167O - Prevalence and clinical outcomes for patients with ALK gene rearrangement in Europe: preliminary results from the European Thoracic Oncology Platfor...

Date 29 September 2012
Event ESMO Congress 2012
Session Biomarkers in lung cancer
Topics Biomarkers
Non-Small-Cell Lung Cancer, Metastatic
Presenter Fiona Blackhall
Authors F.H. Blackhall1, S. Peters2, K. Kerr3, K.J. O'Byrne4, H. Hager5, A. Sejda6, A. Soltermann7, C. Dooms8, E. Felip9, A. Marchetti10, E.J. Speel11, N. Price3, S. Savic12, J. De Jong13, M. Martorell14, E. Thunnissen15, L. Bubendorf16, O. Dafni17, R. Rosell18, R.A. Stahel19
  • 1Medical Oncology, The Christie NHS Foundation Trust, M20 4BX - Manchester/UK
  • 2Oncology, Centre Hospitalier Universitaire Vaudois - CHUV, CH-1011 - Lausanne/CH
  • 3Department Of Pathology, Aberdeen Royal Infirmary, Aberdeen/UK
  • 4Oncology, St James's Hospital, Dublin/IE
  • 5Department Of Pathology, Aarhus University Hospital, 8000 - Aarhus/DK
  • 6Medical University Of Gdansk, Medical University of Gdansk, 80-211 - Gdansk/PL
  • 7Institut Für Klinische Pathologie, Universitätsspital Zürich, 8091 - Zurich/CH
  • 8Respiratory Oncology, univ hospital leuven, 3000 - leuven/BE
  • 9Oncologia Médica, Vall d`Hebron University Hospital Institut d'Oncologia, 08035 - Barcelona/ES
  • 10University-foundation, Center of Predictive Molecular, Chieti/IT
  • 11Molecular Diagnostics, Department of Pathology, 6229 HX - Maastricht/NL
  • 12Pathology, Institute Of Pathology, University Hospital Basel, Basel/CH
  • 13Pathology, The Netherlands Cancer Institute, Amsterdam/NL
  • 14Consorcio Hospital General Universitario De Valencia, Universitat de Valencia, 46014 - Valencia/ES
  • 15Pathology, Vrije Universiteit Medical Center, 1081 HV - Amsterdam/NL
  • 16Division Of Cytology, Institute For Pathology, University Hospital Basel, 4031 - Basel/CH
  • 17Nursing - Laboratory Of Biostatistics, Frontier Science Foundation-Hellas, Athens/GR
  • 18Medical Oncology Service, Catalan Institute of Oncology, Hospital Germans Trias i Pujol, 08916 - Badalona/ES
  • 19Clinic Of Oncology, University Hospital Zürich, 8091 - Zürich/CH

Abstract

Background

The prevalence of ALK gene rearrangement (ALK+) in European patients with non-small cell lung cancer (NSCLC) is unknown. The Lungscape project provides a platform to evaluate its expression and clinical significance in a large cohort of patients with resected NSCLC from 13 European sites in 11 countries.

Methods

Participating sites retrospectively identified cases of NSCLC with clinical demographic and outcome data, and available tissue for research according to predefined protocol criteria. Local ethical and regulatory approvals were adhered to. Clinical data were entered to a central, secure database. Accepted cases on the basis of completeness of clinical data were assessed for ALK expression using immunohistochemistry (IHC) using antibody clone 5A4 (Novocastra) and an H-score modified after Ruschoff et al. All cases were analysed at participating clinical pathology laboratories using the same protocol, control tissue microarray and after passing an external quality assurance exercise.

Results

To date 998 cases of adenocarcinoma have been accepted to the database and ALK IHC results are available for 743 (74%). Positive IHC staining is present in 54 cases (7.3%) with IHC 3+ in 17 cases (2.3%), 2+ in 6 cases and 1+ in 31 cases. The median H-score is 45 (range 1-300) with homogeneous staining in 30% of cases and heterogeneous staining in at least 70% of cases. In total there are 38% women and 62% men, the proportion of stage I, II and III is 55, 23 and 22 % respectively, 16% of cases are never smokers and 99% Caucasian ethnicity. The median age of all cases (n = 998) is 65 years (range 23 - 86) and for IHC + 63.2 years. With respect to gender and smoking status 11% of women, 5.6% of men, 13% of never-smokers, 5.3% of former smokers and 9.3% of current smokers demonstrated positive IHC for ALK.

Conclusions

The preliminary results for this large multicentre European cohort demonstrate a prevalence of ALK assessed by IHC of 7.3%, with IHC 3+ expression in 2.3% of cases. Correlation of IHC scores with fluorescent in situ hybridisation, clinical demographics and outcomes is ongoing and will be presented.

Disclosure

All authors have declared no conflicts of interest.