Stanislaw R. Burzynski*, Tomasz J. Janicki, Gregory S. Burzynski, Radoslaw J. Siwiec and Samuel W. Beenken
Background: High-Grade Gliomas (HGGs) are among the most aggressive and deadly primary brain tumors. Standard treatment includes surgery, external beam radiation and temozolomide, which can cause marked toxicity. Despite intensive therapy, the prognosis remains poor.
Objective: To assess long-term outcomes and safety in non-Glioblastoma (non-GBM) HGG patients treated with Antineoplastons A10 and AS2-1 (ANP) at the Burzynski Clinic (BC) under phase II protocols.
Methods: Sixty-one non-GBM HGG patients received intravenous ANP. Eligibility required Karnofsky/Lansky Performance Scores (KPS/LPS) of at least 60 and a life expectancy of at least 2 months. ANP was administered via a subclavian catheter and automated pump. Maximum tolerated doses of A10 and AS2-1 were achieved. Outcomes included objective response, survival and toxicity
Results: As of October 2025, all 61 patients had survived for at least 5 years, with one patient surpassing 33 years. The criteria of a cure was met when 23 patients survived over 12 years. Ages ranged from 1.08 to 62.66 years (median 35.9). KPS/LPS scores ranged from 40 to 90 (median 60). Four patients experienced six Serious Adverse Events (SAE’s) possibly related to ANP (fever without infection, nausea, dizziness and three cases of somnolence); all recovered fully. In a Kaplan-Meier analysis of 310 non-GBM HGG patients treated at BC, median survival was 1.867 years.
Conclusions: ANP therapy shows significant potential for non-GBM HGG, with many long-term survivors and no observed long-term toxicity. This cohort represents the most extensive documented series of HGG survivors with unusually long-term survivals. Findings support ANP as a viable treatment option.
Published Date: 2025-12-11; Received Date: 2025-11-11
