[Efficacies of gefitinib versus paclitaxel/carboplatin for patients with advanced pulmonary adenocarcinoma].
OBJECTIVE
To compare the clinical efficacies of gefitinib versus paclitaxel/carboplatin in patients with advanced pulmonary adenocarcinoma.


METHODS
A total of 51 advanced pulmonary adenocarcinoma patients were recruited from Guangdong General Hospital during October 2006 to September 2007. Eligible patients were ≥ 18 years old, either non-smokers or former light smokers and receiving no prior chemotherapy or biological/immunological therapy. According to performance status, smoking status and gender, they were selected with dynamic equilibrium randomized method 1: 1 to receive first-line gefitinib (250 mg/d) in gefitinib arm or carboplatin/paclitaxel (carboplatin, area under the curve 5 mg × ml⁻¹ × min⁻¹, 21-day cycle; paclitaxel, 200 mg/m², 21-day cycle in chemotherapy arm. The primary endpoint was progression free survival (PFS). And the secondary endpoints were objective response rate (ORR) and overall survival (OS).


RESULTS
They were randomized into gefitinib arm (n = 25) and paclitaxel/carboplatin arm (n = 26). The median PFS was 4.2 months in gefitinib arm and 8.3 months in paclitaxel/carboplatin arm (P = 0.422); ORR 36.0% in gefitinib arm and 42.3% in paclitaxel/carboplatin arm (P = 0.645); Median OS 14.4 months in gefitinib arm and 15.0 months in paclitaxel/carboplatin arm (P = 0.290). Multifactorial Cox regression analysis showed that age (P = 0.004), epidermal growth factor receptor (EGFR) gene mutation status (P = 0.012) and subsequent treatments (platinum-based chemotherapy, P = 0.001; EGFR-tyrosine kinase inhibitors (TKI), P = 0.005) were the significant predictors of OS.


CONCLUSIONS
No significant differences exist in terms of efficacy and survival between first-line gefitinib and paclitaxel/carboplatin for Chinese patients with pulmonary adenocarcinoma who are non-smokers or former light smokers. And age, EGFR gene mutation status and subsequent treatments are significant predictor of OS. However, first-line gefitinib should not be recommended for advanced non-small cell lung cancer (NSCLC) patients only based on clinical factors, due to a very small sample-size in our study.
Department of Pulmonary Oncology, Guangdong General Hospital, Guangdong Lung Cancer Institute, Guangdong Academy of Medical Science, Guangzhou 510080, China.
Nana
N
Lou
Department of Pulmonary Oncology, Guangdong General Hospital, Guangdong Lung Cancer Institute, Guangdong Academy of Medical Science, Guangzhou 510080, China.
Jinji
J
Yang
Department of Pulmonary Oncology, Guangdong General Hospital, Guangdong Lung Cancer Institute, Guangdong Academy of Medical Science, Guangzhou 510080, China.
Honghong
H
Yan
Department of Pulmonary Oncology, Guangdong General Hospital, Guangdong Lung Cancer Institute, Guangdong Academy of Medical Science, Guangzhou 510080, China.
Qing
Q
Zhou
Department of Pulmonary Oncology, Guangdong General Hospital, Guangdong Lung Cancer Institute, Guangdong Academy of Medical Science, Guangzhou 510080, China.
Riqiang
R
Liao
Department of Pulmonary Oncology, Guangdong General Hospital, Guangdong Lung Cancer Institute, Guangdong Academy of Medical Science, Guangzhou 510080, China.
Chongrui
C
Xu
Department of Pulmonary Oncology, Guangdong General Hospital, Guangdong Lung Cancer Institute, Guangdong Academy of Medical Science, Guangzhou 510080, China.
Yisheng
Y
Huang
Department of Pulmonary Oncology, Guangdong General Hospital, Guangdong Lung Cancer Institute, Guangdong Academy of Medical Science, Guangzhou 510080, China.
Xuening
X
Yang
Department of Pulmonary Oncology, Guangdong General Hospital, Guangdong Lung Cancer Institute, Guangdong Academy of Medical Science, Guangzhou 510080, China.
Yan
Y
Yang
Department of Pulmonary Oncology, Guangdong General Hospital, Guangdong Lung Cancer Institute, Guangdong Academy of Medical Science, Guangzhou 510080, China.
Bin
B
Gan
Department of Pulmonary Oncology, Guangdong General Hospital, Guangdong Lung Cancer Institute, Guangdong Academy of Medical Science, Guangzhou 510080, China. Email: syylwu@live.cn.
Yilong
Y
Wu
D000230:Adenocarcinoma; D000077192:Adenocarcinoma of Lung; D000970:Antineoplastic Agents; D044466:Asian People; D016190:Carboplatin; D018572:Disease-Free Survival; D000077156:Gefitinib; D006769:Hospitals, General; D006801:Humans; D008175:Lung Neoplasms; D017239:Paclitaxel; D010984:Platinum; D011799:Quinazolines; D012907:Smoking
D000970:Antineoplastic Agents; D011799:Quinazolines; D010984:Platinum; D016190:Carboplatin; D017239:Paclitaxel; D000077156:Gefitinib