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Updated: Feb 11, 2026

Profiling Sensitivity to Targeted Therapies in EGFR-Mutant NSCLC Patient-Derived Organoids
Published on: November 22, 2021
A study of therapy targeted EGFR/ALK mutations in Indian patients with lung adenocarcinoma: A clinical and
Vandana Rana1, Praveer Ranjan2, Rajat Jagani2
1Classified Specialist (Pathology), Command Hospital (Southern Command), Pune 411040, India.
Background:
Established predictive biomarkers for Non-Small Cell Lung Carcinoma (NSCLC) include sensitizing Epidermal Growth Factor Receptor (EGFR) mutations and Anaplastic Lymphoma Kinase (ALK) fusion oncogene. The primary aim of the study is to ascertain the prevalence of EGFR mutation and ALK gene rearrangement in patients of lung adenocarcinoma in Indian population and the second objective is to impress upon the importance of adequate processing of limited tissue samples.
Methods:
Histopathologically confirmed cases of lung adenocarcinoma, whose tumour had been tested for both EGFR and ALK gene mutations, were included in this study. The EGFR mutations were analyzed using PCR and Gene Sequencing. ALK fusion oncogene was found by Fluorescence In Situ Hybridization (FISH) technique using kit of Vysis LSI ALK Dual colour Break Apart Rearrangement probe.
Results:
A total of 152 cases of lung adenocarcinoma were included. Out of which, 92 (60.5%) were male and 60 (39.5%) were female. After exclusion of 17 cases due to unsatisfactory result, EGFR mutations were found positive in 35.5% cases (48/135). ALK gene rearrangement was found in 7.6% (10/131) after excluding 21 cases with unsatisfactory result.
Conclusion:
EGFR mutations and ALK gene rearrangement was found to be mutually exclusive. Incidence of EGFR mutations (35.5%) is much higher in Indian population than in Caucasians (13%) and is close to the incidence in East Asian countries. The 7.6% incidence of ALK fusion oncogene in Indian patients establishes the importance of molecular studies to give maximum benefit of targeted therapy to the patients.
Insights
EGFR mutations (35.5%) and ALK gene rearrangement (7.6%) are prevalent in Indian lung adenocarcinoma patients. These biomarkers are mutually exclusive, guiding targeted therapy decisions.
Area of Science:
- Oncology
- Molecular Biology
- Genetics
Background:
- Non-Small Cell Lung Carcinoma (NSCLC) diagnosis relies on biomarkers like Epidermal Growth Factor Receptor (EGFR) mutations and Anaplastic Lymphoma Kinase (ALK) gene rearrangements.
- Understanding the prevalence of these biomarkers in diverse populations is crucial for effective treatment strategies.
- Limited tissue samples pose challenges in molecular testing for lung adenocarcinoma.
Purpose of the Study:
- To determine the prevalence of EGFR mutations and ALK gene rearrangements in Indian lung adenocarcinoma patients.
- To highlight the significance of proper tissue sample processing for accurate molecular diagnostics.
- To compare biomarker incidence in Indian versus other ethnic groups.
Main Methods:
- Analysis of histopathologically confirmed lung adenocarcinoma cases.
- EGFR mutation analysis using Polymerase Chain Reaction (PCR) and Gene Sequencing.
- ALK gene rearrangement detection via Fluorescence In Situ Hybridization (FISH).
Main Results:
- Out of 152 cases, 135 were evaluable for EGFR mutations, with 35.5% testing positive.
- Of 131 evaluable cases, 7.6% showed ALK gene rearrangement.
- EGFR mutations and ALK rearrangements were found to be mutually exclusive.
Conclusions:
- The incidence of EGFR mutations in Indian patients (35.5%) is significantly higher than in Caucasians (13%) and comparable to East Asian populations.
- The 7.6% incidence of ALK fusion oncogene in Indian patients underscores the need for molecular testing.
- Accurate molecular profiling is essential for optimizing targeted therapy benefits in lung adenocarcinoma.
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