HER2 Support Group Forums - View Single Post - Todays FDA hearing on Avastin,news from Genentech..

gdpawel · 07-04-2011, 07:16 AM

In reading one of Dr. Nagourney's lastest blog postings "So What Happened to the PARP Inhibitors in Breast Cancer Anyway? ASCO 2011," I was struck by his comments about the dosage of gemcitabine in Dr. O'Shaughnessy's clinical trial (1000 mg/ml2 vs 800 mg/ml2 vs 600 mg/ml2). It reminds me of the dosages with Avastin brought up by Dr. Haines.

Nagourney originally reported the carboplatin plus gemcitabine combination in breast cancer, as a split-dose doublet in 2008 (Nagourney, Clin Breast Cancer Research, 2008). He observed, in that original clinical trial, that even a lower starting dose of gemcitabine (i.e. 800mg/ml2 vs. the O’Shaughnessy 1000 mg/m2) resulted in significant toxicity and in his concluding comments in that paper, he suggested 600mg/ml2. At 1000 mg/m2, Dr. O’Shaughnessy’s trial nearly doubled his recommended dose in this patient population.

Bottom line: more is not always better. How the role the drug delivery schedule plays in the disease control.

07-04-2011, 07:16 AM	#8
gdpawel Senior Member Join Date: Aug 2006 Location: Pennsylvania Posts: 1,080	The issue surrounding Avastin In reading one of Dr. Nagourney's lastest blog postings "So What Happened to the PARP Inhibitors in Breast Cancer Anyway? ASCO 2011," I was struck by his comments about the dosage of gemcitabine in Dr. O'Shaughnessy's clinical trial (1000 mg/ml2 vs 800 mg/ml2 vs 600 mg/ml2). It reminds me of the dosages with Avastin brought up by Dr. Haines. Nagourney originally reported the carboplatin plus gemcitabine combination in breast cancer, as a split-dose doublet in 2008 (Nagourney, Clin Breast Cancer Research, 2008). He observed, in that original clinical trial, that even a lower starting dose of gemcitabine (i.e. 800mg/ml2 vs. the O’Shaughnessy 1000 mg/m2) resulted in significant toxicity and in his concluding comments in that paper, he suggested 600mg/ml2. At 1000 mg/m2, Dr. O’Shaughnessy’s trial nearly doubled his recommended dose in this patient population. Bottom line: more is not always better. How the role the drug delivery schedule plays in the disease control.