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A phase III randomized comparison of lapatinib plus capecitabine versus capecitabine alone in women with advanced breast cancer that has progressed on trastuzumab: updated efficacy and biomarker analyses

Cameron, David ; Casey, Michelle ; Press, Michael ; Lindquist, Deborah ; Pienkowski, Tadeusz ; Romieu, C. Gilles ; Chan, Stephen ; Jagiello-Gruszfeld, Agnieszka ; Kaufman, Bella ; Crown, John ; Chan, Arlene ; Campone, Mario ; Viens, Patrice ; Davidson, Neville ; Gorbounova, Vera ; Raats, Johannes Isaac ; Skarlos, Dimosthenis ; Newstat, Beth ; Roychowdhury, Debasish ; Paoletti, Paolo ; Oliva, Cristina ; Rubin, Stephen ; Stein, Steven ; Geyer, Charles E.

Breast cancer research and treatment, 2008-12, Vol.112 (3), p.533-543 [Periódico revisado por pares]

Boston: Springer US

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Título:
A phase III randomized comparison of lapatinib plus capecitabine versus capecitabine alone in women with advanced breast cancer that has progressed on trastuzumab: updated efficacy and biomarker analyses
Autor: Cameron, David ; Casey, Michelle ; Press, Michael ; Lindquist, Deborah ; Pienkowski, Tadeusz ; Romieu, C. Gilles ; Chan, Stephen ; Jagiello-Gruszfeld, Agnieszka ; Kaufman, Bella ; Crown, John ; Chan, Arlene ; Campone, Mario ; Viens, Patrice ; Davidson, Neville ; Gorbounova, Vera ; Raats, Johannes Isaac ; Skarlos, Dimosthenis ; Newstat, Beth ; Roychowdhury, Debasish ; Paoletti, Paolo ; Oliva, Cristina ; Rubin, Stephen ; Stein, Steven ; Geyer, Charles E.
Assuntos: Adult ; Aged ; Aged, 80 and over ; Anthracyclines ; Antibodies, Monoclonal - administration & dosage ; Antibodies, Monoclonal, Humanized ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biomarkers, Tumor ; Breast cancer ; Breast Neoplasms - drug therapy ; Cancer ; Capecitabine ; Chemotherapy ; Clinical Trial ; Clinical trials ; Comparative analysis ; Comparative studies ; Deoxycytidine - administration & dosage ; Deoxycytidine - analogs & derivatives ; Disease Progression ; Drug therapy ; Epidermal growth factor ; Female ; Fluorouracil - administration & dosage ; Fluorouracil - analogs & derivatives ; Humans ; Medicine ; Medicine & Public Health ; Metastasis ; Middle Aged ; Neoplasm Metastasis ; Oncology ; Oncology, Experimental ; Protein-Tyrosine Kinases - antagonists & inhibitors ; Quinazolines - administration & dosage ; Trastuzumab ; Tyrosine ; Universities and colleges ; Women
É parte de: Breast cancer research and treatment, 2008-12, Vol.112 (3), p.533-543
Notas: ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
ObjectType-News-3
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Descrição: Purpose Lapatinib is a small molecule, dual tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor type 2 (HER2). Initial results of a phase III trial demonstrated that lapatinib plus capecitabine is superior to capecitabine alone in women with HER2-positive advanced breast cancer that progressed following prior therapy including trastuzumab. Updated efficacy and initial biomarker results from this trial are reported. Methods Women with HER2-positive, locally advanced or metastatic breast cancer previously treated with anthracycline-, taxane-, and trastuzumab-containing regimens were randomized to lapatinib 1,250 mg/day continuously plus capecitabine 2,000 mg/m 2 days 1–14 of a 21-day cycle or capecitabine 2,500 mg/m 2 on the same schedule. The primary endpoint was time to progression (TTP) as determined by an independent review panel. Relationship between progression-free survival (PFS) and tumor HER2 expression and serum levels of HER2 extracellular domain (ECD) were assessed. Results 399 women were randomized. The addition of lapatinib prolonged TTP with a hazard ratio (HR) of 0.57 (95% CI, 0.43–0.77; P < 0.001) and provided a trend toward improved overall survival (HR: 0.78, 95% CI: 0.55–1.12, P = 0.177), and fewer cases with CNS involvement at first progression (4 vs. 13, P = 0.045). Baseline serum HER2 ECD did not predict for benefit from lapatinib. Conclusion The addition of lapatinib to capecitabine provides superior efficacy for women with HER2-positive, advanced breast cancer progressing after treatment with anthracycline-, taxane-, and trastuzumab-based therapy. Biomarker studies could not identify a subgroup of patients who failed to benefit from the addition of lapatinib to capecitabine.
Editor: Boston: Springer US
Idioma: Inglês;Russo

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A phase III randomized comparison of lapatinib plus capecitabine versus capecitabine alone in women with advanced breast cancer that has progressed on trastuzumab: updated efficacy and biomarker analyses

Boston: Springer US

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