ACTR-70. INCREASING SURVIVAL IN BIOPSY-ONLY GBM PATIENTS

Abstract

It is generally expected that survival from GBM is correlated to the extent of resection. That is, patients having only a biopsy don’t live as long as those having partial or complete resections. Fifteen years ago, 2-year survival of biopsy-only patients was 5%. In 2005, Stupp et al. added temozolomide (TM Z) to radiation therapy and also established a follow-up TMZ chemotherapy regimen. This increased 2-year survival of unresected GBM patients from 4.6% to 10.4 % (Stupp et al., 2009). Lately, due to the still-low survival rate, biopsy-only patients are often excluded from GBM clinical trials. It is known that hypoxic tumors are resistant to radiation therapy (Sheehan et al., 2010). Thus, Diffusion Pharmaceuticals Inc. added trans sodium crocetinate (TSC) to temozolomide-radiation therapy, but not to the chemotherapy in a Phase 2 clinical trial (Gainer, et al., 2017). TSC stimulates re-oxygenation of hypoxic tumors (Sheehan, et al, 2009, 2011). It acts systemically to re-oxygenate hypoxic tissue but has no effect on normal cells. When combined with temozolomide and radiation, TSC resulted in a 2-year survival of biopsy-only patients of 40%, in effect quadrupling the 2005 Stoop results. TSC is being currently studied in a Phase 3 GBM trial involving solely biopsy-only patients. In this trial, TSC is added to both the radiotherapy and chemotherapy sessions, preceding the dosing of TMZ. This trial is called INTACT (NCT03393000) and is currently enrolling patients.