An Open-Label Phase II Study Evaluating the Safety and Efficacy of Ramucirumab Combined With mFOLFOX-6 as First-Line Therapy for Metastatic Colorectal Cancer
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An Open-Label Phase II Study Evaluating the Safety and Efficacy of Ramucirumab Combined With mFOLFOX-6 as First-Line Therapy for Metastatic Colorectal Cancer

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An Open-Label Phase II Study Evaluating the Safety and Efficacy of Ramucirumab Combined With mFOLFOX-6 as First-Line Therapy for Metastatic Colorectal Cancer

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dc.contributor.author Garcia-Carbonero, Rocio es_ES
dc.contributor.author Rivera, Fernando es_ES
dc.contributor.author Maurel, Joan es_ES
dc.contributor.author Ayoub, Jean-Pierre M. es_ES
dc.contributor.author Moore, Malcolm J. es_ES
dc.contributor.author Cervantes Ruipérez, Andrés es_ES
dc.contributor.author Asmis, Timothy R. es_ES
dc.contributor.author Schwartz, Jonathan D. es_ES
dc.contributor.author Nasroulah, Federico es_ES
dc.contributor.author Ballal, Shaila es_ES
dc.contributor.author Tabernero, Josep es_ES
dc.date.accessioned 2015-06-10T08:38:58Z
dc.date.available 2015-06-10T08:38:58Z
dc.date.issued 2014 es_ES
dc.identifier.uri http://hdl.handle.net/10550/44285
dc.description.abstract Background.Vascular endothelial growth factor (VEGF) and VEGF receptor 2 (VEGFR-2) are believed to mediate angiogenesis in colorectal cancer (CRC). Ramucirumab (RAM; IMC-1121B) is a human IgG1 monoclonal antibody that inhibits VEGF ligand binding to VEGFR-2, inhibiting VEGFR-2 activation and signaling.Methods.Patients with metastatic CRC, Eastern Cooperative Oncology Group performance status 0–1, and adequate organ function who had not received chemotherapy for metastatic disease received RAM and the modified FOLFOX-6 regimen every 2 weeks. Endpoints included progression-free survival (PFS), objective response rate, overall survival, and safety. The sample size was based on a potentially improved median PFS from 8 months to 11 months.Results.Forty-eight patients received therapy. Median PFS was 11.5 months (95% confidence interval [CI]: 8.6–13.1 months). The objective response rate was 58.3% (95% CI: 43.21–72.39). The disease control rate (complete or partial response plus stable disease) was 93.8% (95% CI: 82.8–98.7). Median overall survival was 20.4 months (95% CI: 18.5–25.1 months). The most frequent grade 3–4 adverse events included neutropenia (grade 3: 33.3%; grade 4: 8.3%), hypertension (grade 3: 16.7%), and neuropathy (grade 3: 12.5%). Two patients died during the study due to myocardial infarction and cardiopulmonary arrest.Conclusion.RAM may enhance the efficacy of modified FOLFOX-6 chemotherapy with an acceptable safety profile in metastatic CRC. es_ES
dc.source The Oncologist Vol. 19 Issue 4: pp. 350-351 es_ES
dc.title An Open-Label Phase II Study Evaluating the Safety and Efficacy of Ramucirumab Combined With mFOLFOX-6 as First-Line Therapy for Metastatic Colorectal Cancer es_ES
dc.type info:eu-repo/semantics/article es_ES
dc.identifier.doi 10.1634/theoncologist.2014-0028 es_ES
dc.identifier.idgrec 099972 es_ES

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