title: Clinical experience with gefitinib in Indian patients.
abstract: 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.
authors: Tata Memorial Hospital, Mumbai, India. purvish@rediffmail.com
authors: Purvish
authors: P
authors: Parikh
authors: Alex Yuang-Chi
authors: AY
authors: Chang
authors: Shona
authors: S
authors: Nag
authors: Raghunadharao
authors: R
authors: Digumarti
authors: Gouri Shankar
authors: GS
authors: Bhattacharyya
authors: Dinesh Chandra
authors: DC
authors: Doval
authors: Govind
authors: G
authors: Babu
authors: Raju Titus
authors: RT
authors: Chacko
authors: Suresh
authors: S
authors: Advani
authors: Anantbhushan
authors: A
authors: Ranade
authors: Shyam
authors: S
authors: Aggarwal
authors: Ramesh
authors: R
authors: Jagannathan
authors: Laura
authors: L
authors: Hargreaves
authors: Nick
authors: N
authors: Thatcher
mesh_terms: 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
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; D066246:ErbB Receptors; D000077156:Gefitinib