Irresponsible Insolence

Some Burzynski “critics” rely on the 1999 Mayo Clinic Phase 2 clinical trial publication as “support” for their position that:

“No patient demonstrated tumor regression”

Therefore, they claim that antineoplastons do not work

2/1999 – A10 & AS2-1 – Phase II
Mayo Clinic Proceedings
http://www.ncbi.nlm.nih.gov/m/pubmed/10069350
Phase II Study of Antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in Patients With Recurrent Glioma
Objective:

To assess the pharmacokinetics, toxicity, & efficacy of antineoplastons A10 (NSC 648539) & AS2-1 (NSC 620261)

Design:
We initiated a phase II trial in order to determine whether evidence of antitumor activity of A10 & AS2-1 could be documented

However, the CONCLUSION was:
“Although we could not confirm any tumor regression in patients in this study, the small sample size precludes definitive conclusions about treatment efficacy”

Comment in Jun; 74 (6): 641-2

Mayo Clin Proc 74(2):9 (1999)

©1999 Elsevier Ltd.

DOI: 10.4065/74.2.137

Mayo Clin Proc 1999; 74: 137–45
http://www.mayoclinicproceedings.org/article/S0025-6196(11)63835-4/fulltext

http://linkinghub.elsevier.com/retrieve/pii/S0025-6196(11)63835-4

http://www.sciencedirect.com/science/article/pii/S0025619611638354

http://download.journals.elsevierhealth.com/pdfs/journals/0025-6196/PIIS0025619611638354.pdf

http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2796.2003.01098.x/full

http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2796.2003.01098.x/references

http://onlinelibrary.wiley.com/store/10.1046/j.1365-2796.2003.01098.x/asset/j.1365-2796.2003.01098.x.pdf?v=1&t=hbs6xce2&s=3423e3cd1955667e8e8cdf33323faf0bd85b6a29

http://onlinelibrary.wiley.com/store/10.1046/j.1365-2796.2003.01098.x/asset/j.1365-2796.2003.01098.x.pdf?v=1&t=hbrndkdf&s=e0af2d3bfb13841852d92a839d3a4932a5f4bb48
Burzynski responded by pointing out:
6/1999 – A10 & AS2-1 – SRB
http://www.ncbi.nlm.nih.gov/m/pubmed/10377942
Efficacy of antineoplastons A10 and AS2-1

1. The study tested a dosing regimen known to be ineffective

2. The dosages used in the study were meant for the treatment of a single small lesion

3. 5 of the 6 evaluable patients had either multiple nodules or tumors larger than a “single small lesion”

4. As the provider of A10 & AS2-1 I strongly suggested to the National Cancer Institute (NCI) that these patients receive a much higher dose, consistent with their greater tumor load

5. The study was closed when I insisted that the NCI either increase the dosage or inform the patients that the drug manufacturer believed that the treatment was unlikely to be effective at the dosages being used (letter to Dr M. Sznol, NCI, on 4/20/1995)

6. Review of the clinical data in the article proves the validity of my position

7. Patients had extremely low plasma antineoplaston levels

8. My study produced phenylacetylglutamine levels 35 times greater

9. phenylacetylisoglutamine levels 53 times greater

10. phenylacetate levels 2 times greater

11. They reported no tumor regression

12. In 1 of my ongoing studies on protocol BT-9, 4 of 8 evaluable patients with astrocytoma had objective responses

13. Another factor that may have caused a lack of response is that the duration of treatment was too brief

14. Almost all patients received treatment for less than 30 days

15. 1 patient received only 9 days

16. Current studies indicate that objective tumor responses are usually observed after 3 months of therapy

17. An additional 8 months of treatment is usually needed to obtain a maximal therapeutic effect

18. In.2 patients, tumor necrosis was attributed to “radio-necrosis” However, such an interpretation is clouded by the fact that antineoplaston-induced necrosis can be indistinguishable from radionecrosis

19. The analysis could have highlighted the 2 patients with recurrent glioblastoma who survived for more than 1 year

20. This is of interest because these patients typically have a life expectancy of 3 to 6 months

S R Burzynski

Mayo Clin Proc 74 (6): 641-2 (1999),

Mayo Clin Proc. 1999 Jun; 74 (6): 641-2
Comment on
Mayo Clin Proc. 1999 Feb; 74 (2): 137-45 PMID .10377942 Elsevier Science

Mayo Clinic Proc. 1999; 74: 641–642 (letter) 74 (6): 641-2

Mayo Clin Proc 74 (6): 1 (1999),
©1999 Elsevier Ltd.

DOI: 10.4065/74.6.641
http://www.mayoclinicproceedings.org/article/S0025-6196(11)64143-8/fulltext

http://linkinghub.elsevier.com/retrieve/pii/S0025-6196(11)64143-8

http://download.journals.elsevierhealth.com/pdfs/journals/0025-6196/PIIS0025619611641438.pdf

1999 –
Mayo Clin Proc 74(6):2 (1999),
DOI: 10.4065/74.6.641-a
http://www.mayoclinicproceedings.org/article/S0025-6196(11)64144-X/fulltext

http://download.journals.elsevierhealth.com/pdfs/journals/0025-6196/PIIS002561961164144X.pdf

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