469P - Clinical outcome study of crizotinib in IHC proven EML4-ALK fusion gene among Indian patients with adenocarcinoma lung

Date 18 December 2016
Event ESMO Asia 2016 Congress
Session Poster lunch
Topics Cytotoxic agents
Non-Small-Cell Lung Cancer, Metastatic
Presenter Ullas Batra
Citation Annals of Oncology (2016) 27 (suppl_9): ix139-ix156. 10.1093/annonc/mdw594
Authors U. Batra1, M. Sharma2, A. Jain1, M. Agarwal1, P. Goyal2
  • 1Medical Oncology, Rajiv Gandhi Cancer Institute & Research Center, 110085 - New Delhi/IN
  • 2Medical Oncology, Rajiv Gandhi Cancer Institute, 110085 - Delhi/IN



The USA Food and Drug Administration (FDA) approved VENTANA anti-ALK (D5F3) CDx assay can more accurately identify a new ALK clone, 5A4 than any other commonly used immunohistochemistry (IHC) assay, for the selection of ALK rearranged lung adenocarcinoma patients eligible to receive Crizotinib therapy. However, Indian data on efficacy of Crizotinib in IHC positive non-small-cell lung cancer patients is lacking.


Patients with NSCLC, adenocarcinoma histology, whose tumours had been tested for EML4-ALK fusion gene using IHC, were considered in our study. Clinical characteristics and treatment details were collected from the patient’s medical records. IHC analysis was performed using a Ventana automated immunostainer (Ventana Medical Systems, Illkirch Graffenstaden, France) using a primary monoclonal ALK antibody (mAb) from Abcam.


A total of 24 NSCLC adenocarcinoma patients were included in the study. There were 10 (41.7%) men and 14 (58.3%) women with a median age of 57 years (range 35-80 years). Of the 24 patients, 13 (54%) were non-smokers and ECOG performance status of 1, 2 and 3 was present in 18 (75%), 5 (20.8%) and 1 (4.2%) patient respectively. All patients had stage-IV disease at the time of initiation of Crizotinib therapy. 20 out of the 24 patients who received Crizotinib therapy were eligible for efficacy analysis. 1 patient achieved CR and 15 achieved PR for an overall response rate of 80% . At a median follow-up of 4.7 months (range 0.3 to 20.8 months) the PFS has not yet reached. Common reported adverse events were vomiting, anaemia, cough and hyponatremia in 7(29.2%), 5 (20.8%), 4 (16.7%) and 2 (8.3%) patients respectively that did not require any dose modification. 2 (8.3%) patients experienced severe hepatotoxicity requiring discontinuation of Crizotinib therapy.


Crizotinib has shown a very good response rate in patients with adenocarcinoma lung that has been tested for EML4-ALK gene fusions using IHC. Crizotinib therapy is very well tolerated with two patients experiencing dose limiting hepatotoxicity.

Clinical trial indentification


Legal entity responsible for the study

Dr Ullas Batra, sr Medical oncologist C/O Rajiv Gandhi Cancer Institute & Research Centre, Sector 5, Rohini, New Delhi, Delhi 110085, India




All authors have declared no conflicts of interest.