Table 4. Studies supporting current use of tailored treatment according to epidermal growth factor receptor protein expression 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 docetaxelPositive: 2589 versus 11; p = 0.661.6 versus 2.81.29 (0.98–1.70); p = 0.77.9 versus 6.51.0 (0.77–1.29); p = 0.98OS: p = 0.87
Negative: 8715.8 versus 6.1; p = 0.272.9 versus 3.00.90 (0.53–1.52); p = 0.697.5 versus 9.21.0 (0.65–1.55); p = 0.99
Hirsch [17] (ISEL Study)GefitinibRCT and URES second- or third-line: gefitinib versus placeboPositive: 2648.2 versus 1.5; p = NA2.8 versus 3.20.83# (0.61–1.12); p = ns5.5 versus 4.6NAOS: p = 0.049
Negative: 1151.5 versus 0; p = NA1.9 versus 3.91.24# (0.77–2.02); p = ns4.2 versus NRNA
Tsao [18] (BR21 Study)ErlotinibRCT and PRES second- or third-line: erlotinib versus placeboPositive: 10612 versus 3; p = 0.10NANANA0.68+ (0.49–0.95); p = 0.02OS: p = 0.25
Negative: 800.93+ (0.63–1.36); p = 0.70
  • 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; ISEL: Iressa Survival Evaluation in Lung Cancer; URES: unplanned retrospective exploratory study; NA: not available; ns: nonsignificant difference; NR: not reached. #: time to treatment failure; : erlotinib group only; +: erlotinib versus placebo group.