BIO23: Hyperthermic Extracorporeal Applied Tumor Therapy (HEATT®) for Treatment of Advanced, Unresponsive, Hospice Eligible Cancer Patients: Update

Abstract

Purpose: HEATT® is veno-venous perfusion-induced systemic hyperthermia with a heart-lung pump, dialysis, blood sorbent, and CO2/pH control with flow at 20% of cardiac output to homogeneously increase core temperature to 42°C for 120 min while normalizing fluid and electrolyte changes. Two Phase 1 FDA trials (advanced lung, ovarian cancer), demonstrated safety and efficacy. We are reporting progress on an open label, non-randomized, early feasibility, single dose of HEATT® to treat select cancer patients with persistent or recurrent unresectable cancers unresponsive to chemo-, immuno-, and/or curative therapy. Method: Informed consent was obtained. Exclusion criteria: recent brain surgery, metastasis or stroke; organ failure; sepsis; or active bleeding. HEATT® uses 13-17 Fr Femoral-Jugular cannulas placed by image guidance in a veno-venous circuit. All individual components are FDA approved. Upon general anesthesia and systemic anticoagulation, Interventional Radiology placed a triple lumen central line, arterial line, and IVC/SVC venous cannula at L2 for drainage and at SVC/RA junction for infusion of heated blood for a targeted 20% cardiac output flow to increase core temperature to 42°C for 120 min. Patients are cooled to 38°C, then recovered. Results: All patients met criteria and were hospice eligible with a mean predicted survival of 90 days. Primary cancers included ovarian (5), colon (2), breast (2), lung (1), pancreatic (1), cholangiocarcinoma (1), and lipo-sarcoma (1). All achieved 42°C core temperature for 120 min with stable hemodynamics, heat transfer, and circuit dynamics. No complications were identified specific to HEATT®. Length of stay was 2-4 days including treatment, 12/13 survived to 30-day all-cause mortality, while 1/13 died of pulmonary hemorrhage from multiple metastasis. Eight of 13 exceeded expected median survival, 6/13 exceeded 180 day predicted maximum end-of-life. Four are alive and active at 500, 386, 360, and 288 days (Max 530). Twelve of 13 recovered to receive additional therapies. Frailty, age >80, and immobility negatively impact recovery. HEATT® does not predictably relieve tumor obstruction. Summary: We recommend HEATT® for treatment of advanced cancer patients unresponsive to conventional treatments.