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Incidence and Management of Olaratumab Infusion-Related Reactions.
Van Tine, Brian A; Govindarajan, Rangaswamy; Attia, Steven; Somaiah, Neeta; Barker, Scott S; Shahir, Ashwin; Barrett, Emily; Lee, Pablo; Wacheck, Volker; Ramage, Samuel C; Tap, William D.
Afiliación
  • Van Tine BA; Washington University in St Louis, St Louis, MO.
  • Govindarajan R; University of Arkansas for Medical Sciences, Little Rock, AR.
  • Attia S; Mayo Clinic, Jacksonville, FL.
  • Somaiah N; The University of Texas MD Anderson Cancer Care Center, Houston, TX.
  • Barker SS; Eli Lilly, Indianapolis, IN.
  • Shahir A; Eli Lilly, Indianapolis, IN.
  • Barrett E; Eli Lilly, Indianapolis, IN.
  • Lee P; Eli Lilly, Indianapolis, IN.
  • Wacheck V; Eli Lilly, Indianapolis, IN.
  • Ramage SC; Eli Lilly, Indianapolis, IN.
  • Tap WD; Memorial Sloan Kettering Cancer Center, New York, NY.
J Oncol Pract ; 15(11): e925-e933, 2019 11.
Article en En | MEDLINE | ID: mdl-31268811
PURPOSE: Olaratumab is a human monoclonal immunoglobulin G1 antibody against platelet-derived growth factor receptor-α. We report the nature and frequency of infusion-related reactions (IRRs) with olaratumab in clinical trials and postmarketing reports. METHODS: Data from patients exposed to olaratumab across nine clinical trials were reviewed for IRRs. Blood samples were also analyzed for pre-existing immunoglobulin E anti-galactose-α-1,3-galactose (anti-α-Gal) antibodies. RESULTS: In the clinical trials, IRRs were identified in 70 of 485 patients (14.4%). The most frequent symptoms included flushing, fever or chills, and dyspnea. For 68 of 70 patients (97.1%), the first IRR occurred during the first two cycles of treatment. Grade 3 or worse IRRs were reported in 11 patients (2.3%), all during the first infusion and usually within 15 minutes of the start of the infusion. One IRR-related fatality (0.2%) occurred in a nonpremedicated patient with grade 3 or worse cardiac comorbidities. There was an association between grade 3 or worse IRRs and pre-existing anti-α-Gal antibodies, with a trend toward higher IRR rates in US geographies known to have a higher prevalence of anti-α-Gal antibodies. IRRs in postmarketing reports were consistent in nature and severity with those in the clinical trials. CONCLUSION: Premedication with corticosteroids and antihistamines should occur in all patients before olaratumab infusion, as indicated in labels in the United States and the European Union. Patients receiving olaratumab should be monitored for IRRs in a setting where resuscitation equipment is available for the treatment of IRRs.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Índice de Severidad de la Enfermedad / Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos / Anticuerpos Monoclonales / Neoplasias / Antineoplásicos Tipo de estudio: Diagnostic_studies / Etiology_studies / Incidence_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: J Oncol Pract Año: 2019 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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XML
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Índice de Severidad de la Enfermedad / Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos / Anticuerpos Monoclonales / Neoplasias / Antineoplásicos Tipo de estudio: Diagnostic_studies / Etiology_studies / Incidence_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: J Oncol Pract Año: 2019 Tipo del documento: Article Pais de publicación: Estados Unidos