title: Gefitinib (ZD1839) monotherapy as a salvage regimen for previously treated advanced non-small cell lung cancer.
abstract: OBJECTIVE
  A worldwide compassionate-use program has enabled >42,000 patients with advanced non-small cell lung cancer (NSCLC) to receive gefitinib treatment. Here we report the outcome of gefitinib therapy in patients who enrolled in the "Iressa" Expanded Access Program at the Samsung Medical Center.
  
  
  METHODS
  Patients with advanced or metastatic NSCLC who had progressed after prior systemic chemotherapy and for whom no other treatment option was available were eligible to receive gefitinib treatment as part of the Expanded Access Program. A post hoc assessment of potential prognostic factors for response and survival was performed by multivariate analysis.
  
  
  RESULTS
  All 111 evaluable patients had stage IV disease; most patients had a baseline performance status of 2 [n = 52 (47%)] or 3 [n = 18 (16%)] and had received >/=2 prior chemotherapy regimens (56%). The objective response rate was 26%, the disease control rate (measured over >/=8 weeks) was 40%, and the 1-year survival rate was 44%. Adenocarcinoma histology was associated with better response and disease control rates, and a performance status of 0-2 was also associated with a better disease control rate. Both of these factors, as well as female gender, were significantly associated with longer survival. Gefitinib was well tolerated; the most common adverse event was grade 1 skin rash.
  
  
  CONCLUSIONS
  Gefitinib demonstrated significant antitumor activity and a favorable tolerability profile in this series of NSCLC patients with poor prognosis.
authors.affiliation: Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
authors.forename: Jinny
authors.initials: J
authors.lastname: Park
authors.forename: Byung Bae
authors.initials: BB
authors.lastname: Park
authors.forename: Jee Youn
authors.initials: JY
authors.lastname: Kim
authors.forename: Se-Hoon
authors.initials: SH
authors.lastname: Lee
authors.forename: Soon Il
authors.initials: SI
authors.lastname: Lee
authors.forename: Ho Young
authors.initials: HY
authors.lastname: Kim
authors.forename: Jung Han
authors.initials: JH
authors.lastname: Kim
authors.forename: Se Hoon
authors.initials: SH
authors.lastname: Park
authors.forename: Kyung-Eun
authors.initials: KE
authors.lastname: Lee
authors.forename: Joon Oh
authors.initials: JO
authors.lastname: Park
authors.forename: Kihyun
authors.initials: K
authors.lastname: Kim
authors.forename: Chul Won
authors.initials: CW
authors.lastname: Jung
authors.forename: Young Suk
authors.initials: YS
authors.lastname: Park
authors.forename: Young-Hyuck
authors.initials: YH
authors.lastname: Im
authors.forename: Won Ki
authors.initials: WK
authors.lastname: Kang
authors.forename: Mark H
authors.initials: MH
authors.lastname: Lee
authors.forename: Keunchil
authors.initials: K
authors.lastname: Park
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000494:pharmacology; D002289:Carcinoma, Non-Small-Cell Lung / Q000175:diagnosis / Q000188:drug therapy*; D018450:Disease Progression; D005260:Female; D000077156:Gefitinib; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011379:Prognosis; D011799:Quinazolines / Q000494:pharmacology*; D016879:Salvage Therapy; D012737:Sex Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; D000077156:Gefitinib