Targeted therapy with antineoplastons A10 and AS2-1 of
high-grade, recurrent, and progressive brainstem glioma.
Abstract
BACKGROUND:
Brainstem glioma carries the worst prognosis
of all malignancies of the brain. Most patients with brainstem glioma fail
standard radiation therapy and chemotherapy and do not survive longer than 2
years. Treatment is even more challenging when an inoperable tumor is of
high-grade pathology (HBSG). The objective of this report is to summarize the
outcome of patients with HBSG treated with antineoplastons in 4 phase 2 trials.
Patients: The following group of 18 patients was evaluable: 4 patients with
glioblastomas and 14 patients with anaplastic HBSG. Fourteen patients had
diffuse intrinsic tumors. Twelve patients suffered from recurrence, and 6
patients did not have radiation therapy or chemotherapy.
METHODS:
Antineoplastons, which consist of
antineoplaston A10 (A10I) and AS2-1 injections, were given in escalating doses
by intravenous injections. The median duration of antineoplaston administration
was 5 months, and the average dosage of A10I was 9.22 g/kg/d and of AS2-1 was
0.31 g/kg/d. Responses were assessed by gadolinium-enhanced magnetic resonance
imaging and positron emission tomography.
RESULTS:
The overall survival at 2 and 5 years was 39%
and 22%, respectively, and maximum survival was more than 17 years for a
patient with anaplastic astrocytoma and more than 5 years for a patient with
glioblastoma. Progression-free survival at 6 months was 39%. Complete response
was achieved in 11%, partial response in 11%, stable disease in 39%, and
progressive disease in 39% of patients. Antineoplastons were tolerated very
well with 1 case of grade 4 toxicity (reversible anemia).
CONCLUSION:
Antineoplastons contributed to more than a
5-year survival in recurrent diffuse intrinsic glioblastomas and anaplastic
astrocytomas of the brainstem in a small group of patients.
PMID:
16484713
[PubMed
- indexed for MEDLINE]
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