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Clinical experience with gefitinib in Indian patients
Purvish Parikh1, Alex Yuang-Chi Chang, Shona Nag
1Tata Memorial Hospital, Mumbai, India. purvish@rediffmail.com
Introduction:
Treatment options are limited in patients with advanced or refractory non-small cell lung cancer and lead to suboptimal outcome and/or benefit. The epidermal growth factor tyrosine kinase inhibitor gefitinib (IRESSA) has been approved in many countries. Increased responsiveness to gefitinib has been demonstrated in particular subsets of patients, for example never smokers and patients of Asian origin. However, to date, little is known of its use specifically in patients from India.
Methods:
Retrospective ad hoc analysis of clinical data from experience with gefitinib in patients with advanced NSCLC from India enrolled in the IRESSA Survival Evaluation in Lung (ISEL) study (n = 77) or included in the gefitinib expanded-access program in India (n = 133).
Results:
Among Indian patients enrolled in the ISEL study, median survival was 6.4 months with gefitinib and 5.1 month with placebo. The objective response rate in Indian patients was 14% with gefitinib versus 0% with placebo. In ISEL, tolerability data from Indian patients were consistent with the overall study population. In the Indian gefitinib expanded-access program, median survival was 6 months and gefitinib was well tolerated.
Conclusions:
Gefitinib seems well tolerated in Indian patients with advanced NSCLC, with some clinical benefit observed.
Insights
Gefitinib shows tolerability and clinical benefit in Indian patients with advanced non-small cell lung cancer. This study evaluated gefitinib
Area of Science:
- Oncology
- Pharmacology
- Epidemiology
Background:
- Limited treatment options exist for advanced or refractory non-small cell lung cancer (NSCLC).
- Gefitinib (IRESSA), an epidermal growth factor tyrosine kinase inhibitor, shows increased responsiveness in specific patient subsets.
- Data on gefitinib use in Indian patients with advanced NSCLC is scarce.
Purpose of the Study:
- To evaluate the efficacy and tolerability of gefitinib in Indian patients with advanced non-small cell lung cancer.
- To assess gefitinib's clinical benefit in a specific ethnic population.
Main Methods:
- Retrospective analysis of clinical data from Indian patients with advanced NSCLC.
- Data sourced from the IRESSA Survival Evaluation in Lung (ISEL) study and a gefitinib expanded-access program in India.
Main Results:
- In the ISEL study, Indian patients receiving gefitinib had a median survival of 6.4 months versus 5.1 months with placebo.
- Objective response rate was 14% with gefitinib compared to 0% with placebo in ISEL.
- Gefitinib was well-tolerated in both the ISEL study and the expanded-access program in India, with median survival of 6 months.
Conclusions:
- Gefitinib demonstrates good tolerability in Indian patients with advanced NSCLC.
- Clinical benefit, including improved survival and response rates, was observed in this patient population.
- Gefitinib represents a potential treatment option for advanced NSCLC in India.
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