First-line gefitinib for patients with advanced non-small-cell lung cancer harboring epidermal growth factor receptor mutations without indication for chemotherapy.
OBJECTIVE
This multicenter phase II study was undertaken to investigate the efficacy and feasibility of gefitinib for patients with advanced non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations without indication for chemotherapy as a result of poor performance status (PS).


METHODS
Chemotherapy-naïve patients with poor PS (patients 20 to 74 years of age with Eastern Cooperative Oncology Group PS 3 to 4, 75 to 79 years of age with PS 2 to 4, and >or= 80 years of age with PS 1 to 4) who had EGFR mutations examined by the peptide nucleic acid-locked nucleic acid polymerase chain reaction clamp method were enrolled and received gefitinib (250 mg/d) alone.


RESULTS
Between February 2006 and May 2007, 30 patients with NSCLC and poor PS, including 22 patients with PS 3 to 4, were enrolled. The overall response rate was 66% (90% CI, 51% to 80%), and the disease control rate was 90%. PS improvement rate was 79% (P < .00005); in particular, 68% of the 22 patients improved from >or= PS 3 at baseline to <or= PS 1. The median progression-free survival, median survival time, and 1-year survival rate were 6.5 months, 17.8 months, and 63%, respectively. No treatment-related deaths were observed.


CONCLUSIONS
This is the first report indicating that EGFR mutation-positive patients with extremely poor PS benefit from first-line gefitinib. Because there previously has been no standard treatment for these patients with short life expectancy other than best supportive care, examination of EGFR mutations as a biomarker is recommended in this patient population.
Inoue
Akira
A
Tohoku University, Graduate School of Medicine and School of Medicine, Japan.
Kobayashi
Kunihiko
K
Usui
Kazuhiro
K
Maemondo
Makoto
M
Okinaga
Shoji
S
Mikami
Iwao
I
Ando
Masahiro
M
Yamazaki
Koichi
K
Saijo
Yasuo
Y
Gemma
Akihiko
A
Miyazawa
Hitoshi
H
Tanaka
Tomoaki
T
Ikebuchi
Kenji
K
Nukiwa
Toshihiro
T
Morita
Satoshi
S
Hagiwara
Koichi
K
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000201:enzymology / Q000235:genetics*; D066246:ErbB Receptors / Q000235:genetics*; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000201:enzymology / Q000235:genetics*; D008875:Middle Aged; D009154:Mutation; D011446:Prospective Studies; D055815:Young Adult
D066246:ErbB Receptors