Clinical experience with gefitinib in Indian patients.
BACKGROUND
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.
Parikh
Purvish
P
Tata Memorial Hospital, Mumbai, India. purvish@rediffmail.com
Chang
Alex Yuang-Chi
AY
Nag
Shona
S
Digumarti
Raghunadharao
R
Bhattacharyya
Gouri Shankar
GS
Doval
Dinesh Chandra
DC
Babu
Govind
G
Chacko
Raju Titus
RT
Advani
Suresh
S
Ranade
Anantbhushan
A
Aggarwal
Shyam
S
Jagannathan
Ramesh
R
Hargreaves
Laura
L
Thatcher
Nick
N
D000230:Adenocarcinoma / Q000188:drug therapy / Q000453:epidemiology / Q000556:secondary; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D018287:Carcinoma, Large Cell / Q000188:drug therapy / Q000453:epidemiology / Q000556:secondary; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000453:epidemiology / Q000556:secondary; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000453:epidemiology / Q000556:secondary; D002986:Clinical Trials as Topic; D066246:ErbB Receptors / Q000037:antagonists & inhibitors; D005260:Female; D000077156:Gefitinib; D006801:Humans; D007194:India / Q000453:epidemiology; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D011379:Prognosis; D011799:Quinazolines / Q000627:therapeutic use*; D012189:Retrospective Studies; D015996:Survival Rate
D000970:Antineoplastic Agents; D011799:Quinazolines; D066246:ErbB Receptors; D000077156:Gefitinib