Steven J. Katz MD, MPH Professor, Departments of Medicine and Health Management and Policy

Transcription

1 Steven J. Katz MD, MPH Professor, Departments of Medicine and Health Management and Policy ddress the challenges of individualizing treatment for breast cancer Describe the evolving status of evaluative testing Reflect on lessons about context and consequences of advances in personalized medicine for patients with breast cancer 1

2 October 24, 2011 Mammogram s Role as Savior Is Tested Tara Parker-Pope In-situ Local Regional Distant nderson et al. J Clin Oncol :

3 Net benefit of treatment options is often small and difficult to formulate for individual patients Management and treatment options are morbid and burdensome Increasing recognition of potential harm if treatment is too aggressive Primum non nocere- First do no harm Studies underway to evaluate strategies to reduce morbidity and burden on patients Surgery: Less vs more Radiation: Omit, less vs more Chemotherapy: Omit 3

4 Individualized care is achieved when The right evaluative tests are ordered and the results are used in the right way Treatment decisions are largely driven by evidence-based clinical indications that address expected net benefit Decision quality is high: the patient is informed and her preferences and values are incorporated into those decisions Incident diagnosis Most of the beneficial treatments are delivered or initiated in the first year of diagnosis Virtually all the treatment decisions are made in the first few weeks after diagnosis Strong commitment to multi-disciplinary decision making and patient centered-care Strong commitment to developing the evidence base dvances in the quality of the clinical information 4

5 60 yr old principal bnormal mammogram Core biopsy: invasive breast cancer, low grade tumor, ER positive, HER2 negative Surgical path: 2 cm tumor, SN negative. No treatment Locoregional tx Hormonal tx djuvant Chemo CPM reast Cancer recurrence or death at 10 years Death from other causes 10% at 10 years 5

6 Diagnosis confirmed by biopsy History, PE, Imaging Initial locoreg therapy decisions Final locoreg therapy decisions Systemic treatment decisions Path node and margin status 21 gene assay Est tumor size Clinical nodes Comorbidity Tumor behavior ER/HER2 21 gene assay 6

7 Surgeon Radiation Oncologist Medical Oncologist Ms.Landry Plastic Surgeon Other Providers The more choice, the less choosing Patient autonomy is valued but easily relinquished when decisions are difficult Going with standards or rules makes decisionmaking more manageable arry Schwartz, The Paradox of Choice

8 Peer and professional influences Clinical guidelines and consensus statements Collaborative decision models (tumor board) Opinion leaders Financial factors Non-financial factors Social consequences of treatment decisions Cognitive and emotional factors Patient cues 8

9 Physicians are generally free to formulate recommendations within community standards Guidelines are powerful determinant of physician recommendations Markedly reduce decision burden Provide norms that reduce clinician concern about social consequences of treatment decisions Choice and interpretation of evaluative testing likely explains a lot of the variation in application of guidelines to individual patients reast conserving surgery with radiation Hormonal therapy Systemic chemotherapy? 9

10 No treatment Locoregional tx Hormonal tx djuvant Chemo reast Cancer recurrence or death at 10 years Death from other causes 10% at 10 years djuvant! Online Host factors Tumor biology Extent of disease 10

11 100 Patients treated with local therapies 66% alive and without cancer in 10 years. 24% relapse or die from bc 10% die of other causes. Net benefit of treatment: Hormones: 8% Chemo 3% HER2 - (90 patients) <3% net benefit + (10 patients) 7% net benefit 21-Gene High (18 patients) 7% net benefit Inter (22 patients) 3% net benefit Low (50 patients) <1% net benefit None are guideline concordant 60 receive chemo vg net benefit 3% 78 are guideline concordant 53 receive chemo vg net benefit of 4.5% 11

12 More precision on net benefit of treatment Stronger evidence base for test use Less measurement variability in the community More opportunities for quality control Test Tumor biology ER HER2/neu 21-gene assay Histology Extent of disease Physical exam Mammography/MRI Sentinel node bx Host factors Comorbidites ge RC Reliability and Validity - + D C - 12

13 Test Tumor biology ER HER2/neu 21-gene assay Histology Extent of disease Physical exam Mammography/MRI Sentinel node bx Host factors Comorbidites ge RC Evidence base (level) C /D C + Test Tumor biology ER HER2/neu 21-gene assay Histology Extent of disease Physical exam Mammography/MRI Sentinel node bx Host factors Comorbidites ge RC Level of variability D C 13

14 Test Tumor biology ER HER2/neu 21-gene assay Histology Extent of disease Physical exam Mammography/MRI Sentinel node bx Host factors Comorbidites ge RC Level of quality control D C C For no other condition has individualized treatment advanced further than for breast cancer Strong evidence base for treatment decisions Growing influence of tumor biology-based evaluative tests Diffusion of multi-disciplinary decision-making models Level of commitment to developing the evidence base Growing recognition of primum non nocere- first do no harm ddressing challenges of individualizing treatments for breast cancer provides lessons for other cancer and non-cancer conditions 14

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