Hyperthermic Extracorporeal Applied Tumor Therapy (HEATT ® ) in hospice- eligible cancer patients

Background Two previous clinical studies indicated veno-venous perfusion-induced systemic hyperthermia (VV-PISH), producing elevated temperatures of 42°C, induces cell death, apoptosis, or senescence of responsive cancers. The VV-PISH circuit has been refined and rebranded as Hyperthermic Extracorporeal Applied Tumor Treatment (HEATT ® ). Methods The local IRB approved this retrospective chart review. All devices are FDA-approved. The referring physician judged each patient to be hospice-eligible with a median predicted survival of 3 months and maximum predicted survival of 6 months. We evaluated HEATT ® in hospice-eligible patients ( n = 13) with unresponsive, advanced cancer, conducted at a single site, with a select, consistent team of healthcare providers (critical care, anesthesia, perfusionist, interventional radiologist, HEATT ® consultant). HEATT ® treatment (42°C for 120 min) was delivered once between June 2021 and April 2022. The referring physician followed patients until documented death. HEATT circuit and criteria were refined to maximize safety. Results In a retrospective chart review of the 13 consecutive patients, 8/13 patients exceeded expected median survival, 6/13 exceeded the 6-months predicted end-of-life, and 5/13 exceeded 12 months. Lessons learned allowed the refinement of inclusion/exclusion criteria of Karnofsky >70, ability to ambulate, and age