BACKGROUND: Evidence regarding drug provocation test (DPT) with antineoplastic and biological agents is scarce. Our aim was to assess the usefulness of including DPT as a paramount gold standard diagnostic tool (prior to desensitization). METHODS: Prospective, observational, longitudinal study with patients who, during a 3-year period, were referred to the Desensitization Program at Ramon y Cajal University Hospital. Patients underwent a structured diagnostic protocol by means of anamnesis, skin tests (ST), risk assessment, and DPT. Oxaliplatin-specific IgE was determined in oxaliplatin-reactive patients (who underwent DPT regardless of oxaliplatin-specific IgE results). Univariate analysis and multivariate analysis were used to identify predictors of the final diagnosis among several variables. RESULTS: A total of 186 patients were assessed. A total of 104 (56%) patients underwent DPT. Sixty-four percent of all DPTs were negative (i.e., hypersensitivity was excluded). Sensitivity for oxaliplatin-specific IgE (0.35 UI/l cutoff point) was 34%, specificity 90.3%, negative predictive value 45.9%, positive predictive value 85%, negative likelihood ratio 0.7, and positive likelihood ratio 3.5. CONCLUSIONS: These are the first reported data based on more than 100 DPTs with antineoplastic and biological agents (paclitaxel, oxaliplatin, rituximab, infliximab, irinotecan, and other drugs). Implementation of DPT in diagnostic protocols helps exclude hypersensitivity (in 36% of all referred patients), and avoids unnecessary desensitizations in nonhypersensitive patients (30-56% of patients, depending on culprit-drug). Drug provocation test is vital to validate diagnostic tools; consequently, quality data are shown on oxaliplatin-specific IgE and oxaliplatin-ST in the largest series of oxaliplatin-reactive patients reported to date (74 oxaliplatin-reactive patients). Identifying phenotypes and predictors of a diagnosis of hypersensitivity may be helpful for tailored plans.
BACKGROUND: Evidence regarding drug provocation test (DPT) with antineoplastic and biological agents is scarce. Our aim was to assess the usefulness of including DPT as a paramount gold standard diagnostic tool (prior to desensitization). METHODS: Prospective, observational, longitudinal study with patients who, during a 3-year period, were referred to the Desensitization Program at Ramon y Cajal University Hospital. Patients underwent a structured diagnostic protocol by means of anamnesis, skin tests (ST), risk assessment, and DPT. Oxaliplatin-specific IgE was determined in oxaliplatin-reactive patients (who underwent DPT regardless of oxaliplatin-specific IgE results). Univariate analysis and multivariate analysis were used to identify predictors of the final diagnosis among several variables. RESULTS: A total of 186 patients were assessed. A total of 104 (56%) patients underwent DPT. Sixty-four percent of all DPTs were negative (i.e., hypersensitivity was excluded). Sensitivity for oxaliplatin-specific IgE (0.35 UI/l cutoff point) was 34%, specificity 90.3%, negative predictive value 45.9%, positive predictive value 85%, negative likelihood ratio 0.7, and positive likelihood ratio 3.5. CONCLUSIONS: These are the first reported data based on more than 100 DPTs with antineoplastic and biological agents (paclitaxel, oxaliplatin, rituximab, infliximab, irinotecan, and other drugs). Implementation of DPT in diagnostic protocols helps exclude hypersensitivity (in 36% of all referred patients), and avoids unnecessary desensitizations in nonhypersensitive patients (30-56% of patients, depending on culprit-drug). Drug provocation test is vital to validate diagnostic tools; consequently, quality data are shown on oxaliplatin-specific IgE and oxaliplatin-ST in the largest series of oxaliplatin-reactive patients reported to date (74 oxaliplatin-reactive patients). Identifying phenotypes and predictors of a diagnosis of hypersensitivity may be helpful for tailored plans.
Authors: Oliver Pfaar; Ludger Klimek; Marek Jutel; Cezmi A Akdis; Jean Bousquet; Heimo Breiteneder; Sharon Chinthrajah; Zuzana Diamant; Thomas Eiwegger; Wytske J Fokkens; Hans-Walter Fritsch; Kari C Nadeau; Robyn E O'Hehir; Liam O'Mahony; Winfried Rief; Vanitha Sampath; Manfred Schedlowski; María José Torres; Claudia Traidl-Hoffmann; De Yun Wang; Luo Zhang; Matteo Bonini; Randolf Brehler; Helen Annaruth Brough; Tomás Chivato; Stefano R Del Giacco; Stephanie Dramburg; Radoslaw Gawlik; Aslı Gelincik; Karin Hoffmann-Sommergruber; Valerie Hox; Edward F Knol; Antti Lauerma; Paolo M Matricardi; Charlotte G Mortz; Markus Ollert; Oscar Palomares; Carmen Riggioni; Jürgen Schwarze; Isabel Skypala; Eva Untersmayr; Jolanta Walusiak-Skorupa; Ignacio J Ansotegui; Claus Bachert; Anna Bedbrook; Sinthia Bosnic-Anticevich; Luisa Brussino; Giorgio Walter Canonica; Victoria Cardona; Pedro Carreiro-Martins; Alvaro A Cruz; Wienczyslawa Czarlewski; João A Fonseca; Maia Gotua; Tari Haahtela; Juan Carlos Ivancevich; Piotr Kuna; Violeta Kvedariene; Désirée Erlinda Larenas-Linnemann; Amir Hamzah Abdul Latiff; Mika Mäkelä; Mário Morais-Almeida; Joaquim Mullol; Robert Naclerio; Ken Ohta; Yoshitaka Okamoto; Gabrielle L Onorato; Nikolaos G Papadopoulos; Vincenzo Patella; Frederico S Regateiro; Bolesław Samoliński; Charlotte Suppli Ulrik; Sanna Toppila-Salmi; Arunas Valiulis; Maria-Teresa Ventura; Arzu Yorgancioglu; Torsten Zuberbier; Ioana Agache Journal: Allergy Date: 2021-03 Impact factor: 14.710