Economic analysis of targeting chemotherapy using a 21-gene RT-PCR assay in lymph-node-negative, estrogen-receptor-positive, early-stage breast cancer.

OBJECTIVE To appraise the economics of a recurrence score (RS), based on an assay that predicts distant recurrence-free survival in lymph-node-negative (LN-), estrogen-receptor-positive (ER+) patients with early-stage breast cancer receiving tamoxifen. STUDY DESIGN Cost-utility analyses using a decision analytic model. METHODS Using a Markov model, we forecast overall survival, costs, and cost effectiveness of using the RS in patients classified as having low or high risk of distant recurrence based on National Comprehensive Cancer Network (NCCN) clinical guidelines. Data from a large multicenter clinical trial (NSABP B-14) were analyzed to derive risk classification based on guideline criteria and RS assignments. Efficacy of adjuvant chemotherapy (CT) on distant recurrence-free survival (DRFS) was based on published meta-analyses of CT trials. The analysis took a societal perspective, considering survival, quality of life, and relevant costs. RESULTS Fifty-three patients (8%) were classified as having low risk of distant recurrence by NCCN guidelines and the RS reclassified 15 of these patients (28%) to an intermediate/high-risk group. The remaining 615 patients (92%) were classified at high risk of distant recurrence by NCCN guidelines and the RS reclassified 300 of these patients (49%) to a low-risk group. Among a hypothetical cohort of 100 patients, RS is predicted on average to increase quality-adjusted survival by 8.6 years and reduce overall costs by $202 828. RS was cost saving in more than two-thirds of probabilistic simulations, with cost effectiveness most influenced by the propensity to administer CT based on RS results, and by the proportion of patients at low risk as defined by NCCN guidelines. CONCLUSIONS The RS predicts more accurately than current guidelines recurrence risk in LN-, ER+ patients with early-stage breast cancer. If applied appropriately, the assay is predicted to increase quality-adjusted survival and save costs.

[1]  R. Gelber,et al.  Meeting highlights: international expert consensus on the primary therapy of early breast cancer 2005. , 2005, Annals of oncology : official journal of the European Society for Medical Oncology.

[2]  Adrienne Y. Stith,et al.  Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care , 2005 .

[3]  M. Cronin,et al.  A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. , 2004, The New England journal of medicine.

[4]  R. Bast,et al.  Individualized care for patients with cancer - a work in progress. , 2004, The New England journal of medicine.

[5]  Roman Rouzier,et al.  Gene expression profiles in paraffin-embedded core biopsy tissue predict response to chemotherapy in women with locally advanced breast cancer. , 2004, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[6]  G. Hortobagyi,et al.  Influence of prior therapy on breast cancer survivors' preferences for adjuvant systemic therapy in hypothetical scenarios. , 2004, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[7]  A. Garber.  Cost-effectiveness and evidence evaluation as criteria for coverage policy. , 2004, Health affairs.

[8]  Gerard F Anderson,et al.  U.S. health care spending in an international context. , 2004, Health affairs.

[9]  J. Coebergh,et al.  Breast carcinoma diagnosis, treatment, and prognosis before and after the introduction of mass mammographic screening , 2004, Cancer.

[10]  Ken Garber,et al.  Gene Expression Tests Foretell Breast Cancer's Future , 2004, Science.

[11]  M. Weinstein,et al.  HER-2 testing and trastuzumab therapy for metastatic breast cancer: a cost-effectiveness analysis. , 2004, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[12]  C. Zuiani,et al.  Proteomic evaluation of core biopsy specimens from breast lesions. , 2004, Cancer letters.

[13]  B. Bloom,et al.  Breast cancer treatment in clinical practice compared to best evidence and practice guidelines , 2004, British Journal of Cancer.

[14]  C. Sotiriou,et al.  New data on chemotherapy in the adjuvant setting. , 2003, Breast.

[15]  M. Piccart,et al.  The best use of chemotherapy in the adjuvant setting. , 2003, Breast.

[16]  H. Muss.  Adjuvant therapy for older women with breast cancer. , 2003, Breast.

[17]  K. Pritchard.  The best use of adjuvant endocrine treatments. , 2003, Breast.

[18]  J. Bergh.  Best use of adjuvant systemic therapies II, chemotherapy aspects: dose of chemotherapy-cytotoxicity, duration and responsiveness. , 2003, Breast.

[19]  R. Gelber,et al.  Comments on the St. Gallen Consensus 2003 on the Primary Therapy of Early Breast Cancer. , 2003, Breast.

[20]  J. Daling,et al.  Risk of mortality by histologic type of breast cancer among women aged 50 to 79 years. , 2003, Archives of internal medicine.

[21]  R. Gelber,et al.  Meeting highlights: updated international expert consensus on the primary therapy of early breast cancer. , 2003, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[22]  Larry Norton,et al.  Long‐term adjustment of survivors of early‐stage breast carcinoma, 20 years after adjuvant chemotherapy , 2003, Cancer.

[23]  Syed Mohsin,et al.  Gene expression profiling for the prediction of therapeutic response to docetaxel in patients with breast cancer , 2003, The Lancet.

[24]  Carlos Caldas,et al.  Predictive cancer genomics—what do we need? , 2003, The Lancet.

[25]  Peter A Ubel,et al.  What is the price of life and why doesn't it increase at the rate of inflation? , 2003, Archives of internal medicine.

[26]  A. Goldhirsch,et al.  Adjuvant systemic therapies in women with breast cancer: an audit of clinical practice in Italy. , 2003, Annals of oncology : official journal of the European Society for Medical Oncology.

[27]  B. Röhrig,et al.  A population-based study on variations in the use of adjuvant systemic therapy on postmenopausal patients with early stage breast cancer , 2003, Journal of Cancer Research and Clinical Oncology.

[28]  S. Mariani.  Functional genomics: improving cancer prognosis and drug development. , 2003, MedGenMed : Medscape general medicine.

[29]  A. Nattinger.  Quality of care for breast cancer. , 2003, Medical care.

[30]  N. Bickell,et al.  Physicians’ Reasons for Failing to Deliver Effective Breast Cancer Care: A Framework for Underuse , 2003, Medical care.

[31]  S. Crystal,et al.  Medical expenditures during the last year of life: findings from the 1992-1996 Medicare current beneficiary survey. , 2002, Health services research.

[32]  G. Parrinello,et al.  Are International Guidelines for the Prescription of Adjuvant Treatment for Early Breast Cancer Followed in Clinical Practice? Results of a Population-Based Study on 1547 Patients , 2002, Tumori.

[33]  Eduardo Bruera,et al.  Treatment decisions for breast carcinoma , 2002, Cancer.

[34]  L. Clegg,et al.  Adjuvant therapy for breast cancer: practice patterns of community physicians. , 2002, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[35]  R. Weinberg,et al.  Functional genomics and the breast cancer problem. , 2002, Cancer cell.

[36]  R. Gelber,et al.  Meeting highlights: international consensus panel on the treatment of primary breast cancer. , 2002, Journal of the National Cancer Institute.

[37]  R. Gelber,et al.  Polychemotherapy for early breast cancer , 2001, The Lancet.

[38]  R. Gelber,et al.  Meeting highlights: International Consensus Panel on the Treatment of Primary Breast Cancer. Seventh International Conference on Adjuvant Therapy of Primary Breast Cancer. , 2001, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[39]  S. Jansen,et al.  Stability of Patients’ Preferences for Chemotherapy , 2001, Medical decision making : an international journal of the Society for Medical Decision Making.

[40]  J. Lynn,et al.  Medicare beneficiaries' costs of care in the last year of life. , 2001, Health affairs.

[41]  W. Doucette,et al.  Influences on oncologists' adoption of new agents in adjuvant chemotherapy of breast cancer. , 2001, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[42]  P J Neumann,et al.  Systematic overview of cost-utility assessments in oncology. , 2000, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[43]  J. de Haes,et al.  Adjuvant chemotherapy in node negative breast cancer: patterns of use and oncologists' preferences. , 2000, Annals of oncology : official journal of the European Society for Medical Oncology.

[44]  Mike Clarke,et al.  Polychemotherapy for early breast cancer: an overview of the randomised trials , 1998, The Lancet.

[45]  R. Peto,et al.  Variation in use of adjuvant tamoxifen , 1998, The Lancet.

[46]  S. Coughlin,et al.  Mammography Use Helps To Explain Differences in Breast Cancer Stage at Diagnosis between Older Black and White Women , 1998, Annals of Internal Medicine.

[47]  A. Garber,et al.  Economic foundations of cost-effectiveness analysis. , 1997, Journal of health economics.

[48]  D. Rubens,et al.  Targeting the TMPRSS2/ERG fusion mRNA using liposomal nanovectors enhances docetaxel treatment in prostate cancer , 2019, The Prostate.

[49]  J R Beck,et al.  Markov Models in Medical Decision Making , 1993, Medical decision making : an international journal of the Society for Medical Decision Making.

[50]  B. Hillner,et al.  Should the elderly receive chemotherapy for node-negative breast cancer? A cost-effectiveness analysis examining total and active life-expectancy outcomes. , 1993, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[51]  M. Weinstein,et al.  Cost effectiveness of prophylactic intravenous immune globulin in chronic lymphocytic leukemia. , 1991, The New England journal of medicine.

[52]  B E Hillner,et al.  Efficacy and cost effectiveness of adjuvant chemotherapy in women with node-negative breast cancer. A decision-analysis model. , 1991, The New England journal of medicine.

[53]  S G Pauker,et al.  The toss-up. , 1981, The New England journal of medicine.

[54]  J. Mathias,et al.  Program , 1970, 2021 Symposium on VLSI Technology.

[55]  M. Stano,et al.  An analysis of the cost of clinical surveillance after primary therapy for women with early stage invasive breast cancer , 2005, Breast Cancer Research and Treatment.

[56]  M. Cronin,et al.  Gene expression profiles of paraffin-embedded core biopsy tissue predict response to chemotherapy in patients with locally advanced breast cancer. , 2004, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[57]  A. Jemal,et al.  Cancer Statistics, 2004 , 2004, CA: a cancer journal for clinicians.

[58]  Milton C Weinstein,et al.  Principles of good practice for decision analytic modeling in health-care evaluation: report of the ISPOR Task Force on Good Research Practices--Modeling Studies. , 2003, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[59]  B. Smedley,et al.  Unequal Treatment: Con-fronting Racial and Ethnic Disparities in Health Care , 2002 .

[60]  S. Singer,et al.  Prospects for improved decision making about medical necessity. , 2001, Health affairs.

[61]  K. Titus.  Reclassifying cancer, guided by genomics. , 2001, CAP today.

[62]  C. Somkin,et al.  Cost of Care for Cancer in a Health Maintenance Organization , 1997, Health care financing review.