HER2 Support Group Forums - View Single Post - FDA finds Avastin doesn't extend lives in BC patients... ?

gdpawel · 08-11-2010, 02:39 PM

"In any case the issue with all these targeted drugs is we need better biomarkers to pick which patients are more likely to benefit from them to get the most for our buck."

Couldn't have said it any better!

The new targeted drugs mostly need to be combined with active chemotherapy to provide any benefit and the need for predictive tests for individualized therapy selection has increased. Given the technical and conceptual advantages of "functional tumor cell profiling" of cell culture assay, together with their performance and modest efficacy of therapy prediction based on analysis of genome expression, there is reason for renewed interest in them for optimized use of medical treatment of malignant disease.

Cell culture assays are a "functional" biomarker. A functional biomarker providing information about the biomarker uptake rate in tumor cells or on tumor cell surfaces through fluorescence intensity changes. In vitro apoptosis for choosing drugs is not different than a marker like estrogen receptor or CD20 or a gene expression pattern. They are all markers. One is a structural marker, the other is a functional marker. There is no conceptual difference regarding the sort of study and data which is required to "validate" any of them.

Over the past few years, gene expression profiling has been suggested as the best way of determing ex vivo drug sensitivity. However due to most patients being treated with combination chemotherapy, this methodology cannot even be calibrated without the use of "functional profiling" cell culture assays, which can integrate all the gene expression into one convenient test result.

08-11-2010, 02:39 PM	#13
gdpawel Senior Member Join Date: Aug 2006 Location: Pennsylvania Posts: 1,080	Re: FDA finds Avastin doesn't extend lives in BC patients... ? "In any case the issue with all these targeted drugs is we need better biomarkers to pick which patients are more likely to benefit from them to get the most for our buck." Couldn't have said it any better! The new targeted drugs mostly need to be combined with active chemotherapy to provide any benefit and the need for predictive tests for individualized therapy selection has increased. Given the technical and conceptual advantages of "functional tumor cell profiling" of cell culture assay, together with their performance and modest efficacy of therapy prediction based on analysis of genome expression, there is reason for renewed interest in them for optimized use of medical treatment of malignant disease. Cell culture assays are a "functional" biomarker. A functional biomarker providing information about the biomarker uptake rate in tumor cells or on tumor cell surfaces through fluorescence intensity changes. In vitro apoptosis for choosing drugs is not different than a marker like estrogen receptor or CD20 or a gene expression pattern. They are all markers. One is a structural marker, the other is a functional marker. There is no conceptual difference regarding the sort of study and data which is required to "validate" any of them. Over the past few years, gene expression profiling has been suggested as the best way of determing ex vivo drug sensitivity. However due to most patients being treated with combination chemotherapy, this methodology cannot even be calibrated without the use of "functional profiling" cell culture assays, which can integrate all the gene expression into one convenient test result.