The role of gefitinib treatment for Korean never-smokers with advanced or metastatic adenocarcinoma of the lung: a prospective study.
OBJECTIVE
This prospective trial was conducted to evaluate the role of gefitinib in never-smokers with advanced or metastatic adenocarcinoma of the lung.


METHODS
The main inclusion criteria were stage IIIB/IV adenocarcinoma of the lung and status as a lifetime never-smoker. Patients received a 250-mg single oral daily dose of gefitinib until disease progression, unacceptable toxicity, or patient's refusal. Tumor response was assessed after every two 4-week cycles according to the World Health Organization response criteria. Additional analyses were performed to identify predictors of response and survival.


RESULTS
Between August 2003 and March 2005, 72 Korean patients were enrolled; 55 chemotherapy naive, 17 previously treated; 6 male, 66 female; and ECOG PS 0/1/2, 24/42/4. All patients were assessed for response, toxicity, quality of life, and survival. Overall objective tumor response rate was 55.6% (95% confidence interval [CI], 43.4-67.3%). With a median follow-up of 23 months, the median survival time was 19.7 months (95% CI, 18.5-21.0 months) with a 1-year survival rate of 76.3%. The median duration of response was 6.8 months (95% CI, 4.7-9.0 months). Therapy-related improvement of symptoms and quality of life was observed within 2 to 4 weeks after the commencement of therapy in the responders. In a multivariate Cox proportional hazard model, good performance status and no prior history of chemotherapy were the two significant predictors of better survival (p = 0.005 and 0.042).


CONCLUSIONS
Gefitinib showed very promising antitumor activity and survival outcome in Korean never-smokers with adenocarcinoma of the lung. It seems to be a good alternative to standard chemotherapy as a first-line therapy for this subgroup.
Lee
Dae Ho
DH
Research Institute and Hospital, Research Institute for National Cancer Control and Evaluation, Gyeonggi, Korea.
Han
Ji-Youn
JY
Yu
Sun Young
SY
Kim
Hyae Young
HY
Nam
Byung-Ho
BH
Hong
Eun Kyung
EK
Kim
Heung Tae
HT
Lee
Jin Soo
JS
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D000284:Administration, Oral; D000368:Aged; D001707:Biopsy, Needle; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D000077156:Gefitinib; D006801:Humans; D007150:Immunohistochemistry; D007723:Korea; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009361:Neoplasm Invasiveness / Q000473:pathology*; D009367:Neoplasm Staging; D011336:Probability; D011379:Prognosis; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011788:Quality of Life; D011799:Quinazolines / Q000008:administration & dosage*; D018570:Risk Assessment; D016037:Single-Blind Method; D012907:Smoking; D015996:Survival Rate; D016896:Treatment Outcome
D011799:Quinazolines; D000077156:Gefitinib