Sarah Kraus*, Boaz Shalev, Shir Arbib, Pazit Rukenstein, Moshe Eltanani, Udi Ron1, Shaul Atar and Ofer Shalev
Background: We report a case of a patient with metastatic breast cancer that was treated with a novel magnetic nanoparticle hyperthermia approach for the treatment of solid tumors comprising of systemic administration of iron oxide multicore encapsulated nanoparticles, named Sarah Nanoparticles (SaNPs), and Alternating Magnetic Field (AMF) irradiation.
Case description: The patient participated in an ongoing open label feasibility ascending dose study designed to evaluate patients with stage IV solid tumors. The primary objective of the trial was to assess the safety profile of the approach. Eligibility criteria included patients with a life expectancy of at least 30 days, histologically confirmed advanced metastatic solid tumors that have progressed on or after standard therapy. Toxicity was evaluated using standard criteria for the grading of adverse events and tumor response was assessed after a follow-up period of 30 days by evaluating changes in the treated metastatic sites. The case, a 39-year-old female, was diagnosed with invasive lobular breast cancer with multifocal leptomeningeal dissemination and was enrolled to the trial in accordance with the eligibility criteria.
The patient received a SaNP dose of 10% followed by an AMF irradiation dose corresponding to two irradiation intervals of 5 minutes each, and successfully completed the treatment procedures in accordance with the study protocol, demonstrating feasibility and good tolerability. Although tumor response was not expected at these first dose levels, MRI and CT results showed a significant effect in a breast tumor without any concomitant toxicities observed.
Conclusion: The treatment was proven safe and induced necrosis of a tumor mass in a case of advanced breast cancer.
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