RC0639: phase II study of paclitaxel, trastuzumab, and lapatinib as adjuvant therapy for early stage HER2-positive breast cancer
| Autor: | Tejal Patel, Donald W. Northfelt, S. P. Kahanic, Sandra X. Franco, Edith A. Perez, Ismael Ghanem-Cañete, Robert B. Jenkins, David B. Johnson, Frances M. Palmieri, Gerardo Colon-Otero, Ann E. McCullough, Alvaro Moreno-Aspitia, Shaker R. Dakhil, Richard J. Rodeheffer, Kathleen S. Tenner, Amylou C. Dueck |
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| Jazyk: | angličtina |
| Předmět: |
Adult
Oncology Gastrointestinal medicine.medical_specialty Cancer Research Paclitaxel Receptor ErbB-2 medicine.medical_treatment Phases of clinical research Breast Neoplasms Kaplan-Meier Estimate Antibodies Monoclonal Humanized Lapatinib Disease-Free Survival Ventricular Function Left Preclinical Study Breast cancer Trastuzumab Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Adjuvant therapy Humans skin and connective tissue diseases Adjuvant Aged Neoplasm Staging Heart Failure Chemotherapy Taxane business.industry Stroke Volume Middle Aged Tolerability medicine.disease Treatment Outcome Chemotherapy Adjuvant Quinazolines Female HER2 cardiac business medicine.drug |
| Zdroj: | Breast Cancer Research and Treatment |
| ISSN: | 0167-6806 |
| DOI: | 10.1007/s10549-013-2469-2 |
| Popis: | Lapatinib adds to the efficacy of trastuzumab in preclinical models and also in the neo-adjuvant setting. This study assesses the safety and feasibility of adding lapatinib to paclitaxel and trastuzumab (THL) as part of the adjuvant therapy for HER2-positive breast cancer (HER2+ BC). In this single-arm phase II study, patients with stages I–III HER2+ BC received standard anthracycline-based chemotherapy followed by weekly taxane, with concurrent standard trastuzumab, plus daily lapatinib for a total of 12 months. The primary endpoint was symptomatic congestive heart failure, secondary endpoints included overall safety. A total of 109 eligible patients were enrolled. Median follow-up is 4.3 years. No patients experienced congestive heart failure while on treatment. Mean left ventricular ejection fraction at baseline and at the end of THL were 63.6 % (N = 109, SD = 5.7) and 59.8 % (N = 98, SD = 8.1), respectively [mean change −3.95 % (N = 98, SD = 8.3), p |
| Databáze: | OpenAIRE |
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