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Updated: May 27, 2025

Establishment and Characterization of Three Afatinib-resistant Lung Adenocarcinoma PC-9 Cell Lines Developed with Increasing Doses of Afatinib
Published on: June 26, 2019
Indian experience of Afatinib for EGFR mutation-positive advanced lung adenocarcinoma a real-world retrospective
Ullas Batra1, Mansi Sharma1, Parveen Jain1
1Department of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Centre, Delhi, India.
Introduction:
Afatinib, a second-generation EGFR TKI, was approved in 2015 for the treatment of metastatic NSCLC in India. We aimed to evaluate the clinical outcomes of Afatinib therapy in a real-world setting.
Patients And Methods:
Electronic medical records of 43 patients who received Afatinib for advanced EGFR-mutant advanced NSCLC were retrospectively reviewed. In total, 43 patients were analyzed of whom 31 received Afatinib in first-line therapy.
Results:
The patient population was younger than Lux-Lung 3. Median PFS was 15.03 months with 95% CI (7.8-18.3 months). At 14% maturity OS was not reached. However, 95% CI lower limit was 34.9 months. The most common adverse reactions were skin rash and diarrhea which were managed with dose alteration without compromising efficacy.
Conclusion:
Currently, there are multiple first-line strategies to manage advanced NSCLC in India including EGFR TKIs. To the best of our knowledge, this is the first real-world study published from India which looks into the efficacy of Afatinib in advanced NSCLC. Afatinib showed a manageable safety profile and comparable efficacy in real-world practice compared with those described in previous studies.
Insights
Afatinib demonstrated comparable efficacy and a manageable safety profile in Indian patients with advanced non-small cell lung cancer (NSCLC) in a real-world setting. This study provides valuable insights into EGFR TKI treatment outcomes in India.
Area of Science:
- Oncology
- Pharmacology
Background:
- Afatinib, a second-generation EGFR TKI, is approved for metastatic NSCLC in India.
- Real-world data on Afatinib's clinical outcomes in India is limited.
Purpose of the Study:
- To evaluate the clinical outcomes of Afatinib therapy in a real-world setting for advanced EGFR-mutant NSCLC in India.
- To assess the safety and efficacy of Afatinib in a diverse patient population.
Main Methods:
- Retrospective review of electronic medical records for 43 patients with advanced EGFR-mutant NSCLC treated with Afatinib.
- Analysis included patients receiving Afatinib as first-line therapy (n=31).
Main Results:
- Median progression-free survival (PFS) was 15.03 months (95% CI: 7.8-18.3 months).
- Overall survival (OS) was not reached at 14% maturity, with a lower 95% CI limit of 34.9 months.
- Common adverse reactions included skin rash and diarrhea, managed effectively with dose alteration.
Conclusions:
- Afatinib exhibits a manageable safety profile and comparable efficacy in real-world Indian practice.
- This is the first real-world study from India evaluating Afatinib's efficacy in advanced NSCLC.
- Afatinib represents a viable first-line treatment option alongside other EGFR TKIs for advanced NSCLC in India.
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