The above chart is used for ease of reading since it is similar to the one used by Gorski in his article. The below relates to Gorski’s chart
Data as of July 17, 2011 based on medical records of the first 1770 evaluable patients
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The table shows response rates for 22 selected common cancer types treated at the Burzynski Clinic (by highest rate of OR – Objective Response)
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DEFINITIONS:
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OR – Objective Response includes CR, PR, MR & IM
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CR – Complete Response. Complete disappearance of all signs of cancer in response to treatment of 4 weeks or longer
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PR – Partial Response. More than 50% decrease in the size of the tumors (the sum of cross-sectioned area of the tumor) in response to treatment of 4 weeks or longer
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MR – Minor Response. Significant decrease (more than 25% in the size of tumors with simultaneous increase in size of some of the other tumors
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IM – Improvement. Decrease in size of the tumors, not confirmed yet by the second follow-up radiological measurement
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SD – Stable Disease
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PD – Progressive Disease
======================================
[1] – 12/12/2012 – Gorski posted: Stanislaw Burzynski: A pioneering cancer researcher or a quack?
“What I found interesting is a table that posted from the brochure”
“Looking at the table, I noticed immediately that Dr. Burzynski says nothing about survival rates, only “objective response rates,” which are not defined in a meaningful way”
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Gorski, what do you NOT understand about:
Objective Response (OR) includes:
Complete Response (CR)
Partial Response (PR)
Minor Response (MR)
Improvement (IM)
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[1] – 12/12/2012 – “The pamphlet defines them as as anything from an “improvement” (defined as “decrease in size of the tumors, not confirmed yet by the second follow-up radiological measurement”) to “complete disappearance of all signs of cancer,” which is utter bollocks”
“There are standardized ways of measuring tumor response agreed upon by radiologists and oncologists, such as the RECIST criteria”
“Burzynski lumps all responses together in an oncologically meaningless way”
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Gorski, when I did a search in PubMed on this data, why did I get these results ?
6,421-“Objective Response” (2013+prior)
570-phase I:”Objective Response” (2013+)
2,453-phase II:”Objective Response” (2013+)
618-phase III:”Objective Response” (2013+)
19,385-“Complete Response” (2013+prior)
1,182-phase I:”Complete Response” (2013+)
3,851-phase II:”Complete Response” (2013+)
811-phase III:”Complete Response” (2013+)
15,718-“Partial Response” (2013+prior)
1,688-phase I:”Partial Response” (2013+)
4,421-phase II:”Partial Response” (2013+)
497-phase III:”Partial Response” (2013+)
969-“Minor Response” (2013+prior)
155-phase I:”Minor Response” (2013+prior)
314-phase II:”Minor Response” (2013+prior)
12-phase III:”Minor Response” (2009+prior)
10,617-“Stable Disease” (2012+prior)
1,890-phase I:”Stable Disease” (2013+prior)
4,114-phase II:”Stable Disease” (2013+prior)
379-phase III:”Stable Disease” (2013+prior)
11,616-“Progressive Disease” (2013+prior)
615-phase I:”Progressive Disease” (2013+)
1,941-phase II:”Progressive Disease” (2013+)
261-phase III:”Progressive Disease” (2013+)
361,181-Improvement (2013+prior)
1,372-phase I:Improvement (2013+prior)
2,838-phase II:Improvement (2013+prior)
2,293-phase III:Improvement (2013+prior)
1,593-RECIST:(2013+prior)
165-phase I:RECIST:(2013+prior)
475-phase II:RECIST:(2013+prior)
87-phase III: RECIST:(2013+prior)
======================================
And these results ?
——————————————————————
[34] – 5/2007 – “Objective Response” (OR)
Guidance for Industry
Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
——————————————————————
[35] – 5-6/2008 – “Complete Response” (CR)
Translating Cancer Trial Endpoints Into the Language of Managed Care
National Cancer Institute (NCI) defines Complete Response (CR) as the “disappearance of all signs of cancer in response to treatment.”
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[36] – 12/1998 – “Partial Response” (PR)
Response Evaluation Criteria in Solid Tumors (RECIST) Quick Reference:
At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD
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[37] – 1/20/2006 – “Minor Response” (MR)
FDA/AACR/ASCO
Public Workshop on Brain Tumor Clinical Trial Endpoints
——————————————————————
[38] – 5/2007 – “Stable Disease” (SD)
Response Evaluation Criteria in Solid Tumors (RECIST) Quick Reference:
Neither sufficient shrinkage to qualify for Partial Response (PR) nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum LD since the treatment started
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[39] – 4/2008 – “Progressive Disease” (PD)
Response Evaluation Criteria in Solid Tumors (RECIST) Quick Reference:
At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
======================================
REFERENCES:
======================================
[1] – 12/12/2012 – Stanislaw Burzynski: A pioneering cancer researcher or a quack?
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http://scienceblogs.com/insolence/2012/12/12/stanislaw-burzynski-a-pioneering-cancer-researcher-or-a-quack/
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[2] – 6,421 – “Objective Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Objective+Response%22
======================================
[3] – 570 – phase I: “Objective Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Objective+Response%22+%22Phase+I%22
======================================
[4] – 2,453 – phase II: “Objective Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Objective+Response%22+%22Phase+II%29
======================================
[5] – 618 – phase III: “Objective Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Objective+Response%22+%22phase+III%22
======================================
[6] – 19,385 – “Complete Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Complete+Response%22
======================================
[7] – 1,182 – phase I: “Complete Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Complete+Response%22+%22phase+I%22
======================================
[8] – 3,851 – phase II: “Complete Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Complete+Response%22+%22phase+II%22
======================================
[9] – 811 – phase III: “Complete Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Complete+Response%22+%22phase+III%22
======================================
[10] – 15,718 – “Partial Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Partial+Response%22
======================================
[11] – 1688 – phase I: “Partial Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Partial+Response%22+%22phase+I%22
======================================
[12] – 4,421 – phase II: “Partial Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Partial+Response%22+%22phase+II%22
======================================
[13] – 497 – phase III: “Partial Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Partial+Response%22+%22phase+III%22
======================================
[14] – 969 – “Minor Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Minor+Response%22
======================================
[15] – 155 – phase I: “Minor Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Minor+Response%22+%22phase+I%22
======================================
[16] – 314 – phase II: “Minor Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Minor+Response%22+%22phase+II%22
======================================
[17] – 12 – phase III: “Minor Response” (2009+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Minor+Response%22+%22phase+III%22
======================================
[18] – 10,617 – “Stable Disease” (2012+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Stable+Disease%22
======================================
[19] – 1890 – phase I: “Stable Disease” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Stable+Disease%22+%22phase+I%22
======================================
[20] – 4,114 – phase II: “Stable Disease” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Stable+Disease%22+%22phase+II%22
======================================
[21] – 379 – phase III: “Stable Disease” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Stable+Disease%22+%22phase+III%22
======================================
[22] – 11,616 – “Progressive Disease” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Progressive+Disease%22
======================================
[23] – 615 – phase I: “Progressive Disease” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Progressive+Disease%22+%22phase+I%22
======================================
[24] – 1,941 – phase II: “Progressive Disease” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Progressive+Disease%22+%22phase+II%22
======================================
[25] – 261 – phase III: “Progressive Disease” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Progressive+Disease%22+%22phase+III%22
======================================
[26] – 361,181 – Improvement (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=Improvement
======================================
[27] – 1372 – phase I: Improvement (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=Improvement+%22phase+I%22
======================================
[28] – 2,838 – phase II: Improvement (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=Improvement+%22phase+II%22
======================================
[29] – 2,293 – phase III: Improvement (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=Improvement+%22phase+III%22
======================================
[30] – 1,593 – RECIST (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=RECIST
======================================
[31] – 165 – phase I: RECIST (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=RECIST+%22phase+I%22
======================================
[32] – 475 – phase II: RECIST (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=RECIST+%22phase+II%22
======================================
[33] – 87 – phase III: RECIST (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=RECIST+%22phase+III%22
======================================
[34] – 5/2007 – “Objective Response” (OR)
Guidance for Industry
Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
——————————————————————
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.pdf
——————————————————————
http://www.fda.gov/ohrms/dockets/ac/01/slides/3782s1_02_matrix/sld025.htm
======================================
[35] – 5-6/2008 – “Complete Response” (CR)
Translating Cancer Trial Endpoints Into the Language of Managed Care
——————————————————————
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2651701/
Biotechnol Healthc. 2008 May-Jun; 5(1): 22–35.
PMCID: PMC2651701
======================================
[36] – 12/1998 – “Partial Response” (PR)
Response Evaluation Criteria in Solid Tumors (RECIST) Quick Reference:
——————————————————————
http://ctep.cancer.gov/protocolDevelopment/docs/quickrcst.doc
======================================
[37] – 1/20/2006 – “Minor Response” (MR)
FDA/AACR/ASCO
Public Workshop on Brain Tumor Clinical Trial Endpoints
——————————————————————
http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ucm120811.pdf
======================================
[38] – 5/2007 – “Stable Disease” (SD)
Response Evaluation Criteria in Solid Tumors (RECIST) Quick Reference:
——————————————————————
http://ctep.cancer.gov/protocolDevelopment/docs/quickrcst.doc
======================================
[39] – 4/2008 – “Progressive Disease” (PD)
Response Evaluation Criteria in Solid Tumors (RECIST) Quick Reference:
——————————————————————
http://ctep.cancer.gov/protocolDevelopment/docs/quickrcst.doc
======================================
