This study aims to assess the prevalence of EGFR mutations in patients with advanced non-small cell lung carcinoma (NSCLC) at a tertiary care center in Rajasthan, India. The study will collect tissue samples from 90 NSCLC patients and test for EGFR mutations using real-time PCR. Previous studies have found EGFR mutation rates ranging from 20-37.9% in Indian NSCLC patients. Detecting EGFR mutations could help predict response to EGFR tyrosine kinase inhibitors and improve patient outcomes. This would be the first study to report the prevalence of EGFR mutations in lung cancer patients in Rajasthan.

1. EGFR mutation testing in patients with Advanced NSCLC at
Tertiary care center of Rajasthan
SMS MEDICAL COLLEGE,JAIPUR
Presented By:
Dr Ranjana Solanki
Professor, Dept of Pathology,
Nodal Officer, MDRU Lab,

2. Introduction

3. • In India, lung cancer is the second most common cancer in men and the fourth most common cancer in the overall
population (Globocon 2018).
• EGFR is a tyrosine kinase receptor belonging to the ErbB family; it is widely expressed in NSCLC (40-80% of NSCLC) and
plays a significant role in carcinogenesis.
• Several investigators worldwide have identified activating somatic mutations in the kinase domain of EGFR in NSCLC
patients ranging from 10% in United States to 30% to 50 % in Asian population.
• There have been several studies conducted from different parts of our country regarding the prevalence of EGFR mutations
in patients of NSCLC which range from 20% to 37.9%.
• Usefulness of EGFR mutation testing in all NSCLC patients at SMS Medical College would help in identification of a subset
of patients who could benefit from EGFR TKI therapy at the time of initial presentation of the disease, thereby controlling
the progression and providing survival benefits.

4. Aims & Objectives of the study
Aim: To assess the prevalence of specific EGFR mutations in patients with advanced non-small cell lung
carcinoma.
Objectives:
1) To detect the EGFR mutation in patients with advanced non-small cell lung carcinoma by Real Time PCR.
2) To establish clinical association in patients with EGFR mutations.
3) To assess the treatment response, time to progression and overall survival, in patients with and without
EGFR mutations.

5. Sample Size
Sample size is calculated at 95% confidence level assuming 30% prevalence of
EGFR mutations in non-small cell lung cancer patients as found in seed article
Bharadwaj R et al. 2016). At the absolute allowable error of 10%, 84 cases of
non-small cell lung cancer are required for sample size which is further enhanced
and rounded off to 90 cases as final sample size, expecting 10% attrition or loss
to follow up.

6. Methodology
• A total of 90 tissue sample of NSCLC patient’s will be collected attending OPD & IPD at SMS Medical College
& attached Hospital, Jaipur.
• Clinical data in the form of age, gender, smoking status, occupation, local residence, family history of cancer will
be obtained from clinical records
• Radiological details particularly CT chest findings at presentation will be noted and images archived in a database
• Lung Biopsy with histopathological examination and IHC study..
• DNA extraction from tissue samples by using FFPE kit as per manufacture’s instructions.
• DNA quality check by using a Nanodrop .
• Real Time PCR for clinically relevant EGFR mutations by using Qiagen thera screen EGFR RGQ PCR Kit .EGFR
Mutation assay will be done along with the positive control and no template control (NTC).
• The analysis will be performed according to the manufacturer’s instructions and data will be analyzed by looking at CT
(Cycle of the threshold) values.

7. Flow chart
Sample collection
90 cases of NSCLC patients
Lung Biopsy (Histomorphology and IHC )
DNA Extraction from FFPE
EGFR Mutation by using
Real Time PCR
Data Analysis
Inclusion criteria Exclusion criteria
Non Small cell Lung Cancer
Inference

8. Expected outcomes
 We expect to understand the prevalence of EGFR mutations and its contribution to lung cancer.
 Detection of these mutations would help in the effective prediction of response to EGFR-TKIs and also would help to
detect the presence of secondary mutations that could alter the response of the patients to drugs.
Novelty of the study:
Our study will highlight the prevalence of EGFR mutations in Lung cancer in Rajasthan for the first time. This will help in
outlining a systematic treatment protocol for such patients.

9. Budget for the study
S.No. Items Quantity
Approx. Price
1 FFPE Tissue extraction kit 2 kits (50test each) Rs.1,00,000
2 RGQ Real Time PCR kit 3 kits (24rxns each) Rs 3,00,000
3 Misllaneous Items Rs 50,000
Total Rs 4,50,000/-

10. Seed article