European Studies in Lung Cancer
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1 European Studies in Lung Cancer Paul Baas 12 th International Lung Cancer Conference 2011, Carlsbad, CA S
2 Overview of trials and other European research activities
3 Question S Which country has the highest unemployment rate in the Euro zone? S Greece S Italy S Spain S Lichtenstein
4 Studies in NSCLC: Europe 2011
5 European Studies Phase III in NSCLC S Belagenpumatucel-L vaccine study S Darbepoetin-α in stage IV S PCI in NSCLC stage III S BLP25 liposome vaccine study (completed accrual) S Ramucirumab in 2nd line S Avaperl1 +/- maintenance pemetrexed
6 European Studies Phase III in NSCLC S MAGE study vaccination as adjuvant after surgery S Erlotinib high/low in smokers S Pemetrexed and radiation in Stage III S Carbo/Gemcitabine +/- Iniparib (PARP inhibitor) in squamous ca S Crizotinib in patients with EML4-ALK translocation
7 EORTC S LUNGART S RT or no RT to the mediastinum in unforeseen N2 after resection in NSCLC S Amendments for TR submitted
8 EORTC : Trial Design LUNG-ART Completely resected NSCLC with proven N2 involvement Max 6 wks Post-op CT Max 2 wks R A N D O M No Irradiation Thoracic irradiation 54 Gy/30 fr DFS Local control OS 2nd cancer Max 2 wks Late Toxicity Accrual: Follow-up: 4 years 1 year 2011: ± 120 patients entered
9 EORTC S Double blind randomized phase III study of maintenance pazopanib versus placebo in NSCLC patients non progressive after first line chemotherapy. S Integrated phase II/III study S Pazopanib or placebo starts at 600 mg/day then at a daily dose of 800 mg if well tolerated. S Stats: improvement in OS from 9.7 to 12.7 months required number of patients: 587
10 EORTC 080xx S Denosumab (MoAb against RANK Ligand) in NSCLC S Protocol in preparation S Study to be combined with ETOP
11 EURTAC (ASCO 2011) N=174 N=1227 N=86 N=87 RR: 55% vs. 15% PFS: 9.7 m vs m OS: 22.9 m vs m
12 International BREC (BRCA1 Expression Customization) CONTROL Docetaxel/Cis Advanced NSCLC 1:1 T1 RAP80 (T1-T3 BRCA1) Gem/Cis EXPERIMENTAL T2-T3 RAP80 (T1-T2 BRCA1) Docetaxel/Cis 216 patients per arm total: 432 T2-T3 RAP80 (T3 BRCA1) Docetaxel Spanish Lung Cancer Group, French Lung Cancer Group, Hellenic Cooperative Cancer Group Gulf countries, Saudi Arabia, Colombia, China
13 Studies in SCLC: World wide
14 European Studies in SCLC S Carbo/Etoposide +/- Ipilimumab in ES S CONVERT study in LS S Platinum/Etoposide +/- Pravastatin S Concurrent Chemo- IMRT in Stage I-III
15 EORTC S Sunitinib as first line in patients with SCLC ES first or second line S Phase II open for inclusion 2009 S Early stopping rule PET/CT at 4 weeks S Accrual planned 48 (2x 24) S Study ended prematurely after 9 pts entered
16 EORTC S Amrubicin in SCLC LS S Randomized 3 arm phase II study S Amrubicin vs Amrubicin + CDDP vs CDDP/Etop S Inclusion 91/97 S Published 2011 in European J Cancer, June 2011 S Plan: proceed to phase III
17 CONVERT UK/French/EORTC Concurrent ONce-daily VErsus twice-daily RadioTherapy in LS SCLC S Recently opened S Intergroup study S SCLC LS cisplatin/etoposide with 45 Gy BID or 60 Gy OD S Accrual through EORTC (6 sites open) S Survival benefit OD RT: 12% at 2 years (CI 43-50%) 532 patients
18 Limited Stage Small Cell Lung Cancer CONVERT STUDY Once daily Thoracic Irradiation D1 D3 D22 D24 D43 D45 D64 D66 RT 66Gy/45D/33F SD, PR,CR PCI Twice daily Thoracic Irradiation D1 D3 D22 D24 D43 D45 D64 D66 If<SD No PCI RT 45Gy/19D/30F Restage Chemotherapy Radiotherapy
19 EORTC studies in Mesothelioma S E S Phase II study of Bortezomib + CDDP 1 th line S Endpoint PFS at 18 weeks S Statistics: Simon two stage total of 78 patients required (19 of 37 in first step) S Currently included 53/76
20 European Thoracic Oncology Platform Support received from the following institutions: Logo? Associazione Italiana di Oncologia Toracica (AIOT), Italy Hellenic Cooperative Oncology Group (HeCOG), Greece Leuven Lung Cancer Group, Belgium Logo? British Thoracic Oncology Group (BTOG), GB Hellenic Oncology Research Group (HORG), Greece TOGA - FLOT, Belgium Logo? Danish Lung Cancer Group (DLCG), Denmark Manchester Lung Group, GB Groupe Français de Pneumo-Cancérologie (GFPC), France EORTC Lung Cancer Group, Netherlands, Belgien? SAKK and its Lung Project Group, CH Grupo de estudos do cancro do pulmäo (GECP), Portugal Logo? European Lung Cancer Working Party (ELCWP), Belgium Spanish Lung Cancer Group, Spain
21 Goal S To serve as an umbrella for the national tumor groups S To facilitate large studies in Europe S To add translational dedicated research S To identify centers suitable for certain studies S Not to become a second EORTC
22 LUNGSCAPE is a translational research project designed by ETOP
23 About LUNGSCAPE S The LUNGSCAPE addresses the challenges of studying the molecular epidemiology of lung cancer S S by coordinating and harmonizing the procedures of of lung cancer specialists working in translational research across Europe by facilitating analysis of larger series of cases. S This will: S S S Expedite knowledge of the prevalence and context of current and emerging molecular biomarkers Facilitate more rapid translation of biomarker knowledge to the clinic Provide a platform for marker-driven trials of novel therapeutics
24 Current activities S Step 1: Retrospective analysis of 1500 completely resected NSCLC from a limited number of 13 sites: Mutation testing, immunohistochemistry, selected FISH on FFPE tumor tissue S Step 2: Expansion to biopsies from advanced disease and an increase of participating sites S Further steps and issues under considerations: Enlargement of biobank, exon sequencing (selected frozen tissue), circulating biomarkers, technology platforms, resource utilization and health economics research
25 Comprehensive clinical data capture ETOP Lungscape Project description Berne, April 5, 2011
26 Thanks for your attention
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