Symptom Benefit Committee Chicago May 2018 F. Hilpert/JE Kurtz
Symptom Benefit Committee Published studies SOLO 2-QoL accepted in Lancet Oncology NOVA-QoL submitted
MOST questionnaire
Update: ongoing studies OVAR 12 - QoL QoL working group Chair: F. Joly Discussion of QoL analysis in progress
GCIG Intergroup Study AGO-OVAR 12 /LUME-Ovar 1 Hypothesis Efficacy : clinically negative study 1) Hyp QoL : Maintenance therapy with Nintedanib with more significant GI side effects during treatment: exploratory QoL analysis will expose no clinical net benefit to patients AGO Study Group 2) Evaluation of the time without deterioration of QoL 3) TWIST? 4) Exploratory analysis : Exploration of Symptoms induced by treatments (duration of diarrhea,.) : duration, intensity,. Links between symptoms induced by treatments and QoL Difference of QoL according to the world countries? Provided by F. Joly
Expression series EXPRESSION I: Breast cancer patients' expectations in respect of the physician patient relationship and treatment management / n= 624 EXPRESSION II: What do primary and recurrent ovarian cancer (OC) patients expect from their Doctors and therapy management? (only in Germany) n=755 EXPRESSION III: ENGOT-ov4: What do primary and recurrent ovarian cancer (OC) patients expect from their Doctors and therapy management? n=1830 EXPRESSION III(i) : Survey in Indian patients n=333 EXPRESSION IV: ENGOT-ov22: What do primary and recurrent ovarian cancer patients expect from mainenance therapy? n= 1854 Expression VI: ENGOT-ov40: Survey in Ovarian Cancer Long Term Survivor EXPRESSION VII: Survey in Ovarian cancer patients regarding sexuality, incontinence and fatigue (planed) Expression VIII: Survey for patients with low grad carcinome (only in Germany) Expression IX: Longterm survival with gynecological cancer
Expression VI - Caroline meets HANNA Holistic Analysis of longterm survivors with ovarian cancer/noggo S13/ENGOT-ov40 Trial setting: Longterm Survivors with ovarian, fallopian tube or peritoneal cancer ( 8 years) Planned No. of patients: 1000 Current accrual: 244 (11th of May 2018) NOGGO: 193 patients BGOG: vote from 05.05.2017, 2 patients AGO-Austria: vote from 26.04.2017, 49 patients MITO: translation of the questionnaire, under contract negotiation TRSGO, Romania, GEICO: ethic vote CEEGOG/MITO/Switzerland: translations of the questionnaire (contract, EC) countries from PARSGO: Lebanon + Jordania submission to ethic
Expression IX - Longterm survival with gynecological cancer ENGOT model: A Sponsor(s): NOGGO e.v. Planned No. of patients: 150-200 per participating country International Survey of Longterm-Survivors Paper-based and internet version (www. carolinmeetshanna.com) Basic history (age, diagnosis, stage, comorbidies, co-medikation) therapy, side effects, follow-up care, quality of life, lifestyle (diet, physical activity, religion) Inclusion criteria: Diagnosis of gynecological cancer (including cancer of the uterine corpus, uterine cervix and gynecological sarcoma and other rare gynecological cancers) 8 years With/without recurrent disease Any stage and grading Timeline: ethics vote: QII 2018 start of survey: QIII 2018 Who wants to participate? Contact: m.keller@charite.de kristin.schnuppe@charite.de hannah.woopen@charite.de
Symptom Benefit Committee JE Kurtz: QoL measurements in patients on IO drugs issues & perspectives 50 clinical trials with IO drugs in OC Some IO side effects are life threatening (mostly colitis and interstitial pneumonia) and certainly alter QoL even at low grade Most of IO side effects are frequent, of low grade but may alter QoL (fatigue, pruritus, hypothyroidism) being undetected by classic QoL tools No relevant publication on IO drugs and QoL/PRO
Symptom Benefit Committee JE Kurtz: QoL measurements in patients on IO drugs issues & perspectives 10-20% of pts are long responders in whom QoL must be assessed and not «diluted» in data from non responders Pts in whom IO drugs are stopped: IO side effects may persist and alter QoL? Single agents well tolerated, issues for combos FACT-G and EORTC QLQ 030 not adapted to IO and perhaps insufficiently sensitive to IO drugs side-effects
Symptom Benefit Committee JE Kurtz: QoL measurements in patients on IO drugs issues & perspectives PROs likely to better describe toxicity/qol as they are coming from the patient directly More adapted to long-term follow-up and low-intensity side-effects Chance for user-friendly epro long-term assessment Pick the CTC-PROAE items likely to be relevant Test feasibility by running the assessment in parallel of some GCIG trial (exploratory cohort) Have some feedback from patients and statisticians/methodologists As all IO drugs have more or less the same spectrum of side effects (apart from ipilimumab) Can we build an international scoring tool using CTC that would fit (almost) all IO drugs trials?
End of Life treatment proposal by NSGO/Kristina Lindemann Background Despite the encouraging increase in hospice care an intensive end of life care has been reported in these patients. Aggressive care has been defined according to the following criteria: Overuse of chemotherapy near death high rates of emergency department (ED) visits hospital and intensive care unit stays underuse of hospice or palliative care services 3. These indicators may serve as a benchmark for future trials on interventions aiming at the improvement of palliative care. Discussion of EoL-project as a substudy of SBS New ethics submission and funding required Output may not justify the effort We may just as well consider prospective design incorporating findings from SBS1
Translation of evidence into clinical practice SB 2- using the MOST to inform patient care
CHARACTERISTIC Age Median 63 years Range 23-100 Number of lines of prior chemotherapy Median 2 Range 1-10 Type of Resistance Percentage (%) - Platinum refractory 155 16 - Platinum resistant 415 44 Potentially platinum sensitive>3 BASELINE CHARACTERISTICS OF PATIENTS IN THE GCIG SBS 378 40 Cancer related symptoms 674 71 Symptomatic ascites 210 22 Cramping abdominal pain 381 40 Friedlander et al J Clin Oncol 33, 2015 (suppl; abstr 5536)
Top 10 Symptoms scored by patients -MOST ( >5- moderate to severe on a 10 point scale) SYMPTOM PRR N=529 % PPS>3 N=350 % Fatigue 49 48 48 Abdominal swelling/bloating TOTAL % 41 37 39 Poor appetite 38 40 39 Abdominal cramping pain 35 36 36 Pain 34 34 34 Shortness of breath 26 27 26 Constipation 25 27 26 Trouble eating 26 22 24 Indigestion 21 20 20 Nausea 19 17 18 Friedlander et al J Clin Oncol 33, 2015 (suppl; abstr 5536
GCIG Symptom Benefit Study Baseline QoL data as prognostic factor in PRROC Univariate analysis of baseline QoL data (n= 545) for overall survival Multivariate analysis of QoL domains
GCIG Symptom Benefit Study Baseline QoL data as prognostic factor in PRROC Association of QoL and early treatment discontinuation (< 8 weeks)
Symptom Benefit 2- translating research into practice Builds on the findings of SB1 use PRO s to document symptoms and inform management MOSTv2 has 24 items and five multi-item scales: abdominal symptoms (MOST-Abdo) disease or treatment-related symptoms (MOST-DorT) chemotherapy-related symptoms (MOST- Chemo) psychological symptoms (MOST-Psych) MOST-Wellbeing Incorporate MOST v2 (and Glasgow PS at baseline) into clinical practice for PRROC and PSROC> 3 lines Include all therapeutic modalities Register all patients in whom treatment is being considered Document the proportion who do not have further treatment and offered palliative care only Prospective evaluation of how the patient reported symptoms inform treatment
SB2 continued Collect data on all supportive medications and interventions analgesic use / antidepressants / paracenteses/ etc Electronic capture of MOST v2 using an APPtracks trajectory of symptoms Collect data on last 4 weeks of life based on the Lindemann proposal
Bringing SBS into the next level: Symptom Benefit Study 2 ROC TFIp < 6m or 3 rd relapse ECOG 0-3 Treatment is considered Baseline MOST v2 clinical and tumor-related factors mgps Prospective assessment of EoLdata based on NSGO/Lindemann Treatment according to investigators decision endpoints: Prospective evaluation of BL-QoL as a predictor and part of a prognostic nomogram in ROC and how the patient reported symptoms inform treatment Longitudinal epro MOST v2- assessment, supportive treatment and follow-up conditions tbd: epro-induced interventions (eg Info to staff/patient)
Thanks to GCIG