Quality of Life and Survivorship:

Transcription

1 Quality of Life and Survivorship: Implications for Future Ovarian Cancer Research and Care Lari Wenzel, PhD Professor of Medicine & Public Health Associate Director, Population Science and Cancer Control Chao Family Comprehensive Cancer Center University of California, Irvine Institute of Medicine April 7, 2015

2 Introduction HRQOL and PRO measurement contributions to current trials Symptom indexing and symptom concerns Targeted interventions Decision-making 2

3 PRO QOL HRQL Evaluation of all aspects of life QOL Health-Related Quality of Life Patient Reported Outcomes Quality of Life HRQL PROs Anything reported by the patient Evaluation of impact of illness or treatment on physical, emotional, & social aspects of QOL

4 Clinical Benefit in Oncology Ongoing debate on appropriate trial endpoints Overall survival considered gold standard Surrogate endpoints like progression-free survival often used Traditional endpoints do not fully address treatment responses experienced by the patient Symptom relief, functional improvement HRQoL and Patient-reported outcomes can complement traditional efficacy measures Markman M. Current Oncology Reports. 2009;11:1-2. Knox J. The Lancet. 2008;372(9637): Bukowski R, et al. American Journal of Clinical Oncology. 2007;3: Lipscomb J, et al. CA Cancer J Clin. 2007;57:

5 Aurelia Trial: Abdominal/GI Symptoms (QLQ-OV28) Wk 8/9 Bev+CT > 15% improvement Stockler, et al. Journal of Clinical Oncology doi: /jco

6 Assessing Patient Reported Outcomes PROs are increasingly important in cancer treatment research Correlated with survival and tumor response Symptom patterns may signal disease progression Health-related QoL has become an important component of oncology clinical outcome Assessment can provide substantial information on a treatment s net effect as experienced by the patient Bukowski R, et al. American Journal of Clinical Oncology. 2007;3: Rao D, et al. Journal of Pain and Symptom Management. 2009;38(2): Cella D. Cancer Treatment Reviews

7 GOG 218: Baseline FACT-O-TOI is prognostic AND Trends in improvement or worsening HRQOL associated with survival Overall Survival Probability O Censored Logrank p <.0001 Progression Free Survival Q2-4 Tumor Type Improvement of QOL Worsening of QOL QoL improved QoL worsened mpfs 16.7 vs 11.1 months Log-Rank p= Overall Survival Probability O Censored Logrank p <.0001 Overall Survival Q2-4 QoL improved QoL worsened mos 54.4 vs 33.6 months Log-Rank p= Tumor Type Improvement of QOL Worsening of QOL Months Months Phippen, et al. Society of Gynecologic Oncology Late Breaking Abstracts April 2015

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9 Symptom Prevalence (severity >0) % 1. Fatigue 95.3% 2. Anxiety 78.1% 3. Memory Problems 76.8% 4. Peripheral Neuropathy 74.2% 5. Sleep Disturbance 73.2% 6. Drowsiness 70.8% 7. Constipation 66.8% 8. Pain 63.1% 9. Mood Swings 62.1% 10. Abdominal Bloating 61.6% 11. Depression 60.9% 12. Lack of Appetite 54.1% 13. Nausea 53.6% 14. Shortness of Breath 52.8% 15. Headaches 50.9%

10 Rank Top 3 symptoms to get better control over Total Count 1 Fatigue Peripheral Neuropathy 82 3 Constipation 75 4 Pain 66 5 Sleep Disturbances 57 6 Weight Gain 57 7 Memory Problems 43 8 Anxiety 42 9 Abdominal Bloating Nausea Hair Loss Depression Sexuality Concerns Urinary Problems Hot Flashes 22

11 Salient PROs for ovarian clinical trials? Abdominal Pain Bloating Cramping Fear of recurrence/disease progression Indigestion Sexual dysfunction Vomiting Weight gain and weight loss Anorexia, cognition, constipation, diarrhea, dyspnea, fatigue, nausea, neuropathy, pain, insomnia Donovan, et al. Journal of the National Cancer Institute doi: /jnci/dju128

12 Consent Baseline Assessment Randomization Week 1-4 Care as usual Self-Directed WRITE Symptoms Nurse-delivered WRITE Symptoms Week 5 Outcome Assessment Weeks 5-6 Work independently on selected strategies Work independently on selected strategies Week 7 WRITE Symptoms Self-directed review WRITE symptoms review over message boards Week 8 Outcome Assessment Week12 and monthly Outcome Assessment

13 Do PROs relate to treatment preference? Progression free survival? Patient treatment experience OS Disease symptoms Side effect burden Tolerability Treatment preference Cella D. J Community Support Oncol. 2014;12: OS, overall survival.

14 Whose preference matters? Economic analysis usually takes societal perspective May exclude hope and adjustment factors May overestimate disutility Patient preference matters For individual decision making Preferences change with experience How can we really help patients know what lies ahead? if I knew then.

15 Relative Influence of Factors Determining a Woman s Preference for Treatment in EOC Conclusions PFS is the predominant driver of patient preferences for chemotherapy. Women are willing to trade significant PFS time for reductions in treatment-related toxicity. Havrilesky LJ Cancer 2014

16 Ovarian Cancer Patient-Centered Decision Aid The most effective advanced treatment regimen to date (GOG 172) was IP/IV With worse quality of life (QOL) and more treatment-related toxicities during active treatment Despite NCI Clinical Alert, use of IP treatment is variable and many patients are not aware of their options The tradeoff between short-term reduced QOL and longer survival is difficult for patients to understand and then incorporate meaningfully into their decision-making process

17 PCOA s Structure PCOA includes 3 modules: An educational module explaining the QOL implications of potential toxicities A preferences elicitation exercise: What are the patient s relative ranks for all toxicities? What is the patient s value of healthy life relative to the worst toxicity? Time Trade Off question A feedback module: Result of the tradeoff The patient's preferences Recommendation to discuss with her physician

18 Educational Module

19 Side Effects Concerns Exercise

20 Conclusions and Evolving Directions Symptom Indexing. Disease-related symptoms and treatment side effect scores Exclusive focus on symptoms is inadequate Setting the bar too low on continuum of minimal expectations versus aspirations Interventions to manage symptoms, and aid decisionmaking in the recurrent setting 20