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High-Dose Acetaminophen as a Treatment for Cancer.

Jeffrey Wu1, Bradley Maller2,3, Rujul Kaul2

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High-dose acetaminophen (AAP) shows anti-tumor efficacy via novel mechanisms, independent of free radicals. Combining AAP with fomepizole and n-acetylcysteine (NAC) enables higher, non-toxic doses for cancer treatment.

Keywords:
N-acetylcysteineacetaminophencancerfomepizole

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Area of Science:

  • Oncology
  • Pharmacology
  • Immunology

Background:

  • High-dose acetaminophen (AAP) with n-acetylcysteine (NAC) rescue has shown early promise as an anti-cancer therapy.
  • Existing research suggests AAP's anti-tumor effects may be independent of the free-radical mechanisms linked to its known hepatotoxicity.

Purpose of the Study:

  • To investigate novel, free-radical-independent mechanisms of high-dose AAP anti-tumor activity.
  • To evaluate the efficacy and safety of high-dose AAP combined with fomepizole and NAC in pre-clinical cancer models.

Main Methods:

  • Phase I trials and correlative analyses were conducted.
  • Reverse translational studies identified mechanisms involving JAK-STAT signaling modulation.
  • Pre-clinical studies administered high-dose AAP with fomepizole and NAC in mouse models.

Main Results:

  • High-dose AAP demonstrated anti-tumor efficacy through mechanisms independent of free radicals.
  • Novel mechanisms include modulation of JAK-STAT signaling in tumor cells and the immune microenvironment.
  • Concurrent administration of AAP, fomepizole, and NAC achieved 100-fold higher AAP levels in mice without toxicity, showing efficacy in lung and breast cancer models resistant to standard therapies.

Conclusions:

  • High-dose AAP exhibits potent anti-tumor activity via novel, free-radical-independent pathways.
  • Combining AAP with fomepizole and NAC allows for significantly higher, non-toxic therapeutic levels.
  • Further clinical trials are warranted to explore this combination as a potential cancer treatment.