|
| Author (yr) | Setting | Design | Pts | Treatment | RR (%) | PFS (mos) | OS (mos) |
|
| Giaccone et al. (2004) [24] | Chemonaive | Phase 3 | 1093 | CIS/GEM + gefitinib 500 versus CIS/GEM + gefitinib 250 versus CIS/GEM + placebo | 50.3 versus 51.2 versus 47.2
ns | 5.5 versus 5.8 versus 6.0 | 9.9 versus 9.9 versus 10.9 |
| Herbst et al. (2004) [25] | Chemonaive | Phase 3 | 1037 | Carbo/taxol + gefitinib 500 versus Carbo/taxol + gefitinib 250 versus Carbo/taxol + placebo | 30 versus 30.4 versus 28.7
ns | 4.6 versus 5.3 versus 5.0 | 8.7 versus 9.8 versus 9.9 |
| Takeda et al. (2010) [29] | Chemonaive | Phase 3 | 604 | CIS/GEM × 3 → gefitinib versus CIS/GEM × 6 | 34.2 versus 29.3 | 4.6 versus 4.3 HR: 0.68, 95% CI 0.57–0.80, | 13.7 versus 12.9 HR 0.86, 95% CI 0.72–1.03, |
|
| Thatcher et al. (2005) [30] | Pretreated with 1-2 lines | Phase 3 | 1692 | Gefitinib 250 mg + BSC versus placebo + BSC | 8 versus 1.3 | 3 versus 2.6 HR: 0.82, 95% CI 0.73–0.92, | 5.6 versus 5.1 HR: 0.89, 95% CI 0.77–1.02, |
| Cufer et al. (2006) [32] | Second line | Randomized phase 2 | 133 | Gefitinib 250 mg versus Docetaxel 75 mg/mq | 13.2 versus 13.7 HR 0.98, 95% CI 0.47–2.03 | 3 versus 3.4 HR: 0.94, 95% CI 0.64–1.39 | 7.5 versus 7.1 HR: 0.97, 95% CI 0.61–1.52 |
| Kim et al. (2008) [33] | Pretreated with 1-2 lines | Phase 3 | 1466 | Gefitinib 250 mg versus Docetaxel 75 mg/mq | 9.1 versus 7.6 | 2.2 versus 2.7 HR: 1.04, 95% CI 0.93–1.18, | 7.6 versus 8.0 HR: 1.020, 95% CI 0.905–1.150 |
| Maryuama et al. (2008) [35] | Pretreated with 1-2 lines | Phase 3 | 489 | Gefitinib 250 mg versus Docetaxel 60 mg/mq | 22.5 versus 12.8 | 2 versus 2 HR: 0.90, 95% CI 0.72–1.12, | 11.5 versus 14 HR: 1.12, 95% CI 0.89–1.40, |
| D. H. Lee et al. (2010) [36] | Second line | Phase 3 | 161 | Gefitinib 250 mg versus Docetaxel 60 mg/mq | 28.1 versus 7.6 | 3.3 versus 3.4 HR 0.729, 95% CI 0.533–0.998, | HR: 0.870, 95% CI 0.613–1.236, |
|
| Crinò et al. (2008) [40] | Chemonaive ≥70 yrs | Randomized phase 2 | 196 | Gefitinib 250 mg versus Vinorelbine 30 mg/mq 1–8 | 3.1 versus 5.1 | 2.7 versus 2.9 HR:1.19, 95% CI 0.85–1.65 | 5.9 versus 8 HR: 0.98, 95% CI 0.66–1.47 |
| G. Goss et al. (2009) [41] | Chemonaive PS 2-3 | Randomized phase 2 | 201 | Gefitinib 250 mg + BSC versus Placebo + BSC | 6% versus 1% OR: 6.57, 95% CI 0.74–58.17 | 1,4 versus 1,3 HR: 0.82, 95% CI 0.60–1.12 | 3.7 versus 2.8 HR:0.84, 95% CI 0.62–1.15 |
|
| Kelly et al. (2008) [39] | Maintenance after chemo-radio Inoperable stage III | Phase 3 | 243 | Gefitinib 500/250 mg versus Placebo | — | 8.3 versus 11.7 HR: 0.80, 95% CI 0.58–1.10, | 23 versus 35.0 HR: 0.633, 95% CI 0.44–0.91, |
| G. D. Goss et al. (2010) [38] | Adjuvant | Phase 3 | 503 | Gefitinib 250 mg versus Placebo | — | 4.2 yrs*versus nr HR: 1.22, 95% CI 0.93–1.61, | 5.1 yrs* versus nr HR: 1.24, 95% CI 0.94–1.64, |
|
