Abstract
<p class="cco-body"><span lang="EN-GB">It is estimated that as many as 30% of patients with primary CNS tumors have leptomeningeal, disseminated, and/or multicentric disease (LDM). These patients respond poorly to conventional therapy. Fifty-seven children with LDM (median age of 7.1 years) were treated in multiple prospective phase II clinical studies of high- and low-grade primary CNS tumors with Antineoplastons A10 and AS2-1 (ANP). Their inclusion in this analysis was based on MRI imaging. Patients with glioblastoma were excluded. The patients received ANP therapy 6 times daily; A10: 8.77 g/kg/d; AS2-1: 0.35 g/kg/d. The response to ANP was monitored by MRIs every 8 weeks. Patients evaluable for efficacy (<em>N </em>= 40) received 12 or more weeks of ANP or developed progressive disease (PD) before 12 weeks. 10 patients (17.5%) achieved an objective response (OR) with 4 (7%) achieving a complete response (CR) and 6 (10.5%) had a partial response (PR). Stable disease (SD) was maintained in 7 patients (12.3%) and PD developed in 23 patients (40.4%). Survival analysis of the 57 children showed 2- and 5-year overall survival (OS) were both 28% while 10- and 15-year OS were both 26%. One of the patients achieving an OR had atypical teratoid/rhabdoid tumor (AT/RT) while nine had low-grade gliomas (LGGs). Grade 3 and 4 toxicities included hypokalemia (14.0%); fatigue, anemia, hypernatremia and leukopenia (3.5% each); diarrhea, hypertension, joint pain, thrombocytopenia, and somnolence (1.8% each). These findings suggest the need for a single-arm, phase II study of ANP in children with LDM.</span></p>
Highlights
Leptomeningeal, disseminated and/or multicentric disease (LDM) have been associated with a poor prognosis in childhood brain tumors when compared to solitary lesions
Multifocal glioma consisted of tumors separated by white matter tracts within the same hemisphere, whereas multicentric glioma consisted of widespread tumors, such as those occurring in opposite hemispheres or separated by the tentorium
We present our review of 57 children with primary central nervous system (CNS) tumors and LDM treated with ANP therapy in phase II studies at the Burzynski Clinic (BC) in Houston, Texas
Summary
Leptomeningeal, disseminated and/or multicentric disease (LDM) have been associated with a poor prognosis in childhood brain tumors when compared to solitary lesions. Dissemination refers to widespread involvement with the disease of the brain and spinal cord. Batzdorf and Malamud (Batzdorf, & Malamud, 1963) characterized the modes of growth in gliomas by establishing the initial criteria for distinguishing “multiple” ( referred to as multifocal) and “multicentric” gliomas. Multifocal gliomas were thought to disseminate along established CNS routes while multicentric gliomas were widely separated in location and/or time. By this definition, multifocal glioma consisted of tumors separated by white matter tracts within the same hemisphere, whereas multicentric glioma consisted of widespread tumors, such as those occurring in opposite hemispheres or separated by the tentorium
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