Are there any studies of ivermectin for stage IV (metastatic) cancer?

Ivermectin for Stage IV Cancer: Current Evidence

Ivermectin is not recommended for the treatment of stage IV cancer, as it has no proven therapeutic utility for cancer and is FDA-approved only for specific parasitic infections. 1

Regulatory Status and Clinical Guidelines

• The FDA does not approve ivermectin for cancer treatment, and current medical guidelines do not support its use in oncology. 2, 1
• The Infectious Diseases Society of America's pattern of recommending against ivermectin for off-label uses (such as COVID-19) due to insufficient evidence of benefit extends to cancer treatment, highlighting the lack of adequate clinical evidence. 2
• The World Health Organization has raised concerns that using ivermectin for unproven indications risks diverting attention and resources away from evidence-based treatments. 2

Critical Gap Between Laboratory and Clinical Evidence

Preclinical Studies Show Activity But Lack Human Validation

• Preclinical studies demonstrate ivermectin's anticancer effects in laboratory settings, including inhibition of cancer cell proliferation, induction of apoptosis, and modulation of signaling pathways (Wnt/β-catenin, Akt/mTOR) across various cancer types. 3, 4
• In vitro studies show ivermectin inhibits tumor metastasis by regulating the Wnt/β-catenin/integrin β1/FAK signaling pathway in colorectal and breast cancer cell lines. 5
• Animal studies demonstrate reduced tumor size and weight in tumor-bearing mice treated with ivermectin. 6

The Dosing Problem

• The standard clinical dose of ivermectin for approved parasitic infections is 200 μg/kg orally, which is significantly lower than concentrations needed for anti-cancer effects. 2
• The safety profile of ivermectin at doses that might achieve anti-cancer effects has not been established. 2
• Higher doses of ivermectin, potentially needed for anticancer effects, may cause significant adverse effects. 1

Absence of Human Clinical Trials

• Clinical evidence in humans is limited, with no large-scale randomized controlled trials (RCTs) confirming therapeutic benefits for cancer. 3
• The lack of clinical studies creates a critical translational gap between preclinical results and practical clinical application. 3

Risks of Pursuing Unproven Therapy

• Observational studies and case reports highlight risks of self-medication driven by social media touting ivermectin's unproven cancer benefits, which can lead to toxicity in oncology patients. 3
• Patients may be attracted to ivermectin due to its low cost and accessibility, particularly in resource-limited settings, but this creates ethical challenges from misinformation that may lead patients to forgo proven therapies. 1, 3

Evidence-Based Alternatives for Stage IV Cancer

For patients with stage IV cancer, established treatment options depend on cancer type:

• Lung cancer (NSCLC): Platinum-based chemotherapy regimens are recommended based on survival advantage and improvement in quality of life over best supportive care. 7
• Melanoma: Clinical trials are the preferred treatment option, with systemic therapy options including single-agent chemotherapy, combination chemotherapy, or biochemotherapy for disseminated disease. 7
• Gastric cancer: Combination regimens incorporating a platinum agent and a fluoropyrimidine are generally used for palliative chemotherapy. 7
• Urothelial carcinoma: Cisplatin-based chemotherapy is recommended as first-line treatment for eligible patients, with emerging evidence showing survival times exceeding 20 months with immuno-oncology agents. 7

Clinical Recommendation

Healthcare providers must communicate responsibly to counter misinformation and guide patients toward evidence-based interventions for stage IV cancer, while supporting rigorous clinical trials to bridge the preclinical-clinical gap for ivermectin. 3