191P - Experience of ALK mutation testing in 3351 Indian patients of NSCLC

Date 28 September 2014
Event ESMO 2014
Session Poster Display session
Topics Biomarkers
Lung and other Thoracic Tumours
Presenter Sarjana Dutt
Citation Annals of Oncology (2014) 25 (suppl_4): iv58-iv84. 10.1093/annonc/mdu326
Authors S. Dutt1, S. Advani2, B.N. Dhabhar3, P.S. Dattatreya4, S. Patil5, S. Chatterjee6, S. Srinivasan7, D.K. Mishra8, T. Raja9, K. Pavithran10, P.V.A. Reddy11, R.G. Nambiar12, R. Gaur12
  • 1Dept Of Pathology, Oncquest Laboratories Ltd, 110029 - Delhi/IN
  • 2Medical Oncology, S. L. Raheja Hospital, Mumbai/IN
  • 3Medical Oncology, Fortis Hospital, Mumbai/IN
  • 4Medical Oncology, Omega Hospital, Hyderabad/IN
  • 5Medical Oncology, HCG Hospital, Bangalore/IN
  • 6Radiation Oncology, Tata Medical Center, Kolkata/IN
  • 7Medical Oncology, Apollo Hospital, Chennai/IN
  • 8Hematology & Laboratory Sciences, Tata Medical Center, Kolkata/IN
  • 9Medical Oncology, Apollo Speciality Hospital, Chennai/IN
  • 10Medical Oncology, Amrita Institute of Medical Sciences & Research Centre, Kochi/IN
  • 11Radiation Oncology, Apollo Cancer Hospital, Hyderabad/IN
  • 12Dept Of Pathology, Oncquest Laboratories Ltd, Delhi/IN

Abstract

Aim

In the last decade, we have witnessed a revolution in the molecular genetics of NSCLC (Non Small Cell Lung Cancer). These advances have led to the development of a multitude of prognostic and predictive biomarkers. Somatic mutations in EGFR (Epidermal Growth Factor Receptor) gene & ALK (Anaplastic Lymphoma Kinase) translocation are two “actionable” biomarkers that have passed clinical validation and are incorporated into current treatment paradigms. This abstract contributes towards understanding the epidemiology of ALK mutation in NSCLC patients in India.

Methods

This was an observational study within the cohort of NSCLC patients. Pfizer Ltd supported this study as a part of Diagnostic Assistance Program. A total of 3351 patients of lung adenocarcinoma were tested from Jan 2013 to Mar 2014. These samples were collected from various locations across the country. ALK mutation was studied using the FDA approved Vysis ALK Gene Breakapart Probe Kit and the EGFR mutation testing (exons 18-21) was done using PCR followed by bidirectional Sanger's Sequencing.

Results

Of the 3351 samples tested, 2146 (64.04%) were male & 1205 (35.96%) were females. Patients ranged in age from 25-90yrs with a median age of 57.94yrs. Biomarker testing for EGFR and ALK was performed on FFPE specimen of patients with confirmed adenocarcinoma histology. ALK testing was performed on 3351 samples and EGFR analysis on 3079. Of samples received for EGFR, 2653 (86.16%) were successfully analyzed & reported, 177 (5.75%) showed unsatisfactory results, and test could not be performed in 249 cases (8.09%). 2810 (83.86%) samples received for ALK testing by FISH could be successfully reported, 287 (8.56%) showed unsatisfactory results and 254 samples (7.58%) could not be tested. Common reasons for unsatisfactory results were presence of high degree of necrosis, scanty tumor or suboptimal fixation. Of the successfully reported cases, 28.19% were positive for presence of EGFR mutations. Mutations were observed in exon 18 (2.27%), exon 19 (72.99%), exon 20 (3.48%) and exon 21 (21.26%). 71 (2.53%) of the 2810 successfully reported cases were found Positive for ALK Gene Rearrangement. None of the samples showed a concomitant mutation.

Conclusions

This study on 3351 adenocarcinoma enriched NSCLC patients of Indian origin, shows an ALK positivity of 2.53% & EGFR mutation positivity of 28.19%.

Disclosure

All authors declare that he study was funded by Pfizer Ltd as a part of its Diagnostic Assistance Program. Other than that there is no disclosure to declare.