Method of determining a chemotherapeutic regimen based on glutathione-S-transferase pi expression
AssigneeResponse Genetics, Inc.
InventorKathleen D. Danenberg
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Abstract
The present invention relates to prognostic methods which are useful in medicine, particularly cancer chemotherapy. The object of the invention to provide a method for assessing GST-pi expression levels in fixed or fixed and paraffin embedded tissues and prognosticate the probable resistance or sensitivity of a patient's tumor to treatment with platinum-based therapies by examination of the amount of GST-pi mRNA in a patient's tumor cells and comparing it to a predetermined threshold expression level. More specifically, the invention provides to oligonucleotide primer pair GST-pi and methods comprising their use for detecting levels of GST-pi mRNA.
Claims13
A method for determining a platinum-based chemotherapeutic regimen for treating a tumor in a patient comprising:
- (a) obtaining a tissue sample of the tumor and fixing the sample, to obtain a fixed tumor sample;
- (b) isolating mRNA from the fixed tumor sample;
- (c) subjecting the mRNA to amplification using a pair of oligonucleotide primers capable of amplifying a region of the GST-pi gene, to obtain an amplified sample;
- (d) determining the amount of GST-pi mRNA in the amplified sample;
- (e) comparing the amount of GST-pi mRNA from step (d) to an amount of mRNA of an internal control gene to obtain a relative GST-pi expression level;
- and
- (f) determining a platinum-based chemotherapeutic regimen based on the relative GST-pi expression level in the amplified sample and a predetermined threshold level for GST-pi gene expression.
A method of treating a tumor with a platinum-based chemotherapeutic regimen comprising:
- (a) obtaining a tissue sample of the tumor and fixing the sample, to obtain a fixed tumor sample;
- (b) isolating mRNA from the fixed tumor sample;
- (c) subjecting the mRNA to amplification using a pair of oligonucleotide primers capable of amplifying a region of the GST-pi gene, to obtain an amplified sample;
- (d) determining the amount of GST-pi mRNA in the amplified sample;
- (e) comparing the amount of GST-pi mRNA from step (d) to an amount of mRNA of an internal control gene to obtain a relative GST-pi expression level;
- (f) providing a platinum-based chemotherapeutic regimen comprising a cytotoxic agent when the determined relative GST-pi expression level is below a predetermined threshold value.
A method for determining a platinum-based chemotherapeutic regimen for treating a tumor in a patient comprising:
- (a) obtaining a tissue sample of the tumor and fixing the sample, to obtain a fixed tumor sample;
- (b) isolating mRNA from the fixed tumor sample;
- (c) determining the amount of GST-pi mRNA in the fixed tumor sample;
- (d) comparing the amount of GST-pi mRNA from step (c) to an amount of mRNA of an internal control gene in the fixed tumor sample to obtain a relative GST-pi expression level;
- and
- (e) determining a platinum-based chemotherapeutic regimen based on the relative GST-pi expression level in the fixed tumor sample and a predetermined threshold level for GST-pi gene expression.
Dependencies are inferred from the claim text.