TY - JOUR
T1 - Clinical experience with gefitinib in Indian patients
AU - Parikh, Purvish
AU - Chang, Alex Yuang Chi
AU - Nag, Shona
AU - Digumarti, Raghunadharao
AU - Bhattacharyya, Gouri Shankar
AU - Doval, Dinesh Chandra
AU - Babu, Govind
AU - Chacko, Raju Titus
AU - Advani, Suresh
AU - Ranade, Anantbhushan
AU - Aggarwal, Shyam
AU - Jagannathan, Ramesh
AU - Hargreaves, Laura
AU - Thatcher, Nick
PY - 2008/4
Y1 - 2008/4
N2 - 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.
AB - 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.
KW - Clinical
KW - Gefitinib
KW - IRESSA
KW - Indian patients
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U2 - 10.1097/JTO.0b013e318168f794
DO - 10.1097/JTO.0b013e318168f794
M3 - Article
C2 - 18379356
AN - SCOPUS:41749096598
SN - 1556-0864
VL - 3
SP - 380
EP - 385
JO - Journal of Thoracic Oncology
JF - Journal of Thoracic Oncology
IS - 4
ER -