Incidence and management of adverse events in patients with relapsed and/or refractory multiple myeloma receiving single-agent carfilzomib

Incidence and management of adverse events in patients with relapsed and/or refractory multiple myeloma receiving single-agent carfilzomib

R Donald HarveyPhase 1 Clinical Trials Section, Winship Cancer Institute of Emory University, Atlanta, GA, USAAbstract: Carfilzomib, a selective proteasome inhibitor approved in the USA in 2012, is a single agent for relapsed and refractory multiple myeloma. Carfilzomib is administered as a 2&n...

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Autor principal: Harvey RD
Formato: article
Lenguaje:EN
Publicado: Dove Medical Press 2014
Materias:
Therapeutics. Pharmacology
RM1-950
Acceso en línea:https://doaj.org/article/e61e73945e8e499f9a1d996fbc7afd8c
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spelling oai:doaj.org-article:e61e73945e8e499f9a1d996fbc7afd8c2021-12-02T02:06:49ZIncidence and management of adverse events in patients with relapsed and/or refractory multiple myeloma receiving single-agent carfilzomib1179-1438https://doaj.org/article/e61e73945e8e499f9a1d996fbc7afd8c2014-05-01T00:00:00Zhttp://www.dovepress.com/incidence-and-management-of-adverse-events-in-patients-with-relapsed-a-a16731https://doaj.org/toc/1179-1438 R Donald HarveyPhase 1 Clinical Trials Section, Winship Cancer Institute of Emory University, Atlanta, GA, USAAbstract: Carfilzomib, a selective proteasome inhibitor approved in the USA in 2012, is a single agent for relapsed and refractory multiple myeloma. Carfilzomib is administered as a 2–10-minute infusion on days 1, 2, 8, 9, 15, and 16 of a 28-day cycle at a starting dose of 20 mg/m2 for cycle 1 and a target dose of 27 mg/m2 thereafter. In the pivotal Phase II study (PX-171-003-A1), carfilzomib 20/27 mg/m2 provided durable responses in a heavily pretreated population with relapsed and refractory multiple myeloma (n=266), with an overall response rate of 22.9% and a median duration of response of 7.8 months. In an integrated safety analysis of four Phase II studies, common adverse events (32.7%–55.5%) included fatigue, anemia, nausea, thrombocytopenia, dyspnea, and diarrhea. Grade 3/4 adverse events were generally hematologic and included thrombocytopenia (23.4%), anemia (22.4%), and lymphopenia (18.1%). Serious adverse events included pneumonia (9.9%), acute renal failure (4.2%), pyrexia (3.4%), and congestive heart failure (3.4%). New or worsening peripheral neuropathy was infrequent (13.9% overall, 1.3% grade 3, no grade 4). This review discusses findings of the integrated safety analysis and provides practical experience from a single institution in managing treatment-related and disease-related adverse events. Individualized treatment with proactive management of side effects and complications allows patients with advanced multiple myeloma to remain on carfilzomib for extended periods.Keywords: carfilzomib, relapsed, refractory, myeloma, safety, adverse events, toxicityHarvey RDDove Medical PressarticleTherapeutics. PharmacologyRM1-950ENClinical Pharmacology: Advances and Applications, Vol 2014, Iss default, Pp 87-96 (2014)
institution DOAJ
collection DOAJ
language EN
topic Therapeutics. Pharmacology
RM1-950
spellingShingle Therapeutics. Pharmacology
RM1-950
Harvey RD
Incidence and management of adverse events in patients with relapsed and/or refractory multiple myeloma receiving single-agent carfilzomib
description R Donald HarveyPhase 1 Clinical Trials Section, Winship Cancer Institute of Emory University, Atlanta, GA, USAAbstract: Carfilzomib, a selective proteasome inhibitor approved in the USA in 2012, is a single agent for relapsed and refractory multiple myeloma. Carfilzomib is administered as a 2–10-minute infusion on days 1, 2, 8, 9, 15, and 16 of a 28-day cycle at a starting dose of 20 mg/m2 for cycle 1 and a target dose of 27 mg/m2 thereafter. In the pivotal Phase II study (PX-171-003-A1), carfilzomib 20/27 mg/m2 provided durable responses in a heavily pretreated population with relapsed and refractory multiple myeloma (n=266), with an overall response rate of 22.9% and a median duration of response of 7.8 months. In an integrated safety analysis of four Phase II studies, common adverse events (32.7%–55.5%) included fatigue, anemia, nausea, thrombocytopenia, dyspnea, and diarrhea. Grade 3/4 adverse events were generally hematologic and included thrombocytopenia (23.4%), anemia (22.4%), and lymphopenia (18.1%). Serious adverse events included pneumonia (9.9%), acute renal failure (4.2%), pyrexia (3.4%), and congestive heart failure (3.4%). New or worsening peripheral neuropathy was infrequent (13.9% overall, 1.3% grade 3, no grade 4). This review discusses findings of the integrated safety analysis and provides practical experience from a single institution in managing treatment-related and disease-related adverse events. Individualized treatment with proactive management of side effects and complications allows patients with advanced multiple myeloma to remain on carfilzomib for extended periods.Keywords: carfilzomib, relapsed, refractory, myeloma, safety, adverse events, toxicity
format article
author Harvey RD
author_facet Harvey RD
author_sort Harvey RD
title Incidence and management of adverse events in patients with relapsed and/or refractory multiple myeloma receiving single-agent carfilzomib
title_short Incidence and management of adverse events in patients with relapsed and/or refractory multiple myeloma receiving single-agent carfilzomib
title_full Incidence and management of adverse events in patients with relapsed and/or refractory multiple myeloma receiving single-agent carfilzomib
title_fullStr Incidence and management of adverse events in patients with relapsed and/or refractory multiple myeloma receiving single-agent carfilzomib
title_full_unstemmed Incidence and management of adverse events in patients with relapsed and/or refractory multiple myeloma receiving single-agent carfilzomib
title_sort incidence and management of adverse events in patients with relapsed and/or refractory multiple myeloma receiving single-agent carfilzomib
publisher Dove Medical Press
publishDate 2014
url https://doaj.org/article/e61e73945e8e499f9a1d996fbc7afd8c
work_keys_str_mv AT harveyrd incidenceandmanagementofadverseeventsinpatientswithrelapsedandorrefractorymultiplemyelomareceivingsingleagentcarfilzomib
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