# US 8,568,968 B2 · EGFR polymorphisms predict gender-related treatment

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- Number: US 8,568,968 B2
- Document ID: US8568968B2
- Status: Granted
- Kind: B2
- Application number: 12/758,763
- Filed: 2010-04-12
- Published: 2010-11-11
- Granted: 2013-10-29
- Earliest claimed: 2009-04-13
- Assignees: University of Southern California
- Applicants: Heinz-Josef Lenz
- Inventors: Heinz-Josef Lenz
- Web page: https://patentgrep.com/patent/US8568968B2

## CPC

- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- A61K 31/513: having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
- A61P 35/00: Antineoplastic agents
- A61P 35/04: specific for metastasis
- C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
- C12Q 2600/156: Polymorphic or mutational markers
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The invention provides compositions and methods for identifying a gender-specific cancer patient suitable for treatment with various treatment regimens available to cancer patients. After determining if a patient is suitable for therapy, the invention also provides methods for treating these patients.

## Claims

### Claim 1

A method for identifying and treating a female colon cancer patient suitable for a pyrimidine antimetabolite based therapy, comprising screening a cell or tissue sample isolated from the patient for the EGFR polymorphism of R497K and administering an effective amount of the therapy to a patient having the genotype of Arg/Arg for R497K.

### Claim 2 (depends on 1)

The method of claim 1, wherein the colon cancer patient suffers from metastatic colon cancer or advanced colon cancer.

### Claim 3 (depends on 1)

The method of claim 1, wherein the colon patient identified as suitable for the therapy and treated is a patient more likely to experience longer overall survival as compared to a patient not suitable for the therapy.

### Claim 4 (depends on 1)

The method of claim 1, wherein the patient was identified by a method comprising screening a cell or tissue sample isolated from the patient for the EGFR polymorphism of R497K.

### Claim 5 (depends on 1, 2)

The method of claim 1 or 2, wherein the pyrimidine antimetabolite based therapy comprises administration of 5-fluorouracil (5-FU) or a chemical equivalent thereof.

### Claim 6 (depends on 5)

The method of claim 5, wherein the therapy further comprises administration of irinotecan (CPT-11) or a chemical equivalent thereof.

### Claim 7 (depends on 5)

The method of claim 5, wherein the therapy further comprises administration of oxaliplatin or a chemical equivalent thereof.

### Claim 8 (depends on 1, 2)

The method of claim 1 or 2, wherein the therapy is selected from the group consisting of first line therapy, second line therapy, third line therapy, fourth line therapy and fifth line therapy.

### Claim 9 (depends on 1, 2)

The method of claim 1 or 2, wherein the sample comprises a tumor cell, a normal cell adjacent to a tumor, a normal cell corresponding to a tumor tissue type, a blood cell, a peripheral blood lymphocyte or combinations thereof.

### Claim 10 (depends on 1, 2)

The method of claim 1 or 2, wherein the sample is at least one of a fixed tissue, a frozen tissue, a biopsy tissue, a resection tissue, a microdissected tissue, a paraffin-embedded tissue or combinations thereof.

### Claim 11 (depends on 1, 2)

The method of claim 1 or 2, wherein the genotype is determined by a method comprising PCR, PCR-RFLP, sequencing or microarray.

### Claim 12 (depends on 1, 2)

The method of claim 1 or 2, wherein the patient is a human patient.