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Methods and compositions for evaluating breast cancer prognosis

A technology for breast cancer and prognosis, which is applied in special data processing applications, instruments, measuring devices, etc., and can solve problems such as specificity and sensitivity method requirements

Inactive Publication Date: 2007-10-17
TRIPATH IMAGING INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Although current prognostic criteria and molecular markers provide some guidance in predicting patient outcome and selecting an appropriate course of treatment, there are still significant gaps in the specificity and sensitivity of methods for evaluating breast cancer prognosis, especially in early node-negative patients need

Method used

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  • Methods and compositions for evaluating breast cancer prognosis
  • Methods and compositions for evaluating breast cancer prognosis
  • Methods and compositions for evaluating breast cancer prognosis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0107] Example 1: Detection of Biomarker Overexpression Using Immunohistochemistry

[0108] Slide preparation

[0109] 4 [mu]M sections of formalin-fixed paraffin-embedded breast tumor tissue samples were cut using a microtome and mounted on SuperFrost+ slides (VWR). The slides were baked in a forced air oven for 20 minutes and then exposed to the Histo-Orienter until the paraffin melted. Slides were washed 3 times with xylene for 5 minutes each to remove paraffin and then rinsed 3 times with absolute ethanol for 2 minutes each.

[0110] Pretreatment and Antigen Retrieval

[0111] To prevent nonspecific background staining, slides were incubated in a hydrogen peroxide / methanol block for 5 min at room temperature. Then replace dH several times with 2 ORinse slides thoroughly.

[0112] To render the antigen ready for antibody binding, slides were incubated in antigen retrieval solution for 5 minutes in a pressure cooker. Allow the slides to cool on the benchtop to room tem...

Embodiment 2

[0119] Example 2: Detection of overexpression of various biomarkers in clinical samples

[0120] About 130 breast tumor tissue samples from different disease stages were collected. The mean age of the patients was 77 years. The actual clinical outcome data for each patient is known and each patient is classified as having a good or poor outcome. In this study, a good outcome was defined as remaining cancer-free for at least 5 years; a poor outcome was defined as experiencing disease recurrence, recurrence, or death within 5 years. The table below represents the number of samples within each diagnostic group analyzed and the actual clinical outcome data.

[0121] stage

good result

bad result

total

T1N0

50

13

63

T1N1

6

4

10

T2N0

26

19

45

T2N1

9

7

16

T3N0

0

3

3

T3N1

0

1

1

Lymph node status

g...

Embodiment 3

[0147] Example 3: Detection of Biomarker Overexpression in Clinical Samples - Pooled Biomarkers

[0148] The data from Example 2 were further analyzed to determine whether the sensitivity and specificity of the methods of the invention could be improved if multiple biomarkers were combined. Thus, combinations of various biomarkers were considered and samples that stained positive for any biomarker in the combination of interest were considered positive. These results are compared to known actual clinical outcome data obtained for each patient and then given as described above for each slide for True Positive (TP), True Negative (TN), False Positive (FP) , the final result of a false negative (FN). Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated for each biomarker combination.

[0149] result

[0150] The results for each combination of biomarkers are summarized below.

[0151] TP

[0152] TP ...

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PUM

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Abstract

The invention provides a method and a composition used for evaluating patients with breast cancer, particularly the prognosis of the patients with the breast cancer at an early stage. The method of the invention comprises the detection of at least one of body samples, particularly the expression of at least two biological markers, wherein, the over-expression of the biological markers or the combination of the biological markers indicates the prognosis of the breast cancer. The body samples in a plurality of implementation proposals are the mammary tissue samples, particularly the primary breast tumor samples. The biological markers of the invention are proteins and / or genes, and the over-expression indicates the good or poor cancer prognosis. The concerned biological markers include the proteins and genes which participate in cell cycle regulation, DNA replication, transcription, signal transduction, cell proliferation, cell invasion, protein hydrolysis or transfer. The biological marker-specific antibody is used on the protein level or the nucleic acid hybridization technology is used on the nucleic acid level for detecting the over-expression of the concerned biological markers in certain aspects of the invention.

Description

field of invention [0001] The present invention relates to methods and compositions for assessing the prognosis of patients with breast cancer, particularly early stage breast cancer. Background of the invention [0002] Breast cancer is the second most common cancer among American women, often just below skin cancer. American women have a one in eight chance of developing breast cancer during their lifetime, and the American Cancer Society estimates that more than 250,000 new breast cancer cases will be reported in the United States this year. Breast cancer is the second leading cause of cancer death in women, with more than 40,000 Americans expected to die from the disease in 2004. [0003] Improved detection methods, population screening tests, and treatment advances in the last decade have significantly improved the outlook for women diagnosed with breast cancer. Currently, about 80 percent of breast cancer cases are diagnosed in the early stage...

Claims

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Application Information

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IPC IPC(8): G01N33/574G06F19/00
Inventor T·J·费希尔C·M·怀特黑德D·P·马利诺斯基R·马塞尔普瓦尔D·莫雷尔
Owner TRIPATH IMAGING INC
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