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Safety and Pharmacokinetics of Second-line Ramucirumab plus FOLFIRI in Japanese Patients with Metastatic Colorectal Carcinoma.
- Source :
-
Anticancer research [Anticancer Res] 2015 Jul; Vol. 35 (7), pp. 4003-7. - Publication Year :
- 2015
-
Abstract
- 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 and 5-fluorouracil (FOLFIRI) in Japanese patients with metastatic colorectal carcinoma (mCRC).<br />Patients and Methods: Eligible patients had Eastern Cooperative Oncology Group performance status 0-1, and disease progression during or within 6 months following first-line therapy with bevacizumab, oxaliplatin and a fluoropyrimidine. Six enrolled patients received 8 mg/kg ramucirumab plus FOLFIRI every 2 weeks.<br />Results: One out of six patients experienced a dose-limiting toxicity (grade 2 proteinuria and grade 4 neutropenia, resulting in a dose delay >2 weeks). All patients experienced at least one grade 3 or higher adverse event: neutropenia (five patients, 83%), proteinuria (two patients; 33%) and anemia, thrombocytopenia and hypertension (one patient each, 17%). There were no serious adverse events or deaths.<br />Conclusion: Ramucirumab plus FOLFIRI was well-tolerated in Japanese patients with mCRC, warranting further investigation of this combination therapy.<br /> (Copyright© 2015 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.)
- Subjects :
- Aged
Antibodies, Monoclonal administration & dosage
Antibodies, Monoclonal adverse effects
Antibodies, Monoclonal, Humanized
Antineoplastic Agents administration & dosage
Antineoplastic Agents adverse effects
Antineoplastic Combined Chemotherapy Protocols administration & dosage
Antineoplastic Combined Chemotherapy Protocols adverse effects
Asian People
Camptothecin administration & dosage
Camptothecin adverse effects
Camptothecin analogs & derivatives
Disease Progression
Female
Fluorouracil administration & dosage
Fluorouracil adverse effects
Humans
Leucovorin administration & dosage
Leucovorin adverse effects
Male
Middle Aged
Ramucirumab
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Colorectal Neoplasms drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1791-7530
- Volume :
- 35
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- Anticancer research
- Publication Type :
- Academic Journal
- Accession number :
- 26124348