Tag Archives: http://www.ncbi.nlm.nih.gov/m/pubmed/17278121

Critiquing https://theotherburzynskipatientgroup.wordpress.com

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Critiquing https://theotherburzynskipatientgroup.wordpress.com

Robert J. (Bob) Blaskiewicz operates The Other Burzynski Patient Group (TOBPG)

The problem is:

1. Bob Blaskiewicz Faux Skeptic Exposed! does NOT want to debate or want people to consider the failures of Science Based Medicine compared to Burzynski, because he has an agenda

2. @rjblaskiewicz is a known LIAR

Making unsubstantiated claims like this:

Bob Blaskiewicz (@rjblaskiewicz) tweeted at 9:45am – 25 Aug 13:

@dixon_frederick @AlaaTheWarrior Actually, he CLAIMS a success rate, but is unable to publish. Suspicious: clinicaltrials.gov/ct2/results?te…

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374 – TOTAL CHILDREN DIED:
Science Based Medicine
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[6] .9/15/1999 – 29 / 85% died
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[9] .9/15/1994 – 51 / 88% – children died
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[8] 1/1998 – 8 / 89% of 9 children died of their disease at median of 44 weeks
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[5] .10/21/2002 – 12 / 100% – all children patients died
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[2] 5/1/2010 – 18 – children patients have died from disease progression
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[3] 2/2008 – All 30 / 100% – children have died
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[4] 1/1/2005 – 33 / 100% – children died of disease progression
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[1] 4/2011 – 63 / 100% – children died
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[7] .3/15/1999 – 130 / 100% – children died
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COMBINED:
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[1] 4/2011 – children with newly diagnosed diffuse intrinsic pontine glioma (DIPG)
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[1] 4/2011 – children with DIPG
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[1] 5/1/2010 children with newly diagnosed diffuse intrinsic pontine glioma
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[1] 5/1/2010 children with diffuse intrinsic pontine gliomas (DIPGs)
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[1] 5/1/2010 Pediatric patients with newly diagnosed DIPGs
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[3] 2/2008 – children with diffuse intrinsic brain stem glioma
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[3] 2/2008 – diffuse intrinsic pontine glioma
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[4] 1/1/2005 – newly diagnosed diffuse brainstem glioma in children
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[4] 1/1/2005 – children with newly diagnosed diffuse brainstem glioma
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[4] 1/1/2005 – newly diagnosed, diffuse, intrinsic brain stem glioma
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[5] .10/21/2002 – typical diffuse pontine glioma
or
histologically proven anaplastic astrocytoma/glioblastoma multiforme located in the pons
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[5] .10/21/2002 – pontine glioma patients
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[5] .10/21/2002 – paediatric patients with pontine gliomas
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[5] .10/21/2002
brain tumours
brain stem glioma
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[5] .10/21/2002
Histological diagnoses included
8 – glioblastoma multiforme
5 – no histology
3 – anaplastic astrocytoma
3 – astrocytoma with no other specification
1 – pilocytic astrocytoma
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[6] .9/15/1999 – Brainstem gliomas
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[6] .9/15/1999 – diffuse intrinsic pontine tumor
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[6] .9/15/1999 – high grade glioma was required for nonpontine brain stem tumors
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[7] .3/15/1999 children with newly diagnosed brainstem tumor
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[7] .3/15/1999 tumors arising in the pons
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[7] .3/15/1999 diffusely infiltrating pontine lesion
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[8] 1/1998 – children with diffuse pontine gliomas
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[8] 1/1998 – pediatric malignancies
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[8] 1/1998 – Diffuse pontine gliomas
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[9] .9/15/1994 – Brain stem gliomas
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[9] .9/15/1994 – childhood brain tumors
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[9] .9/15/1994 – children with brain stem gliomas
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[9] .9/15/1994 – patients with diffuse intrinsic brain stem gliomas
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[9] .9/15/1994 – children with diffuse intrinsic brain stem gliomas
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# OF CHILDREN
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[8] 1/1998 – 9 / 100% – consecutive children
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[5] .10/21/2002 – 20 – enrolled (9 male / 11 female)
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[2] 5/1/2010 – 20 – children accrued
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[3] 2/2008 – 31 – children enrolled
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[4] 1/1/2005 – 33 / 100% – patients enrolled
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[6] .9/15/1999 – 34 / 100% – patients enrolled
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[1] 4/2011 – 63 / 100% – children enrolled in study
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[9] .9/15/1994 – 66 children
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[7] .3/15/1999
130 – eligible patients
66 – arm 1
64 – arm 2
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# OF EVALUABLE CHILDREN
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[8] 1/1998 – 9 / 100% – consecutive children evaluable
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[5] .10/21/2002 – 12 – Evaluable patients
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[2] 5/1/2010 – 20 – children evaluable
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[3] 2/2008 – 30 – eligible and evaluable for survival and toxicity
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[4] 1/1/2005 – 33 / 100% – patients evaluable
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[6] .9/15/1999 – 34 / 100% – patients evaluable
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[9] .9/15/1994 – 58 / 100% – evaluable patients
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[1] 4/2011 – 63 / 100% – children evaluable
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[7] .3/15/1999
130 – evaluable patients
66 – arm 1
64 – arm 2
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AGE RANGE OF CHILDREN
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[5] .10/21/2002 – 3-17 years of age
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[6] .9/15/1999 – 3.6–15.4 years
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[3] 2/2008 – 3–21 – age children enrolled
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[4] 1/1/2005 – 3-21 years – eligible for current multiinstitutional study
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[7] .3/15/1999 3-21 years of age
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MEDIAN AGE OF CHILDREN
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[5] .10/21/2002 – 6 years – median age
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[4] 1/1/2005 – 6.4 years – Median age at diagnosis
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[9] .9/15/1994 – 7.5 years – mean age at diagnosis
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[6] .9/15/1999 – 7.8 years – median age of patients
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[3] 2/2008 – 8 – median age (3–14 years)
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[2] 5/1/2010 – 8.3 years – mean age
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1 YEAR OR LESS SURVIVAL RATES
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[1] 4/2011 – 9 / 14% – mean 1-year Event-Free Survival (EFS)
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[1] 4/2011 – 14 / 21.9% – no evidence produced 1-year Event-Free Survival (EFS) rate higher than
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10/2006.–.5 / 26% – 1 year: Burzynski Antineoplastons: Progression-Free Survival Rate (PFS): Protocol – BT-11 BRAINSTEM GLIOMAS and multicentric tumors (MBSG) (Pg. 466)
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[7] 3/15/1999 – 17 / 27.0% – ARM 2: 1 year Patients Surviving: Protocol – easier to treat cases of newly diagnosed BRAIN STEM (tumor) GLIOMA patients: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992–10/1997) 2004 (Pg. 58)
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10/2004.–.9 / 29% – Burzynski Antineoplastons: 1 year Progression-Free Survival (PFS): Protocol – patients with diffuse intrinsic BRAIN STEM GLIOMA (DBSG): Special Exception (SE) (Pg. 386)
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[7] 3/15/1999 – 40 / 30.9% – ARM 1: 1 year Patients Surviving: Protocol – easier to treat cases of newly diagnosed BRAIN STEM (tumor) GLIOMA patients: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992–10/1997) 2004 (Pg. 58)
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[9] .9/15/1994 – 20 / 35% – 1 year Overall Survival
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3/2006.–.39% – Burzynski Antineoplastons Patients with high-grade, recurrent and progressive BRAINSTEM GLIOMAS: Progression-Free Survival (PFS) at 6 months: BRAINSTEM GLIOMA (BSG) (Pgs. 40 + 44-45)
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[1] 4/2011 – 25 / 40% – mean 1-year Overall Survival (OS)
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10/2004.–.12 / 41% – Burzynski l: 1 year Progression-Free Survival (PFS): Protocol – patients with diffuse intrinsic BRAIN STEM GLIOMA (DBSG) (Pg. 386)
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3/2004 – 43% – Burzynski Antineoplastons – % of responding Patients didn’t develop Progression: 6/1/2003 Protocol – BT-11 – BRAIN STEM GLIOMA (Pg. 51)
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[4] 1/1/2005 – 16 / 48% – 1 year estimated Survival rate
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10/2006.–.10 / 53% – Burzynski Antineoplastons 1 year Overall Survival Rate (OS): Protocol – BT-11 BRAINSTEM GLIOMAS and multicentric tumors (MBSG) (Pg. 466)
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3/2004 – 61% – Burzynski Antineoplastons % of Objective Response (OR) Patients hadn’t had Progression: 6/1/2003 Protocol – HIGH-GRADE GLIOMA (Pg. 53)
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[3] 2/2008 – 27 / 90% – 1 year  - Overall survival
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LESS THAN 1 YEAR SURVIVAL (MST)
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[7] 3/15/1999 – 5 months – ARM 2: Median time to Disease Progression: Protocol – easier to treat cases of newly diagnosed BRAIN STEM (tumor) GLIOMA patients: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992–10/1997) 2004 (Pg. 58)
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3/2006.-.6 months – Patients with Recurrent Tumors Survive no more than, despite standard treatment: (Pgs. 40 + 45-46)
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[7] 3/15/1999 – 6 months – ARM 1: Median time to Disease Progression: Protocol – easier to treat cases of newly diagnosed BRAIN STEM (tumor) GLIOMA patients: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992–10/1997) 2004 (Pg. 58)
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2003 – 6.4 months – Burzynski Antineoplastons Median Survival: Protocol patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA: BT-11 Special Exception (SE) (Pg. 99)
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2003 – 7 months – Burzynski Antineoplastons Median Survival: Protocol patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA: BT-11 (Pg. 99)
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3/2004 – 7 months – Burzynski Antineoplastons – Progression-Free Survival (PFS): 6/1/2003 Protocol – BT-11 BRAIN STEM GLIOMA (Pg. 51)
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3/2004 – 7 months – Burzynski Antineoplastons Progression-Free Survival (PFS): Protocol – subgroup very difficult to treat recurrent diffuse intrinsic BRAIN STEM GLIOMA (Pg. 52)
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[7] 3/15/1999 – 8 months – ARM 2: Median time to Death: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992 – 10/1997) 2004 (Pg. 58)
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[7] 3/15/1999 – 8 months – ARM 2: Median Overall Survival from Diagnosis (OSD): Median time to Death: Protocol – easier to treat cases of newly diagnosed BRAIN STEM (tumor) GLIOMA patients: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992–10/1997) 2004 (Pg. 58)
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[7] 3/15/1999 – 8 months – ARM 2: Median Overall Survival from start of Treatment (OST): Median time to Death: Protocol – easier to treat cases of newly diagnosed BRAIN STEM (tumor) GLIOMA patients: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992–10/1997) 2004 (Pg. 58)
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[7] 3/15/1999 – 8.5 months – Median Survival (MST): standard radiation therapy in combination with chemotherapy (RAT) (Mandell et al.) (6/1992–10/1997) children with newly diagnosed diffuse intrinsic BRAIN STEM TUMORS: results of pediatric oncology group
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[7] 3/15/1999 – 8.5 months – ARM 1: Median Overall Survival from start of Treatment (OST): Median time to Death: Protocol – easier to treat cases of newly diagnosed BRAIN STEM (tumor) GLIOMA patients: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992–10/1997) 2004 (Pg. 58)
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[7] 3/15/1999 – 8.5 months – ARM 1: Median time to Death: Median Overall Survival from Diagnosis (OSD): Protocol – easier to treat cases of newly diagnosed BRAIN STEM (tumor) GLIOMA patients: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992–10/1997) 2004 (Pg. 58)
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3/2004 – 10.3 months – Burzynski Antineoplastons – Median Overall Survival from start of Treatment (OST): 6/1/2003 Protocol – BT-11 BRAIN STEM GLIOMA (Pg. 51)
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1 YEAR SURVIVAL
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3/2004 – 12 months (1 year) – Burzynski Antineoplastons: Progression-Free Survival (PFS): 6/1/2003 Protocol – HIGH-GRADE GLIOMA (Pg. 53)
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1+ YEAR SURVIVAL
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3/2004 – 13.7 months (1 year 1.7 months) – Burzynski Antineoplastons: Median Overall Survival from Diagnosis (OSD): 6/1/2003 Protocol – BT-11 BRAIN STEM GLIOMA (Pg. 51)
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4/2007 – 16.4 months (1 year 4.4 months) – Burzynski Antineoplastons(ANP): Median Survival (MST): Protocol – newly diagnosed diffuse, intrinsic BRAINSTEM GLIOMAs (NDBSG) BT-11 (Pg. 206)
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3/2004 – 17 months (1 year 5 months) – Median Survival without Treatment (Pg. 53)
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2006 – 19.9 months (1 year 7.9 months) – Median Survival Time (MST): next best traditional standard of care study (Pg. 172)
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2006 – 19.9 months (1 year 7.9 months) – Burzynski Antineoplastons (ANP): Median Survival Time (MST): Treatments for Astrocytic Tumors – recurrent and progressive tumor: Treatment of diffuse, intrinsic BRAINSTEM GLIOMA in children (Pg. 172)
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2 YEAR SURVIVAL
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3/2006 – 2 years – Most Patients with BRAINSTEM GLIOMA fail standard radiation therapy and chemotherapy and don’t survive longer: (Pgs. 40 + 45-46)
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[7] 3/15/1999 – 4 / 6.7% – ARM 2: 2 year Patients Surviving: Protocol – easier to treat cases of newly diagnosed BRAIN STEM (tumor) GLIOMA patients: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992–10/1997) 2004 (Pg. 58)
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[7] 3/15/1999 – 7% – 2 year Overall Survival (OS): standard radiation therapy in combination with chemotherapy (RAT) (Mandell et al.) (6/1992–10/1997) children with newly diagnosed diffuse intrinsic BRAIN STEM TUMORS: results of pediatric oncology group
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[7] 3/15/1999 – 9 / 7.1% – ARM 1: 2 year Patients Surviving: Protocol – easier to treat cases of newly diagnosed BRAIN STEM (tumor) GLIOMA patients: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992–10/1997) 2004 (Pg. 58)
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Less than 10% – 2 year Survival: standard radiation therapy: for newly diagnosed diffuse intrinsic BRAIN STEM GLIOMA (DBSG)
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[3] 2/2008 – 3 / 10% – 2 years – Overall survival
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10/2006.–.3 / 16% – 2 years: Burzynski Antineoplastons: Progression-Free Survival Rate (PFS): Protocol – BT-11 BRAINSTEM GLIOMAS and multicentric tumors (MBSG) (Pg. 466)
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10/2006.–.6 / 32% – 2 year Overall Survival Rate (OS): Burzynski Antineoplastons: Protocol – BT-11 BRAINSTEM GLIOMAS and multicentric tumors (MBSG) (Pg. 466)
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2003 – 4 / 33.3% – 2 year Survival: Burzynski Antineoplastons Protocol patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA: BT-11 (Pgs. 91-92)
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3/2006 – 39% – 2 year Overall Survival: Burzynski Antineoplastons: Patients with high-grade, recurrent and progressive BRAINSTEM GLIOMAS (BSG) (Pgs. 40 + 44-45)
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4/2007 – 8 / 40% – 2 year Overall Survival (OS): Burzynski Antineoplastons (ANP): Protocol – newly diagnosed diffuse, intrinsic BRAINSTEM GLIOMAs (NDBSG) BT-11 (Pg. 206)
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2004 – 42% – 2 year Patients (Surviving) Survival: Burzynski Antineoplastons: 6/1/2003 Protocol – BRAIN STEM GLIOMA (Pgs. 52-53)
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10/2004.–.13 / 45% – 2 year Overall Survival (Survival: Special Exception (SE)) Burzynski Antineoplastons: Protocol – patients with diffuse intrinsic BRAIN STEM GLIOMA (DBSG) (Pg. 386)
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2006 – 14 / 46.7% – 2 year Overall Survival (OS) (%) – Efficacy: Burzynski Antineoplastons (ANP): Treatments for Astrocytic Tumors – recurrent and progressive tumor: Treatment of diffuse, intrinsic BRAINSTEM GLIOMA in children (Pg. 172)
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2006 – 30 / 46.7% – 2 year Overall Survival (OS) (%) – Efficacy: next best traditional standard of care study (Pg. 172)
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7/2005 – 5 / 50% – 2 year Overall Survival: Burzynski Antineoplastons: children less than 4 years old with inoperable BRAIN STEM GLIOMAs (BSG) BT-11 (study and Special Exception (SE)) (Pg. 300)
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2006 – 6 / 60% – 2 year Overall Survival (OS) (%) – Efficacy: Burzynski Antineoplastons (ANP) – recurrent and progressive (RPS) tumors in children aged <4y: children less than 4 years old with inoperable BRAIN STEM GLIOMAS (Pg. 172) 2005
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2006 – 6 / 60% – 2-year Survival rate: Burzynski Antineoplastons (ANP) – children aged <4 years diagnosed with diffuse intrinsic BRAIN STEM GLIOMA (DBSG) treated with ANP (Pg. 173) 2005
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2+ YEARS PATIENTS SURVIVED
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3/2006 – 2+ years – Most Patients with Newly Diagnosed High-Grade BRAIN STEM GLIOMAS (HBSG) don’t Survive more than: (Pgs. 40 + 45-46)
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2006 – 12 / >40% – 2+ year patients survived Burzynski Antineoplastons (ANP) recurrent and progressive diffuse intrinsic BRAINSTEM GLIOMA (DBSG) (Pg. 173)
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3 YEAR OVERALL SURVIVAL
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[9] .9/15/1994 – 7 / 11% – 3 years Overall Survival
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4+ YEARS FROM START OF TREATMENT
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2003 – 4+ years – 1 alive – From start of Treatment: Burzynski Antineoplastons Protocol patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA: BT-11 (Pgs. 91-92)
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LONG TERM SURVIVORS
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2003 – 5+ years – 1 alive – Burzynski Antineoplastons: From start of Treatment: Protocol patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA: BT-11 (Pgs. 91-92)
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[7] 3/15/1999 – 0% – 5 year Overall Survival (OS): standard radiation therapy in combination with chemotherapy (RAT) (Mandell et al.) (6/1992–10/1997) children with newly diagnosed diffuse intrinsic BRAIN STEM TUMORS: results of pediatric oncology group
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[6] .9/15/1999 – 5 / 15% – long term survivors who remained in continuous remission after mean follow-up period of 79 months {6 years 7 months} (46–104 months [3 years 10 months – 8 years 8 months])
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10/2006.–.3 / 16% – 5 year Overall Survival Rate (OS): Burzynski Antineoplastons: Protocol – BT-11 BRAINSTEM GLIOMAS and multicentric tumors (MBSG) (Pg. 466)
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10/2004.–.5 / 16% – 5 years: Burzynski Antineoplastons: Overall Survival (Survival: Special Exception (SE)) Protocol – patients with diffuse intrinsic BRAIN STEM GLIOMA (DBSG): Special Exception (SE) (Pg. 386)
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7/2005 – 2 / 20% – 5 year Overall Survival: Burzynski Antineoplastons: children less than 4 years old with inoperable BRAIN STEM GLIOMAs (BSG) BT-11 (study and Special Exception (SE)) (Pg. 300)
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2005 – 2 / 20% – 5 year Overall Survival (OS) (%) – Efficacy: Burzynski Antineoplastons (ANP) – recurrent and progressive (RPS) tumors in children aged <4y: children less than 4 years old with inoperable BRAIN STEM GLIOMAS 2006 (Pg. 172)
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2005 – 2 / 20% – 5-year Survival rate: 2006 Burzynski Antineoplastons (ANP) – children aged <4 years diagnosed with diffuse intrinsic BRAIN STEM GLIOMA (DBSG) treated with ANP (Pg. 173)
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3/2006 – 22% – Burzynski Antineoplastons 5 year Overall Survival: Patients with high-grade, recurrent and progressive BRAINSTEM GLIOMAS (BSG) (Pgs. 40 + 44-45)
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10/2004.–.7 / 24% – 5 years: Burzynski Antineoplastons: Overall Survival (Survival: Special Exception (SE)) Protocol – patients with diffuse intrinsic BRAIN STEM GLIOMA (DBSG) (Pg. 386)
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4/2007 – 6 / 30% – 5 year Overall Survival (OS): Burzynski Antineoplastons ((ANP): Protocol – newly diagnosed diffuse, intrinsic BRAINSTEM GLIOMAs (NDBSG) BT-11 (Pg. 206)
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2005 – 9 / 30% – 5 year Overall Survival (OS) (%) – Efficacy: Burzynski Antineoplastons (ANP): Treatments for Astrocytic Tumors – recurrent and progressive tumor: Treatment of diffuse, intrinsic BRAINSTEM GLIOMA in children 2006 (Pg. 172)
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2005 – 9 / 30% – 5+ year patients survived Burzynski Antineoplastons (ANP) recurrent and progressive diffuse intrinsic BRAINSTEM GLIOMA (DBSG) 2006 (Pg. 173)
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2003 – 2 / 17% – 5+ years Alive and Tumor Free since Initial Diagnosis: Burzynski Antineoplastons: Protocol patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA: BT-11 (Pgs. 91-92)
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9 / 30% – 5+ year patients survived 2006 Burzynski Antineoplastons (ANP) recurrent and progressive diffuse intrinsic BRAINSTEM GLIOMA (DBSG) (Pgs. 172-173)
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� � � � � � � � � � � � � � � � �
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SURVIVAL
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[2] 5/1/2010 – 6.9 months – Progression-Free Survival (PFS)
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[5] .10/21/2002 – 8 months – Overall Median Survival
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[3] 2/2008 – 9 months (3–36 months [3 years]) – Median Survival (MS)
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[2] 5/1/2010 – 9.15 months – Median Overall Survival
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[1] 4/2011 – 9.6 months – Median Time to Death
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[4] 1/1/2005 – 12 months (1 year) – Median Survival (MS)
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[6] .9/15/1999 – 12 months (1 year) – Overall Survival (5–104+ months [5 months – 8 years 8+ months])
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2 YEARS 2.3 MONTHS MEDIAN SURVIVAL TIME (MST)
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2006 – 26.3 months (2 years 2.3 months) – Burzynski Antineoplastons (ANP) – Median Survival Time (MST): recurrent and progressive (RPS) tumors in children aged <4y: children less than 4 years old with inoperable BRAIN STEM GLIOMAS 2005 (Pg. 172)
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� � � � � � � � � � � � � � � � �
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3 YEARS MEDIAN OVERALL SURVIVAL FROM DIAGNOSIS (OSD)
======================================
� � � � � � � � � � � � � � � � �
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2004 – 3 years – with treatment, may approach (Pg. 53)
——————————————————————
2004 – 3 years – Burzynski Antineoplastons Median Overall Survival from Diagnosis (OSD): 6/1/2003 Protocol – HIGH-GRADE GLIOMA (Pg. 53)
======================================
� � � � � � � � � � � � � � � � �
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5+ YEARS SURVIVAL
======================================
� � � � � � � � � � � � � � � � �
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3/2006 – 5+ years – Burzynski Antineoplastons: Survival in recurrent diffuse intrinsic GLIOBLASTOMAS and anaplastic ASTROCYTOMAS of the BRAINSTEM in a small group of Patients: BRAINSTEM GLIOMA (BSG) Patient with GLIOBLASTOMA (Pgs. 40 + 44-45)
======================================
� � � � � � � � � � � � � � � � �
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6+ YEARS MAXIMUM SURVIVAL (MS)
======================================
� � � � � � � � � � � � � � � � �
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7/2005 – 6+ years – Burzynski Antineoplastons: Maximum Survival (MS): children less than 4 years old with inoperable BRAIN STEM GLIOMAs (BSG) BT-11 (study and Special Exception (SE)) (Pg. 300)
——————————————————————
6+ years – Burzynski Antineoplastons Patient with recurrent, diffuse, intrinsic GLIOBLASTOMA MULTIFORME (GBM)
======================================
� � � � � � � � � � � � � � � � �
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6.3 YEARS MEDIAN OVERALL SURVIVAL FROM DIAGNOSIS (OSD)
======================================
� � � � � � � � � � � � � � � � �
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2004 – 6.3 years – Burzynski Antineoplastons: Median Overall Survival from Diagnosis (OSD): 6/1/2003 Protocols – LOW-GRADE GLIOMA IN CHILDREN (Pg. 50)
======================================
� � � � � � � � � � � � � � � � �
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7+ YEARS LONGEST / MAXIMUM SURVIVAL
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� � � � � � � � � � � � � � � � �
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3/2004 – 7+ years – Burzynski Antineoplastons: Longest Survival (the Patients are currently alive): Protocol – subgroup very difficult to treat recurrent diffuse intrinsic BRAIN STEM GLIOMA (Pg. 52)
——————————————————————
2006 – 7+ years – Burzynski Antineoplastons (ANP) – Maximum Survival (MS): children aged <4 years diagnosed with diffuse intrinsic BRAIN STEM GLIOMA (DBSG) treated with ANP (Pg. 173)
======================================
� � � � � � � � � � � � � � � � �
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7.5+ YEARS MAXIMUM SURVIVAL (MS)
======================================
� � � � � � � � � � � � � � � � �
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2004 – 7.5+ years – Burzynski Antineoplastons Maximum Survival (MS): 6/1/2003 Protocol – BT-11 BRAIN STEM GLIOMA (Pg. 51)
======================================
� � � � � � � � � � � � � � � � �
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9+ YEARS MAXIMUM SURVIVAL (MS)
======================================
� � � � � � � � � � � � � � � � �
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10/2006 – 9+ years – Burzynski Antineoplastons: Maximum Survival Rate: Protocol – BT-11 BRAINSTEM GLIOMAS and multicentric tumors (MBSG) (Pg. 466)
======================================
� � � � � � � � � � � � � � � � �
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11 YEARS MAXIMUM SURVIVAL (MS)
======================================
� � � � � � � � � � � � � � � � �
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10/2004.–.11 years – Burzynski Antineoplastons: Maximum Survival: Protocol – patients with diffuse intrinsic BRAIN STEM GLIOMA (DBSG): Special Exception (SE): (high-grade diffuse intrinsic BRAIN STEM GLIOMA (DBSG) recurrent after radiation and chemotherapy) (Pg. 386)
======================================
� � � � � � � � � � � � � � � � �
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12.5+ YEARS MAXIMUM SURVIVAL (MS)
======================================
� � � � � � � � � � � � � � � � �
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2004 – 12.5+ years – Burzynski Antineoplastons: Maximum Survival (MS): 6/1/2003 Protocol – HIGH-GRADE GLIOMA (Pg. 53)
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� � � � � � � � � � � � � � � � �
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15.5+ YEARS MAXIMUM SURVIVAL (MS)
======================================
� � � � � � � � � � � � � � � � �
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10/2004 – 15.5+ years – Burzynski Antineoplastons: Maximum Survival: Protocol – patients with diffuse intrinsic BRAIN STEM GLIOMA (DBSG): (high-grade diffuse intrinsic BRAIN STEM GLIOMA (DBSG) recurrent after radiation and chemotherapy) (Pg. 386)
======================================
� � � � � � � � � � � � � � � � �
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17+ YEARS MAXIMUM SURVIVAL (MS)
======================================
� � � � � � � � � � � � � � � � �
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3/2006 – 17+ years (approaching 18 years) – Burzynski Antineoplastons: BRAINSTEM GLIOMA (BSG) Maximum Survival for Patient with recurrent, diffuse, intrinsic anaplastic ASTROCYTOMA (Pgs. 40 + 44-45)
======================================
� � � � � � � � � � � � � � � � �
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Burzynski: BRAINSTEM GLIOMAs (DBSG):
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/31/burzynski-brainstem-gliomas-dbsg/
======================================
References:
======================================
[1] 4/2011 – children with newly diagnosed diffuse intrinsic pontine gliomas
======================================
Temozolomide in the treatment of children with newly diagnosed diffuse intrinsic pontine gliomas: a report from the Children’s Oncology Group
http://www.ncbi.nlm.nih.gov/pubmed/21345842/
Neuro Oncol. 2011 Apr;13(4):410-6. doi: 10.1093/neuonc/noq205. Epub 2011 Feb.22
http://www.ncbi.nlm.nih.gov/m/pubmed/21345842/
Neuro-oncology 2011 Apr; 13(4):410-6
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3064697/
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA

Click to access noq205.pdf

the Children’s Oncology Group
http://m.neuro-oncology.oxfordjournals.org/content/13/4/410.long?view=long&pmid=21345842
open-label phase II study (ACNS0126)
7/6/2004-9/6/2005
======================================
[2] 5/1/2010 – Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma
======================================
Prospective Evaluation of Radiotherapy With Concurrent and Adjuvant Temozolomide in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma
http://www.ncbi.nlm.nih.gov/pubmed/19647954/
Int J Radiat Oncol Biol Phys. 2010 May 1;77(1):113-8. doi: 10.1016/j.ijrobp.2009.04.031. Epub 2009 Aug 3
http://www.ncbi.nlm.nih.gov/m/pubmed/19647954/
International Journal of Radiation Oncology * Biology * Physics
Volume 77, Issue 1 , Pages 113-118, 1 May 2010
http://www.redjournal.org/article/S0360-3016(09)00597-5/abstract
published online 03 August 2009
Department of Radiation Oncology, Tata Memorial Centre, Mumbai, India
Presented at the Eighth Congress of the European Association for Neuro-Oncology, Barcelona, Spain, September 12–14, 2008
3/2005-11/2006
======================================
[3] 2/2008 – children with diffuse intrinsic brain stem glioma
======================================
Research Article
Treatment of children with diffuse intrinsic brain stem glioma with radiotherapy, vincristine and oral VP-16: A Children’s Oncology Group phase II study
http://www.ncbi.nlm.nih.gov/pubmed/17278121/
Pediatr Blood Cancer. 2008 Feb;50(2):227-30
http://www.ncbi.nlm.nih.gov/m/pubmed/17278121/
Pediatr Blood Cancer 2008;50:227–230
http://onlinelibrary.wiley.com/doi/10.1002/pbc.21154/abstract
Pediatric Blood & Cancer
Volume 50, Issue 2, pages 227–230, February 2008
http://onlinelibrary.wiley.com/doi/10.1002/pbc.21154/abstract;jsessionid=1C9E44F96D6558468F0D7EB45D50FE23.d04t03
Pediatric Blood & Cancer
Volume 50, Issue 2, Article first published online: 2 FEB 2007
http://onlinelibrary.wiley.com/doi/10.1002/pbc.21154/full
The Pediatric Oncology Group (POG, now part of the Children’s Oncology Group)
http://onlinelibrary.wiley.com/doi/10.1002/pbc.21154/pdf
DOI 10.1002/pbc.21154

Click to access Pediatric-Paper-04.pdf

University of Rochester Medical Center, Rochester, New York, USA
======================================
[4] 1/1/2005 – newly diagnosed diffuse brainstem glioma in children
======================================
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/pubmed/15565574
Cancer. 2005 Jan 1;103(1):133-9.
http://www.ncbi.nlm.nih.gov/m/pubmed/15565574
Cancer 103, 133-139
http://onlinelibrary.wiley.com/doi/10.1002/cncr.20741/abstract;jsessionid=6717837591CCC8FCBD8E46163808E221.d03t01
Cancer
Volume 103, Issue 1, pages 133–139, 1 January 2005
http://onlinelibrary.wiley.com/doi/10.1002/cncr.20741/full
Article first published online: 24 NOV 2004
References:
http://onlinelibrary.wiley.com/doi/10.1002/cncr.20741/references
Cited By:
http://onlinelibrary.wiley.com/doi/10.1002/cncr.20741/citedby
DOI: 10.1002/cncr.20741
Department of Hematology-Oncology, St. Jude Children’s Research Hospital, Memphis, Tennessee, USA
======================================
[5] .10/21/2002 – paediatric pontine glioma
======================================
Treatment of paediatric pontine glioma with oral trophosphamide and etoposide
http://www.ncbi.nlm.nih.gov/pubmed/12434281/
Br J Cancer. 2002 Oct 21;87(9):945-9
http://www.ncbi.nlm.nih.gov/m/pubmed/12434281/
British Journal of Cancer (2002) 87, 945–949. doi:10.1038/sj.bjc.6600552
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2364312/
Published online 21 October 2002
http://www.nature.com/bjc/journal/v87/n9/full/6600552a.html
St. Hedwigs Klinik, Hämato/Onkologie, Steinmetzstr. 1–3, Regensburg, Germany

Click to access 6600552a.pdf

======================================
[6] .9/15/1999 – brainstem gliomas
======================================
A Phase I/II study of carboplatin combined with hyperfractionated radiotherapy for
brainstem gliomas
http://onlinelibrary.wiley.com/doi/10.1002/(SICI)1097-0142(19990915)86:6%3C1064::AID-CNCR24%3E3.0.CO;2-1/full
Cancer 1999;86:1064–9
1999 American Cancer Society
Cancer
Volume 86, Issue 6, pages 1064–1069, 15 September 1999
Article first published online: 20 NOV 2000
DOI: 10.1002/(SICI)1097-0142(19990915)86:63.0.CO;2-1
======================================
[7] 3/15/1999 children with newly diagnosed diffuse intrinsic brainstem tumors
======================================
There is no role for hyperfractionated radiotherapy in the management of
children with newly diagnosed diffuse intrinsic brainstem tumors: results of a Pediatric Oncology Group phase III trial comparing conventional vs. hyperfractionated radiotherapy
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 , Pages 959-964, 15 March 1999
http://www.redjournal.org/article/S0360-3016(98)00501-X/abstract
Department of Radiation Oncology, Mount Sinai Medical Center, New York, NY 10029-6574, USA
======================================
[8] 1/1998 – children with newly diagnosed diffuse pontine gliomas
======================================
Carboplatin and etoposide with hyperfractionated radiotherapy in children with newly diagnosed diffuse pontine gliomas: a phase I/II study
http://www.ncbi.nlm.nih.gov/pubmed/9371386/
Med Pediatr Oncol. 1998 Jan;30(1):28-33
http://www.ncbi.nlm.nih.gov/m/pubmed/9371386/
Medical and Pediatric Oncology
Volume 30, Issue 1, pages 28–33, January 1998
http://onlinelibrary.wiley.com/doi/10.1002/(SICI)1096-911X(199801)30:13.0.CO;2-2/abstract;jsessionid=94E4BFEF2606B89ADDD9682528353D47.d03t02
Article first published online: 7 DEC 1998
http://onlinelibrary.wiley.com/doi/10.1002/(SICI)1096-911X(199801)30:13.0.CO;2-2/pdf
DOI: 10.1002/(SICI)1096-911X(199801)30:13.0.CO;2-2
Department of Hematology-Oncology, St. Jude Children’s Research Hospital, University of Tennessee, Memphis, USA
Pediatric Oncology
======================================
[9] .9/15/1994 – children with brain stem gliomas
======================================
Outcome of children with brain stem gliomas after treatment with 7800 cGy of hyperfractionated radiotherapy. A Childrens Cancer Group Phase I/II Trial
http://www.ncbi.nlm.nih.gov/pubmed/8082086/
Cancer. 1994 Sep 15;74(6):1827-34
http://www.ncbi.nlm.nih.gov/m/pubmed/8082086/
Department of Neurology, Children’s National Medical Center, Washington, DC
======================================
� � � � � � � � � � � � � � � � �
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The Burzynski Skeptics:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/18/the-burzynski-skeptics/
======================================
Perfessor Robert J. (Bob) Blaskiewicz Blatherskitewicz:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/31/the-burzynski-b-s-app/
======================================
Bob Blaskiewicz (Blatherskitewicz), Faux Skeptic Exposed!:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/07/bob-blaskiewicz-blatherskitewicz-faux-skeptic-exposed/
======================================
Critiquing the #SkepticCanary: “The Skeptics™” (SkeptiCowards©) Bob Blatherskitewicz and the so-called, “self-proclaimed” “CANCER RESEARCHER”:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/03/critiquing-the-skepticcanary-the-skeptics-skepticowards-bob-blatherskitewicz-and-the-so-called-self-proclaimed-cancer-researcher/
======================================
Critiquing Bob Blaskiewicz (#Burzynski Cancer is Serious Business, Part II):
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/26/critiquing-bob-blaskiewicz-burzynski-cancer-is-serious-business-part-ii/
======================================
My Critique of Bob Blaskiewicz (Colorado Public Television – PBS CPT12):
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/26/my-critique-of-bob-blaskiewicz-colorado-public-television-pbs-cpt12/
======================================
“The Skeptics” (Burzynski: Cancer is Serious Business, Part II):
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/24/the-skeptics/
======================================
� � � � � � � � � � � � � � � � �

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Burzynski: Why has the FDA NOT granted Accelerated Approval for Antineoplastons A10 (Atengenal) and AS2-1 (Astugenal) ?

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Reply

======================================
1996 – Accelerated approval started by United States Food and Drug Administration Commissioner, Dr. David A. Kessler
(.4:18 – .6:10):

======================================
Tamoxifen:
======================================
7/1997 – A phase I study of high-dose tamoxifen for the treatment of refractory malignant GLIOMAS OF CHILDHOOD
http://www.ncbi.nlm.nih.gov/pubmed/9815790/
Clin Cancer Res. 1997 Jul;3(7):1109-15
http://www.ncbi.nlm.nih.gov/m/pubmed/9815790/
Clin Cancer Res July 1997 3; 1109
http://m.clincancerres.aacrjournals.org/content/3/7/1109.full.pd
Departments of Neurosurgery, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania, USA

http://clincancerres.aacrjournals.org/content/3/7/1109
Children with malignant GLIOMAS THAT PROGRESSED AFTER CONVENTIONAL THERAPY
——————————————————————
0 / 0% – EXHIBITED CLEAR-CUT TUMOR regression
——————————————————————
17 months (1 year 5 months) – longest survivor lived for after beginning tamoxifen
======================================
2000 – Radiation therapy and high-dose tamoxifen in the treatment of patients with diffuse BRAINSTEM GLIOMAS:

results of a Brazilian cooperative study
http://www.ncbi.nlm.nih.gov/pubmed/10715294/
Brainstem Glioma Cooperative Group
http://www.ncbi.nlm.nih.gov/m/pubmed/10715294/
J Clin Oncol 18, 1246-1253
http://m.jco.ascopubs.org/content/18/6/1246.long
——————————————————————
22 – assessable patients
——————————————————————
10.3 months – Median Survival
——————————————————————
4 / 18% – remain alive without tumoral progression
——————————————————————
8 / 37.0% {+/- 2 / 9.5%} (mean +/- SD) – 1-year Survival rate
——————————————————————
treatment combination PRODUCED NO SIGNIFICANT CHANGE in overall POOR prognosis of patients

Most tumors responded initially to treatment but recurred as study progressed

Based on POOR RESULTS, recommend ALTERNATIVE TREATMENTS be tested in patients with this type of tumor
======================================
Temodar (Temozolomide):
======================================
Temozolomide received accelerated approval by the U.S. Food and Drug Administration 1/1999 for treatment of ANAPLASTIC ASTROCYTOMA (brain cancer) patients
——————————————————————
54 patients
——————————————————————
12 / 22% – response rate
——————————————————————
5 / 9% – Complete Response rate
——————————————————————
50 weeks (16-114 weeks) – Median duration of all responses
——————————————————————
64 weeks (52-114 weeks) – Median duration of Complete Response
——————————————————————
4.4 months – Median Progression-Free Survival
——————————————————————
15.9 months (1 year 3.9 months) – Median Overall Survival
——————————————————————
At time of approval, NO RESULTS were available from randomized controlled trials in refractory ANAPLASTIC ASTROCYTOMA that show clinical benefit such as improvement in disease-related symptoms or prolonged survival
——————————————————————
http://clincancerres.aacrjournals.org/content/11/19/6767.full
======================================
Was the United States Food and Drug Administration’s 1/1999 accelerated approval based on the PUBLISHED FINAL RESULTS OF A PHASE II (2) CLINICAL TRIAL?
======================================
12/2000 – Temozolomide and ANAPLASTIC ASTROCYTOMA:

new indication

NO CLEAR PROOF OF EFFICACY
http://www.ncbi.nlm.nih.gov/pubmed/11475493/
Prescrire Int. 2000 Dec;9(50):170-1.
http://www.ncbi.nlm.nih.gov/m/pubmed/11475493/
(1) Temozolomide recently licensed in France for treating patients with ANAPLASTIC ASTROCYTOMA who are in relapse or progression after standard therapy
——————————————————————
(2) clinical dossier contains only one non comparative trial
——————————————————————
(3) 111 patients with ANAPLASTIC ASTROCYTOMA or oligoanaplastic astrocytoma had not all had the standard treatment with surgery, radiotherapy and chemotherapy
——————————————————————
54 patients – subgroup who met criteria
——————————————————————
16 months (1 year 4 months) – Median Global Survival
——————————————————————
31 months (2 years 7 months) – Median Global Survival from start of initial treatment
——————————————————————
NO BETTER THAN SURVIVAL BEFORE THE INTRODUCTION OF temozolomide
======================================
The answer is: NO

1/1999 – FDA Accelerated Approval
9/1999 – Phase 2 publication
======================================
9/1999 – Multicenter phase II trial of temozolomide in patients with ANAPLASTIC ASTROCYTOMA or anaplastic oligoastrocytoma at first relapse

Temodal Brain Tumor Group
http://www.ncbi.nlm.nih.gov/pubmed/10561351/
J Clin Oncol. 1999 Sep;17(9):2762-71.
http://www.ncbi.nlm.nih.gov/m/pubmed/10561351/
University of Texas M.D. Anderson Cancer Center, Houston, TX, USA
======================================
http://www.drugs.com/pro/temodar.html
======================================
http://www.pharmainfo.net/fda-articles/fda-safety-page-fatal-medication-errors-associated-temodar
======================================
TEMODAR ADVERSE EVENTS REPORTED TO THE FDA OVER TIME:
http://www.drugcite.com/?q=TEMODAR
======================================
ADVERSE EVENTS:
Primary Suspect Reports: 4,436
Total Reports: 6,350
http://www.adverseevents.com/drugdetail.php?AEDrugID=1794&BrandName=TEMODAR
======================================
http://www.temodar.com/temodar/index.do
======================================
2004 – Supratentorial high-grade ASTROCYTOMA and DIFFUSE BRAINSTEM GLIOMA:

two challenges for the pediatric oncologist
http://www.ncbi.nlm.nih.gov/pubmed/15047924/
Oncologist. 2004;9(2):197-206.
http://www.ncbi.nlm.nih.gov/m/pubmed/15047924/
Oncologist 9, 197-206
http://m.theoncologist.alphamedpress.org/content/9/2/197.long
Division of Neuro-Oncology, Department of Hematology-Oncology, St. Jude Children’s Research Hospital, Memphis, Tennessee, USA

neoplasms predominantly involve supratentorial hemispheres or pons, in which case tumors are usually called DIFFUSE BRAINSTEM GLIOMAS

supratentorial neoplasms
——————————————————————
diagnosis of DIFFUSE BRAINSTEM GLIOMA based upon typical imaging, dispensing with need for surgery in majority of cases

Radiation therapy is mainstay of treatment for children with DIFFUSE BRAINSTEM GLIOMAS
——————————————————————
2 years – Less than 10% of children with diffuse brainstem gliomas survive
——————————————————————
outcome for patients with either type of tumor is POOR when standard multimodality therapy is used

children are ideal candidates for INNOVATIVE TREATMENT approaches
——————————————————————
3-21 years Patients were eligible for current multiinstitutional study
——————————————————————
33 patients (6.4 years – Median age at diagnosis) enrolled
——————————————————————
33 / 100% – DIED OF DISEASE PROGRESSION
——————————————————————
12 months (1 year) – Median Survival
——————————————————————
16 / 48% – estimated 1-year Survival rate (standard error, 1 / 8%)
——————————————————————
administration of temozolomide after RT DIDN’T ALTER POOR PROGNOSIS associated with newly diagnosed diffuse BRAINSTEM GLIOMA in children
======================================
1/1/2005 (11/24/2004) – 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/pubmed/15565574
Cancer. 2005 Jan 1;103(1):133-9.
http://www.ncbi.nlm.nih.gov/m/pubmed/15565574
Cancer 103, 133-139
http://onlinelibrary.wiley.com/doi/10.1002/cncr.20741/abstract;jsessionid=6717837591CCC8FCBD8E46163808E221.d03t01
Cancer
Volume 103, Issue 1, pages 133–139, 1 January 2005
http://onlinelibrary.wiley.com/doi/10.1002/cncr.20741/full
Article first published online: 24 NOV 2004
References:
http://onlinelibrary.wiley.com/doi/10.1002/cncr.20741/references
Cited By:
http://onlinelibrary.wiley.com/doi/10.1002/cncr.20741/citedby
DOI: 10.1002/cncr.20741

Department of Hematology-Oncology, St. Jude Children’s Research Hospital, Memphis, Tennessee, USA
——————————————————————
33 patients: (33 / 100% – 6.4 years: Median age)
——————————————————————
33 / 100% – ALL DIED OF DISEASE PROGRESSION
——————————————————————
12 months (1 year) – Median Survival
——————————————————————
16 / 48% – 1 year estimated Survival rate
——————————————————————
Table 1. Results of radiation therapy in combination with chemotherapy for newly diagnosed, diffuse, intrinsic BRAIN STEM GLIOMA

Author
Study Type
Patients Total No.
Treatment Radiation Therapy
Additional Chemotherapy
Efficacy
OS MST CR PR SD PD

Multiinstitutional 33 56 Temozolomide, irinotecan 0 0 12 NA NA NA

response rates based on evaluable patients
32 54 Topotecan

CR – complete response
GCSF – granulocyte colony stimulating factor
HD – high dose tamoxifen
HDB – high dose chemotherapy and autologous bone marrow transplantation HF – hyperfractionated
M – months
MST – median survival time
NA – not available
OS – overall survival
PD – progressive disease
PR – partial response
SD – stable disease
UNK – unknown
* 1 patient had radiological improvement

Cancer 103, 133-139
——————————————————————
3-21 years – eligible for current multiinstitutional study
——————————————————————
33 – (Median age at diagnosis
6.4 years) enrolled
——————————————————————
ALL PATIENTS DIED OF DISEASE PROGRESSION
——————————————————————
12 months (1 year) – Median Survival
——————————————————————
48% – estimated 1-year Survival rate (standard error 8%)
——————————————————————
administration of temozolomide after RT DIDN’T ALTER POOR PROGNOSIS associated with newly diagnosed diffuse BRAINSTEM GLIOMA in children
======================================
2/2008 (2/2/2007)
Treatment of children with diffuse intrinsic BRAIN STEM GLIOMA with radiotherapy, vincristine and oral VP-16:

a Children’s Oncology Group phase II study
http://www.ncbi.nlm.nih.gov/pubmed/17278121
Pediatr Blood Cancer. 2008 Feb;50(2):227-30
http://www.ncbi.nlm.nih.gov/m/pubmed/17278121
University of Rochester Medical Center, Rochester, New York, USA.

http://onlinelibrary.wiley.com/doi/10.1002/pbc.21154/abstract;jsessionid=DE7A67EFBAC1A184F6805F11CFC4F30B.d02t02
Article first published online: 2 FEB 2007
DOI: 10.1002/pbc.21154

prognosis for children with BRAIN STEM GLIOMA remains grim

The Pediatric Oncology Group (POG, now part of Children’s Oncology Group) conducted study using agents in combination with standard external beam radiation for children with newly diagnosed BRAIN STEM GLIOMA
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Children eligible
3-21 years of age, had MRI-evidence of diffuse intrinsic pontine glioma, and had neurologic deficits of <6 months duration
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30 eligible and evaluable for Survival / toxicity
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8 years (3-14 years) – Median age
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7 / 23% – Partial Response following radiation
18 / 60% – Stable Disease
2 / 7% – Progressive Disease
3 / 10% – Response Not measured
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30 / 100% CHILDREN DIED
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Overall Survival 1 year
27 +/- 7%
2 years, 3 +/- 2%
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9 months (3-36 months) – Median Survival
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addition of vincristine and oral VP-16 to standard external beam radiation causes moderate toxicity and DOESN’T IMPROVE SURVIVAL OF CHILDREN WITH DIFFUSE INTRINSIC BRAIN STEM GLIOMA
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Avastin (Bevacizumab):
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5/6/2009 – U.S. Food and Drug Administration (FDA) granted accelerated approval of Avastin (bevacizumab) for people with GLIOBLASTOMA (brain cancer) with progressive disease following prior therapy

effectiveness of Avastin in AGGRESSIVE form of BRAIN CANCER based on improvement in objective response rate

Currently, NO DATA available from randomized controlled trials demonstrating improvement in disease-related symptoms or increased survival with Avastin in GLIOBLASTOMA
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11.3 months – Progression-Free Survival
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http://www.drugs.com/newdrugs/fda-grants-accelerated-approval-avastin-combination-paclitaxel-chemotherapy-first-line-advanced-852.html
According to FDA analysis of study

Study AVF3708g
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22 / 26% – tumor responses observed of 85 patients treated with Avastin alone
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4.2 months – Median duration of response in patients
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Study NCI 06-C-0064E

Efficacy of Avastin in GLIOBLASTOMA that progressed following prior therapy supported by another study that used same response assessment criteria as AVF3708g

56 patients treated with Avastin alone
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11 / 20% of patients – Responses were observed
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3.9 months – Median duration of response
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http://www.cancer.gov/cancertopics/druginfo/fda-bevacizumab
FDA – “People with this type of brain cancer have had no new treatments in more than a decade”
http://www.drugs.com/newdrugs/fda-grants-accelerated-approval-avastin-brain-cancer-glioblastoma-has-progressed-following-prior-1342.html
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Avastin is gene-targeted therapy, which can only target certain specific genes
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Afinitor (Everolimus):
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Afinitor (ubependymal giant cell ASTROCYTOMA (SEGA) brain tumor)
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10/29/2010 – FDA granted accelerated approval for Afinitor after single Phase 2 study of only 28 patients
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32% experienced 50% reduction of tumor
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none of their tumors went away completely
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Was the United States Food and Drug Administration’s 10/29/2010 accelerated approval based on the PUBLISHED FINAL RESULTS OF A PHASE II (2) CLINICAL TRIAL?
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10/12/2011 (8/1/2011) – Everolimus tablets for patients with subependymal giant cell ASTROCYTOMA
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3389821/
Expert Opin Pharmacother. Author manuscript; available in PMC 2012 July 5.
Published in final edited form as:
Expert Opin Pharmacother. 2011 October; 12(14): 2265–2269.
Published online 2011 August 1. doi: 10.1517/14656566.2011.601742
PMCID: PMC3389821
NIHMSID: NIHMS385824
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http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm231967.htm
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The answer is: NO

10/29/2010 – FDA Accelerated Approval
10/12/2011 – publication
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COMPARE COMBINED:
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ANAPLASTIC ASTROCYTOMA
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22% – Objective Response: Objective response = complete response and partial response – Antineoplastons
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22% – response rate: Temodar
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11% – Complete Response: Antineoplastons
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9% – Complete Response rate: Temodar
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17+ years – Maximum Survival : patient with ANAPLASTIC ASTROCYTOMA – Antineoplastons
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50 weeks (16-114 weeks) – Median duration of all responses: Temodar
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17+ years – Maximum Survival : patient with ANAPLASTIC ASTROCYTOMA – Antineoplastons
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64 weeks (52-114 weeks) – Median duration of Complete Response: Temodar
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6 months – 7 / 39% Progression-Free Survival: Antineoplastons
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4.4 months – Median Progression-Free Survival: Temodar
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5 years – 4 / 22% Overall Survival: Antineoplastons
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2 years – 7 / 39% Overall Survival: Antineoplastons
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2 years – Most patients with brainstem glioma fail standard radiation therapy and chemotherapy and do not survive longer
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15.9 months (1 year 3.9 months) – Median Overall Survival: Temodar
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COMPARE COMBINED:
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GLIOBLASTOMA
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39% – Progression-Free Survival (PFS) at 6 months: Antineoplastons
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5.28 months – Median Progression-Free Survival (PFS): Antineoplastons
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11.3 months – Progression-Free Survival: Avastin
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32% – % of Patients Showing Objective Response = complete response and partial response: Antineoplastons
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26% – tumor responses observed Avastin
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42% – special exception (SE): Overall survival (OS) – 2 years: Antineoplastons
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36% – BT-11: Overall survival (OS) – 2 years: Antineoplastons
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19% – special exception (SE): Overall survival (OS) – 5 years: Antineoplastons
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25% – BT-11: Overall survival (OS) – 5 years: Antineoplastons
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4.2 months – Median duration of response in patients: Avastin
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9 / 32% – # and % of Patients Showing Objective response = complete response and partial response – Antineoplastons
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11 / 20% of patients – Responses were observed: Avastin
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5+ years – Maximum Survival : patient with GLIOBLASTOMA – Antineoplastons
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3.9 months – Median duration of response: Avastin
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COMPARE COMBINED:
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ASTROCYTOMA
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47% / 7 – % and # of Patients Showing Objective response = complete response (6) and partial response (1) – Antineoplastons
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32% experienced 50% reduction of tumor – Afinitor
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Burzynski: Complete Response, Partial Response, Stable Disease, Progressive Disease, Objective Response, and Response:
https://stanislawrajmundburzynski.wordpress.com/2013/07/04/burzynski-complete-response-partial-response-stable-disease-progressive-disease-objective-response-and-response/
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Burzynski: Progression-Free Survival:
https://stanislawrajmundburzynski.wordpress.com/2013/07/04/burzynski-progression-free-survival/
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WHAT IS MISDIRECTION ? Critiquing “Antineoplastons: Has the FDA kept its promise to the American people ?”:
https://stanislawrajmundburzynski.wordpress.com/2013/06/08/what-is-misdirection-critiquing-antineoplastons-has-the-fda-kept-its-promise-to-the-american-people/
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