Stanislaw Rajmund Burzynski, Stanislaw R. Burzynski, Stanislaw Burzynski, Stan R. Burzynski, Stan Burzynski, S. R. BURZYNSKI, S. Burzynski, Arthur Burzynski, Hippocrates Hypocrite Hypocrites Critic Critics Critical HipoCritical
[1] – 9/9/2013 – Dr. David H. “Orac” Gorski published this article
[2] – 9/10/2013 – I responded to the LIE one “Woo Fighter” made
Some of “The Skeptics™” interjected themselves, and this is “The Skeptics™” stupidity that results from them:
====================================== #45 – Old Rockin’ Dave – Hobbs End Station, on the Central Line of the Underground – September 10, 2013
“Was that #38 person claiming that Orac took a chunk out of Winnie the Pooh?”
“He seems to be a Bear of Very Little Brain indeed”
—————————————————————— No
That’s me referring to one “Woo Fighter” as being a Biter of the Poo a la poop, NOT to be confused with a Fighter of the Foo a la Foo Fighter
—————————————————————— #46 – Antaeus Feldspar – September 10, 2013
Lawrence, JKW, Khani, ORD –
“I put my brain cells in jeopardy to check out iDJiT’s blathering”
——————————————————————
After reading your comments, it’s questionable as to how many brain cells you have, that could be put “in jeopardy”
Where are you from ?
Montreal, Canada ?
—————————————————————— “Stripped of the word salad, it’s a response to Woo Fighter’s comment at 21, where he says that he (WF) notified the Guardian of iDJiT being persona non grata status just about everywhere and a paid shill for Burzynski“
“iDJiT’s contention is that he is not a paid shill for Burzynski and besides there’s also some places where his spamming hasn’t gotten him banned yet; ergo WF’s statements to the Guardian were lies“
—————————————————————— No
The points were:
[B] – I am NOT “a paid shill”
[C] – I am NOT “an employee of Burzynski”
—————————————————————— “In My Humble Analysis, the issues pretty much break down to two: his banned status, and whether he’s a paid shill for Burzynski or not”
“As regards the former, I think the doctrine of “substantial truth” probably applies, morally if not legally”
——————————————————————
What do “The Skeptics™” know about “substantial truth” when y’all are best known for LIES ?
—————————————————————— “The fact is that iDJiT’s abusive spamming has gotten him banned from multiple blogs; getting the exact number wrong doesn’t really rise to the level of “lie””
——————————————————————
Why don’t you do some Skeptic research, and determine how many comments I’ve made before I’ve been “banned” from each Skeptics blog ?
Oh, wait !
“The Skeptics™” do NOT like doing ANY research
—————————————————————— “As regards the latter, if iDJiT isn’t Burzynski’s representative, what is he doing setting up a WordPress blog under Burzynski’s name??“
——————————————————————
it’s called:
location
Location
LOCATION
—————————————————————— “We’re supposed to believe that the same Burzynski who employed the infamous Mark Stephens is looking the other way while someone who isn’t his representative operates stanislawrajmundburzynski.wordpress.com?“
—————————————————————— Who cares what you believe ?
If you’re anything like Gorski, you’re too much of a Kenny Roger’s COWARD of the County to debate whatever you may claim you “believe”
—————————————————————— “In any case, what iDJiT seems not to realize (besides how much of a freaking loony he looks) that the Guardian is very, very unlikely to ban one commenter based solely on another’s say-so”
——————————————————————
I even went to the David Grimes’ blog and posed a question, but he’s been too much of a COWARD to reply
Par for the course !
—————————————————————— “Woo Fighter may have alerted them to iDJiT’s history, but without a doubt, iDJiT’s ban was due to his own self”
——————————————————————
That’s what you would like to believe, but much of what “The Skeptics™” post is FUD
—————————————————————— #47 – Alain – September 10, 2013
“Speaking of iDJiT, did he ever had any comments on his blog?”
March 29, 1996
�
Then United States Food and Drug Administration Commissioner, David Kessler told the American people:
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1. We will eliminate unnecessary paperwork … that used to delay or discourage … cancer research … by non-commercial clinical investigators
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2. The … FDA’s initiatives … will allow …the agency … to rely on smaller trials … fewer patients … if there is evidence … of partial response in clinical trials
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I don’t want to get into any particular … agent … except let me point out … that … the information needs to be part … of clinical trials
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3. We will accept … less information … up front –
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4. we’re going to require further study AFTER … approval … because the science … has matured
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5. The important – point … is that information needs to be gathered … through scientific means … through clinical – trials … and I think – that’s … that’s very important uhh very … important point
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You can’t … just … use an agent here – or there … you have to use it … as part of a clinical trial … so we can get information … on whether the drug works
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6. The uhh agency has … many … trials … has has approved trials … for patients … with antineoplastons
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7. We are committed to providing expanded access … availability … for American patients for any drug … there’s reason to believe … may work
—————————————————————— BOTTOM LINE:
—————————————————————— Everything else is MISDIRECTION
—————————————————————— https://stanislawrajmundburzynski.wordpress.com/2013/03/22/antineoplastons-has-the-fda-kept-its-promise-to-the-american-people
——————————————————————
A. What is the FDA’s definition of “unnecessary paperwork”?
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B. What is the FDA’s definition of “smaller trials”?
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C. What is the FDA’s definition of “fewer patients”?
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D. What is the FDA’s definition of “evidence … of partial response“?
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E. What is the FDA’s definition of “less information … up front”?
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F. What is the FDA’s definition of “we’re going to require further study AFTER … approval”?
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G. What is the FDA’s definition of “We are committed to providing expanded access … availability … for American patients for any drug … there’s reason to believe … may work”?
======================================
2003 – 2009 Phase II preliminary
——————————————————————
2003 – Phase II http://www.ncbi.nlm.nih.gov/m/pubmed/12718563
Drugs R D. 2003;4(2):91-101
(Drugs in R and D / Drugs in Research and Development)
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2003: Protocol – recurrent diffuse intrinsic brain stem glioma
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12 – Patients Accrued
10 – Evaluable Patients
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2 / 20% – # and % of Patients Showing Complete Response 3 / 30% – # and % of Patients Showing Partial Response
3 / 30% – # and % of Patients Showing Stable Disease
2 / 20% – # and % of Patients Showing Progressive Disease
====================================== http://www.burzynskiclinic.com/scientific-publications.html
Interim Reports on Clinial Trials:
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1. 10/2003
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NEURO-ONCOLOGY
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Burzynski, S.R., Weaver, R.A., Bestak, M., Lewy, R.I., Janicki, T.J., Jurida, G.F., Paszkowiak, J.K., Szymkowski, B.G., Khan, M.I.
�
Phase II study of Antineoplastons A10 and AS2-1 (ANP) in children with recurrent and progressive MULTICENTRIC GLIOMA
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A preliminary report
Neuro-Oncology. 2003; 5: 358
Volume 5 Issue 4 October 2003
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10/2003 – Protocol – MULTICENTRIC GLIOMA
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12 – Children Patients Accrued
10 – Evaluable Patients
(9 months-17 years / 9 – median age)
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4 / 33% – # and % of Patients Showing Complete Response 2 / 25% – # and % of Patients Showing Partial Response
4 / 33% – # and % of Patients Showing Stable Disease
0 / 0% – # and % of Patients Showing Progressive Disease
1 / 9% – # and % of Patients Nonevaluable due to only 4 weeks of treatment / lack of follow-up scans
======================================
Interim Reports on Clinial Trials:
�
16. 2003
�
DRUGS IN R&D
Drugs in R and D
(Drugs in Research and Development)
� BT-11 BRAIN STEM GLIOMA
�
Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA:
�
a preliminary report. http://www.ncbi.nlm.nih.gov/pubmed/12718563
Burzynski, S.R., Lewy, R.I., Weaver, R.A., Axler, M.L., Janicki, T.J., Jurida, G.F., Paszkowiak, J.K., Szymkowski, B.G., Khan, M.I., Bestak, M. http://www.ncbi.nlm.nih.gov/m/pubmed/12718563
Drugs R D. 2003;4(2):91-101
Drugs in R&D 2003;4:91-101
Neuro-Oncology. 2004; 6: 384
Volume 6 Issue 4 October 2004
Abstracts from the Society for Neuro-Oncology Ninth Annual Meeting, Toronto, Ontario, Canada, November 18-21, 2004
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Pg. 385
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10/2004 – Protocol – glioblastoma multiforme (GBM) which recurred or progressed post surgery, radiation therapy, and / or chemotherapy
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22 – Evaluable Patients
(6 men / 16 women / 27-63 /47 – median age)
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1 / 4.5% – # and % of Patients Showing Complete Response 1 / 4.5% – # and % of Patients Showing Partial Response
12 / 54.5% – # and % of Patients Showing Stable Disease
8 / 36.5% – # and % of Patients Showing Progressive Disease
======================================
Interim Reports on Clinial Trials:
�
3. 10/2004 (DBSG)
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NEURO-ONCOLOGY
�
Burzynski, S.R., Weaver, R. Bestak. M., Lewy, R.I., Janicki, T., Jurida, G., Szymkowski, B., Khan, M., Dolgopolov, V.
�
Long-term survivals in phase II studies of Antineoplastons A10 and AS2-1 (ANP) in patients with diffuse intrinsic BRAIN STEM GLIOMA
Neuro-Oncology. 2004; 6: 386
Volume 6 Issue 4 October 2004
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60 patients
(31 didn’t meet admission criteria to the study and were treated under Special Exception (SE))
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10/2004 – Protocol – patients with diffuse intrinsic BRAIN STEM GLIOMA (DBSG)
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29 – Evaluable Patients
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7 / 24% – # and % of Patients Showing Complete Response 6 / 21% – # and % of Patients Showing Partial Response
6 / 21% – # and % of Patients Showing Stable Disease
10 / 34% – # and % of Patients Showing Progressive Disease
——————————————————————
31 – Evaluable Patients: Special exception (SE)
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5 / 16% – # and % of Patients Showing Complete Response 2 / 6% – # and % of Patients Showing Partial Response
16 / 52% – # and % of Patients Showing Stable Disease
8 / 26% – # and % of Patients Showing Progressive Disease
======================================
Interim Reports on Clinial Trials:
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4. 10/2004 (AT/RT of CNS)
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NEURO-ONCOLOGY
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BT-14
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CHILDREN WITH RHABDOID TUMOR OF THE CENTRAL NERVOUS SYSTEM
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Burzynski, S.R., Weaver, R. Bestak. M., Janicki, T., Jurida, G., Szymkowski, B., Khan, M., Dolgopolov, V.
�
Phase II studies of antineoplastons A10 and AS2-1 (ANP) in children with atypical teratoid/rhabdoid tumors (AT/RT) of the central nervous system
�
A preliminary report
Neuro-Oncology. 2004; 6: 427
Volume 6 Issue 4 October 2004
Abstracts from the Eleventh International Symposium on Pediatric Neuro-Oncology, Boston, Massachusetts, June 13-16, 2004
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10/2004 – Protocol – children with atypical teratoid / rhabdoid tumors (AT / RT) of the central nervous system
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11 – Children Patients Accrued
8 – Evaluable Patients
(7 treated under Special Exception (SE))
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2 / 25% – # and % of Patients Showing Complete Response 1 / 12.5% – # and % of Patients Showing Partial Response
1 / 12.5% – # and % of Patients Showing Stable Disease
4 / 50% – # and % of Patients Showing Progressive Disease
======================================
Interim Reports on Clinial Trials:
�
5. 10/2004
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NEURO-ONCOLOGY
�
BT-12
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CHILDREN WITH PRIMITIVE NEUROECTODERMAL TUMORS (PNET)
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Burzynski, S.R., Weaver, R. Bestak. M., Janicki, T., Szymkowski, B., Jurida, G., Khan, M., Dolgopolov, V.
�
Treatment of PRIMITIVE NEUROECTODERMAL TUMORS (PNET) with antineoplastons A10 and AS2-1 (ANP)
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Preliminary results of phase II studies
Neuro-Oncology. 2004; 6: 428
Volume 6 Issue 4 October 2004
Abstracts from the Eleventh International Symposium on Pediatric Neuro-Oncology
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10/2004 – Protocol – PRIMITIVE NEUROECTODERMAL TUMORS (PNET)
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17 – Patients Accrued
15 – Evaluable Patients
(12 months – 23 years / 6 – median age)
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3 / 20% – # and % of Patients Showing Complete Response 2 / 13.4% – # and % of Patients Showing Partial Response
5 / 33.3% – # and % of Patients Showing Stable Disease
5 / 33.3% – # and % of Patients Showing Progressive Disease
======================================
Interim Reports on Clinial Trials:
�
17. 2004
�
DRUGS IN R&D
Drugs in R and D
(Drugs in Research and Development)
�
Burzynski, S.R., Weaver, R., Lewy, R., Janicki, T. Jurida, G., Szymkowski, B., Khan, M., Bestak, M.
�
Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive multicentric glioma.
�
A Preliminary Report. http://www.ncbi.nlm.nih.gov/pubmed/15563234
Drugs R&D 2004;5(6):315-326. http://www.ncbi.nlm.nih.gov/m/pubmed/15563234
Drugs R D. 2004;5(6):315-26
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incurable recurrent and progressive multicentric glioma
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Pg. 320
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3 – treated under Special Exception (SE) granted by the US FDA
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Pgs. 317 and 320
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7/31/1996 – (7/31/1996 – 4/3/2002 as of 3/1/2004) Protocol – children with recurrent and progressive multicentric glioma (MCG)
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Pg. 317
�
BT-13
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children with low-grade astrocytoma
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BT-23
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children with visual pathway gliomas
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Pgs. 317 and 320-321
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12 – Children Patients Accrued (Pgs. 315-316)
(9 months – 17 years / 9- median age)
(6 – male / 6 – females)
10 – Evaluable Patients (Pg. 315)
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4 / 33% – # and % of Patients Showing Complete Response 3 / 25% – # and % of Patients Showing Partial Response
4 / 33% – # and % of Patients Showing Stable Disease
0 / 0% – # and % of Patients Showing Progressive Disease
1 / 9% – # and % of Patients Non-evaluable
——————————————————————
Pg. 325
�
Compare: Chamberlain and Grafe. [38]
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1995 – Protocol – solitary recurrent chiasmatic hypothalamic gliomas treated with oral etoposide
�
14 – Patients Accrued
14 – Evaluable Patients
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1 / 7% – # and % of Patients Showing Complete Response 4 / 29% – # and % of Patients Showing Partial Response
3 / 21% – # and % of Patients Showing Stable Disease
6 / 43% – # and % of Patients Showing Progressive Disease
�
Pg. 326
�
38. Chamberlain MC, Grafe MR. Recurrent chiasmatic-hypothalamic glioma treated with oral etoposide. J Clin Oncol 1995; 13: 2072-6 http://www.ncbi.nlm.nih.gov/pubmed/7636550/
J Clin Oncol. 1995 Aug;13(8):2072-6. http://www.ncbi.nlm.nih.gov/m/pubmed/7636550/
Department of Neurosciences, University of California, San Diego, La Jolla, USA. http://m.jco.ascopubs.org/content/13/8/2072.long
Arch Neurol. 1995 May;52(5):509-13. http://www.ncbi.nlm.nih.gov/pubmed/7733847/
Department of Neurosciences, University of California-San Diego, USA. http://www.ncbi.nlm.nih.gov/m/pubmed/7733847/
Arch Neurol. 1995;52(5):509-513. doi:10.1001/archneur.1995.00540290099024. http://archneur.jamanetwork.com/Mobile/article.aspx?articleid=593460
——————————————————————
Compare: The Pediatric Oncology Group. [39]
�
10/2000 – Protocol – solitary progressive optic pathway tumors with carboplatin
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50 – Patients Accrued
50 – Evaluable Patients
� 2 / 4% – # and % of Patients Showing Partial Response
37 / 74% – # and % of Patients Showing Stable Disease
11 / 22% – # and % of Patients Showing Progressive Disease
�
39. Mahoney DH, Cohen ME, Friedman HS, et al. Carboplatin is effective therapy for young children with progressive optic pathway tumors: a Pediatric Oncology Group phase II study. Neuro-oncol 2000; 2: 213-20 http://www.ncbi.nlm.nih.gov/pubmed/11265230/
Neuro Oncol. 2000 Oct;2(4):213-20. http://www.ncbi.nlm.nih.gov/m/pubmed/11265230/
Baylor College of Medicine, Houston, TX, USA. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1920597/
�
Volume 8 Issue 4 October 2006
Abstracts for the Eleventh Annual Meeting of the Society for Neuro-Oncology (SNO)
�
Brainstem gliomas and multicentric tumors (MBSG)
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10/2006 – Protocol – Brainstem gliomas and multicentric tumors (MBSG)
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19 – Evaluable Patients
3.9 – 40.8 years (9.2 – median age)
(90% less than 18 years old)
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2 / 11% – # and % of Patients Showing Complete Response 1 / 5% – # and % of Patients Showing Partial Response
7 / 37% – # and % of Patients Showing Stable Disease
9 / 47% – # and % of Patients Showing Progressive Disease
======================================
2007
Volume 11 Issue 6 December 2009
Abstracts from the Third Quadrennial Meeting of the World Federation of Neuro-Oncology (WFNO) and the Sixth Meeting of the Asian Society for Neuro-Oncology (ASNO)
May 11-14, 2009
Yokohama, Japan
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12/2009 – Protocol – BRAINSTEM GLIOMAs
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40 – Patients Accrued
28 – Evaluable Patients
(23 children / 5 young adults)
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5 / 18% – # and % of Patients Showing Complete Response 4 / 14% – # and % of Patients Showing Partial Response
12 / 43% – # and % of Patients Showing Stable Disease
7 / 25% – # and % of Patients Showing Progressive Disease
—————————————————————— Special exception (SE)
�
12/2009 – Protocol – BRAINSTEM GLIOMAs
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52 – Evaluable Patients
(40 children / 12 young adults)
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5 / 10% – # and % of Patients Showing Complete Response 2 / 4% – # and % of Patients Showing Partial Response
28 / 54% – # and % of Patients Showing Stable Disease
17 / 32% – # and % of Patients Showing Progressive Disease
——————————————————————
BT-11 and special exception (SE)
92% – diffuse intrinsic brainstem gliomas (DBSG)
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Overall survival (OS) – 2 years:
42% – special exception (SE)
36% – BT-11
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Overall survival (OS) – 5 years:
19% – special exception (SE)
25% – BT-11
======================================
Compare: standard radiation therapy in combination with chemotherapy (RAT) (Mandell et al. 1999)
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2% – % of Patients Showing Complete Response 31% – % of Patients Showing Partial Response
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Mandell LR, Kadota R, Freeman C, et al. There is no role for hyperfractionated radiotherapy in the management of children with newly diagnosed diffuse intrinsic brain stem tumors: results of pediatric oncology group phase III trial comparing conventional vs. hyperfractionated radiotherapy. Int J Radiat Oncol Biol Phys. 1999;43:959-964. http://www.ncbi.nlm.nih.gov/pubmed/10192340/
Int J Radiat Oncol Biol Phys. 1999 Mar 15;43(5):959-64. http://www.ncbi.nlm.nih.gov/m/pubmed/10192340/
International Journal of Radiation Oncology*Biology*Physics
Volume 43, Issue 5, 15 March 1999, Pages 959–964 http://www.sciencedirect.com/science/article/pii/S036030169800501X
Department of Radiation Oncology, Mount Sinai Medical Center, New York, NY, USA.
6/1992 – 10/1997
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Overall survival (OS):
7% – 2 years
0% – 5 years
=====================================
COMBINED:
——————————————————————
Overall survival (OS) – 2 years:
——————————————————————
42% – antineoplastons: special exception (SE)
�
36% – antineoplastons: BT-11
�
7% – standard radiation therapy in combination with chemotherapy (RAT)
——————————————————————
Overall survival (OS) – 5 years:
——————————————————————
25% – antineoplastons: BT-11
�
19% – antineoplastons: special exception (SE)
�
0% – standard radiation therapy in combination with chemotherapy (RAT)
� � � � � � � � � � � � � � � � �
Break The Walls Down:
——————————————————————
And “THAT’s The BOTTOM LINE”
Because Stone Cold Said So
——————————————————————
IT’s GO TIME
Time To Play The Game: