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ABC1 - P. Ganz - Relevant endpoints for advanced breast cancer patients

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  • 1. Relevant Endpoints for Advanced Breast Cancer Patients Patricia A. Ganz, M.D. UCLA Schools of Medicine & Public Health Jonsson Comprehensive Cancer Center ABC-1 Conference November 3-5, 2011
  • 2. The many faces of ABC is a challenge……. Disease & patients are heterogeneous, with different needs and goals • Newly diagnosed with metastatic disease—HER 2 + vs. negative • Endocrine responsive, slowly progressing • Rapidly progressing triple negative • Young vs. older • Soft tissue/bone vs.
  • 3. ‘Treatment for metastatic breast cancer islifelong and focuses on control and quality oflife vs. curative intent. ("Treatable butunbeatable.“)’ From 13 facts everyone should know about metastatic breast cancer. www.mbcn.org
  • 4. • What happens when breast cancer recurs? – Significant decline in physical functioning, social functioning and health perceptions – Increased intrusive and avoidant thoughts
  • 5. Most Prevalent Symptoms
  • 6. Relationship between Symptoms and QOLSymptoms are more sensitive to change over time than QOL. Sarenmalm, et al. 2008
  • 7. Living with advancedbreast cancer and theSword of Damocles……When disease or dis-ease threatens us orour loved ones, its the forethought ofloss, of pain, of grief that flips on theanxiety switch.When our friends and colleagues arelosing their jobs, when we see mediacoverage of layoffs, we feel badly forothers but we also see that sword overour own heads and imagine it comingdown on us. http://middle-aged-diva.blogspot.com/2011/03/anticipation-worry- cut-from-same-cloth.html
  • 8. Challenges of Metastatic Breast Cancer Maintenance of Symptom Control Independence Cancer as a chronic disease Management of Social Support & Anxiety & Social Isolation Depression
  • 9. What are the goals of therapy in ABC?• Symptom control• Prolonged remission or stable disease• Prevention of disease-related morbidity, e.g. pathologic fracture, hypercalcemia• Maintenance of physical functioning and ability to care for self• Reduction in psychological morbidity that is affected by disease burden and health status
  • 10. What are the burdens of therapy?• Acute and chronic toxicities, e.g., neuropathy, fatigue, hair loss, mucositis• Time spent in treatment—complex vs. simple regimens, oral vs. intravenous• Financial/economic loss—out of pocket, time lost from work, family caregiving time• LIVING WITH ONGOING DISEASE AND SYMPTOMS
  • 11. Balancing the goals and burdens… Treatment Toxicity Treatment Benefit
  • 12. Focus on Patient Reported Outcomes (PROs) in Advanced Breast Cancer• Challenge to collect these data in ABC when disease is rapidly progressing – Missing data, inadequate sample size and power (see Goodwin et al. JNCI, 2003)• Quality of Life scales are not usually discriminating and symptoms have been less frequently measured (see Lemieux et al. JNCI, 2011)• Assessment of symptoms with PROs, especially targeting pain, fatigue, physical limitations may be necessary
  • 13. Relevant Endpoints• Progression free-survival??? – Need concomitant PROs that support improved symptoms, function, and no serious AEs• Stable disease??? – Need concomitant PROs to support stable or improved symptoms, function, and no serious AEs• Symptom benefit/improvement/control – Use of composite endpoints that demonstrate improvement in serious symptoms, e.g. pain, fatigue, without requirement of measurable response or prolongation of life
  • 14. Conclusions• There are several potential endpoints to consider in advanced breast cancer• Prioritization should reflect the particular disease setting and patient population• Incorporation of PROs that focus on symptom control, improved physical function, and prevention of disability, may enhance the value of more traditional disease- response/survival outcomes
  • 15. Recommendations• Phase III RCTs should measure PROs of symptoms and functioning to assess needs of ABC patients, and to measure impact of treatment on these outcomes• Drug approval and sequencing of therapies should include PRO symptom outcomes as a major endpoint• Patients with ABC should be classified by disease characteristics AND symptoms to better match treatments to relevant outcomes
  • 16. ‘Treatment for metastatic breast cancer islifelong and focuses on control and quality oflife vs. curative intent. ("Treatable butunbeatable.“)’ From 13 facts everyone should know about metastatic breast cancer. www.mbcn.org