IP Library Granted Patent US 9,605,318
Granted Patent B2
US 9,605,318 · App. 12/941,877 · Granted Mar 28, 2017

Gene expression markers for predicting response to chemotherapy

Inventors: Joffre B. Baker (Montara, CA); Steven Shak (Hillsborough, CA); Luca Gianni (Milan, IT)
Assignee: Genomic Health, Inc.
C12Q1/6886C12Q2600/106Y10S435/96
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Quick Facts
Patent No.
US 9,605,318
App. No.
12/941,877
Granted
Mar 28, 2017
Kind
B2
Abstract

The present invention provides sets of genes the expression of which is important in the prognosis of cancer. In particular, the invention provides gene expression information useful for predicting whether cancer patients are likely to have a beneficial treatment response to chemotherapy FHIT; MTA1; ErbB4; FUS; BBC3; IGF1R; CD9; TP53BP1; MUC1; IGFBP5; rhoC; RALBP1; STAT3; ERK1; SGCB; DHPS; MGMT; CRIP2; ErbB3; RAP1GDS1; CCND1; PRKCD; Hepsin; AK055699; ZNF38; SEMA3F; COL1A1; BAG1; AKT1; COL1A2; Wnt.5a; PTPD1; RAB6C; GSTM1, BCL2, ESR1; or the corresponding expression product, is determined, said report includes a prediction that said subject has a decreased likelihood of response to chemotherapy.

Claims (33)

1. A method for predicting the response of a human patient diagnosed with breast cancer to chemotherapy and of treating the patient comprising:

extracting RNA from a fresh, frozen, or fixed, paraffin-embedded tissue (FPET) sample comprising cancer cells obtained from said patient;

reverse transcribing an RNA transcript of GBP1 to produce cDNA of GBP1;

amplifying the cDNA of GBP1 using a PCR-based method to produce an amplicon of the RNA transcript of GBP1;

quantitatively assaying a level of the amplicon of the RNA transcript of GBP1;

normalizing said level against a level of an amplicon of at least one reference RNA transcript in the sample to provide a normalized GBP1 amplicon level;

comparing the normalized GBP1 amplicon level to a normalized GBP1 amplicon level in reference samples comprising breast cancer cells;

predicting the response of said patient to chemotherapy, wherein the patient is predicted to have an increased likelihood of response to chemotherapy if the patient has an increased normalized GBP1 amplicon level compared to the GBP1 amplicon level in the reference samples; and

administering chemotherapy to the patient with an increased normalized GBP1 amplicon level compared to the GBP1 amplicon level in the reference samples.

2. The method of claim 1 , wherein said response is a complete pathological response.

3. The method of claim 1 , wherein said breast cancer is invasive breast cancer.

4. The method of claim 1 , wherein said chemotherapy is adjuvant chemotherapy.

5. The method of claim 1 , wherein said chemotherapy is neoadjuvant chemotherapy.

6. The method of claim 5 , wherein said neoadjuvant chemotherapy comprises the administration of a taxane derivative.

7. The method of claim 6 , wherein said taxane is docetaxel or paclitaxel.

8. The method of claim 6 , wherein said neoadjuvant chemotherapy further comprises administration of a member of the anthracycline class of anti-cancer agents.

9. The method of claim 1 , wherein said chemotherapy further comprises the administration of an additional anti-cancer agent.

10. The method of claim 9 , wherein said additional anti-cancer agent is a member of the anthracycline class of anti-cancer agents.

11. The method of claim 10 , wherein said anthracycline is doxorubicin.

12. The method of claim 9 , wherein said additional anti-cancer agent is a topoisomerase inhibitor.

13. The method of claim 1 , wherein the sample is from fine needle, core, or other types of biopsy.

14. The method of claim 1 , further comprising creating a report summarizing the prediction of the response of said patient to chemotherapy.

15. The method of claim 14 , wherein said report includes a recommendation for a treatment modality for said patient.

16. The method of claim 1 , wherein the sample is a fixed, paraffin-embedded tissue (FPET) sample.

17. The method of claim 1 , wherein said chemotherapy comprises the administration of a taxane derivative and further comprises administration of a member of the anthracycline of anti-cancer agents.

18. A method for predicting the response of a human patient diagnosed with breast cancer to chemotherapy-comprising:

extracting RNA from a fresh, frozen, or fixed, paraffin-embedded tissue (FPET) sample comprising cancer cells obtained from said patient;

reverse transcribing an RNA transcript of GBP1 to produce cDNA of GBP1;

amplifying the cDNA of GBP1 using a PCR-based method, wherein the PCR-based method comprises use of a polynucleotide comprising a sequence selected from SEQ ID NO.: 130-132, to produce an amplicon of the RNA transcript of GBP1;

quantitatively assaying a level of the amplicon of the RNA transcript of GBP1;

normalizing said level against a level of an amplicon of at least one reference RNA transcript in the sample to provide a normalized GBP1 amplicon level;

comparing the normalized GBP1 amplicon level to a normalized GBP1 amplicon level in reference samples comprising breast cancer cells; and

predicting the response of said patient to chemotherapy, wherein the patient is predicted to have an increased likelihood of response to chemotherapy if the patient has an increased normalized GBP1 amplicon level compared to the GBP1 amplicon level in the reference samples.

Assignments (5)
TERMINATION AND RELEASE OF SECURITY INTEREST IN PATENT RIGHTS (REEL/FRAME 69898/0380) Recorded Mar 27, 2026
From: JPMORGAN CHASE BANK, N.A.
To: GENOMIC HEALTH, INC.
Reel/Frame 075294/0821 →
PATENT SECURITY AGREEMENT Recorded Jan 14, 2025
From: GENOMIC HEALTH, INC.
To: JPMORGAN CHASE BANK, N.A.
Reel/Frame 069898/0380 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 13, 2016
From: FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI
To: GENOMIC HEALTH, INC.
Reel/Frame 040723/0393 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 18, 2011
From: GIANNI, LUCA
To: ISTITUTO NAZIONALE TUMORI
Reel/Frame 026773/0725 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 18, 2011
From: BAKER, JOFFRE B.; SHAK, STEVEN
To: GENOMIC HEALTH, INC.
Reel/Frame 026773/0764 →
Continuity (3)
Division 11102228 · Apr 7, 2005
Provisional Application 60561035 · Apr 9, 2004
Related Publication 20110129833A1 · Jun 2, 2011