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EGFR inhibitor gefitinib in advanced pretreated non-small cell lung cancer patients: Experience from a centre in north India.

17141 Background: Gefitinib is an orally active EGFR-TKI (Epidermal Growth Factor Tyrosine Kinase Inhibitor) that demonstrated, clinically meaningful anti tumor activity, favorable toxicity profile in phase II trials involving patients with advanced pretreated NSCLC. The aim of this study was to assess the antitumour activity (time to disease progression) and toxicity profile of Gefitinib.


METHODS
Twenty five patients of NSCLC advanced were included in this study who have failed at least one chemotherapy regimen and completed at least one month Gefitinib (250 mg/day) therapy. The study included 18 male and 7 female patients with, a median age of 60 years (32-80 years) and performance status ECOG 0-I 64%. The histologically included were Adenocarcinoma 56%, Squamous Cell Carcinoma 40% and Large Cell Carcinoma 1%. 64% patients had failed to response to 1 (CT) chemotherapy regimen, 28% to 2 CT and 8% to 3 CT regimens.


RESULTS
A total of 25 patients (18 male, 7 female) were evaluated for response. 2 Complete Response (CR) and 1 Partial Response (PR) were observed with an Overall Response Rate (ORR) of 12% (CR+PR). All the three patients were with Adenocarcinoma histology. A total of 14 patients (56%) had Stable Disease (SD). This led to an Overall Disease Control Rate (CR+PR+SD) of 68% (17 patients). The Median Time to Progression (TTP) was 3.8 months using the SAS method for statistical analysis (95% CI 4.4-9.3). The number of previous chemotherapy regimens did not alter the response to therapy. All the patients were evaluated for toxicity profile assessment (25 patients). The most frequent toxicity observed was Asthenia in 52% of patients. Other toxicities were Diarrhaea 24%, Skin Disorders 32%, Anorexia 32%, Vomitings 44%. Only 1 patient had grade IV skin related toxicity. No deaths related to Gefitinib treatment were reported.


CONCLUSION
Gefitinib shows antitumour activity in pretreated patients of advanced NSCLC. Gefitinib therapy of (250 mg/day) has a favourable toxicity profile and is well tolerated. Gefitinib is a viable therapy in NSCLC patients who have limited treatment options. No significant financial relationships to disclose.