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|Ref Type||Journal Article|
|Authors||Garcia-Carbonero R, Rivera F, Maurel J, Ayoub JP, Moore MJ, Cervantes A, Asmis TR, Schwartz JD, Nasroulah F, Ballal S, Tabernero J|
|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.|
|Abstract Text||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.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.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.RAM may enhance the efficacy of modified FOLFOX-6 chemotherapy with an acceptable safety profile in metastatic CRC.|
|Molecular Profile||Treatment Approach|
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|Unknown unknown||colorectal cancer||not applicable||Fluorouracil + Leucovorin + Oxaliplatin + Ramucirumab||Phase II||Actionable||In a Phase II study, Cyramza (ramuciramab), in combination with mFOLFOX-6 chemotherapy regimen, demonstrated safety and efficacy in metastatic colorectal cancer (PMID: 24674871).||24674871|
|Unknown unknown||duodenum adenocarcinoma||not applicable||Ramucirumab||Phase II||Actionable||In a Phase II study, Cyramza (ramuciramab), in combination with mFOLFOX-6 chemotherapy regimen (Wellcovorin (leucovorin), Adrucil (fluorouracil) and Eloxatin (oxaliplatin)), demonstrated safety and efficacy in metastatic colorectal cancer (PMID: 24674871).||24674871|