TY - JOUR
T1 - Incidence of infusion reactions to anti-neoplastic agents in early phase clinical trials
T2 - The MD Anderson Cancer Center experience
AU - Bupathi, Manojkumar
AU - Hajjar, Joud
AU - Bean, Stacie
AU - Fu, Siqing
AU - Hong, David
AU - Karp, Daniel
AU - Stephen, Bettzy
AU - Hess, Kenneth
AU - Meric-Bernstam, Funda
AU - Naing, Aung
N1 - Funding Information:
This work was supported by the NIH Clinical and Translational Science Award UL1 RR024148 and by the NIH Cancer Center Support Grant (CCSG) award CA016672 to MD Anderson Cancer Center
Publisher Copyright:
© 2016, Springer Science+Business Media New York.
PY - 2017/2/1
Y1 - 2017/2/1
N2 - 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.
AB - 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.
KW - Anti-neoplastic agent
KW - Cytokine reaction
KW - Hypersensitivity
KW - Infusion reaction
KW - Monoclonal antibody
KW - Phase I
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U2 - 10.1007/s10637-016-0395-y
DO - 10.1007/s10637-016-0395-y
M3 - Article
C2 - 27687047
AN - SCOPUS:84989159342
SN - 0167-6997
VL - 35
SP - 59
EP - 67
JO - Investigational New Drugs
JF - Investigational New Drugs
IS - 1
ER -