Quality of Life assessment: A perspective from The EORTC
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1 Quality of Life assessment: A perspective from The EORTC Presentation to the European Commission Iniciative in Breast Cancer meeting Andrew Bottomley, PhD Assistant Director, Head of the QOL Department European Organization for Research and Treatment of Cancer Brussels, Belgium 21 November, 2017
2 European Organization for Research and Treatment of Cancer (EORTC) Private and not-for-profit organization, created over 50 years ago Main mission: promote and conduct research to improve cancer survival and improve quality of life Core activity: conduct clinical trials International, Multidisciplinary, Develop new treatments Define new standards of care Large academic trials Funded by member states, EU grants, Charitable Foundations, private donations, and for specific trials by sponsors
3 EORTC network in 2017 key facts and figures 4000 patients entered into clinical trials every year 600 institutions from 35 countries involved in our trials 200 trials with QOL in since members of the QOL Group (started in 1986) Over 50 academic projects ongoing to develop new QOL tools
4 QOL and outcome measures
5 The early years of QoL measurement in research and clinical practice QoL was a new concept for researchers (USA and EU) Skepticism was high (worldwide) No robust standardized measure was available; few translations were available Only a few modules were available Investigators debated the added value of QoL Consequently, QoL was a challenge but things have changed and interest in QOL has skyrocketed
6 Current thinking regarding assessing QOL.. US NIH PATIENT GROUPS Patient advocacy is one of the major players and critical to voice and be involved in all activities ISOQOL ICHOM PCORI VIEWS OF QOL FDA EMA ISPOR 6
7 Working definition of HRQOL Subjective Multi-dimensional Dynamic Physical Functioning Social Functioning Emotional Functioning 7
8 Common QOL problems in women with BC Physical and Mental health Ability to perform daily roles Sexual function Pain, fatigue and other side effects of treatment or symptoms of the breast cancer (eg. Skin problems, etc) Non-health related issues (such as financial concerns) 8
9 Which tools are frequently used in Breast Cancer Outcome Studies? Systematic review: 2002 of 20 RCT in BC showed EORTC BC 23 tool used on 60% of trials1 Systematic review : of 50 RCTs in BC this showed: EORTC QLQ-C30 and BR23 most frequently used tool 52% of trials The Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer (FACT-B) 1993, used in 25 % of BC RCTs. Tools used in less than 10% of RCTS Rotterdam Symptom Checklist EuroQOL Five Dimension Scale was used in Less than 2% of trials used Functional Living Index Cancer (1984) Developed in cancer, but missing dimensions important to cancer patients, such as body image or sexual enjoyment Cancer Rehabilitation Short Form (1991) Developed in USA. Missing items of breast symptoms or Arm symptoms reported by breast cancer patients 1.The Lancet Oncology, Bottomley and Therasse,, 2 Ghislain I. et al, The Lancet Oncology
10 New possible alternative measures: Patient Reported Outcome Measurement Information System (PROMIS) Cella et al 2013 Funded and developed by USA government and tested and validated in US population, limited translations (i.e. 6). Limited experience in clinical practice or trials Patient Reported Outcome Common Toxicity Criteria Adverse Events (PRO- CTCAE) Basch et al 2014 developed in the US population, funded by NCI, currently limited translation (n=7), only assessing symptoms so not capturing full patient experience,. Limited experience in clinical practice or in breast cancer trials. 10
11 QOL Parameters for EORTC QLQ-C30 tool COGNITIVE FUNCTIONING EMOTIONAL FUNCTIONING FATIGUE PAIN APPETITE LOSS PHYSICAL FUNCTIONING ROLE FUNCTIONING SOCIAL FUNCTIONING DYSPNEA CONSTIPATION INSOMNIA NAUSEA/VOMITING DIARRHEA EORTC QLQ-C30 GLOBAL HEALTH STATUS/QOL 11
12 QLQ-C30 How does it looks like?
13 EORTC Quality of Life Questionnaire- Breast 23 (QLQ-BR23) Developed in 1996 (Sprangers et al) Developed across the EU, with extensive patient interviews Scales (Five): Functional Scales: Body image, Sexuality Symptom scales: Arm, Breast and systemic side effects Translated into 80 languages Major validation globally e.g. Korea, Iran, Mexico, etc all support validity Easy to complete :10 mins to complete with QLQ-C30 13
14 QLQ-BR23 How does it looks like?
15 The EORTC Modular Approach: Disease specific Breast cancer Breast reconstrucion EORTC QLQ-C30 30 items Esophageal cancer Ovarian cancer Colorectal cancer Brain cancer Head &Neck cancer
16 Developmental process of EORTC measures: Phase 1-4 Average cost to develop= 400,000 euros BR23 currently being revised at 400,000 euros Phase 4 Field Testing Up to 800 patients Phase 3 - Pretesting (acceptability n=100) Development time= 6 years min Phase 2 - Operationalization (standardization) Phase 1 - Generation of QL issues (Lit review, patient/medic interviews, n=50)
17 Is QOL an important measure in clinical practice? International Consortium for Health Outcomes Measurement (ICHOM) recommend data capture with the Electronic Medical Records using a standard data-set of outcomes including the EORTC tool (JAMA Oncology, 2017) UK NHS- ongoing evaluation to use EORTC tool or EQ5D in all cancer patients across the England + same study in HNS Wales European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS), which includes QOL that increases or decreases the score of each new treatment studied (in trials and real world data studies) 17
18 Summary There has been a huge increase in QOL research in breast cancer in trials and clinical practice Most organizations value the views of breast cancer patients, their QOL, and not just their symptoms. Tools have been developed robustly, with large amount of data to support there development across countries. The newer technology, such as electronic collection on web or tablets will make QOL cheaper, and more accessible to patients. The EORTC is happy to share use of the EORTC tools at no cost, for use in future guidelines. 18
19 19
20 BACKUP 20
21 Why is the EORTC BR 23 so often cited in the literture? Developed by independent academics History of robust validation since 1993 A robust translation process over 100 languages History of use in most clinical trials and preference of researchers and investigators EORTC tends to be used in conventional studies, versus FACT-B used in complementary/alternative trials. (eg. Nguyen J et al 2015) The most commonly used breast tool in other publications A large data set to help interpret scores to understand clinical relevance of scores Free to all academic and public, governmental researchers Major re-investment to regularly update the tool and maintain translations and produce for free 21
22 Preference of researchers and investigators (eg. Nguyen J et al 2015, Aaronson and Fayers, 2016, Apolone et al 1998, etc. ) 22
23 The EORTC Modular System: Newer symptom tools/situational EORTC QLQ-C30 30 items Information Arrasse et al Fatigue Weiss et al Satisfaction Care, Bredart et al, Bone Mets Chow et al Palliative care Short form
24 23 fully validated modules Cholangiocarcinoma and Gallbladder Cancer (QLQ-BIL21) Bone Metastases (QLQ-BM22) Brain (QLQ-BN20) Breast (QLQ-BR23) Breast Reconstruction (QLQ-BRECON23) Colorectal (QLQ-CR29) Cervical (QLQ-CX24) Elderly Cancer Patients (QLQ-ELD14) Endometrial (QLQ-EN24) Cancer Related Fatigue (QLQ-FA12) Neuroendocrine Carcinoid (QLQ-GINET21) Hepatocellular Carcinoma (QLQ-HCC18) Head & Neck (QLQ-H&N35) Information (QLQ-INFO25) Lung (QLQ-LC13) Colorectal Liver Metastases (QLQ-LMC21) Multiple Myeloma (QLQ-MY20) Esophageal (QLQ-OES18) Oral Health (QLQ-OH15) Esophagus-Gastric (QLQ-OG25) Ovarian (QLQ-OV28) Prostate (QLQ-PR25) Gastric (QLQ-STO22) and of course the core questionnaire QLQ-C30 (currently available in 100 language versions)
25 and around 30 + modules in development Chemotherapy-Induced Peripheral Neuropathy (QLQ-CIPN20) Muscle Invasive Bladder Cancer (QLQ-BLM30) High-Dose Chemotherapy (QLQ-HDC29) Melanoma (QLQ-MEL38) Non-Muscle-Invasive Bladder Cancer (QLQ- NMIBC24) Ophthalmic Cancer (QLQ-OPT30) Pancreatic Cancer (QLQ-PAN26) Cancer Cachexia (QLQ-CAX24) Chronic Lymphocytic Leukemia (QLQ-CLL17) Chronic Myeloid Leukemia (QLQ-CML24) Communication (QLQ-COMU26) Head & Neck Cancer (QLQ-H&N43) (update of QLQ- H&N35) Lung Cancer (QLQ-LC29) (update of QLQ-LC13) High Grade Non-Hodgkin s Lymphoma (QLQ-NHL-HG29) Satisfaction with Cancer Care - Core questionnaire Low Grade Non-Hodgkin s Lymphoma (QLQ-NHL-LG20) (PATSAT-C33) Satisfaction with Outpatient Cancer Care (OUT- PATSAT7) Hodgkin s Lymphoma (QLQ-HL27) Sexual Health (QLQ-SHQ22) Radiation Proctitis (QLQ-PRT23) Anal Cancer (QLQ-ANL27) Spiritual Wellbeing (QLQ-SWB32) Thyroid Cancer (QLQ-THY34) Testicular Cancer (QLQ-TC26) Adolescents and Young Adults Symptom-based questionnaire Hereditary Cancer Predisposition Syndrome Breast Cancer (update of QLQ-BR23) IADL in Brain Tumor Patients Vulva Cancer Pancreatic Neuroendocrine Tumour Nasopharyngeal Carcinoma (QLQ-NPC42) Spinal Cord Compression Survivorship
26 Accrual of patients in EORTC clinical studies in 2016: 4000 patients European Union: Austria: 52 Belgium: 439 Cyprus: 16 Czech Republic: 13 Denmark: 60 Finland: 5 France: 660 Germany: 289 Hungary: 14 Ireland: 19 Italy: 467 Latvia: 1 Luxemburg: 3 Poland: 174 Portugal: 58 Rest of the World: Australia: 8 Egypt: 18 Israel: 16 South Africa: 2 Taiwan: 69 Slovakia: 50 Slovenia: 40 Spain: 129 Sweden: 27 The Netherlands: 848 United Kingdom: 813 Non-EU Countries: Croatia: 35 Norway: 27 Romania: 1 Russia: 5 Serbia and Montenegro: 27 Switzerland: 53 Turkey: 68 Canada: 200
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