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

Abstract

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 <80. Likewise, refining the circuitry led to improved standardization of the HEATT^® perfusion technique and management.

Conclusions

This consecutive series of 13 hospice-eligible patients demonstrated the refinement of HEATT^®, focusing on perfusion technique and selection criteria. In this small series of physician-referred hospice-eligible patients unresponsive to conventional therapy or other integrative oncology treatments, HEATT^® demonstrated safety with an increase in the length of survival over median expected in eight of 13 patients, with five of 13 patients living 12 to 18 months, 2-3 times longer than the referring physician expected. These refinements are essential to enable prospective randomized trials of like-patient populations to generate evidence-based medical recommendations.