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

Rocio Garcia-Carbonero, Fernando Rivera, Joan Maurel, Jean Pierre M. Ayoub, Malcolm J. Moore, Andres Cervantes, Timothy R. Asmis, Jonathan D. Schwartz, Federico Nasroulah, Shaila Ballal, Josep Tabernero

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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 duringthe 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. © AlphaMed Press 2014.
Original languageEnglish
Pages (from-to)350-351
JournalOncologist
Volume19
Issue number4
DOIs
Publication statusPublished - 1 Jan 2014

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    Garcia-Carbonero, R., Rivera, F., Maurel, J., Ayoub, J. P. M., Moore, M. J., Cervantes, A., Asmis, T. R., Schwartz, J. D., Nasroulah, F., Ballal, S., & Tabernero, J. (2014). 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. Oncologist, 19(4), 350-351. https://doi.org/10.1634/theoncologist.2014-0028