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Burzynski has published several trials claiming effectiveness for antineoplastons, although reviewers have criticized these trials as being "of a rather unclear design,"<ref name="vickers"/> and the [[National Cancer Institute]] reports that no randomized, controlled trials showing the effectiveness of antineoplastons have been published in peer-reviewed scientific journals.<ref name="Natcancer">{{cite web | url=http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/patient/page2 | title=Questions and Answers About Antineoplastons | publisher=National Cancer Institute | accessdate=January 15, 2012}}</ref> Independent researchers have failed to [[reproducibility|reproduce]] the benefits reported by Burzynski. The evidence for use of antineoplaston therapy as a treatment for cancer is inconclusive.<ref name="nci-evidence"/>
Burzynski has published several trials claiming effectiveness for antineoplastons, although reviewers have criticized these trials as being "of a rather unclear design,"<ref name="vickers"/> and the [[National Cancer Institute]] reports that no randomized, controlled trials showing the effectiveness of antineoplastons have been published in peer-reviewed scientific journals.<ref name="Natcancer">{{cite web | url=http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/patient/page2 | title=Questions and Answers About Antineoplastons | publisher=National Cancer Institute | accessdate=January 15, 2012}}</ref> Independent researchers have failed to [[reproducibility|reproduce]] the benefits reported by Burzynski. The evidence for use of antineoplaston therapy as a treatment for cancer is inconclusive.<ref name="nci-evidence"/>


However, in the documentary Burzynski, letters are produced which show that Burzynski objected to protocols being changed by the National Cancer Institute which allowed patients with advanced cancers to be allowed into the trials, but treated with insufficient antineoplaston treatments. According to Burzynski's letters, the dosage amounts should have been three times higher. This, coupled with the fact that the trials were terminated early, is the reason why the trials were inconclusive.
However, in the documentary ''Burzynski: Cancer Is Serious Business'' (2010), letters are produced which show that Burzynski objected to protocols being changed by the National Cancer Institute which allowed patients with advanced cancers to be allowed into the trials, but treated with insufficient antineoplaston treatments. According to Burzynski's letters, the dosage amounts should have been three times higher. This, coupled with the fact that the trials were terminated early, is the reason why the trials were inconclusive.


===Phase II trial===
===Phase II trial===

Revision as of 11:42, 22 August 2012

Antineoplaston (ANP), a word derived from neoplasm,[1] is a name coined by Stanislaw Burzynski for a group of peptides, derivatives, and mixtures that he uses as an alternative cancer treatment.[2] These compounds are not licensed as drugs but are instead sold and administered by Burzynski as part of clinical trials that he runs at his own establishments, the Burzynski Clinic and the Burzynski Research Institute in Houston, Texas.[3][4][5] Although Burzynski and his associates claim success in the use of antineoplaston combinations for the treatment of various diseases, there is no evidence of clinical efficacy of these methods. Oncologists have described Burzynski's studies as flawed, with one doctor stating that they are "scientific nonsense".[6] In particular, independent scientists have been unable to reproduce the positive results reported in Burzynski's studies.[7]

There is no convincing evidence from any randomized controlled trial that antineoplastons are useful for the treatment of cancer. The U.S. Food and Drug Administration (FDA) has not approved antineoplastons for the treatment of any disease.[3] The American Cancer Society has found no evidence that antineoplastons have any beneficial effects in cancer, and it has recommended that people do not spend money on antineoplaston treatments.[8] A 2004 medical review described this treatment as a "disproven therapy".[9]

Background

Burzynski stated that he began investigating the use of antineoplastons after detecting what he considered significant differences in peptides between the blood of cancer patients and a control group.[10] Burzynski first identified antineoplastons from human blood. Since similar peptides had been isolated from urine, in 1970 Burzynski initially purified urine as a bulk source of antineoplastons. Since 1980 he has been reproducing his compounds synthetically.[11]

The first active peptide fraction identified was called antineoplaston A-10 (3-phenylacetylamino-2,6-piperidinedione). From A-10, antineoplaston AS2-1, a 4:1 mixture of phenylacetic acid and phenylacetylglutamine, was derived.[12] The website of the Burzynski clinic states that the active ingredient of antineoplaston A10-I is phenylacetylglutamine.[13]

Treatment

Treatment is offered by Burzynski only at the Burzynski Clinic in West Houston, Texas. Since antineoplastons are not licensed as treatments for any disease, Burzynski can only sell his products as part of clinical trials. Patients receiving cancer treatment with antineoplastons must therefore first qualify for one of the currently available clinical trials. There are certain qualifications that a patient must meet to enter the therapy, which are only addressed by the physician with the patient.[14] Treatment with antineoplastons can be very costly to patients without insurance coverage, exceeding $100,000 for the first year of intravenous treatment. Insurance companies consider antineoplaston therapy to be investigational and experimental, with insufficient evidence published in peer-reviewed journals, and, therefore, do not cover the cost.[15][16]

Clinical trials

Burzynski has published several trials claiming effectiveness for antineoplastons, although reviewers have criticized these trials as being "of a rather unclear design,"[9] and the National Cancer Institute reports that no randomized, controlled trials showing the effectiveness of antineoplastons have been published in peer-reviewed scientific journals.[17] Independent researchers have failed to reproduce the benefits reported by Burzynski. The evidence for use of antineoplaston therapy as a treatment for cancer is inconclusive.[7]

However, in the documentary Burzynski: Cancer Is Serious Business (2010), letters are produced which show that Burzynski objected to protocols being changed by the National Cancer Institute which allowed patients with advanced cancers to be allowed into the trials, but treated with insufficient antineoplaston treatments. According to Burzynski's letters, the dosage amounts should have been three times higher. This, coupled with the fact that the trials were terminated early, is the reason why the trials were inconclusive.

Phase II trial

A Phase II trial in patients with anaplastic astrocytoma or glioblastoma multiforme was conducted under the auspices of the National Cancer Institute.[18] The study was halted due to poor accrual of new patients "after Burzynski failed to agree with the investigators on possible expansion of the eligibility criteria."[9] Nine patients were accrued, six of whom were evaluated for response. Neurologic side effects occurred in five patients, while none showed any benefit from treatment. All six patients showed evidence of tumor progression after treatment durations of between 16 to 66 days.[9][18] The mean time to treatment failure was 29 days. Eight patients died due to tumor progression, and all nine patients died before the end of the study.[9][18]

References

  1. ^ Brownlee, Shannon; Cohen, Gary (1998). "Trials of a Cancer Doc: Experimental drugs and a 20-year fight with the FDA". US News & World Report. 125 (13): 28–30, 32, 35. PMID 10186429.
  2. ^ Block, Keith I. (2004). "Antineoplastons and the Challenges of Research in Integrative Care". Integrative Cancer Therapies. 3 (1): 3–4. doi:10.1177/1534735404263274. PMID 15035867.
  3. ^ a b Antineoplastons National Cancer Institute
  4. ^ The Lancet (1997). "Lessons from antineoplaston". Lancet. 349 (9054): 741. doi:10.1016/S0140-6736(97)21011-1. PMID 9091754.
  5. ^ Burzynski, S. R.; Janicki, TJ; Weaver, RA; Burzynski, B (2006). "Targeted Therapy With Antineoplastons A10 and AS2-1 of High-Grade, Recurrent, and Progressive Brainstem Glioma". Integrative Cancer Therapies. 5 (1): 40–7. doi:10.1177/1534735405285380. PMID 16484713.
  6. ^ Langford, Terri (October 1, 1998). "Oncologists criticize methods of controversial cancer treatment". Associated Press.
  7. ^ a b "Overall level of evidence for antineoplastons". National Cancer Institute. Archived from the original on 28 March 2011. Retrieved April 18, 2011. {{cite web}}: Unknown parameter |deadurl= ignored (|url-status= suggested) (help)
  8. ^ "Antineoplastons". CA. 33 (1): 57–9. 1983. doi:10.3322/canjclin.33.1.57. PMID 6401577.
  9. ^ a b c d e Vickers, A. (2004). "Alternative Cancer Cures: 'Unproven' or 'Disproven'?". CA. 54 (2): 110–8. doi:10.3322/canjclin.54.2.110. PMID 15061600.
  10. ^ Burzynski, SR (1986). "Antineoplastons: history of the research (I)". Drugs under experimental and clinical research. 12 (Suppl 1): 1–9. PMID 3527634.
  11. ^ Moss, Ralph (1996). The Cancer Industry. ISBN 1-881025-09-8.[page needed]
  12. ^ NCI Drug Dictionary, Definitions of antineoplastons A10 and AS2-1
  13. ^ "The proposed mechanism of antitumor activity of Antineoplastons (ANPs) in high grade glioma pathology (HBSG)" (PDF). from Burzynski, S. R.; Janicki, TJ; Weaver, RA; Burzynski, B (2006). "Targeted Therapy With Antineoplastons A10 and AS2-1 of High-Grade, Recurrent, and Progressive Brainstem Glioma". Integrative Cancer Therapies. 5 (1): 40–7. doi:10.1177/1534735405285380. PMID 16484713.
  14. ^ "Introduction to Clinical Trials". Burzynski Clinic. Retrieved 2011-12-06.
  15. ^ "Aetna Clinical Policy Bulletin, Antineoplaston Therapy and Sodium Phenylbutyrate". Aetna. 13 May 2011. Retrieved 2011-12-06.
  16. ^ "Blue Cross/Blue Shield Medical Policy-Antineoplaston Therapy" (PDF). Empire BlueCross/BlueShield. 17 November 2006. Retrieved 2011-12-06.
  17. ^ "Questions and Answers About Antineoplastons". National Cancer Institute. Retrieved January 15, 2012.
  18. ^ a b c Buckner, J C; Malkin, M G; Reed, E; Cascino, T L; Reid, J M; Ames, M M; Tong, W P; Lim, S; Figg, W D (1999). "Phase II study of antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in patients with recurrent glioma". Mayo Clinic Proceedings. 74 (2): 137–45. doi:10.4065/74.2.137. PMID 10069350.
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