Review Article

Clinical Efficacy and Toxicity of Anti-EGFR Therapy in Common Cancers

Table 2

Selected clinical trials of gefitinib. NSCLC, Non-small cell lung cancer; OS, overall survival; ORR, overall response rate; C/P, carboplatin/paclitaxel; PFS, progression free survival; EGFR, epidermal growth factor receptor.

MalignancyRegimenNumber of patientsResultsComments

NSCLCGefitinib vs. placebo [19]1692 pts Second-line or third-line treatment for patients with locally advanced or metastatic NSCLCGefitinib: OS (5.6 mo) Placebo: OS (5.1 mo)No significant improvement in OS ( ) Subgroup analysis showed significantly longer survival in never-smokers and Asian patients

NSCLCGefitinib vs. Carboplatin/paclitaxel (C/P) [23]1,217 pts Previously untreated stage IIIB/IV NSCLC, never- or light ex-smokers, adenocarcinoma histologyGefitinib: ORR (43%) OS (18.6 mo) C/P: ORR (32%) OS (17.3 mo) = .0001No OS difference PFS longer for gefitinib than C/P in EFGR mutation positive patients ( ) PFS longer with C/P in mutation negative patients ( )