Generic ‘Avastin’ May Not Be Suitable For Eye Injections

Szilárd Kiss, MD Director of Clinical Research Director of Compliance  Associate Professor of Ophthalmology Weill Cornell Medical College NewYork-Presbyterian Hospital New York, New York 10021MedicalResearch.com Interview with:
Szilárd Kiss, MD
Director of Clinical Research
Director of Compliance  Associate Professor of Ophthalmology
Weill Cornell Medical College NewYork-Presbyterian Hospital
New York, New York 10021

Medical Research: What is the background for your study?

Dr. Kiss: There has been a good deal of publicity about bevacizumab (Avastin; a Genetech/Roche antibody originally developed for treatment of cancer but now used widely to treat macular degeneration and diabetic retinopathy) being prepared by (mostly unregulated) compounding pharmacies for injection into the eye, and being associated with pathogen contamination.

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Glioblastoma: Avastin Did Not Improve Survival or Symptoms

Minesh P. Mehta, M.B., Ch.B. F.A.S.T.R.O. Professor of Radiation Oncology, University of Maryland School of Medicine Radiation oncologist, University of Maryland Marlene and Stewart Greenebaum Cancer Center, Chair, RTOG brain tumor committeeMedicalResearch.com Interview with:
Minesh P. Mehta, M.B., Ch.B. F.A.S.T.R.O.
Professor of Radiation Oncology,
University of Maryland School of Medicine
Radiation oncologist, University of Maryland Marlene and Stewart Greenebaum Cancer Center

MedicalResearch.com: What are the main findings of the study?

Dr. Mehta: RTOG 0825 was a clinical trial evaluating whether the addition of a novel drug that inhibits tumor vascular growth, bevacizumab, to the standard of care for glioblastoma, an aggressive brain tumor, would prolong survival. Patients were allocated randomly to one of two different treatment regimens – the standard of care, which includes radiotherapy and a drug known as temozolomide, or another regimen of radiation, temozolomide and bevacizumab. The trial design was double-blinded, and therefore, on one arm patients received the bevacizumab, whereas on the other arm they received a placebo. The survival on both arms was equivalent, and therefore it was fairly concluded that bevacizumab failed to prolong survival when given initially as part of treatment for glioblastoma.

Freedom from progression, referred to as progression-free survival was also measured on this trial, and although bevacizumab appeared to lengthen progression-free survival, this level of benefit did not meet the pre-defined goals, and is therefore regarded as statistically not demonstrating an improvement.

Additional endpoints included outcomes reported by the patient, including the burden of symptoms, and the impact of these on the quality of life, as well as effects on the brain, known as neurocognitive changes. Bevacizumab did not improve these endpoints either.

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Advanced Cervical Cancer: Adding Avastin to Chemotherapy Prolonged Survival

Krishnansu S. Tewari, MD, FACOG, FACS| Professor & Director of Research Principal Investigator - The Gynecologic Oncology Group at UC Irvine The Division of Gynecologic Oncology University of California, Irvine Medical Center Orange, CA 92868MedicalResearch.com Interview with:
Krishnansu S. Tewari, MD, FACOG, FACS| Professor & Director of Research
Principal Investigator – The Gynecologic Oncology Group at UC Irvine, Division of Gynecologic Oncology
University of California, Irvine Medical Center
Orange, CA 92868

MedicalResearch.com: What are the main findings of the study?

Dr. Tewari: The main findings of this study were that the addition of bevacizumab to chemotherapy resulted in a significantly improved survival of 3.7 months in a population of patients that have very limited options. This improvement in overall survival was not accompanied by any significant deterioration in quality of life and serious side effects were limited to 3% to 8% of the study population.
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