inhibitors -- Therapeutic use Breast -- Tumors -- Chemotherapy |
Issue Date: | 2012 |
Publisher: | Oxford Academic |
Citation: | Campone, M., Bondarenko, I., Brincat, S., Hotko, Y., Munster, P. N., Chmielowska, E.,…Epstein, R. J. (2012). Phase II study of single-agent bosutinib, a Src/Abl tyrosine kinase inhibitor, in patients with locally advanced or metastatic breast cancer pretreated with chemotherapy. Annals of oncology, 23(3), 610-617. |
Abstract: | Background: This phase II study evaluated single-agent bosutinib in pretreated patients with locally advanced or metastatic breast cancer. Patients and methods: Patients received oral bosutinib 400 mg/day. The primary end point was the progression-free survival (PFS) rate at 16 weeks. Secondary end points included objective response rate, clinical benefit rate, 2-year overall survival rate, safety, and changes in levels of bone resorption/formation biomarkers. Results: Seventy-three patients were enrolled and treated. Median time from diagnosis of metastatic disease to initiation of bosutinib treatment was 24.5 months. For the intent-to-treat population, the PFS rate at 16 weeks was 39.6%. Unexpectedly, all responding patients (n = 4) were hormone receptor positive. The clinical benefit rate was 27.4%. The 2-year overall survival rate was 26.4%. The main toxic effects were diarrhea (66%), nausea (55%), and vomiting (47%). Grade 3-4 laboratory aminotransferase elevations occurred in 14 (19%) patients. Myelosuppression was minimal. No consistent changes in the levels of bone resorption/formation biomarkers were seen. Conclusions: Bosutinib showed promising efficacy in prolonging time to progression in chemotherapy-pretreated patients with locally advanced or metastatic breast cancer. Bosutinib was generally well tolerated, with a safety profile different from that of the Src/Abl tyrosine kinase inhibitor dasatinib in a similar patient population. |
URI: | https://www.um.edu.mt/library/oar/handle/123456789/45889 |
Appears in Collections: | Scholarly Works - FacM&SMed |
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Phase_II_study_of_single-agent_bosutinib_a_SrcAbl_tyrosine_kinase_inhibitor_in_patients_with _locally_advanced_or_metastatic_breast-cancer_2012.pdf | 422.17 kB | Adobe PDF | View/Open |
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