Safety and Pharmacokinetics of Second-line Ramucirumab plus FOLFIRI in Japanese Patients with Metastatic Colorectal Carcinoma.
作者： Federico Nasroulah , Atsushi Ohtsu , Takayuki Yoshino , Naoto Yoshizuka , Kentaro Yamazaki
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摘要: Background: This phase Ib study evaluated the pharmacokinetic profile and safety of ramucirumab, a recombinant human IgG1 neutralizing monoclonal antibody specific for vascular endothelial growth factor receptor 2, in combination with irinotecan, levofolinate 5-fluorouracil (FOLFIRI) Japanese patients metastatic colorectal carcinoma (mCRC). Patients Methods: Eligible had Eastern Cooperative Oncology Group performance status 0-1, disease progression during or within 6 months following first-line therapy bevacizumab, oxaliplatin fluoropyrimidine. Six enrolled received 8 mg/kg ramucirumab plus FOLFIRI every 2 weeks. Results: One out six experienced dose-limiting toxicity (grade proteinuria grade 4 neutropenia, resulting dose delay >2 weeks). All at least one 3 higher adverse event: neutropenia (five patients, 83%), (two patients; 33%) anemia, thrombocytopenia hypertension (one patient each, 17%). There were no serious events deaths. Conclusion: Ramucirumab was well-tolerated mCRC, warranting further investigation this therapy.
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