Waseem Touma1, Sami S Koro2, Jessica Ley2, Tanya M Wildes3, Loren Michel3, Yu Tao4, Douglas Adkins5. 1. Division of Hospital Medicine, Department of Internal Medicine, St. Louis, MO, United States. 2. Division of Medical Oncology, Department of Internal Medicine, St. Louis, MO, United States. 3. Division of Medical Oncology, Department of Internal Medicine, St. Louis, MO, United States; Alvin J. Siteman Cancer Center, St. Louis, MO, United States. 4. Division of Biostatistics, St. Louis, MO, United States. 5. Division of Medical Oncology, Department of Internal Medicine, St. Louis, MO, United States; Alvin J. Siteman Cancer Center, St. Louis, MO, United States. Electronic address: dadkins@dom.wustl.edu.
Abstract
OBJECTIVES: Cetuximab, a chimeric monoclonal antibody, is the only targeted therapy approved for squamous cell carcinoma of the head and neck (SCCHN). Infusion reactions (IRs) occur in 6-18% of patients pre-medicated with diphenhydramine. Evidence for clinical risk factors for IRs is limited and the benefit of additional pre-medication to prevent IRs is unclear. MATERIALS AND METHODS: A retrospective, single institution study of 243 SCCHN patients treated with cetuximab to evaluate potential risk factors for IRs and to assess the efficacy of additional pre-medications (nebulized albuterol and intravenous (IV) corticosteroids and/or H2-blockers) to decrease the risk of IR. RESULTS: IR (grades 1-4) and high grade (grades 3-4 only) IR occurred in 47 (19.3%) and 16 (6.6%) patients, respectively. Multivariate analysis identified Caucasian race (OR7.11, p=0.003), medication allergy (OR3.74, p=0.002), and blood eosinophils >3% (OR2.75, p=0.01) independently increased the risk of IR; Caucasian race (OR5.57, p=0.007) and medication allergy (OR4.10, p=0.0007) increased the risk of high grade IR. IR (grades 1-4) and high grade IR occurred in 31.8% and 22.7% pre-medicated with diphenhydramine alone. Univariate analysis identified albuterol, famotidine, and corticosteroids decreased the risk of high grade IR. Furthermore, there was a significant difference between the possible combinations of the pre-medications and the risk of high grade IR by Fisher Exact test (p=0.003) whereby the combination of albuterol, famotidine and corticosteroids was effective in preventing high grade IR. Thirty (64%) of the 47 patients who developed an IR were re-challenged and did not experience a recurrence of an IR. CONCLUSION: These data may be used to identify patients at higher risk for cetuximab-induced IR who may be advised to not receive cetuximab or who may benefit from additional pre-medications to decrease the risk of a high grade IR.
OBJECTIVES:Cetuximab, a chimeric monoclonal antibody, is the only targeted therapy approved for squamous cell carcinoma of the head and neck (SCCHN). Infusion reactions (IRs) occur in 6-18% of patients pre-medicated with diphenhydramine. Evidence for clinical risk factors for IRs is limited and the benefit of additional pre-medication to prevent IRs is unclear. MATERIALS AND METHODS: A retrospective, single institution study of 243 SCCHN patients treated with cetuximab to evaluate potential risk factors for IRs and to assess the efficacy of additional pre-medications (nebulized albuterol and intravenous (IV) corticosteroids and/or H2-blockers) to decrease the risk of IR. RESULTS: IR (grades 1-4) and high grade (grades 3-4 only) IR occurred in 47 (19.3%) and 16 (6.6%) patients, respectively. Multivariate analysis identified Caucasian race (OR7.11, p=0.003), medication allergy (OR3.74, p=0.002), and blood eosinophils >3% (OR2.75, p=0.01) independently increased the risk of IR; Caucasian race (OR5.57, p=0.007) and medication allergy (OR4.10, p=0.0007) increased the risk of high grade IR. IR (grades 1-4) and high grade IR occurred in 31.8% and 22.7% pre-medicated with diphenhydramine alone. Univariate analysis identified albuterol, famotidine, and corticosteroids decreased the risk of high grade IR. Furthermore, there was a significant difference between the possible combinations of the pre-medications and the risk of high grade IR by Fisher Exact test (p=0.003) whereby the combination of albuterol, famotidine and corticosteroids was effective in preventing high grade IR. Thirty (64%) of the 47 patients who developed an IR were re-challenged and did not experience a recurrence of an IR. CONCLUSION: These data may be used to identify patients at higher risk for cetuximab-induced IR who may be advised to not receive cetuximab or who may benefit from additional pre-medications to decrease the risk of a high grade IR.
Authors: David Cunningham; Yves Humblet; Salvatore Siena; David Khayat; Harry Bleiberg; Armando Santoro; Danny Bets; Matthias Mueser; Andreas Harstrick; Chris Verslype; Ian Chau; Eric Van Cutsem Journal: N Engl J Med Date: 2004-07-22 Impact factor: 91.245
Authors: Christine H Chung; Beloo Mirakhur; Emily Chan; Quynh-Thu Le; Jordan Berlin; Michael Morse; Barbara A Murphy; Shama M Satinover; Jacob Hosen; David Mauro; Robbert J Slebos; Qinwei Zhou; Diane Gold; Tina Hatley; Daniel J Hicklin; Thomas A E Platts-Mills Journal: N Engl J Med Date: 2008-03-13 Impact factor: 91.245
Authors: Leonard B Saltz; Neal J Meropol; Patrick J Loehrer; Michael N Needle; Justin Kopit; Robert J Mayer Journal: J Clin Oncol Date: 2004-03-01 Impact factor: 44.544
Authors: Bert H O'Neil; Robert Allen; David R Spigel; Thomas E Stinchcombe; Dominic T Moore; Jordan D Berlin; Richard M Goldberg Journal: J Clin Oncol Date: 2007-08-20 Impact factor: 44.544
Authors: James A Bonner; Paul M Harari; Jordi Giralt; Nozar Azarnia; Dong M Shin; Roger B Cohen; Christopher U Jones; Ranjan Sur; David Raben; Jacek Jassem; Roger Ove; Merrill S Kies; Jose Baselga; Hagop Youssoufian; Nadia Amellal; Eric K Rowinsky; K Kian Ang Journal: N Engl J Med Date: 2006-02-09 Impact factor: 91.245
Authors: Hugh A Sampson; Anne Muñoz-Furlong; Ronna L Campbell; N Franklin Adkinson; S Allan Bock; Amy Branum; Simon G A Brown; Carlos A Camargo; Rita Cydulka; Stephen J Galli; Jane Gidudu; Rebecca S Gruchalla; Allen D Harlor; David L Hepner; Lawrence M Lewis; Phillip L Lieberman; Dean D Metcalfe; Robert O'Connor; Antonella Muraro; Amanda Rudman; Cara Schmitt; Debra Scherrer; F Estelle R Simons; Stephen Thomas; Joseph P Wood; Wyatt W Decker Journal: J Allergy Clin Immunol Date: 2006-02 Impact factor: 10.793
Authors: Mohammad Fereydouni; Mona Motaghed; Elnaz Ahani; Tal Kafri; Kristen Dellinger; Dean D Metcalfe; Christopher L Kepley Journal: Front Oncol Date: 2022-03-31 Impact factor: 6.244