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Burzynski Clinic#Antineoplaston therapy

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+#redirect [[Burzynski Clinic#Antineoplaston therapy]]
-'''Antineoplaston''' ('''ANP'''), a word derived from ''[[neoplasm]]'',<ref>{{cite journal |first1=Shannon |last1=Brownlee |first2=Gary |last2=Cohen |title=Trials of a Cancer Doc: Experimental drugs and a 20-year fight with the FDA |journal=US News & World Report |pmid=10186429 |url=http://www.usnews.com/usnews/news/articles/981005/archive_004873.htm |year=1998 |volume=125 |issue=13 |pages=28–30, 32, 35}}</ref> is a name coined by [[Stanislaw Burzynski]] for a group of [[peptides]], derivatives, and mixtures that he uses as an [[alternative cancer treatment]].<ref>{{cite journal |last1=Block |first1=Keith I. |title=Antineoplastons and the Challenges of Research in Integrative Care |journal=Integrative Cancer Therapies |volume=3 |issue=1 |pages=3–4 |year=2004 |pmid=15035867 |doi=10.1177/1534735404263274}}</ref> 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.<ref name=ACS/><ref>{{cite journal |pmid=9091754 |year=1997 |title=Lessons from antineoplaston |volume=349 |issue=9054 |pages=741 |journal=Lancet |doi=10.1016/S0140-6736(97)21011-1 |last1=The Lancet}}</ref><ref>{{cite journal |last1=Burzynski |first1=S. R. |last2=Janicki |first2=TJ |last3=Weaver |first3=RA |last4=Burzynski |first4=B |title=Targeted Therapy With Antineoplastons A10 and AS2-1 of High-Grade, Recurrent, and Progressive Brainstem Glioma |journal=Integrative Cancer Therapies |volume=5 |issue=1 |pages=40–7 |year=2006 |pmid=16484713  |doi=10.1177/1534735405285380}}</ref> 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".<ref>{{cite news |first=Terri |last=Langford |date=October 1, 1998 |url=http://www.highbeam.com/doc/1P1-19476029.html |title=Oncologists criticize methods of controversial cancer treatment |publisher=[[Associated Press]]}}</ref> In particular, independent scientists have been unable to [[reproducibility|reproduce]] the positive results reported in Burzynski's studies.<ref name="nci-evidence">{{cite web| publisher = [[National Cancer Institute]] | title = Overall level of evidence for antineoplastons | url = http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page7 | accessdate = April 18, 2011| archiveurl= http://web.archive.org/web/20110328164303/http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page7| archivedate= 28 March 2011 <!--DASHBot-->| deadurl= no}}</ref>
+{{R to section}}
-There is no convincing evidence from any [[randomized controlled trial]] that antineoplastons are useful for the treatment of cancer. The [[Food and Drug Administration (United States)|U.S. Food and Drug Administration]] (FDA) has not approved antineoplastons for the treatment of any disease.<ref name=ACS>[http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/Patient/page2 Antineoplastons] ''[[National Cancer Institute]]''</ref> 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.<ref name=Antineoplastic1983>{{cite journal |title=Antineoplastons |journal=CA |volume=33 |issue=1 |pages=57–9 |year=1983 |pmid=6401577 |doi=10.3322/canjclin.33.1.57}}</ref> A 2004 medical review described this treatment as a "disproven therapy".<ref name="vickers">{{cite journal |last1=Vickers |first1=A. |title=Alternative Cancer Cures: 'Unproven' or 'Disproven'? |journal=CA |volume=54 |issue=2 |pages=110–8 |year=2004 |pmid=15061600 |doi=10.3322/canjclin.54.2.110}}</ref>
-== 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.<ref>{{cite journal |last1=Burzynski |first1=SR |title=Antineoplastons: history of the research (I) |journal=Drugs under experimental and clinical research |volume=12 |issue=Suppl 1 |pages=1–9 |year=1986 |pmid=3527634}}</ref> 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.<ref>{{cite book |first=Ralph |last=Moss |year=1996 |title=The Cancer Industry |isbn=1-881025-09-8}}{{Page needed|date=November 2010}}</ref>
-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.<ref>NCI Drug Dictionary, [http://cancer.gov/Templates/drugdictionary.aspx?searchTxt=antineoplaston Definitions of antineoplastons A10 and AS2-1]</ref> The website of the Burzynski clinic states that the active ingredient of antineoplaston A10-I is [[phenylacetylglutamine]].<ref name="mechanism">{{cite web |title=The proposed mechanism of antitumor activity of Antineoplastons (ANPs) in high grade glioma pathology (HBSG) |url=http://burzynskiclinic.com/assets/documents/ANP_mechamism_of_activity.pdf}} from {{cite journal |last1=Burzynski |first1=S. R. |last2=Janicki |first2=TJ |last3=Weaver |first3=RA |last4=Burzynski |first4=B |title=Targeted Therapy With Antineoplastons A10 and AS2-1 of High-Grade, Recurrent, and Progressive Brainstem Glioma |journal=Integrative Cancer Therapies |volume=5 |issue=1 |pages=40–7 |year=2006 |pmid=16484713 |doi=10.1177/1534735405285380}}</ref>
-== 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.<ref>{{cite web|url=http://www.burzynskiclinic.com/clinical-trials.html|title=Introduction to Clinical Trials|publisher=Burzynski Clinic|accessdate=2011-12-06}}</ref> 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.<ref>{{cite web|url=http://www.aetna.com/cpb/medical/data/200_299/0240.html|title=Aetna Clinical Policy Bulletin, Antineoplaston Therapy and Sodium Phenylbutyrate|publisher=Aetna|date=13 May 2011|accessdate=2011-12-06}}</ref><ref>{{cite web|title=Blue Cross/Blue Shield Medical Policy-Antineoplaston Therapy|url=http://www.empireblue.com/provider/noapplication/f2/s5/t9/pw_ad084920.pdf|publisher=Empire BlueCross/BlueShield|date=17 November 2006|accessdate=2011-12-06}}</ref>
-== Clinical trials ==
-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"/>
-===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.<ref name="mayo">{{cite journal |pages=137–45 |doi=10.4065/74.2.137 |title=Phase II study of antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in patients with recurrent glioma |year=1999 |last1=Buckner |first1=J C |last2=Malkin |first2=M G |last3=Reed |first3=E |last4=Cascino |first4=T L |last5=Reid |first5=J M |last6=Ames |first6=M M |last7=Tong |first7=W P |last8=Lim |first8=S |last9=Figg |first9=W D |journal=Mayo Clinic Proceedings |volume=74 |issue=2 |pmid=10069350}}</ref> 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."<ref name="vickers"/>  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.<ref name=vickers/><ref name="mayo">{{cite journal |pages=137–45 |doi=10.4065/74.2.137 |title=Phase II study of antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in patients with recurrent glioma |year=1999 |last1=Buckner |first1=J C |last2=Malkin |first2=M G |last3=Reed |first3=E |last4=Cascino |first4=T L |last5=Reid |first5=J M |last6=Ames |first6=M M |last7=Tong |first7=W P |last8=Lim |first8=S |last9=Figg |first9=W D |journal=Mayo Clinic Proceedings |volume=74 |issue=2 |pmid=10069350}}</ref> 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.<ref name="vickers"/><ref name="mayo">{{cite journal |pages=137–45 |doi=10.4065/74.2.137 |title=Phase II study of antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in patients with recurrent glioma |year=1999 |last1=Buckner |first1=J C |last2=Malkin |first2=M G |last3=Reed |first3=E |last4=Cascino |first4=T L |last5=Reid |first5=J M |last6=Ames |first6=M M |last7=Tong |first7=W P |last8=Lim |first8=S |last9=Figg |first9=W D |journal=Mayo Clinic Proceedings |volume=74 |issue=2 |pmid=10069350}}</ref>
-== References ==
-{{Reflist|2}}
-== External links ==
-*{{cite journal |title=Unproven methods of cancer management: Antineoplastons |url=http://onlinelibrary.wiley.com/doi/10.3322/canjclin.33.1.57/abstract;jsessionid=A167A335240790A93C6F7FF28AB7092A.d04t02 |journal=[[CA – A Cancer Journal for Clinicians]] |volume=33 |issue=1 |pages=57–9 |year=1983 |pmid=6401577 |doi=10.3322/canjclin.33.1.57}}
-*{{cite book |author=[[Office of Technology Assessment]] |month=September |year=1990 |chapter=Pharmacologic and Biologic Treatments |chapterurl=http://www.quackwatch.com/01QuackeryRelatedTopics/OTA/ota05.html |title=Unconventional Cancer Treatments |location=Washington, DC |publisher=[[United States Government Printing Office]]}}
-*{{cite web|url=http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/Patient/page1|title=Antineoplastons (PDQ®)|publisher=National Cancer Institute|accessdate=2011-12-06}}
-[[Category:Medical controversies]]
-[[Category:Alternative cancer treatments]]
-[[Category:Pseudoscience]]
-[[de:Antineoplastone]]
-[[es:Antineoplaston]]