Method of determining a chemotherapeutic regimen by assaying gene expression in primary tumors
AssigneeResponse Genetics, Inc.
InventorKathleen D. Danenberg
Life of this patent
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Abstract
The invention relates to a method for determining a chemotherapeutic regimen for an individual, comprising obtaining a mRNA sample from a primary tumor specimen; determining a gene expression level for a tumor gene determinant in the specimen; comparing the gene expression level for the tumor gene determinant with a predetermined threshold value for that gene; and providing a chemotherapeutic regimen comprising a chemotherapeutic agent appropriate for the tumor gene determinant to treat the tumor metastases.
Claims7
A method for determining a chemotherapeutic regimen for treating a metastatic tumor in an individual having a primary and metastatic tumor comprising:
- (a) obtaining a primary tumor specimen;
- (b) determining a level of gene expression of Thymidylate Synthase (TS) in a primary tumor comprising
- (1) determining the level of TS mRNA in the specimen;
- (2) comparing said level of TS mRNA to a level of mRNA of an internal control gene;
- and
- (c) determining a chemotherapeutic regimen for treating the metastatic tumor in the individual based on the level of TS mRNA in the primary tumor specimen and a predetermined threshold level for the TS mRNA.
A method for determining a chemotherapeutic regimen for treating a metastatic tumor in an individual having a primary and metastatic tumor, comprising:
- (a) obtaining a fixed primary tumor specimen;
- (b) determining a level of gene expression for Thymidylate Synthase (TS) in the fixed tumor specimen comprising
- (1) isolating TS mRNA from the fixed tumor specimen by heating in the presence of a solution comprising an effective concentration of a chaotropic agent at a temperature in the range of about 50° C. to about 100° C. and recovering the mRNA from the chaotropic solution;
- (2) subjecting the mRNA to amplification using a pair of oligonucleotide primers capable of amplifying a region of TS to obtain an amplified sample;
- (3) determining the quantity of TS mRNA in the amplified sample;
- (c) comparing the quantity of TS mRNA from step (3) to a quantity of mRNA of an internal control gene;
- and
- (d) determining a chemotherapeutic regimen for treating the metastatic tumor based on the quantity of TS mRNA in the fixed primary tumor specimen and a predetermined threshold level for TS mRNA.
A method for determining a chemotherapeutic regimen for treating a metastatic tumor in an individual having a primary and metastatic tumor, comprising:
- (a) obtaining a fixed, paraffin-embedded (FPE) primary tumor specimen;
- (b) deparaffinizing the FPE specimen to obtain a deparaffinized sample;
- (c) determining a level of gene expression for Thymidylate Synthase (TS) in the deparaffinized sample comprising
- (1) isolating TS mRNA from the deparaffinized sample by heating in the presence of a solution comprising an effective concentration of a chaotropic agent at a temperature in the range of about 50° C. to about 100° C.;
- (2) subjecting the mRNA to amplification using a pair of oligonucleotide primers capable of amplifying a region of TS to obtain an amplified sample;
- (3) determining the quantity of TS mRNA in the amplified sample;
- (d) comparing the quantity of TS mRNA from step (3) to a quantity of mRNA of an internal control gene;
- and
- (e) determining a chemotherapeutic regimen for treating the metastatic tumor based on the quantity of TS mRNA in the deparaffinized primary tumor sample and a predetermined threshold level for TS mRNA.
Dependencies are inferred from the claim text.