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Title: Exposure-response relationship of ramucirumab in patients with advanced second-line colorectal cancer: exploratory analysis of the RAISE trial.
Authors: Cohn, Allen Lee
Yoshino, Takayuki
Heinemann, Volker
Obermannova, Radka
Bodoky, György
Prausová, Jana
Garcia-Carbonero, Rocio
Ciuleanu, Tudor
Garcia-Alfonso, Pilar
Portnoy, David C
Van Cutsem, Eric
Yamazaki, Kentaro
Clingan, Philip R
Polikoff, Jonathon
Lonardi, Sara
O'Brien, Lisa M
Gao, Ling
Yang, Ling
Ferry, David
Nasroulah, Federico
Tabernero, Josep
Keywords: Colorectal cancer;Exposure–response;FOLFIRI;Ramucirumab;Second line
metadata.dc.subject.mesh: Aged
Antibodies, Monoclonal
Antibodies, Monoclonal, Humanized
Antineoplastic Agents
Colorectal Neoplasms
Disease-Free Survival
Issue Date: 25-Jul-2017
Abstract: To characterize ramucirumab exposure-response relationships for efficacy and safety in patients with metastatic colorectal cancer (mCRC) using data from the RAISE study. Sparse pharmacokinetic samples were collected; a population pharmacokinetic analysis was conducted. Univariate and multivariate Cox proportional hazards models analyzed the relationship between predicted ramucirumab minimum trough concentration at steady state (C min,ss) and survival. Kaplan-Meier analysis was used to evaluate survival from patients in the ramucirumab plus folinic acid, 5-fluorouracil, and irinotecan (FOLFIRI) treatment arm stratified by C min,ss quartiles (Q). An ordered categorical model analyzed the relationship between C min,ss and safety outcomes. Pharmacokinetic samples from 906 patients were included in exposure-efficacy analyses; samples from 905 patients were included in exposure-safety analyses. A significant association was identified between C min,ss and overall survival (OS) and progression-free survival (PFS) (p  Exploratory exposure-response analyses suggested a positive relationship between efficacy and ramucirumab exposure with manageable toxicities in patients from the RAISE study with mCRC over the ranges of exposures achieved by a dose of 8 mg/kg every 2 weeks in combination with FOLFIRI.
metadata.dc.identifier.doi: 10.1007/s00280-017-3380-z
Appears in Collections:Producción 2020

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