Early Stage Breast Cancer Survivorship

Transcription

1 Early Stage Breast Cancer Survivorship Jennifer R. Klemp, PhD, MPH, MA Associate Professor of Medicine, Division of Clinical Oncology Director, Cancer Survivorship Cancer Risk and Genetic Counseling University of Kansas Cancer Center CEO/Founder, Cancer Survivorship Training July 2014

2 Overview This course will healthcare providers: Demands of Cancer Survivorship Recognize the late effects of breast cancer treatment Accreditation standards integrated into practice Understand how Survivorship Care can promote and contribute to long-term health and integration into the EHR Delivering Multidisciplinary Survivorship Care: What does it look like? Genomic tests and next steps 2

3 Who is a Cancer Survivor? A cancer survivor is anyone who has been diagnosed with cancer from the time of diagnosis and for the balance of his or her life. NCCN: National Coalition for Cancer Survivorship 3

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5 Estimated and projected number of cancer survivors in the United States from 1977 to 2022 by years since diagnosis by American Association for Cancer Research de Moor J S et al. Cancer Epidemiol Biomarkers Prev 2013;22:

6 A Growing Population 3M Breast Cancer Survivors in the US Approximately 29% of all cancers diagnosed in 2014 are breast cancer In 2014, an estimated 232,670 new cases of breast cancer will be diagnosed An additional 62,570 carcinoma in-situ of the breast The majority of patients will have early stage disease Treatment continues to improve ~80% of women diagnosed with breast cancer will achieve extended survivorship American Cancer Society, Surveillance Research 2014

7 Age of Cancer Survivors Estimated Number of Persons Alive in the U.S. Diagnosed With Cancer by Current Age* *(Invasive/1st Primary Cases Only, N=11.4M survivors)

8 Estimated Number of Cancer Survivors in the U.S. based on November 2009 SEER data by Site *(Invasive/1st Primary Cases Only, N=11.4M survivors)

9 Follow-Up Care for Breast Cancer Survivors Monitor and treat symptoms Individualized, patient centered Patient reported outcomes and symptom management Related to completed and ongoing treatment Related to disease diagnosis e.g.., Psychosocial, Pain, Fertility, Weight Gain Diagnosis of new, recurrence, or metastatic cancer New primary cancers Screen for genetic risk (update personal and family history) Locoregional recurrence Distant metastases National recommendations include a treatment summary and survivorship care plan 9

10 Recommended Follow-Up Medical history and physical examination Every three to six months for the first three years after the first treatment Every six to 12 months for years four and five, and every year thereafter. Health care maintenance Bone and cardiovascular health; Weight Control and Exercise Monthly Breast self-examination Update personal and family history of cancer Assess to genetic counseling and testing 10

11 Ongoing Assessment of Personal and Family History of Cancer **Required for QOPI Certification**

12 Do We Take a Detailed Family History?

13 ASCO Recommends Assess Family History and at Key Times for Decisions Making Lu, et.al., JCO 32 (8) MARCH

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15 Red Flags: Hereditary Breast and Ovarian Cancer Syndrome Age at Diagnosis Under age 50 or premenopausal Pathology Triple Negative breast cancer <60 Personal History Ovarian cancer Male breast cancer Two primary breast cancers Ashkenazi Jewish ancestry Breast cancer with >2 relatives with HBOC associated cancers at any age Family History An identified HBOC mutation in family Breast cancer diagnosed <50y Ovarian cancer Male breast cancer Two primary breast cancers Ashkenazi Jewish ancestry with an HBOC associate cancer Three or more HBOC associate cancers at any age (including pancreatic and prostate cancer)

16 Capture Rate for Genetic Testing Leads to Survivor Patient Population AT RISK Missed Patients Y5 Missed Patients Y4 Missed Every year, more patients Patients Y3 are missed than tested Large Survivor Patient Population Missed Patients Y2 Missed Patients Y1 1. Surveillance, Epidemiology, and End Results (SEER), National Cancer Institute, Eisenbraun et al. Hereditary Breast and Ovarian Cancer testing: integration and outcomes within community oncology practices. Comm Oncol. 2010;7: NCCN Clinical Practice Guidelines in Oncology v Genetic/Familial High-Risk Assessment: Breast and Ovarian. Accessed at 4. Kerber RA, et al. Frequency of familial colon cancer and hereditary nonpolypsosis colorectal cancer (Lynch syndrome) in a large population database. Familial Cancer 2005;4: Internal Myriad data

17 Breast Cancer Screening Mammography First post treatment within first year (no earlier than 6 months after RT), then yearly if stable Breast self-exam Monthly Clinical breast exam Every 3-6 months for the first 3 years Every 6-12 months for the next 2 years Then annually MRI Decision should be based on an individual basis considering: Genetic risk factors Young age, dense breasts Mammographically occult tumors Khatcheressian JL, et al, JCO 31:961-5,

18 Mammography Lack of high level evidence to support an impact on DFS or OS (Grunfeld et al, Breast,2002;11:228, Esserman and Thompson, JAMA 2009) Ongoing controversy: mammography is best at detecting low risk disease Observational studies suggest that the method of detection does not influence survival Decreased specificity and sensitivity in the irradiated breast Many survivors do not get a mammogram in the first year post diagnosis 62% of women in one series did not have a follow-up mammogram in the first year following diagnosis (Mandelblatt et al JCO,2006;24:77)

19 Additional Recommended Screening Pelvic examination Continue to recommend regular visits to primary care. Inform primary car about the potential risk of vaginal bleeding and increased risk of uterine cancer associated with the drug tamoxifen. Other routine cancer screening Colonoscopy, skin cancer screening No routine testing (labs, tumor markers or imaging). Testing as indicated by clinical findings NCCN.org ASCO.org/guidelines/breastfollowup) American Cancer Society

20 Cancer Focused Tests Not Currently Recommended by ASCO in Asymptotic Survivors Including: A complete blood count (CBC) test and liver and kidney function tests Chest x-ray Bone scan Liver ultrasound CT scan FDG-PET scan Breast MRI (unless hereditary cancer risk) Breast cancer tumor markers, such as CA 15-3, CA 27.29, and carcinoembryonic antigen (CEA) 20

21 Role of Tumor Associated Antigens Patient outcomes are not improved by routine measurement of tumor antigens to detect early recurrence Average 5-month lead-time in diagnosis does not change treatment or outcome ASCO Clinical guideline expert panel recommend against routine monitoring However, recent findings found 42% of early stage had at least 1 tumor marker test within 2 years of diagnosis Additional expense (~30%), reimbursement may be a challenge in some settings Generates patient anxiety and need for additional follow-up and testing Chan DW, JCO 1997 Ramsey et.al., JCO Oct 2014

22 Detection of Locoregional Recurrences Meta-analysis of 12 studies (n=5,045) 378 isolated LRR (7.5%) 58% diagnosed during routine visits or with routine tests 40% had no symptoms No data on survival or QOL Based on type of surgery 158/1,948 (8%) with mastectomy 47% (75) asymptomatic at routine FU 152/1,648 (9%) with breast conservation 36% (54) asymptomatic at routine FU de Bock et al; JCO 22:4010, 2004

23 Detection of Early Recurrences Hypotheses: 1. Aggressive follow-up detects recurrences at an earlier stage 2. Early treatment of recurrences offers a better chance of cure, longer survival or improvement in QOL. However, data suggest that this is not the case

24 What is the Value of Intensive Diagnostic Follow-up? 26 Italian sites 1320 women < 70 yo, stage I-III breast cancer Treatment defined by nodal status Randomization Intensive follow-up with PE and LFTs (q 3m x 8 then q 6m), CXR (q 6m x 4), bone scan and liver US (q 12m) Control PE (q 3 m x 8 then q 6m), additional tests dictated by symptoms Both had annual mammograms Primary endpoints Overall survival Health Related quality of life GIVIO study, JAMA 1994:271;1587

25 GIVIO Trial: Results Impact of Follow-up Testing 71 mo F/U Deaths (%) Med.Time to Met (mo) Intensive 132 (20) Control 122 (18) Distant mets Asymptomatic in 31% intensive, 21% control 69-79% presented with symptoms No difference in: Overall survival Quality of life GIVIO study, JAMA 1994:271;1587

26 What is the Value of Intensive Diagnostic Follow-up? 1243 women from 12 Italian sites Randomized: Intensive: MD visit, mammogram, CXR, bone scan q 6 mo Control: MD visit, mammogram Primary endpoint 5 year survival Results More thoracic and bone mets detected in intensive arm (112 v70) Increased anticipated diagnosis No impact on survival #Distant Recurrences (%) Mortality (%) Intensive 164 (26.4) 18.6 Control 125 (20.1) 19.5 Roselli Del Turco, JAMA 1994;271:1593

27 Detection of Early Recurrences Justifications: Early detection results in more effective treatment Patients are reassured does this improve quality of life? Investigational endpoint Monitor effectiveness of adjuvant therapy Disadvantages: Aggressive screening results in overtreatment of early disease Routine testing creates anxiety and need for additional tests Increased costs to patients without benefit

28 Smart Phase in EHR 28

29 American Society of Clinical Oncology Patient emotional well being assessed by 2 nd visit Infertility Survivorship Quality Indicators: Palliative Care and End of Life Access to genetic counseling and testing Treatment summary process complete Chemotherapy treatment summary provided to and communicated with patient and practitioner(s) within 3 months of chemotherapy end.

30 ASCO Template 30

31 Survivorship Across the Continuum of Care Modified Cancer Care Trajectory Start Here Delivery of survivorship education, preventive strategies, & treatment summary Treatment with intent to cure Cancer-free survival Managed chronic or intermittent disease Delivery of post-treatment survivorship care plan Recurrence/ second cancer Diagnosis and staging Treatment failure Palliative treatment Delivery of survivorship care in the advanced cancer setting Death Institute of Medicine. From Cancer Patient to Cancer Survivor: Lost in Translation. Available at Accessed July 25,

32 Standard 1.8: Monitoring Community Outreach Standard 1.10: Clinical Education Activity Standard 3.2: Psychosocial Distress Screening Referrals in place Standard 3.3: Survivorship Care Plan (SCP) 32

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34 Components of a Survivorship Care Plan Description of diagnosis Summary of treatment Therapies Contact information for each key provider MAJOR complications experienced Individual risk for late effects, second cancers Risk assessment and management strategies: Give orally & in writing Cancer risk Genetic Counseling for appropriate patients. Long-term monitoring for late effects Ongoing To Do List: Lifestyle strategies, adherence to oral therapies, etc Jacobs, L. Developing Models of Care for Adult Cancer Survivors.2006.

35 Management of the Physical Consequences of Cancer Treatment Late Side Effects from Surgery, Chemotherapy, Radiation Therapy, and extended use of anti-hormonal therapy Endocrine Issues and Symptoms Menopausal symptoms Weight gain Thyroid dysfunction Osteoporosis Loss of Fertility Functional Issues Fatigue Cognitive Impairment Neuropathy Lymphedema; Scar Tissue; Lack of Mobility Tooth and Jaw problems Other Issues Cardiac Risk Arthralgia 35

36 Management of the Psychosocial Effects of Cancer Treatment Psychological Depression, anxiety (fear of recurrence), uncertainty, isolation, altered body image Social Changes in interpersonal relationships, concerns regarding health or life insurance, job loss, return to school, financial burden Existential and spiritual issues Sense of purpose or meaning, appreciation of life 36

37 EPIC Treatment Summary and Survivorship Care Plan Template Highlights: EPIC 2012 (enhanced workflow with fields will auto-fill MUST use the problems list Data can be manually entered or smart text Functionality lost for version 2010 users is limited to discrete data points Meaningful use: Printed and/or Included in MyChart Templates in production: General (customizable) Breast GI GU Lung Adult Survivors of Childhood Cancers

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40 Delivery of Survivorship Care Survivorship care is by nature multidisciplinary and ideally provided using a team approach Specialty/Pri mary Care Mental Health Palliative Care/Pain Management Physical Therapy/ Occupational Therapy Pulmonary Neurology/ Neuropsychology Gynecology/Urology Sexual Health/Fertility Endocrinology/ Genetics Cardiology Modified from IOM,

41 Barriers to Post-Treatment Survivorship Care Planning Limited Experience on how to implement a survivorship care plan? Templates available Time consuming No/lack of reimbursement Not easily configured with medical records What will we do with the plan? Will it really be used??? JCO Dec, 2011: did not improve patient reported outcomes JOP Jan, 2012: not ready for prime time Unrealistic demands on limited staff Shared care providers are not prepared- need continuing ed Oncologist want to maintain control Survivors are in limbo who does what??? Grunfield et al., Evaluating Survivorship Care Plans: Results of a Randomized, Clinical Trial of Patients With Breast Cancer, JCO Dec

42 Online Opportunities for Continuing Education ASCO Survivorship Compendium and Tools Cancer Survivorship Training for Healthcare Professionals **CE and content matter expert developed GW Center for the Advancement of Cancer Survivorship, Navigation, and Policy (casnp)

43 Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis IOM, 2013 Trends Amplifying the Crisis The aging population: 30% in cancer survivors by % in cancer incidence by 2030 Workforce shortages Rising cost of cancer care: $72 billion in 2004 and now $125 billion in 2010 $173 billion anticipated by 2020 (39% ) Complexity of cancer care Reliance on family caregivers and direct care workers Limitations in the tools for improving quality 43

44 Practice Guidelines NCCN Survivorship Version Anxiety and Depression Cognitive Function Exercise Immunizations and Infections Fatigue Pain Sexual Function Sleep Disorders These guidelines are designed to provide a framework for general survivorship care and management and are not intended to provide specific guidelines on the surveillance and follow-up requirement for a survivor s primary care. Accessed Nov 1,

45 Monitoring and Treatment Symptom Hot flashes Sexual dysfunction (libido, dyspareunia) Weight gain Depression, fatigue Cognitive dysfunction Osteopenia/porosis Cardiovascular disease Thrombosis Secondary malignancies Management options SSRIs, SSNRIs, gabapentin Vaginal moisturizer, vaginal estrogen (on tamoxifen) or introitus Exercise and Weight Loss Counseling, treat underlying cause, time Tools for improving function Calcium/Vit D, weight bearing exercise, anti-osteoclast agents Monitor lipid panel, evaluate symptoms Family and personal history Screening, evaluate symptoms Hayes, NEJM 2007;356:2505 Daley et al, JCO 2007;25:1713

46 Survivorship Chronic Care Model Community Resources & Policies Non-profits, advocacy groups Wellness communities Government agencies Self Management & Decision Support Health System Clinical Information Systems EHR, Care Plan Delivery System Design Cancer Survivorship Care Informed Activated Patient Productive Interactions Prepared Proactive Providers Functional & Clinical Outcomes Adapted from: Accessed July 25,

47 Risk Stratified Patient Centered Survivorship Care Community Resources/A dvocates Self- Management Health Care Team Survivor Survivors who partner their care between self-management, community resources and their health care team are often empowered to approach their care in a proactive manner.

48 Testing Options Targeting Survivors to Determine Likely Benefit From Extended Therapy 48

49 CIRCULATING TUMOR CELLS (CTCs) CTCs are intact cells that are thought to detach from metastatic tumors and enter the bloodstream. The number of CTCs decrease as a tumor shrinks in response to treatment. Thus, knowing the number of CTCs (the CTC count) may help physicians better determine how effective treatment is and then change therapy if necessary. Danila D C et al. Clin Cancer Res 2011;17:

50 State of CTCs The potential benefit of using CTC counts to monitor response to treatment is that monitoring (for transition to metastasis or identify residual disease) can begin earlier than with imaging studies (such as CT or ultrasound). Further studies are necessary to confirm the value of the test, and so there are no recommendations for the use of CTC counts to guide treatment planning. Future research: accessible tumor cells for biomarker development 50

51 Promoting a Healthy Lifestyle in Cancer Survivors Be as lean as possible throughout life. Balance caloric intake with physical activity. Avoid excessive weight gain throughout the lifecycle. Achieve and maintain a healthy weight if currently overweight or obese. Consume a healthy diet, with an emphasis on plant sources. Choose foods and beverages in amounts that help achieve and maintain a healthy weight. Eat five or more servings of a variety of vegetables and fruits each day, choose whole grains in preference to processed Limit consumption of processed and red meats. Limit alcohol consumption. Drink no more than one drink per day for women or two per day for men. ACS Cancer Prevention Guidelines AICR.org

52 Exercise Guidelines for Cancer Avoid inactivity Adopt a physically active lifestyle. Adults: at least 30 minutes of moderate-tovigorous physical activity, on 5 or more days of the week minutes of intentional physical activity preferable. Flexibility activities are encouraged daily. Strength training activities are safe Start with a SUPERVISED program Start low, progress slow Survivors Schmitz et al., Med Sci Sports Exerc, 2010

53 Cancer is a Teachable Moment: Discuss Lifestyle Modification

54 Summary Follow-up for women with a history of early stage breast cancer should be: individualized vital for medical and psychosocial benefits and to facilitate adherence routine laboratory and imaging studies have not changed survival earlier identification and novel markers might be benefical Treatment Summary and Survivorship Care Plans are part of national mandates, but evidence is limited Lifestyle Modification is a recommended prescription

55 Being cancer-free is not the same as being free of cancer Julia Rowland, PhD Director, NCI Office of Cancer Survivorship 55

56 Resources IOM: Lost in Transition report from 2005 IOM: Implementing the Survivorship Care Planning, Workshop Report, 2006 JCO Special Review Issue: Cancer Survivorship, November 10, 2006 M. Feuerstein (ed.) Handbook of Cancer Survivorship, Springer, 2007 Journal of Cancer Survivorship: New in 2007 P.Ganz (ed.) Cancer Survivorship: Today and Tomorrow, Springer,