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FDA drug approval summary: lapatinib in combination with capecitabine for previously treated metastatic breast cancer that overexpresses HER-2 Ryan Q; Ibrahim A; Cohen MH; Johnson J; Ko CW; Sridhara R; Justice R; Pazdur ROncologist 2008[Oct]; 13 (10): 1114-9On March 13, 2007, the U.S. Food and Drug Administration approved lapatinib (Tykerb tablets; GlaxoSmithKline, Philadelphia), an oral, small molecule, dual tyrosine kinase inhibitor of ErbB-2 and ErbB-1, for use in combination with capecitabine for the treatment of patients with human epidermal growth factor receptor (HER)-2-overexpressing metastatic breast cancer who had received prior therapy including an anthracycline, a taxane, and trastuzumab. One multicenter, open-label, randomized trial was submitted. Eligible patients had stage IIIb or IV breast cancer, ErbB-2 overexpression (immunohistochemistry 3+ or 2+ with fluorescence in situ hybridization confirmation), measurable disease, a 0 or 1 Eastern Cooperative Oncology Group performance status score, a cardiac ejection fraction within the institutional normal range, and adequate laboratory function. Patients received either lapatinib (1,250 mg once daily on days 1-21) plus capecitabine (1,000 mg/m(2) every 12 hours on days 1-14) every 21 days or capecitabine alone (1,250 mg/m(2) every 12 hours on days 1-14) every 21 days. The primary endpoint was time to progression (TTP) determined by a blinded independent review panel. After TTP results of a prespecified interim analysis were made available, study enrollment was discontinued (399 patients enrolled). The median TTP was 27.1 versus 18.6 weeks (hazard ratio, 0.57; p = .00013) favoring the lapatinib plus capecitabine arm. Response rates were 23.7% (lapatinib plus capecitabine) versus 13.9% (capecitabine alone). Survival data were not mature. Although the toxicities observed in the lapatinib and capecitabine combination arm were generally similar to those in the capecitabine alone arm, a higher incidence of diarrhea and rash was noted with the combination. Grade 3 or 4 adverse reactions that occurred with a frequency of >5% in patients on the combination arm were diarrhea (13%) and palmar-plantar erythrodysesthesia (12%). There was a 2% incidence of reversible decreased left ventricular function in the combination arm.|Adult[MESH]|Aged[MESH]|Aged, 80 and over[MESH]|Antineoplastic Combined Chemotherapy Protocols/*therapeutic use[MESH]|Breast Neoplasms/*drug therapy/enzymology/pathology[MESH]|Capecitabine[MESH]|Deoxycytidine/administration & dosage/adverse effects/analogs & derivatives[MESH]|Disease Progression[MESH]|Drug Approval[MESH]|Drug Resistance, Neoplasm[MESH]|Female[MESH]|Fluorouracil/administration & dosage/adverse effects/analogs & derivatives[MESH]|Humans[MESH]|Lapatinib[MESH]|Middle Aged[MESH]|Neoplasm Metastasis[MESH]|Quinazolines/administration & dosage/adverse effects[MESH]|Receptor, ErbB-2/antagonists & inhibitors/*biosynthesis[MESH]|United States[MESH]|United States Food and Drug Administration[MESH]|Young Adult[MESH] |
