Incidence of infusion reactions to anti-neoplastic agents in early phase clinical trials: The MD Anderson Cancer Center experience.
Infusion reactions (IRs) to anti-neoplastic agents require prompt recognition and immediate treatment to avert significant complications. We conducted a retrospective review of the medical records of consecutive patients who received anti-neoplastic therapy in the outpatient treatment center of the Department of Investigational Cancer Therapeutics from January 1, 2013 to November 30, 2013. Of the 597 patients who received treatment, 9 (1.5 %) had IRs (all ≤ grade 2). The most common IRs observed on first occurrence were chills (n = 5), itching, rash, and facial flushing (n = 3 each). There were no IR-related deaths. All the IRs were reversible with appropriate symptomatic treatment and the therapy was completed after temporary cessation of infusion in 7 of the 9 patients. The infusion was stopped in 2 patients due to symptoms suggestive of IgE-mediated allergic reaction and cytokine storm. Five of the 8 patients who were re-challenged with the same therapy developed a similar reaction. However, the infusion was completed in 4 of the 5 patients after administration of intravenous diphenhydramine and/or hydrocortisone, or slowing the rate of infusion. And, subsequent cycles with the same agents were uneventful. IRs to anti-neoplastic agents are rare. Though the clinical presentations are overlapping, most IRs are not IgE-mediated allergic reactions. Appropriate premedication and slow rate of infusion facilitates uneventful administration of the anti-neoplastic agents in subsequent cycles. Further study in a larger cohort of patients to identify biomarkers of hypersensitivity is warranted.
Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX, 77030, USA.
Manojkumar
M
Bupathi
Section of Immunology, Allergy and Rheumatology, One Baylor Plaza, Baylor College of Medicine, Texas Children's Hospital, 7200 Cambridge St., # 10 C, Houston, TX, 77030-4004, USA. joud.hajjar@bcm.edu.
Joud
J
Hajjar
Department of Pharmacy, The University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA.
Stacie
S
Bean
Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX, 77030, USA.
Siqing
S
Fu
Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX, 77030, USA.
David
D
Hong
Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX, 77030, USA.
Daniel
D
Karp
Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX, 77030, USA.
Bettzy
B
Stephen
Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA.
Kenneth
K
Hess
Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX, 77030, USA.|Division of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA.
Funda
F
Meric-Bernstam
Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX, 77030, USA. anaing@mdanderson.org.
Aung
A
Naing
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D002173:Cancer Care Facilities / Q000706:statistics & numerical data; D017321:Clinical Trials, Phase I as Topic; D016207:Cytokines / Q000276:immunology; D004342:Drug Hypersensitivity; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000276:immunology; D015994:Incidence; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D055815:Young Adult
D000970:Antineoplastic Agents; D016207:Cytokines; D007073:Immunoglobulin E
Anti-neoplastic agent; Cytokine reaction; Hypersensitivity; Infusion reaction; Monoclonal antibody; Phase I
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