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EPCCS STUDY: SYMPTOM BURDEN IN ADVANCED LUNG CANCER PATIENTS Dr. Ana Maria Hermosa Garcia, MD Palliative Care Program, Royal Alexandra Hospital 25th Annual Palliative Education and Research Days October 28th, 2014 Disclosures Ana Maria Hermosa Garcia – postdoctoral fellow This project was grant-funded by Alberta Innovates – Health Solutions Investigators: Konrad Fassbender, Vickie Baracos, Sharon Watanabe, Robin Fainsinger, Cheryl Nekolaichuk, Ann Huot, Quincy Chu Amount: $ 89.930 Term: April 1, 2011 – November 1, 2013 Acknowledgements Alberta Innovates - Health Solutions funding Investigators: Konrad Fassbender, Vickie Baracos, Sharon Watanabe, Robin Fainsinger, Cheryl Nekolaichuk, Ann Huot, Quincy Chu Research Coordinator: Danielle Baron Research Nurse: Asifa Mawani Summer Student: Lisa Fainsinger, Caitlyn Vail Thank-you to the clinicians and staff for the Cross Cancer Institute clinics Thank-you to the patients and their families for their generous participation Background Methods Results Conclusions Background 1: Advanced Lung Cancer Patients Profile • 13.5% of all cancer diagnosis in Canada • Leading cause of cancer deaths (27%) • Only 15% cases are detected at early stage • 85% Non-Small Cell Lung cancer (squamous cell ca, adenoca., large cell ca) • 5 years survival rate for NSCL cancer (17%) • Metastatic= 3.6% 5 y survival http://www.cancer.ca/~/media/cancer.ca/CW/publications/Canadian%20Cancer%20Statistics/canad ian-cancer-statistics-2013-EN.pdf Background 2: Advanced Lung Cancer Patients Profile • >90% patients will experience ≥2 symptoms • Fatigue, loss of appetite, dyspnea, chest pain (>80% patients); cough ~50% • Symptoms are more severe 0-3 m prior to death • QoL is paramount since life expectancy is short 1. Hirsh V. Are the data on quality of life and patient reported outcomes from clinical trials of metastatic non-small-cell lung cancer important? World J Clin Oncol. Nov 10, 2013; 4(4): 82–84. 2. Lutz S. et al. Symptom frequency and severity in patients with metastatic or locally recurrent lung cancer: a prospective study using the Lung Cancer Symptom Scale in a community hospital. J Palliat Med 2001 Summer;4(2):157-65. Background 3: Care trajectory for cancer patients Old concept Modern concept Murray S. et al. Illness trajectories and palliative care. BMJ 2005; 330; 1007-1011 (adapted from Lynn and Adamson 2003) Background 4: Care trajectory for advanced lung ca Death Diagnosis MEDICAL/RADIATION ONCOLOGIST • Chemotherapy combination • (etoposide/vinorelbine/permetrexed/ gemcitabine ± cisplatin or carboplatin ± paclitaxel) • ± Radiation therapy End of Life PALLIATIVE CARE TEAM • Placement support: Hospice • Community Liaison (no further tx) • Symptom control ± poor performance status Background 5: Edmonton Symptom Assessment System (ESAS-r) 1. Bruera E et al.The Edmonton Symptom Assessment System(ESAS):a simple method for the assessment of palliative care patients.JPalliatCare.1991;7(2):6-9 2. Watanabe SM et al.A multicenter study comparing two numerical versions of the ESAS in palliative care patients. J Pain Symptom Manage. 2011 Feb;41(2):456-68 Background 6: Early integration of Palliative Care American Society Clinical Oncology guidelines (1) PC should be “considered early in the course of illness” for any patient with metastatic cancer and/or high symptom burden. European Society Medical Oncology guidelines (2) “Early palliative-care intervention is recommended”, in parallel with standard oncologic care. Guidelines of professional/expert bodies: Fraser Health, Canadian Virtual Hospice, Edmonton Program, Champlain 1. Smith T. et al. ASCO Provisional Clinical Opinion: The Integration of Palliative Care into Standard Oncology Care. Journal of Clinical Oncology, Vol 30, Issue 8 (March), 2012: 880-887 2. Peters S. et al. Metastatic Non-Small-Cell Lung Cancer:ESMO Clinical Practice Guideline.Ann Oncol 2012;23(Suppl 7):vii56-vii64 Research question Since high symptom burden is one criterion for referral for pain and symptom management, what is the severity and trajectory of the symptoms experienced by advanced lung cancer patients? Methods 1: Prospective study Inclusion criteria: Lung cancer Stages IIIB/IV Medical Oncology Clinics CCI from Aug 2012 until Nov 2013 Available for assessment every 3-5 weeks, ongoing Demographics (age, gender), treatment, standardized assessment and symptom burden data (Edmonton symptom assessment system –ESAS-) (also QoL, MMSE, biomarkers – for future analysis). Statistical analysis. Methods 2: Consort Diagram Pain & Symptom Clinic Lung Clinic Recruitment Total patients in clinic (n=353) Total patients in clinic* (n=244) Total approached (n=57) Total approached (n=96) Declined (n=30) Declined (n=25) Consented (n=27) Consented (n=71) Enrollment Lost < to baseline (n=):4 •Deceased (n=1) Failed MMSE (n=2) Withdrew (n=1) Received baseline assessment (n=27) Received baseline assessment (n=67): Follow-Up Lost during follow-up (n=6): Final Pain & Symptom cohort (at least baseline + 1 FU) n=24 Cogn impaired (n=1) Self-withdrawal (n=2) Failure to do visits (n=1) No longer eligible (n=1) Deceased (n=1) Total Cohort (n=85) Final Lung cohort (at least baseline + 1 FU) n=61 Results 1: Demographics N Age Range Mean SD Total patients 67 28-82 64 ± 10.5 Male Female 34 33 28-81 48-82 65 63 ± 9.6 ± 11.3 Sex Performance Status at inclusion 80 ± 10 (70-100) • Patients were assessed every 3-5 weeks • N of assessments per patient between 1-18, mean 5.6 • 67 patients with a total of assessments= 370 Results 2: Symptom prevalence (67 patients with a total of 370 assessments) N Min. Max. Mean SD TIREDNESS 371 0 10 2.78 ±2.50 DROWSINESS 368 0 10 1.95 ±2.49 LACK OF APPETITE 370 0 10 1.73 ±2.7 DYSPNEA 372 0 10 1.95 ±2.5 WELLBEING 370 0 10 2.12 ±2.23 PAIN 372 0 8 1.20 ±1.79 DEPRESSION 372 0 10 0.84 ±1.65 NAUSEA 372 0 9 0.42 ±1.31 ANXIETY 371 0 8 0.92 ±1.56 Results 3: Prevalence of high symptom scores ≥7 (n=23 of 67 patients (34%)) SYMPTOMS (ESAS-r) PATIENTS WITH SYMPTOM SCORES ≥ 7 AT ANY TIME % 34.3% N 23/67 TIREDNESS 28.4% 19 DROWSINESS 20.9% 14 LACK OF APPETITE 19.4% 13 DYSPNEA 17.9% 12 WELLBEING 16.4% 11 PAIN 10.4% 7 DEPRESSION 8.9% 6 NAUSEA 8.9% 6 ANXIETY 7.5% 5 Results 3: Repeated severe symptoms: patients with 2 consecutive high scores ≥7 SYMPTOMS (ESAS-r) PATIENTS WITH PERSISTENT SYMPTOM SCORES ≥ 7 % 19.3% N 13/67 TIREDNESS 8.7% 6 DROWSINESS 4.5% 3 LACK OF APPETITE 4.5% 3 DYSPNEA 10.4% 7 WELLBEING 1.5% 1 3% 2 1.5% 1 NAUSEA 0 0 ANXIETY 1.5% 1 PAIN DEPRESSION •19.3% of patients with multiple/persistent episodes of severe symptoms. •Is this a generality? •Can these symptoms be resolved? Results 4: Survival comparison • Median overall survival was 11 months (95% CI 8-13 months) • Median survival in the persistent high symptoms group was 7 months, versus 11 months in the no persistent high symptoms group (p=0.47, fig.1); compared by Log Rank test Conclusions Overall symptom severity in this sample is moderate however 34.3% of patients had a high symptom score at some point of their disease trajectory. There is also a significant group of patients with repeated high symptom scores (19.3%) potentially affecting quality of life. Moderate symptom scores need to be explored. More research is required to develop and validate algorithms, identifying opportunities for improved symptom treatment. THANKS!!! ANY QUESTIONS???