Abstract | UNLABELLED: PATIENTS AND METHODS: This was a multicenter, open-label, single-arm, Simon two-stage study. Patients with advanced HER2-positive breast cancer in whom disease progression had occurred during prior trastuzumab-based therapy received trastuzumab weekly (4 mg/kg loading dose, then 2 mg/kg every week) or every 3 weeks (8 mg/kg loading dose, then 6 mg/kg every 3 weeks) and pertuzumab every 3 weeks (840 mg loading dose, then 420 mg every 3 weeks). Treatment continued until disease progression or excessive toxicity. RESULTS: All 66 patients were assessable for efficacy and safety. The objective response rate was 24.2%, and the clinical benefit rate was 50%. Five patients (7.6%) experienced a complete response, 11 patients (16.7%) experienced a partial response, and 17 patients (25.8%) experienced stable disease of > or = 6 months. Median progression-free survival was 5.5 months. Overall, the combination of pertuzumab and trastuzumab was well tolerated, and adverse events were mild to moderate. Cardiac dysfunction was minimal, and no patients withdrew as a result of cardiac-related adverse events. CONCLUSION:
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Authors | José Baselga, Karen A Gelmon, Shailendra Verma, Andrew Wardley, Pierfranco Conte, David Miles, Giulia Bianchi, Javier Cortes, Virginia A McNally, Graham A Ross, Pierre Fumoleau, Luca Gianni |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 28
Issue 7
Pg. 1138-44
(Mar 01 2010)
ISSN: 1527-7755 [Electronic] United States |
PMID | 20124182
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- ERBB2 protein, human
- Receptor, ErbB-2
- pertuzumab
- Trastuzumab
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antibodies, Monoclonal
(administration & dosage, adverse effects)
- Antibodies, Monoclonal, Humanized
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Breast Neoplasms
(chemistry, drug therapy, pathology)
- Disease Progression
- Female
- Humans
- Middle Aged
- Neoplasm Metastasis
- Receptor, ErbB-2
(analysis)
- Stroke Volume
(drug effects)
- Trastuzumab
- Ventricular Function, Left
(drug effects)
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