Table 2. Studies supporting current use of tailored treatment according to epidermal growth factor receptor gene amplification in advanced nonsmall cell lung cancer
StudyAgentSubject and level of evidencePatients nRR %PFS monthsHR (95% CI)OS monthsHR (95%CI)Interaction p-value
Douillard [16] (INTEREST Study)GefitinibRCT and PRES second-line: gefitinib versus docetaxelHigh 15813 gefitinib versus 7.4 docetaxel; p = 0.042.5 versus 2.80.84 (0.59–1.19); p = 0.338.4 versus 7.51.09 (0.78–1.51); p = 0.62OS: p = 0.52
Low 179NA2.1 versus 2.81.30 (0.93–1.83); p = 0.126.4 versus 7.70.93 (0.68–1.26); p = 0.64
Hirsch [17] (ISEL Study)GefitinibRCT and URES second- or third-line: gefitinib versus placeboHigh 11416.4 gefitinib versus 3.0 placebo; p = NA4.5 versus 1.90.55# (0.34–0.89); p = NA8.3 versus 4.50.61 (0.36–1.04); p = 0.067NA
Low 2563.2 versus 0; p = NA2.4 versus 3.91.25# (0.92–1.72); p = ns4.3 versus 6.21.16 (0.81–1.64); p = 0.417NA
Tsao [18] (BR21 Study)ErlotinibRCT and PRES second- or third-line: erlotinib versus placeboHigh 255 versus 1; p = 0.03NANANA0.44 (0.23–0.82); p = 0.008OS: p = 0.10
Low 410.59 (0.48–1.51); p = 0.85
  • RR: response rate; PFS: progression-free survival; HR: hazard ratio; OS: median overall survival; INTEREST: Iressa NSCLC Trial Evaluating Response and Survival Versus Taxotere; RCT: randomised clinical phase III trial; PRES: pre-planned retrospective exploratory study; NA: not available; ISEL: Iressa Survival Evaluation in Lung Cancer; URES: unplanned retrospective exploratory study; ns: nonsignificant difference. NA: not available; #: time to treatment failure; : gefitinib group: high versus low: HR 0.78 (95% CI 0.54–1.13); p = ns.