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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|
Bondarenko, Igor N.
Hotko, Y. S.
Münster, Pamela N.
Ward, Robyn L.
Turnbull, Kathleen W.
Zacharchuk, Charles M.
Epstein, Richard John
|Keywords:||Breast -- Cancer -- Case studies|
Breast -- Cancer -- Treatment
Protein-tyrosine kinase -- Inhibitors -- Therapeutic use
Breast -- Tumors -- Chemotherapy
|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.|
|Appears in Collections:||Scholarly Works - FacM&SMed|
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