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Incidence of infusion reactions to anti-neoplastic agents in early phase clinical trials: The MD Anderson Cancer Center experience

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Abstract

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.

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Author information

Authors and Affiliations

  1. Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX, 77030, USA

    Manojkumar Bupathi, Siqing Fu, David Hong, Daniel Karp, Bettzy Stephen, Funda Meric-Bernstam & Aung Naing

  2. 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

  3. Department of Pharmacy, The University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA

    Stacie Bean

  4. Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA

    Kenneth Hess

  5. Division of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA

    Funda Meric-Bernstam

Authors
  1. Manojkumar Bupathi
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  2. Joud Hajjar
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  3. Stacie Bean
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  4. Siqing Fu
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  5. David Hong
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  6. Daniel Karp
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  7. Bettzy Stephen
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  8. Kenneth Hess
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  9. Funda Meric-Bernstam
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  10. Aung Naing
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Corresponding authors

Correspondence to Joud Hajjar or Aung Naing.

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Potential conflict of interest

JH serves as a consultant for Baxter; DH received honoraria for a talk and research funding from Lilly; DK received research funding from Phosplatin Pharma Inc.; FMB received honoraria from Genentech, Roche Diagnostics, and Sysmex, served as a consultant for Genentech, Novartis, Roche, and Inflection Biosciences, and received research funding from Novartis, Astra Zeneca, Taiho Pharmaceutical, Genentech, Calithera Biosciences, Debiopharm Group, and Bayer; MB, SB, SF, BS, KH, and AN have no conflict of interest to disclose.

Funding source

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

Ethical approval

The study was conducted with the approval of and in accordance with the guidelines of the MD Anderson Cancer Center Institutional Review Board.

Additional information

Manojkumar Bupathi and Joud Hajjar contributed equally for this manuscript.

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Bupathi, M., Hajjar, J., Bean, S. et al. Incidence of infusion reactions to anti-neoplastic agents in early phase clinical trials: The MD Anderson Cancer Center experience. Invest New Drugs 35, 59–67 (2017). https://doi.org/10.1007/s10637-016-0395-y

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