PMID- 16996166
OWN - NLM
STAT- MEDLINE
DCOM- 20070123
LR  - 20221207
IS  - 0169-5002 (Print)
IS  - 0169-5002 (Linking)
VI  - 54
IP  - 2
DP  - 2006 Nov
TI  - Gefitinib as front-line treatment in Chinese patients with advanced 
      non-small-cell lung cancer.
PG  - 193-9
AB  - PURPOSE: This phase II single arm, open label study was designed to evaluate the 
      efficacy and toxicity of oral gefitinib (250mg) daily in previously untreated 
      patients with advanced non-small-cell lung cancer (NSCLC). METHODS: Eligible 
      patients had stage IIIB or IV NSCLC with adequate organ functions, and were 
      chemonaive. All eligible patients were treated with oral administration of 250mg 
      of gefitinib until intolerable toxicity, disease progression or death occurred. 
      Responses were assessed after every 8 weeks of therapy. RESULTS: For a total of 
      53 patients, the objective response rate (ORR) was 32.1% and overall disease 
      control rate (DCR) was 52.8%. Median overall and progression-free survivals (PFS) 
      were 9.4 (95% CI, 8.8-13.3) and 3.2 months (95% CI, 1.1-5.2) months, and 1-year 
      survival rate was 41.5%. Patients with adenocarcinoma (n=35) had a higher 
      response rate. Adenocarcinoma, female gender (n=24), and response to gefitinib 
      were predictive factors for better survival. The most commonly seen adverse 
      events (AEs) were skin toxicity (54.7%), diarrhea (43.4%) and nail change 
      (16.9%). Most AEs were mild to moderate and considered manageable. Drug-related 
      interstitial pneumonia was clinically diagnosed in four cases (7.5%). 
      CONCLUSIONS: Oral gefitinib, as compared to conventional chemotherapy, has 
      comparable effect but less toxicity as a first-line treatment in Chinese patients 
      who have advanced NSCLC, especially in those with adenocarcinoma histology. A 
      further phase III prospective study comparing gefitinib to standard chemotherapy 
      to define the efficacy of gefitinib is appropriate in advanced NSCLC patients.
FAU - Lin, Wei-Chun
AU  - Lin WC
AD  - Chest Department, Taipei Veterans General Hospital, Taipei, Taiwan.
FAU - Chiu, Chao-Hua
AU  - Chiu CH
FAU - Liou, Jia-Ling
AU  - Liou JL
FAU - Chen, Yuh-Min
AU  - Chen YM
FAU - Perng, Reury-Perng
AU  - Perng RP
FAU - Tsai, Chun-Ming
AU  - Tsai CM
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20060922
PL  - Ireland
TA  - Lung Cancer
JT  - Lung cancer (Amsterdam, Netherlands)
JID - 8800805
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Quinazolines)
RN  - S65743JHBS (Gefitinib)
SB  - IM
MH  - Adenocarcinoma/*drug therapy/mortality
MH  - Aged
MH  - Antineoplastic Agents/adverse effects/*therapeutic use
MH  - Asian People
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/mortality
MH  - Carcinoma, Squamous Cell/diagnosis/*drug therapy/mortality
MH  - Disease-Free Survival
MH  - Female
MH  - Gefitinib
MH  - Humans
MH  - Lung Neoplasms/*drug therapy/mortality
MH  - Male
MH  - Neoplasm Staging
MH  - Prognosis
MH  - Quinazolines/adverse effects/*therapeutic use
MH  - Survival Rate
EDAT- 2006/09/26 09:00
MHDA- 2007/01/24 09:00
CRDT- 2006/09/26 09:00
PHST- 2006/05/13 00:00 [received]
PHST- 2006/07/17 00:00 [revised]
PHST- 2006/07/18 00:00 [accepted]
PHST- 2006/09/26 09:00 [pubmed]
PHST- 2007/01/24 09:00 [medline]
PHST- 2006/09/26 09:00 [entrez]
AID - S0169-5002(06)00363-1 [pii]
AID - 10.1016/j.lungcan.2006.07.013 [doi]
PST - ppublish
SO  - Lung Cancer. 2006 Nov;54(2):193-9. doi: 10.1016/j.lungcan.2006.07.013. Epub 2006 
      Sep 22.