Aktuelle Therapiestandards und neue Entwicklungen bei der CLL Primärtherapie und Risikostratifikation
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1 Aktuelle Therapiestandards und neue Entwicklungen bei der CLL Primärtherapie und Risikostratifikation Dr. med. Petra Langerbeins Universitätsklinik Köln Deutsche CLL Studiengruppe (DCLLSG)
2 OFFENLEGUNG INTERESSENSKONFLIKTE 1. Anstellungsverhältnis oder Führungsposition - 2. Beratungs-, bzw. Gutachtertätigkeit - 3. Patent, Urheberrecht, Verkaufs 4. Besitz von Geschäftsanteilen, Aktien oder Fonds - 5. Honorare Roche, Janssen, Grifols 6. Finanzierung wissenschaftlicher Untersuchungen Janssen 7. Andere Finanzielle Beziehungen Reisekostenunterstützung: Abbvie, Mundipharma, Janssen, Roche 8. Immaterielle Interessenskonflikte -
3 Objektiv messbare biologische Merkmale, die prognostische, diagnostische RISK ASSESSMENT oder prädiktive Aussagekraft haben. BIOMARKER
4 Biomarker Prognostic vs. predictive Treatment and outcome Prognostic marker both Predictive marker Risk of death infections Richter transformation Eichhorst B. ASH Educational. 2016
5 Biomarker TP53-disruptions RESONATE-17: Ibrutinib 420mg/d Stilgenbauer S. et al. Blood Burger JA. et al. Lancet Oncol. 2014
6 Biomarker NOTCH1 mutations NOTCH1 wildtype Median PFS FCR 57 mo. FC 33 mo. NOTCH1 mutated Median PFS FCR 34 mo. FC 34 mo. Stilgenbauer S et al. Blood Pozzo F et al. Leukemia. 2016
7 Biomarker IGHV status FCR300 CLL8-Studie Thompson et al. Blood Fischer K et al. Blood Guo A et al. Oncotarget. 2016
8 Biomarker Clinical stage Binet A Binet B Binet C Binet JL et al. Cancer.1981 Rai KR et al. Blood Pflug & Bahlo et al. Blood. 2014
9 Cumulative Survival Biomarker Duration of remission 6 yrs yrs yrs <1 yr Months Tam CS et al. Blood Fischer K et al. unpublished.
10 Biomarker MRD status Peripheral blood Progression-free survival Bone marrow Overall survival Böttcher S et al. J Clin Oncol Strati P et al. Blood. 2014
11 Biomarker Comorbidity Goede V et al. Haematologica Stauder et al. Annals of Oncol. 2017
12 Biomarker Comorbidity Stauder et al. Annals of Oncol. 2017
13 Biomarker Age Patients 65 years: P < FCR 53.6 months BR 38.5 months Patients > 65 years: P = FCR not reached BR 48.5 months Eichhorst B et al. Lancet Oncol. 2016
14 Multivariates, statistisches Verfahren zur Analyse hierarchisch strukturierter Daten. RISK ASSESSMENT HIERARCHIAL MODELS
15 Hierarchical model FISH Döhner et al. N Engl J of Med. 2000
16 Integrated cytogenetic model NOTCH1, SF3B1, BIRC3 Rossi D et al. Blood. 2013
17 comorbidity IGHV status age clinical stage FISH MRD NOTCH1 duration of remission RISK ASSESSMENT SCORING SYSTEMS
18 Scoring systems MDACC-score / GCLLSG-score Biomarker Score Age [years] < > 65 3 Sex Female 0 Male 1 ß2-microglobulin < ULN x ULN 1 > 2 ULN 2 Rai stage 0-II 0 III-IV 1 Lymphocyte count [10 9 /L] < >50 2 Involved nodal areas Risk group Low 1-3 Intermediate 4-7 High >7 Biomarker Score Age [years] 60 0 > 60 1 Sex Female 0 Male 1 ß2-microglobulin [mg/dl] > ECOG PS 0 0 > 0 1 Thymidine kinase [U] 10 0 > 10 2 IGHV Mutated 0 Unmutated 1 11q Non-deleted 0 Deleted 1 17p Non-deleted 0 Deleted 6 Risk group Low 1-2 Intermediate 3-5 High 6-10 Very high Wierda WG et al. Blood Pflug N and Bahlo J et al. Blood. 2014
19 Scoring systems CLL-IPI International CLL-IPI working group. Lancet Oncol. 2016
20 Scoring systems CLL-IPI Biomarker Score Age [years] 65 0 > 65 1 Stage Rai 0/Binet A 0 ß2-microglobulin [mg/dl] Rai I-IV/Binet B-C > IGHV Mutated 0 Unmutated 1 TP53 No abnormalities 0 Deletion ± mutation 4 CLL-IPI category OS at 5 ys (%) Low risk 93.2 Do not treat Intermediate risk Potential clinical consequence 79.3 Do not treat except symptomatic High risk 63.3 Treatment indicated except asymptomatic Very high risk 23.3 Do not use chemotherapy (use novel agents or treat within a clinical trial) Risk group Low 0-1 Intermediate 2-3 High 4-6 Very high 7-10 International CLL-IPI working group. Lancet Oncol. 2016
21 ???????? RISK ASSESSMENT FIRST LINE TREATMENT
22 Biomarker Guideline recommendations Clinical stage Disease activity Age Comorbidities TP53 / del17p IGHV Duration of remission IWCLL. International Workshop on CLL ESMO. European Society for Medical Oncology NCCN. National Comprehensive Cancer Network
23 Fit, no TP53-disruption ( 65 years) Rituximab plus FC Binet A, B, C Symptomatic Age 65 CIRS 6 No TP53 / del17p IGHV Duration of remission Wendtner CM et al. Onkopedia. 2017
24 Fit, no TP53-disruption (> 65 years) Rituximab plus Bendamustin Binet A, B, C Symptomatic Age > 65 CIRS 6 No TP53 / del17p IGHV Duration of remission Wendtner CM et al. Onkopedia. 2017
25 Fit, no TP53-disruption FLAIR Binet A, B, C Symptomatic Age CIRS 6 No TP53 / del17p IGHV - irrelevant Duration of remission Patient population Treatment-naive CLL Fit R A N D O M I Z E FCR IR ibrutinib + rituximab I ibrutinib IV ibrutinib + venetoclax Collett L et al. Trials. 2017
26 Fit, no TP53-disruption CLL13 trial Clinical Binet A, stage B, C Disease Symptomatic activity Age Comorbidities CIRS 6 TP53 No TP53 / del17p / del17p IGHV - irrelevant Duration of remission Patient population Treatment-naive CLL Fit R A N D O M I Z E FCR/BR* RV rituximab + venetoclax GV GA venetoclax GIV GA ibrutinib + venetoclax
27 Unfit, no TP53-disruption Chlorambucil + CD20-mAb Binet A, B, C Symptomatic Age CIRS > 6 No TP53 / del17p IGHV - irrelevant Duration of remission Wendtner CM et al. Onkopedia. 2017
28 Unfit, no TP53-disruption ( 65 ys) Ibrutinib Binet A, B, C Symptomatic Age 65 CIRS > 6 No TP53 / del17p IGHV - irrelevant Duration of remission Wendtner CM et al. Onkopedia. 2017
29 Unfit, no TP53-disruption illuminate trial Binet A, B, C Symptomatic Age CIRS > 6 No TP53 / del17p IGHV - irrelevant Duration of remission
30 Unfit, no TP53-disruption CLL14 trial Binet A, B, C Symptomatic Age CIRS > 6 No TP53 / del17p IGHV - irrelevant Duration of remission Patient population Treatment-naive CLL Unfit R A N D O M I Z E Obinutuzumab + Chlorambucil Obinutuzumab + Venetoclax Fischer K. et al., Blood 2017
31 Fit, TP53-disruption Ibrutinib Binet A, B, C Symptomatic Age CIRS 6 TP53 / del17p IGHV - irrelevant Duration of remission Wendtner CM et al. Onkopedia. 2017
32 Unfit, TP53-disruption Ibrutinib Binet A, B, C Symptomatic Age CIRS > 6 TP53 / del17p IGHV - irrelevant Duration of remission Wendtner CM et al. Onkopedia. 2017
33 High risk CLL GIVe trial Binet A, B, C Symptomatic Age CIRS TP53 / del17p IGHV - irrelevant Duration of remission Patient population Treatment-naive del17p / TP53 Obinutuzumab Cycle 1-6 Venetoclax Cycle 1-12 Ibrutinib Cycle 1-12 induction consolidation maintenance
34 Biomarker in CLL Summary A variety of prognostic and predictive biomarkers is available. Prognostic scores help to combine multiple biomarkers. TP53 remains the strongest biomarker. For high risk patients (TP53-disruption) ibrutinib is the first choice. CIT remains the standard of care (FCR, BR, CLB + mab). Comorbidity defines fit, unfit and fragile subgroups. Consider ibrutinib in patients with IGHV unmutated CLL. Combination studies will clarify the role of novel drugs compared to CIT.
35 THANK YOU! Deutsche CLL Studiengruppe
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