Burzynski: STABLE DISEASE

5/2007 – “Guidance for Industry – Food and Drug Administration”
“Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics”
“”STABLE DISEASE should not be a component of ORR”
“STABLE DISEASE can reflect the natural history of disease””
(Pg. 10 of 22 = actual pg. 7 of PDF)
“…STABLE DISEASE can be more accurately assessed by TTP or PFS analysis (see below)”
“Also, STABLE DISEASE can be more accurately assessed by TTP or PFS analysis (see below)”
(Pg. 11 of 22 = actual pg. 8 of PDF)
“Time to Progression and Progression-Free Survival”
“TTP – Time to Progression”
“PFS – Progression-Free Survival”
“TTP and PFS have served as primary endpoints for drug approval”
(Pg. 11 of 22 = actual pg. 8 of PDF)
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.pdf
And in addition, the below 2005 non-Burzynski study also uses “STABLE DISEASE”
Role of temozolomide after radiotherapy for newly diagnosed diffuse brainstem glioma in children
Results of a multiinstitutional study (SJHG-98)
http://www.ncbi.nlm.nih.gov/m/pubmed/15565574
St. Jude Children’s Research Hospital (Memphis, TN)
29 (88)
Texas Children’s Medical Center (Houston, TX)
2 (6)
Children’s Medical Center (Dallas, TX)
2 (6)
Cancer. 2005 Jan 1;103(1):133-9
Cancer 103, 133-139
Cancer Volume 103, Issue 1, pages 133–139, 1 January 2005
DOI: 10.1002/cncr.20741
Article first published online: 24 NOV 2004
American Cancer Society
http://onlinelibrary.wiley.com/doi/10.1002/cncr.20741/full

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