The Prognos+c Value of Pre- Diagnosis Health- Related Quality of Life on Survival: A Prospec+ve Cohort Study of Older Americans with Lung Cancer

Transcription

1 The Prognos+c Value of Pre- Diagnosis Health- Related Quality of Life on Survival: A Prospec+ve Cohort Study of Older Americans with Lung Cancer Laura C. Pinheiro, Timothy M. Zagar, Bryce B. Reeve Laura C. Pinheiro, PhD, MPH Department of Health Policy and Management Gillings School of Global Public Health University of North Carolina at Chapel Hill April 4, 2017

2 Agenda 1 Background 2 Objec1ves 3 Methods 4 Results 5 Conclusions 2

3 BACKGROUND 3

4 Lung Cancer " Most common cancer in the world. " Incidence of lung cancer continues to grow. " 1- and 5-year survival of 42% and 16%, respectively. " High symptom burden (e.g., fatigue, chest pain, and persistent cough) may impact a patient s quality of life.

5 Health-Related Quality of Life " A subjective sense of well-being in response to a major illness encompassing spiritual, functional, emotional, physical and social well-being. " HRQOL decrements occur before, during, and after primary and adjuvant cancer treatments. " Poor HRQOL may exacerbate treatment-related symptoms.

6 HRQOL in Lung Cancer " HRQOL has been shown to be more predictive of overall survival than an individual s performance status. Post-diagnosis HRQOL Studies have shown associations between postdiagnosis HRQOL and overall survival in lung cancer. Pre-diagnosis HRQOL No studies have examined association between prediagnosis HRQOL and overall survival. " Post-diagnosis HRQOL may be confounded by diagnosisrelated stress and treatment-related morbidities.

7 Background Objec+ves Methods Results Conclusions STUDY OBJECTIVES 7

8 Background Objec+ves Methods Results Conclusions Study Objectives 1. Determine if HRQOL self-reported before diagnosis is prognostic for overall survival. 2. How the relationship between HRQOL and survival varies by HRQOL domain and type of measure.

9 METHODS 9

10 Data Source " National Cancer Institute s Surveillance Epidemiology and End Results (SEER) linked with Medicare Health Outcomes Survey (MHOS)

11 SEER Cancer Registry Program

12 Medicare Health Outcomes Survey " Survey individuals enrolled in Medicare Advantage plans from " Plans randomly sample 1,000-1,200 enrollees annually " Collects HRQOL prior to cancer diagnosis

13 Study Sample " 2,921 individuals 65+ years diagnosed with incident lung cancer between in the U.S " Completed a HRQOL assessment before diagnosis " HRQOL assessment within two years of diagnosis

14 HRQOL Measures SF-36/VR-12 ADL Global HRQOL Mode(s) Paper-based; telephone Paper-based; telephone Paper-based; telephone Recall Current; past 4 weeks Current Current Items each Range Domains Physical Component Summary (PCS), Mental Component Summary (MCS). Physical Functioning, General Health, Role Physical, Role Emotional, Bodily Pain, Social Functioning, Mental Health, and Vitality Difficulty bathing, eating, dressing yourself, getting in/out of chairs, walking, and using the toilet Overall Health

15 Covariates " Age at diagnosis, sex, marital status, race/ethnicity, geographic region, education, and smoking status " Proxy survey completion, mode of administration " Non-small cell/small-cell lung cancer, stage of disease " Receipt of surgery and/or radiation " Self-reported comorbid conditions (e.g., diabetes, hypertension, arthritis, heart disease)

16 Analyses " Cox-Proportional Hazards Models " Time from MHOS survey to date of death " Hazard Ratios " 95% Confidence Intervals " Sensitivity analyses " Restricting analyses to individuals with a HRQOL assessment within one-year of diagnosis " Small-cell and non-small cell lung cancer

17 RESULTS 17

18 Cohort Characteristics " Mean age: 75 years old " 51% female " 80% White, 8% Black, 5% Hispanic, 6% Asian, 2% other " 55% married/partnered " 60% current or former smoker " 58% self-reported hypertension, 18% diabetes, and 33% heart disease " Mean pre-diagnosis PCS score: 39.0 (SD 11.9) " Mean pre-diagnosis MCS score: 51.1 (SD 10.7)

19 Overall Results " Worse HRQOL, reported prior to cancer diagnosis, was statistically significantly associated with greater risk of death across all HRQOL measures.

20 Short-Form 36 " Physical Component Summary score below U.S population average was associated with 14% increase in risk of death. " Mental Component Summary score below U.S population average was associated with 15% increase in risk of death. " Did not vary by time before diagnosis

21 Single-items " Compared to reporting excellent, poor overall health was associated with a 62% increase in risk of death. Fair vs. excellent health: 51% increase Good vs. excellent health: 31% increase " Compared to reporting excellent, poor health in relation to others was associated with a 36% increase in risk of death. Fair vs. excellent health: 35% increase Good vs. excellent health: 20% increase

22 Activities of Daily Living " Inability to perform any ADL was associated with large increases in risk of death. Getting in/out of chairs: 123% increase Eating on your own: 108% increase Using the toilet on your own: 105% increase Dressing yourself: 88% increase Bathing yourself: 60% increase Walking on your own: 54% increase

23 CONCLUSIONS 23

24 Discussion " Pre-diagnosis HRQOL is prognostic for overall survival " Association was observed across ten SF-36 measures, two single-item global HRQOL questions, and six ADLs. " Findings consistent with previous studies using postdiagnosis HRQOL to predict survival in lung cancer.

25 Take away messages " Self-reported HRQOL is a predictor for overall survival in lung cancer " Routine HRQOL monitoring may have positive downstream effects, especially for older patients " HRQOL monitoring may enhance patient-physician communication and quality of care received " Future studies should explore associations between changes in HRQOL before/post diagnosis and overall survival

26 The Impact of Cancer Diagnosis on Health- Related Quality of Life: A Prospec+ve Cohort Study of Older Americans with Prostate & Bladder Cancer Angela Smith, Byron Jaeger, Laura Pinheiro, Lloyd Edwards, Bryce Reeve Angela B. Smith, MD, MS Department of Urology Lineberger Comprehensive Cancer Center University of North Carolina at Chapel Hill April 4, 2017

27 BLADDER CANCER

28 Background Objec1ve Methods Results Conclusions Bladder Cancer 5 th most common cancer 77,000 new cases in ,426 living with disease Invasive disease (25%) Radical surgical treatment or chemo- radia1on Non- invasive disease (75%) Periodic surveillance cystoscopy Intravesical therapy HRQOL research among bladder cancer limited

29 Background Objec+ves Methods Results Conclusions Study Objectives 1. Iden1fy HRQOL changes before to aver diagnosis in older adults with bladder cancer 2. Compare changes to non- cancer controls 3. Inves1gate HRQOL stra1fied by disease stage, treatment type and 1me since diagnosis

30 Methods Similar to methods described previously Treatment Defined using codes differen1a1ng between Conserva1ve treatment: biopsy, TURBT, par1al cystectomy Radical treatment: radical cystectomy, pelvic exentera1on Stage AJCC staging variable incomplete Historic stage used (dichotomized as localized/invasive) Time since diagnosis 0-6 months 6-12 months >12 months

31 Statistical Methods Bivariate associa1ons T- test Chi- square Linear mixed models for longitudinal data Restricted maximum likelihood es1ma1on Least- squares means to facilitate group- wise comparison of HRQOL domains

32 Cohort Characteristics Cases: n=535 Non- invasive (n=458) Invasive (n=77) Controls: n=2,770 74% Male 84% White, 4% Black, 6% Hispanic, 6% Asian 62% Married/partnered 37% Current or former smoker 56% HTN, 21% diabetes, 39% heart disease No differences aver propensity score matching

33 Overall Results Physical HRQOL PCS scores worse among cases compared to controls Controls: =- 0.4 Non- invasive: =- 2.0; p=0.01 Invasive: =- 5.3; p<0.01 Mental HRQOL MCS scores not significantly different between cases and controls Controls: =- 0.3 Non- invasive: =- 1.4; p=0.08 Invasive: =- 2.5; p=0.29

34 Adjusted HRQOL Changes by Stage 0 Figure 1: Adjusted HRQOL changes from baseline to follow up of controls and bladder cancer patients stratified by stage Physical Component Summary Bodily Pain Physical Functioning Role Physical General Health 2 Estimated Difference (Follow Up Baseline) Mental Component Summary Mental Health Role Emotional Vitality Social Functioning 6 8 No Cancer Non Invasive Invasive No Cancer Non Invasive Invasive No Cancer Non Invasive Invasive No Cancer Non Invasive Invasive No Cancer Non Invasive Invasive

35 Adjusted HRQOL Changes by Treatment 0 Figure 2: Adjusted HRQOL changes from baseline to follow up of controls and bladder cancer patients stratified by treatment Physical Component Summary Bodily Pain Physical Functioning Role Physical General Health 3 Estimated Difference (Follow Up Baseline) Mental Component Summary Mental Health Role Emotional Vitality Social Functioning 9 Control Bladder Sparing Cystectomy Control Bladder Sparing Cystectomy Control Bladder Sparing Cystectomy Control Bladder Sparing Cystectomy Control Bladder Sparing Cystectomy

36 Adjusted HRQOL Changes by Time Since Diagnosis Figure 3: Adjusted HRQOL changes from baseline to follow up of controls and bladder cancer patients stratified by time since diagnosis Physical Component Summary Bodily Pain Physical Functioning Role Physical General Health 0.0 Estimated Difference (Follow Up Baseline) Mental Component Summary Mental Health Role Emotional Vitality Social Functioning 5.0 No Cancer 0 6 Months 6 12 Months 12+ Months No Cancer 0 6 Months 6 12 Months 12+ Months No Cancer 0 6 Months 6 12 Months 12+ Months No Cancer 0 6 Months 6 12 Months 12+ Months No Cancer 0 6 Months 6 12 Months 12+ Months

37 Activities of Daily Living Significant decrements in all six ADLs for both cases and controls Getting in/out of chairs Eating on your own Using the toilet on your own Dressing yourself Bathing yourself Walking on your own Declines from pre- to post- diagnosis scores more pronounced among cases (p=0.002) Bladder Cancer / Controls /

38 Discussion Bladder cancer pa1ents experience significant declines in physical HRQOL and some mental HRQOL domains rela1ve to controls Decrements most pronounced among pa1ents with invasive disease/radical treatment HRQOL remained stable/low across most domains regardless of 1me since diagnosis Data may be helpful to iden1fy interven1ons to improve physical/mental health among bladder cancer pa1ents

39 PROSTATE CANCER

40 Prostate Cancer Most common cancer among men 1 in 7 men will be diagnosed in their life1me 161,360 new cases in ,730 deaths from prostate cancer in 2017 Localized prostate cancer can be treated a variety of ways (e.g. surgery, radia1on, surveillance) HRQOL and pa1ent/provider preference oven dictates treatment Majority of HRQOL research among prostate cancer pa1ents focuses on post- diagnosis Impact of diagnosis on HRQOL vital in prostate cancer e.g. anxiety, depression may effect a variety of factors

41 Background Objec+ves Methods Results Conclusions Study Objectives 1. Iden1fy HRQOL changes before to aver diagnosis in older adults with prostate cancer 2. Compare changes to non- cancer controls 3. Inves1gate HRQOL stra1fied by disease stage, treatment type and 1me since diagnosis

42 Methods Similar to methods described previously Treatment Defined using codes differen1a1ng between Ac1ve Surveillance Brachytherapy External Beam Radia1on Therapy Prostatectomy Grade/Stage Low/intermediate risk (Gleason 6-7) High risk (Gleason 8-10) Time since diagnosis 0-6 months 6-12 months >12 months

43 Statistical Analysis Bivariate associa1ons T- test Chi- square Linear mixed models for longitudinal data Restricted maximum likelihood es1ma1on Least- squares means to facilitate group- wise comparison of HRQOL domains

44 Cohort Characteristics Cases: n=1,764 Low/Intermediate Risk (n=1040) High Risk (n=724) Controls: n=8,820 70% White, 8% Black, 8% Hispanic, 6% Asian 80% Married/partnered 44% Current or former smoker 55% HTN, 18% diabetes, 29% heart disease No differences aver propensity score matching

45 Overall Results Physical HRQOL PCS scores not significantly different between cases and controls Controls: =- 0.4 Low/Intermediate Risk: =- 1.8; p=0.11 High Risk: =- 1.3; p=0.05 Mental HRQOL MCS scores not significantly different between cases and controls Controls: = Low/Intermediate Risk: =- 0.34; p=0.08 High Risk: =- 0.5; p=0.02

46 Adjusted HRQOL Changes by Grade Phys. Comp. Score Bodily Pain Phys. Functioning Role Physical General Health 0 Estimated Difference (Follow Up Baseline) Mental Comp. Score Mental Health Role Emotional Vitality Score Social Functioning No Cancer Gleason 6 and 7 Gleason 8 10 No Cancer Gleason 6 and 7 Gleason 8 10 No Cancer Gleason 6 and 7 Gleason 8 10 No Cancer Gleason 6 and 7 Gleason 8 10 No Cancer Gleason 6 and 7 Gleason 8 10

47 Adjusted HRQOL Changes by Treatment 2 Phys. Comp. Score Bodily Pain Phys. Functioning Role Physical General Health Estimated Difference (Follow Up Baseline) Mental Comp. Score Mental Health Role Emotional Vitality Score Social Functioning 4 Active Surveillance Brachytherapy External Beam Radiation Radical Prostatectomy Active Surveillance Brachytherapy External Beam Radiation Radical Prostatectomy Active Surveillance Brachytherapy External Beam Radiation Radical Prostatectomy Active Surveillance Brachytherapy External Beam Radiation Radical Prostatectomy Active Surveillance Brachytherapy External Beam Radiation Radical Prostatectomy

48 Adjusted HRQOL Changes by Time Since Diagnosis Phys. Comp. Score Bodily Pain Phys. Functioning Role Physical General Health Estimated Difference (Follow Up Baseline) Mental Comp. Score Mental Health Role Emotional Vitality Score Social Functioning 4 No Cancer 0 6 Months 6 12 Months 12+ Months No Cancer 0 6 Months 6 12 Months 12+ Months No Cancer 0 6 Months 6 12 Months 12+ Months No Cancer 0 6 Months 6 12 Months 12+ Months No Cancer 0 6 Months 6 12 Months 12+ Months

49 Discussion Prostate cancer pa1ents experience similar declines in physical HRQOL and mental HRQOL rela1ve to controls HRQOL similar across treatment type and disease grade HRQOL improves over 1me for physical HRQOL and stable across most domains with regard to 1me since diagnosis General HRQOL may not be specific enough to detect differences in important QOL domains among men with prostate cancer (e.g. urinary con1nence, ED)

50 Strengths and Limitations Limita+ons Generalizability No chemo data Cannot determine cause of death Sample size (subgroups) Granular cancer data SF- 36 in , VR- 12 in Strengths Popula1on- based cohort NSCLC and SCLC types NMIBC & MIBC types Long study period Pre- diagnosis HRQOL assessments Single- item and mul1- item HRQOL measures

51 Acknowledgments " Bryce B. Reeve " Timothy M. Zagar " Byron Jaeger " Lloyd Edwards

52 Thank you!