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Gene expression profiling for guiding adjuvant chemotherapy decisions in women with early breast cancer: an evidence-based and economic analysis.

Abstract In February 2010, the Medical Advisory Secretariat (MAS) began work on evidence-based reviews of published literature surrounding three pharmacogenomic tests. This project came about when Cancer Care Ontario (CCO) asked MAS to provide evidence-based analyses on the effectiveness and cost-effectiveness of three oncology pharmacogenomic tests currently in use in Ontario.Evidence-based analyses have been prepared for each of these technologies. These have been completed in conjunction with internal and external stakeholders, including a Provincial Expert Panel on Pharmacogenomics (PEPP). Within the PEPP, subgroup committees were developed for each disease area. For each technology, an economic analysis was also completed by the Toronto Health Economics and Technology Assessment Collaborative (THETA) and is summarized within the reports.THE FOLLOWING REPORTS CAN BE PUBLICLY ACCESSED AT THE MAS WEBSITE AT: www.health.gov.on.ca/mas or at www.health.gov.on.ca/english/providers/program/mas/mas_about.htmlGENE EXPRESSION PROFILING FOR GUIDING ADJUVANT CHEMOTHERAPY DECISIONS IN WOMEN WITH EARLY BREAST CANCER: An Evidence-Based and Economic AnalysisEpidermal Growth Factor Receptor Mutation (EGFR) Testing for Prediction of Response to EGFR-Targeting Tyrosine Kinase Inhibitor (TKI) Drugs in Patients with Advanced Non-Small-Cell Lung Cancer: An Evidence-Based and Ecopnomic AnalysisK-RAS testing in Treatment Decisions for Advanced Colorectal Cancer: an Evidence-Based and Economic Analysis
PMID
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Authors

Mayor MeshTerms
Keywords
Journal Title ontario health technology assessment series
Publication Year Start
%A Health Quality Ontario
%T Gene expression profiling for guiding adjuvant chemotherapy decisions in women with early breast cancer: an evidence-based and economic analysis.
%J Ontario health technology assessment series, vol. 10, no. 23, pp. 1-57
%D 12/2010
%V 10
%N 23
%M eng
%B In February 2010, the Medical Advisory Secretariat (MAS) began work on evidence-based reviews of published literature surrounding three pharmacogenomic tests. This project came about when Cancer Care Ontario (CCO) asked MAS to provide evidence-based analyses on the effectiveness and cost-effectiveness of three oncology pharmacogenomic tests currently in use in Ontario.Evidence-based analyses have been prepared for each of these technologies. These have been completed in conjunction with internal and external stakeholders, including a Provincial Expert Panel on Pharmacogenomics (PEPP). Within the PEPP, subgroup committees were developed for each disease area. For each technology, an economic analysis was also completed by the Toronto Health Economics and Technology Assessment Collaborative (THETA) and is summarized within the reports.THE FOLLOWING REPORTS CAN BE PUBLICLY ACCESSED AT THE MAS WEBSITE AT: www.health.gov.on.ca/mas or at www.health.gov.on.ca/english/providers/program/mas/mas_about.htmlGENE EXPRESSION PROFILING FOR GUIDING ADJUVANT CHEMOTHERAPY DECISIONS IN WOMEN WITH EARLY BREAST CANCER: An Evidence-Based and Economic AnalysisEpidermal Growth Factor Receptor Mutation (EGFR) Testing for Prediction of Response to EGFR-Targeting Tyrosine Kinase Inhibitor (TKI) Drugs in Patients with Advanced Non-Small-Cell Lung Cancer: An Evidence-Based and Ecopnomic AnalysisK-RAS testing in Treatment Decisions for Advanced Colorectal Cancer: an Evidence-Based and Economic Analysis
%P 1
%L 57
%W PHY
%G AUTHOR
%R 2010.......10....1.

@Article{HealthQualityOntario2010,
author="{Health Quality Ontario}",
title="Gene expression profiling for guiding adjuvant chemotherapy decisions in women with early breast cancer: an evidence-based and economic analysis.",
journal="Ontario health technology assessment series",
year="2010",
month="Dec",
day="01",
volume="10",
number="23",
pages="1--57",
abstract="In February 2010, the Medical Advisory Secretariat (MAS) began work on evidence-based reviews of published literature surrounding three pharmacogenomic tests. This project came about when Cancer Care Ontario (CCO) asked MAS to provide evidence-based analyses on the effectiveness and cost-effectiveness of three oncology pharmacogenomic tests currently in use in Ontario.Evidence-based analyses have been prepared for each of these technologies. These have been completed in conjunction with internal and external stakeholders, including a Provincial Expert Panel on Pharmacogenomics (PEPP). Within the PEPP, subgroup committees were developed for each disease area. For each technology, an economic analysis was also completed by the Toronto Health Economics and Technology Assessment Collaborative (THETA) and is summarized within the reports.THE FOLLOWING REPORTS CAN BE PUBLICLY ACCESSED AT THE MAS WEBSITE AT: www.health.gov.on.ca/mas or at www.health.gov.on.ca/english/providers/program/mas/mas\_about.htmlGENE EXPRESSION PROFILING FOR GUIDING ADJUVANT CHEMOTHERAPY DECISIONS IN WOMEN WITH EARLY BREAST CANCER: An Evidence-Based and Economic AnalysisEpidermal Growth Factor Receptor Mutation (EGFR) Testing for Prediction of Response to EGFR-Targeting Tyrosine Kinase Inhibitor (TKI) Drugs in Patients with Advanced Non-Small-Cell Lung Cancer: An Evidence-Based and Ecopnomic AnalysisK-RAS testing in Treatment Decisions for Advanced Colorectal Cancer: an Evidence-Based and Economic Analysis",
issn="1915-7398",
url="http://www.ncbi.nlm.nih.gov/pubmed/23074401",
language="eng"
}

%0 Journal Article
%T Gene expression profiling for guiding adjuvant chemotherapy decisions in women with early breast cancer: an evidence-based and economic analysis.
%A Health Quality Ontario
%J Ontario health technology assessment series
%D 2010
%8 December 01
%V 10
%N 23
%@ 1915-7398
%G eng
%F HealthQualityOntario2010
%X In February 2010, the Medical Advisory Secretariat (MAS) began work on evidence-based reviews of published literature surrounding three pharmacogenomic tests. This project came about when Cancer Care Ontario (CCO) asked MAS to provide evidence-based analyses on the effectiveness and cost-effectiveness of three oncology pharmacogenomic tests currently in use in Ontario.Evidence-based analyses have been prepared for each of these technologies. These have been completed in conjunction with internal and external stakeholders, including a Provincial Expert Panel on Pharmacogenomics (PEPP). Within the PEPP, subgroup committees were developed for each disease area. For each technology, an economic analysis was also completed by the Toronto Health Economics and Technology Assessment Collaborative (THETA) and is summarized within the reports.THE FOLLOWING REPORTS CAN BE PUBLICLY ACCESSED AT THE MAS WEBSITE AT: www.health.gov.on.ca/mas or at www.health.gov.on.ca/english/providers/program/mas/mas_about.htmlGENE EXPRESSION PROFILING FOR GUIDING ADJUVANT CHEMOTHERAPY DECISIONS IN WOMEN WITH EARLY BREAST CANCER: An Evidence-Based and Economic AnalysisEpidermal Growth Factor Receptor Mutation (EGFR) Testing for Prediction of Response to EGFR-Targeting Tyrosine Kinase Inhibitor (TKI) Drugs in Patients with Advanced Non-Small-Cell Lung Cancer: An Evidence-Based and Ecopnomic AnalysisK-RAS testing in Treatment Decisions for Advanced Colorectal Cancer: an Evidence-Based and Economic Analysis
%U http://www.ncbi.nlm.nih.gov/pubmed/23074401
%P 1-57

PT Journal
AU Health Quality Ontario
TI Gene expression profiling for guiding adjuvant chemotherapy decisions in women with early breast cancer: an evidence-based and economic analysis.
SO Ontario health technology assessment series
JI Ont Health Technol Assess Ser
PD 12
PY 2010
BP 1
EP 57
VL 10
IS 23
LA eng
AB In February 2010, the Medical Advisory Secretariat (MAS) began work on evidence-based reviews of published literature surrounding three pharmacogenomic tests. This project came about when Cancer Care Ontario (CCO) asked MAS to provide evidence-based analyses on the effectiveness and cost-effectiveness of three oncology pharmacogenomic tests currently in use in Ontario.Evidence-based analyses have been prepared for each of these technologies. These have been completed in conjunction with internal and external stakeholders, including a Provincial Expert Panel on Pharmacogenomics (PEPP). Within the PEPP, subgroup committees were developed for each disease area. For each technology, an economic analysis was also completed by the Toronto Health Economics and Technology Assessment Collaborative (THETA) and is summarized within the reports.THE FOLLOWING REPORTS CAN BE PUBLICLY ACCESSED AT THE MAS WEBSITE AT: www.health.gov.on.ca/mas or at www.health.gov.on.ca/english/providers/program/mas/mas_about.htmlGENE EXPRESSION PROFILING FOR GUIDING ADJUVANT CHEMOTHERAPY DECISIONS IN WOMEN WITH EARLY BREAST CANCER: An Evidence-Based and Economic AnalysisEpidermal Growth Factor Receptor Mutation (EGFR) Testing for Prediction of Response to EGFR-Targeting Tyrosine Kinase Inhibitor (TKI) Drugs in Patients with Advanced Non-Small-Cell Lung Cancer: An Evidence-Based and Ecopnomic AnalysisK-RAS testing in Treatment Decisions for Advanced Colorectal Cancer: an Evidence-Based and Economic Analysis
ER

PMID- 23074401
OWN - NLM
STAT- PubMed-not-MEDLINE
DA  - 20121017
DCOM- 20121018
LR  - 20151026
IS  - 1915-7398 (Electronic)
IS  - 1915-7398 (Linking)
VI  - 10
IP  - 23
DP  - 2010
TI  - Gene expression profiling for guiding adjuvant chemotherapy decisions in women
      with early breast cancer: an evidence-based and economic analysis.
PG  - 1-57
AB  - In February 2010, the Medical Advisory Secretariat (MAS) began work on
      evidence-based reviews of published literature surrounding three pharmacogenomic 
      tests. This project came about when Cancer Care Ontario (CCO) asked MAS to
      provide evidence-based analyses on the effectiveness and cost-effectiveness of
      three oncology pharmacogenomic tests currently in use in Ontario.Evidence-based
      analyses have been prepared for each of these technologies. These have been
      completed in conjunction with internal and external stakeholders, including a
      Provincial Expert Panel on Pharmacogenomics (PEPP). Within the PEPP, subgroup
      committees were developed for each disease area. For each technology, an economic
      analysis was also completed by the Toronto Health Economics and Technology
      Assessment Collaborative (THETA) and is summarized within the reports.THE
      FOLLOWING REPORTS CAN BE PUBLICLY ACCESSED AT THE MAS WEBSITE AT:
      www.health.gov.on.ca/mas or at
      www.health.gov.on.ca/english/providers/program/mas/mas_about.htmlGENE EXPRESSION 
      PROFILING FOR GUIDING ADJUVANT CHEMOTHERAPY DECISIONS IN WOMEN WITH EARLY BREAST 
      CANCER: An Evidence-Based and Economic AnalysisEpidermal Growth Factor Receptor
      Mutation (EGFR) Testing for Prediction of Response to EGFR-Targeting Tyrosine
      Kinase Inhibitor (TKI) Drugs in Patients with Advanced Non-Small-Cell Lung
      Cancer: An Evidence-Based and Ecopnomic AnalysisK-RAS testing in Treatment
      Decisions for Advanced Colorectal Cancer: an Evidence-Based and Economic Analysis
      OBJECTIVE: To review and synthesize the available evidence regarding the
      laboratory performance, prognostic value, and predictive value of Oncotype-DX for
      the target population. CLINICAL NEED: CONDITION AND TARGET POPULATION The target 
      population of this review is women with newly diagnosed early stage (stage
      I-IIIa) invasive breast cancer that is estrogen-receptor (ER) positive and/or
      progesterone-receptor (PR) positive. Much of this review, however, is relevant
      for women with early stage (I and II) invasive breast cancer that is specifically
      ER positive, lymph node (LN) negative and human epidermal growth factor receptor 
      2 (HER-2/neu) negative. This refined population represents an estimated incident 
      population of 3,315 new breast cancers in Ontario (according to 2007 data).
      Currently it is estimated that only 15% of these women will develop a distant
      metastasis at 10 years; however, a far great proportion currently receive
      adjuvant chemotherapy, suggesting that more women are being treated with
      chemotherapy than can benefit. There is therefore a need to develop better
      prognostic and predictive tools to improve the selection of women that may
      benefit from adjuvant chemotherapy. TECHNOLOGY OF CONCERN: The Oncotype-DX Breast
      Cancer Assay (Genomic Health, Redwood City, CA) quantifies gene expression for 21
      genes in breast cancer tissue by performing reverse transcription polymerase
      chain reaction (RT-PCR) on formalin-fixed paraffin-embedded (FFPE) tumour blocks 
      that are obtained during initial surgery (lumpectomy, mastectomy, or core biopsy)
      of women with early breast cancer that is newly diagnosed. The panel of 21 genes 
      include genes associated with tumour proliferation and invasion, as well as other
      genes related to HER-2/neu expression, ER expression, and progesterone receptor
      (PR) expression. RESEARCH QUESTIONS: What is the laboratory performance of
      Oncotype-DX?How reliable is Oncotype-DX (i.e., how repeatable and reproducible is
      Oncotype-DX)?How often does Oncotype-DX fail to give a useable result?What is the
      prognostic value of Oncotype-DX?Is Oncotype-DX recurrence score associated with
      the risk of distant recurrence or death due to any cause in women with early
      breast cancer receiving tamoxifen?What is the predictive value of
      Oncotype-DX?Does Oncoytpe-DX recurrence score predict significant benefit in
      terms of improvements in 10-year distant recurrence or death due to any cause for
      women receiving tamoxifen plus chemotherapy in comparison to women receiving
      tamoxifen alone?How does Oncotype-DX compare to other known predictors of risk
      such as Adjuvant! Online?How does Oncotype-DX impact patient quality of life and 
      clinical/patient decision-making? RESEARCH METHODS: LITERATURE SEARCH: SEARCH
      STRATEGY: A literature search was performed on March 19(th), 2010 using OVID
      MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the
      Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane
      Library, and the International Agency for Health Technology Assessment (INAHTA)
      for studies published from January 1(st), 2006 to March 19(th), 2010. A starting 
      search date of January 1(st), 2006 was because a comprehensive systematic review 
      of Oncotype-DX was identified in preliminary literature searching. This
      systematic review, by Marchionni et al. (2008), included literature up to January
      1(st), 2007. All studies identified in the review by Marchionni et al. as well as
      those identified in updated literature searching were used to form the
      evidentiary base of this review. The quality of the overall body of evidence was 
      identified as high, moderate, low or very low according to GRADE methodology.
      INCLUSION CRITERIA: Any observational trial, controlled clinical trial,
      randomized controlled trial (RCT), meta-analysis or systematic review that
      reported on the laboratory performance, prognostic value and/or predictive value 
      of Oncotype-DX testing, or other outcome relevant to the Key Questions, specific 
      to the target population was included. EXCLUSION CRITERIA: Studies that did not
      report original data or original data analysis,Studies published in a language
      other than English,Studies reported only in abstract or as poster presentations
      (such publications were not sought nor included in this review since the MAS does
      not generally consider evidence that is not subject to peer review nor does the
      MAS consider evidence that lacks detailed description of methodology). OUTCOMES
      OF INTEREST: Outcomes of interest varied depending on the Key Question. For the
      Key Questions of prognostic and predictive value (Key Questions #2 and #3), the
      prospectively defined primary outcome was risk of 10-year distant recurrence. The
      prospectively defined secondary outcome was 10-year death due to any cause (i.e.,
      overall survival). All additional outcomes such as risk of locoregional
      recurrence or disease-free survival (DFS) were not prospectively determined for
      this review but were reported as presented in included trials; these outcomes are
      referenced as tertiary outcomes in this review. Outcomes for other Key Questions 
      (i.e., Key Questions #1, #4 and #5) were not prospectively defined due to the
      variability in endpoints relevant for these questions. SUMMARY OF FINDINGS: A
      total of 26 studies were included. Of these 26 studies, only five studies were
      relevant to the primary questions of this review (Key Questions #2 and #3). The
      following conclusions were drawn from the entire body of evidence: There is a
      lack of external validation to support the reliability of Oncotype-DX; however,
      the current available evidence derived from internal industry validation studies 
      suggests that Oncotype-DX is reliable (i.e., Oncotype-DX is repeatable and
      reproducible).Current available evidence suggests a moderate failure rate of
      Oncotype-DX testing; however, the failure rate observed across clinical trials
      included in this review is likely inflated; the current Ontario experience
      suggests an acceptably lower rate of test failure.In women with newly diagnosed
      early breast cancer (stage I-II) that is estrogen-receptor positive and/or
      progesterone-receptor positive and lymph-node negative:There is low quality
      evidence that Oncotype-DX has prognostic value in women who are being treated
      with adjuvant tamoxifen or anastrozole (the latter for postmenopausal women
      only),There is very low quality evidence that Oncotype-DX can predict which women
      will benefit from adjuvant CMF/MF chemotherapy in women being treated with
      adjuvant tamoxifen.In postmenopausal women with newly diagnosed early breast
      cancer that is estrogen-receptor positive and/or progesterone-receptor positive
      and lymph-node positive:There is low quality evidence that Oncotype-DX has
      limited prognostic value in women who are being treated with adjuvant tamoxifen
      or anastrozole,There is very low quality evidence that Oncotype-DX has limited
      predictive value for predicting which women will benefit from adjuvant CAF
      chemotherapy in women who are being treated with adjuvant tamoxifen.There are
      methodological and statistical limitations that affect both the generalizability 
      of the current available evidence, as well as the magnitude and statistical
      strength of the observed effect sizes; in particular:Of the major predictive
      trials, Oncotype-DX scores were only produced for a small subset of women (<40%
      of the original randomized population) potentially disabling the effects of
      treatment randomization and opening the possibility of selection bias;Data is not
      specific to HER-2/neu-negative women;There were limitations with multivariate
      statistical analyses.Additional trials of observational design may provide
      further validation of the prognostic and predictive value of Oncotype-DX;
      however, it is unlikely that prospective or randomized data will become available
      in the near future due to ethical, time and resource considerations.There is
      currently insufficient evidence investigating how Oncoytpe-DX compares to other
      known prognostic estimators of risk, such as Adjuvant! Online, and there is
      insufficient evidence investigating how Oncotype-DX would impact
      clinician/patient decision-making in a setting generalizable to Ontario.
CN  - Health Quality Ontario
LA  - eng
PT  - Journal Article
DEP - 20101201
PL  - Canada
TA  - Ont Health Technol Assess Ser
JT  - Ontario health technology assessment series
JID - 101521610
PMC - PMC3382301
OID - NLM: PMC3382301
EDAT- 2010/01/01 00:00
MHDA- 2010/01/01 00:01
CRDT- 2012/10/18 06:00
PHST- 2010/12/01 [epublish]
PST - ppublish
SO  - Ont Health Technol Assess Ser. 2010;10(23):1-57. Epub 2010 Dec 1.
TY  - JOUR
AU  - Health Quality Ontario
PY  - 2010/12/01
TI  - Gene expression profiling for guiding adjuvant chemotherapy decisions in women with early breast cancer: an evidence-based and economic analysis.
T2  - Ont Health Technol Assess Ser
JO  - Ontario health technology assessment series
SP  - 1
EP  - 57
VL  - 10
IS  - 23
N2  - In February 2010, the Medical Advisory Secretariat (MAS) began work on evidence-based reviews of published literature surrounding three pharmacogenomic tests. This project came about when Cancer Care Ontario (CCO) asked MAS to provide evidence-based analyses on the effectiveness and cost-effectiveness of three oncology pharmacogenomic tests currently in use in Ontario.Evidence-based analyses have been prepared for each of these technologies. These have been completed in conjunction with internal and external stakeholders, including a Provincial Expert Panel on Pharmacogenomics (PEPP). Within the PEPP, subgroup committees were developed for each disease area. For each technology, an economic analysis was also completed by the Toronto Health Economics and Technology Assessment Collaborative (THETA) and is summarized within the reports.THE FOLLOWING REPORTS CAN BE PUBLICLY ACCESSED AT THE MAS WEBSITE AT: www.health.gov.on.ca/mas or at www.health.gov.on.ca/english/providers/program/mas/mas_about.htmlGENE EXPRESSION PROFILING FOR GUIDING ADJUVANT CHEMOTHERAPY DECISIONS IN WOMEN WITH EARLY BREAST CANCER: An Evidence-Based and Economic AnalysisEpidermal Growth Factor Receptor Mutation (EGFR) Testing for Prediction of Response to EGFR-Targeting Tyrosine Kinase Inhibitor (TKI) Drugs in Patients with Advanced Non-Small-Cell Lung Cancer: An Evidence-Based and Ecopnomic AnalysisK-RAS testing in Treatment Decisions for Advanced Colorectal Cancer: an Evidence-Based and Economic Analysis
SN  - 1915-7398
UR  - http://www.ncbi.nlm.nih.gov/pubmed/23074401
ID  - HealthQualityOntario2010
ER  - 
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