Predicting breast cancer treatment outcome

A breast cancer and anti-breast cancer technology, applied in the direction of biomass pretreatment, microbial measurement/inspection, biomass post-treatment, etc.

Inactive Publication Date: 2007-05-23
阿克丘勒斯生物科学股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Currently, there is no reliable method to identify these non-responding patients

Method used

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  • Predicting breast cancer treatment outcome
  • Predicting breast cancer treatment outcome
  • Predicting breast cancer treatment outcome

Examples

Experimental program
Comparison scheme
Effect test

specific Embodiment approach

[0084] In a first aspect, the present invention relates to gene expression patterns (or profiles or "signatures") capable of distinguishing (or correlating) the survival of breast cancer patients treated with tamoxifen (TAM) or other "anti-estrogen" drugs against breast cancer. ”) identification and application. The methods of the invention employ a number of control cells or tissue samples, such as those known to those of ordinary skill in the art of breast cancer pathology, to be breast cancer cells rather than normal or other non-cancerous cells to identify such expression patterns. Patient outcomes can be correlated with expression data to identify expression patterns that correlate with outcomes following treatment with TAM or other anti-breast cancer "anti-estrogen" drugs. Because the overall gene expression profile varies from person to person, cancer to cancer, and cancer cell to cancer cell, certain cells can be correlated with expressed or underexpressed genes as des...

Embodiment

[0440] Example

[0441] general method

[0442] Patient and tumor selection criteria and trial design

[0443] The criteria for the patients in this study were: female patients with ER-positive breast cancer diagnosed at Massachusetts General Hospital (MGH) during 1987-2000, treated with standard breast surgery (modified radical mastectomy or lumpectomy) ) and radiotherapy followed by 5 years of systemic adjuvant tamoxifen; the patient had not received chemotherapy prior to relapse. Clinical and follow-up data were obtained from the MGH Tumor Registry. There were no missing enrollment data and secondary data validation was performed on all available medical records.

[0444] All tumor specimens collected at initial diagnosis were obtained from frozen and formalin-fixed paraffin-embedded (FFPE) tissue banks at Massachusetts General Hospital. Tumor samples with more than 20% tumor cells were selected, and the median of all...

Embodiment 2

[0467] Identification of differentially expressed genes

[0468] Gene expression pattern analysis was performed using the 22,000-gene oligonucleotide microarray described above. In the initial analysis, RNA isolated from frozen tumor tissue sections taken from the primary biopsy was used. The resulting expression data set was first filtered according to the total variance of individual genes, and the top 5,475 highly differential genes (75%) were selected for further study. Using this reduced data set, a t-test comparing tamoxifen responders and lung responders was performed for each gene, resulting in the identification of 19 differentially expressed genes with a P value of 0.001 (Table 2). For treatment outcomes random permutation of patient types and repetition of the t-test procedure 2,000 times, the estimated probability of selecting by chance such a much differentially or more differentially expressed gene is about 0.04. Thus, this analysis reveal...

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Abstract

Methods and compositions are provided for the identification of expression signatures in ER+ breast cancer cases, where the signatures correlate with responsiveness, or lack thereof, to treatment with tamoxifen or another antiestrogen agent against breast cancer. The signature profiles are identified based upon sampling of reference breast tissue samples from independent cases of breast cancer and provide a reliable set of molecular criteria for predicting the efficacy of treating a subject with breast cancer with tamoxifen or another antiestrogen agent against breast cancer. Additional methods and compositions are provided for predicting responsiveness to tamoxifen or another antiestrogen agent against breast cancer in cases of breast cancer by use of multiple biomarkers. Two biomarkers display increased expression correlated with tamoxifen response while two other biomarkers display decreased expression correlated with tamoxifen response.

Description

[0001] related application [0002] This application claims U.S. Patent Applications 60 / 504,087 and 60 / 547,199, filed September 19, 2003, and February 23, 2004, respectively, and U.S. Priority of patent applications 10 / 727,100 and 10 / 773,761. The contents of all four applications are incorporated herein by reference as if fully set forth. field of invention [0003] The present invention relates to the identification and use of tamoxifen (Nolvadex) and other "anti-estrogen" drugs for clinical use against breast cancer, including other "selective estrogen receptor modulators" ("SERMs") , Gene expression profiles or patterns associated with "selective estrogen receptor down-regulator" ("SERD") and aromatase inhibitor ("AI") treatment of breast cancer. Specifically, the present invention provides the identification of gene sequences whose expression correlates with survival and breast cancer recurrence in female patients treated with tamoxifen or other "anti-estrogen" drugs aga...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/68C12M1/34
CPCC12Q2600/112C12Q2600/154C12Q1/6886C12Q2600/158C12Q2600/106
Inventor 马小骏M·G·厄兰德D·C·斯格罗E·恩赖特
Owner 阿克丘勒斯生物科学股份有限公司
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