Abstract | BACKGROUND: The alpha (v) beta (3) (alpha(v) beta(3)) integrin is involved in intracellular signaling regulating cell proliferation, migration, and differentiation and is important for tumor-induced angiogenesis. METHODS: RESULTS: One hundred twelve patients were randomized to receive etaracizumab alone (N = 57) or etaracizumab + dacarbazine (N = 55). Safety of etaracizumab + or - dacarbazine was acceptable with infusion-related, gastrointestinal, and metabolic reactions being the most common adverse events (AEs). The majority of AEs were grade 1 or 2 in severity in both study arms; most events were not considered serious, except for cardiovascular ( myocardial infarction, atrial fibrillation) and thromboembolic events, which occurred in 3 and 5 patients, respectively. None of the patients in the etaracizumab-alone study arm and 12.7% of patients in the etaracizumab + dacarbazine study arm achieved an objective response. The median duration of objective response in the etaracizumab + dacarbazine study arm was 4.2 months. Stable disease rate, time to progression ( TTP), and progression-free survival (PFS) appeared to be similar between the 2 treatment arms. Stable disease occurred in 45.6% of patients in the etaracizumab-alone study arm and 40.0% of patients in the etaracizumab + dacarbazine study arm. Median TTP and median PFS were both 1.8 months in the etaracizumab-alone study arm and 2.5 and 2.6 months in the etaracizumab + dacarbazine study arm, respectively. Median overall survival was 12.6 months in the etaracizumab-alone study arm and 9.4 months in the etaracizumab + dacarbazine study arm. CONCLUSIONS: The survival results in both treatment arms of this study were considered unlikely to result in clinically meaningful improvement over dacarbazine alone.
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Authors | Peter Hersey, Jeffrey Sosman, Steven O'Day, Jon Richards, Agop Bedikian, Rene Gonzalez, William Sharfman, Robert Weber, Theodore Logan, Manuela Buzoianu, Luz Hammershaimb, John M Kirkwood, Etaracizumab Melanoma Study Group |
Journal | Cancer
(Cancer)
Vol. 116
Issue 6
Pg. 1526-34
(Mar 15 2010)
ISSN: 0008-543X [Print] United States |
PMID | 20108344
(Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Integrin alphaVbeta3
- etaracizumab
- Dacarbazine
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antibodies, Monoclonal
(administration & dosage, adverse effects, therapeutic use)
- Antibodies, Monoclonal, Humanized
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Dacarbazine
(administration & dosage, therapeutic use)
- Disease-Free Survival
- Female
- Humans
- Integrin alphaVbeta3
(immunology)
- Male
- Melanoma
(drug therapy, pathology)
- Middle Aged
- Skin Neoplasms
(drug therapy, pathology)
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