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Please use this identifier to cite or link to this item: http://repository.li.mahidol.ac.th/dspace/handle/123456789/34869
Title: Incidence and time course of everolimus-related adverse events in postmenopausal women with hormone receptor-positive advanced breast cancer: Insights from BOLERO-2
Authors: H. S. Rugo
K. I. Pritchard
M. Gnant
S. Noguchi
M. Piccart
G. Hortobagyi
J. Baselga
A. Perez
M. Geberth
T. Csoszi
E. Chouinard
V. Srimuninnimit
P. Puttawibul
J. Eakle
W. Feng
H. Bauly
M. El-hashimy
T. Taran
H. A. Burris
UCSF Helen Diller Family Comprehensive Cancer Center
University of Toronto
Medizinische Universitat Wien
Osaka University
Institut Jules Bordet
University of Texas MD Anderson Cancer Center
Memorial Sloan-Kettering Cancer Center
Memorial Cancer Institute
Praxisklinic am Rosengarten Mannheim
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
Cambridge Memorial Hospital
Mahidol University
Prince of Songkla University
Novartis Pharmaceuticals Corporation
Novartis Pharma AG
Sarah Cannon Research Institute
Keywords: Medicine
Issue Date: 1-Jan-2014
Citation: Annals of Oncology. Vol.25, No.4 (2014), 808-815
Abstract: Background: In the BOLERO-2 trial, everolimus (EVE), an inhibitor of mammalian target of rapamycin, demonstrated significant clinical benefit with an acceptable safety profile when administered with exemestane (EXE) in postmenopausal women with hormone receptor-positive (HR+) advanced breast cancer. We report on the incidence, time course, severity, and resolution of treatment-emergent adverse events (AEs) as well as incidence of dose modifications during the extended follow-up of this study. Patients and methods: Patients were randomized (2:1) to receive EVE 10 mg/day or placebo (PBO), with open-label EXE 25 mg/day (n = 724). The primary end point was progression-free survival. Secondary end points included overall survival, objective response rate, and safety. Safety evaluations included recording of AEs, laboratory values, dose interruptions/adjustments, and study drug discontinuations. Results: The safety population comprised 720 patients (EVE + EXE, 482; PBO + EXE, 238). The median follow-up was 18 months. Class effect toxicities, including stomatitis, pneumonitis, and hyperglycemia, were generally of mild or moderate severity and occurred relatively early after treatment initiation (except pneumonitis); incidence tapered off thereafter. EVE dose reduction and interruption (360 and 705 events, respectively) required for AE management were independent of patient age. The median duration of dose interruption was 7 days. Discontinuation of both study drugs because of AEs was higher with EVE + EXE (9%) versus PBO + EXE (3%).Conclusions: Most EVE associated AEs occur soon after initiation of therapy, are typically of mild or moderate severity, and are generally manageable with dose reduction and interruption. Discontinuation due to toxicity was uncommon. Understanding the time course of class-effect AEs will help inform preventive and monitoring strategies as well as patient education. © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.
URI: https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84897102034&origin=inward
http://repository.li.mahidol.ac.th/dspace/handle/123456789/34869
ISSN: 15698041
09237534
Appears in Collections:Scopus 2011-2015

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