2. Efficacy and survival data.
| Study | ORR (%) | PFS (months) | OS (months) | ||||||
| 1. Gefitinib versus placebo | Gefitinib | Control | P | Gefitinib | Control | P | Gefitinib | Control | P |
| 1st line | |||||||||
| Goss 2009 | 6 | 1.0 | NS | 1.43 | 1.37 | NS | 3.7 | 2.8 | NS |
| 2nd line | |||||||||
| Thatcher 2005 ISEL | 37.5 | 48.3 | NS | 3 | 2.6 | 0.0006 | 5.6 | 5.1 | 0.087 |
| Maintenance therapy | |||||||||
| Kelly 2008 SWOGS0023 | ‐ | ‐ | ‐ | 8.3 | 11.7 | NS | 23 | 35 | 0.013 |
| Gaafar 2011 EORTC08021 | 12 | 1 | 0.004 | 4.1 | 2.9 | 0.0015 | 10.9 | 9.4 | NS |
| 2. Gefitinib versus placebo (Asian population) | Gefitinib | Control | P | Gefitinib | Control | P | Gefitinib | Control | P |
| Chang 2006 ISEL | 12.4 | 2.1 | 0.01 | 4.4 | 2.2 | 0.008 | 9.5 | 5.5 | 0.01 |
| Zhang 2012 INFORM | 24 | 1 | 0.0001 | 4.8 | 2.6 | < 0.0001 | 18.7 | 16.0 | NS |
| 3. Gefitinib versus placebo (EGFR mutation positive) | Gefitinib | Control | P | Gefitinib | Control | P | Gefitinib | Control | P |
| Zhang 2012 INFORM | ‐ | ‐ | ‐ | 16.6 | 2.8 | 0.0063 | 46.87 | 20.97 | 0.036 |
| Gefitinib vs chemotherapy | |||||||||
| 4. General population | Gefitinib | Chemo | P | Gefitinib | Chemo | P | Gefitinib | Chemo | P |
| versus 1st line chemotherapy | |||||||||
| Crino 2008 INVITE | 3.1 | 5.1 | ‐ | 2.7 | 2.9 | NS | 5.9 | 8 | NS |
| Morere 2010 IFCT0301 | ‐ | ‐ | ‐ | 1.9 | 2 | 0.078 | 2.2 | 3.5 | 0.088 |
| Morere 2010 IFCT0301 (Adenocarcinoma) | ‐ | ‐ | ‐ | 1.9 | 2.1 | 0.272 | 2.3 | 4.4 | NS |
| versus 2nd line chemotherapy | |||||||||
| Cufer 2006 SIGN | 13.2 | 13.7 | NS | 7.5 | 7.1 | NS | 3 | 3.4 | NS |
| Kim 2008 INTEREST | 9.1 | 7.6 | NS | 2.2 | 2.7 | NS | 7.6 | 8 | NS |
| Kim 2008 INTEREST | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | 8.5 | 8.9 | NS |
| 5. Asian population | Gefitinib | Chemo | P | Gefitinib | Chemo | P | Gefitinib | Chemo | P |
| versus 1st line chemotherapy | |||||||||
| Lou 2014 | 36 | 42.3 | NS | 4.2 | 8.3 | NS | 14.4 | 15 | NS |
| Maemondo 2010 (EGFR mutation positive) | 73.7 | 30.7 | < 0.001 | 10.8 | 5.4 | < 0.001 | 30.5 | 23.6 | NS |
| Mitsudomi 2010 WJTOG (EGFR mutation positive) | 62.1 | 32.2 | < 0.0001 | 9.2 | 6.3 | < 0.0001 | ‐ | ‐ | ‐ |
| Mok 2009 IPASS | 43 | 32.2 | < 0.001 | 5.7 | 5.8 | NS | 18.6 | 17.3 | NS |
| Han 2012 First‐SIGNAL (adenocarcinoma) | 55.4 | 46 | NS | 5.8 | 6.4 | NS | 22.3 | 22.9 | NS |
| Yang 2014 (Asian) | 47.5 | 41.5 | NS | 9.63 | 8.38 | NS | 27.9 | 26.9 | NS |
| versus 2nd line chemotherapy | |||||||||
| Dai 2013 | 17.4 | 13 | NS | 4.4 | 3.1 | NS | ‐ | ‐ | ‐ |
| Kim 2016 | 8 | 13 | NS | 2 | 2 | NS | 8.5 | 8.5 | NS |
| Li 2010 | 22.4 | 18.8 | NS | ‐ | ‐ | ‐ | 7.1 | 6.9 | NS |
| Kim 2008 INTEREST (subgroup) | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | 10.4 | 12.2 | NS |
| Lee 2010 ISTANA | 28.1 | 7.6 | 0.0007 | 3.3 | 3.4 | NS | 14.1 | 12.2 | NS |
| Maruyama 2008 V‐15‐32 | 22.5 | 12.8 | 0.009 | 2 | 2 | NS | 11.5 | 14 | NS |
| Sun 2012 KCSG‐LU08‐01 (adenocarcinoma, subgroup) | 58.8 | 22.4 | < 0.001 | 9.0 | 3.0 | 0.0006 | 22.2 | 18.9 | NS |
| versus maintenance therapy | |||||||||
| Ahn 2012 (Asian) | 46 | 35 | NS | 9.95 | 6.83 | NS | ‐ | ‐ | ‐ |
| Xu 2015 (Asian) | 18.1 | 29.8 | NS | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| 6. EGFR mutation positive | Gefitinib | Chemo | P | Gefitinib | Chemo | P | Gefitinib | Chemo | P |
| versus 1st line chemotherapy | |||||||||
| Maemondo 2010 (EGFR mutation positive) | 73.7 | 30.7 | < 0.001 | 10.8 | 5.4 | < 0.001 | 30.5 | 23.6 | NS |
| Mitsudomi 2010 WJTOG (EGFR mutation positive) | 62.1 | 32.2 | < 0.0001 | 9.2 | 6.3 | < 0.0001 | ‐ | ‐ | ‐ |
| Mok 2009 IPASS (subgroup) | 71.2 | 47.3 | < 0.001 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| Han 2012 First‐SIGNAL (subgroup) | 84.6 | 37.5 | 0.002 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| Yang 2014 (subgroup) | 70.8 | 65.4 | NS | 16.62 | 12.91 | NS | 45.7 | 32.4 | 0.255 |
| versus 2nd line chemotherapy | |||||||||
| INTEREST Doulliard 2010 (subgroup) | 42.1 | 21.1 | 0.04 | 7 | 4.1 | 0.001 | 14.2 | 16.6 | NS |
| Maruyama 2008 (subgroup) | 67 | 46 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| Sun 2012 KCSG‐LU08‐01 (subgroup) | ‐ | ‐ | ‐ | 15.7 | 2.9 | 0.005 | ‐ | ‐ | ‐ |
| 7. Gefitinib 250 mg versus gefitinib 500 mg | 250 mg | 500 mg | P | 250 mg | 500 mg | P | 250 mg | 500 mg | P |
| 2nd+ line | |||||||||
| Fukuoka 2003 | 18.4 | 19 | NS | 2.7 | 2.8 | NS | 7.6 | 8 | NS |
| Kris 2004 | 12 | 9 | NS | ‐ | ‐ | ‐ | 7 | 6 | NS |
| Maintenance therapy | |||||||||
| Xue 2015 (Asian) | 12.5 | 12.5 | NS | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| 8. Gefitinib versus gefitinib + chemotherapy | Gefitinib | G + Chemo | P | Gefitinib | G + Chemo | P | Gefitinib | G + Chemo | P |
| 1st line | |||||||||
| An 2016 | 73.33 | 80 | NS | 14 | 18 | < 0.05 | 32 | 34 | NS |
| Cheng 2016 | 74 | 80 | NS | 10.9 | 15.8 | 0.014 | ‐ | ‐ | ‐ |
| 2nd+ line | |||||||||
| Chen 2007(Asian, adenocarcinoma) | 55.6 | 52.4 | NS | 7.1 | 12.8 | NS | 13.3 | 23.4 | NS |
| Chen 2011(Asian, adenocarcinoma) | 35 | 37 | NS | 5.3 | 8.3 | 0.04 | ‐ | ‐ | ‐ |
| Chen 2011 (EGFR mutation positive subgroup) | ‐ | ‐ | ‐ | 7.6 | 14.4 | 0.0061 | ‐ | ‐ | ‐ |
| 9. Gefitinib + chemotherapy versus chemotherapy | 250 mg + Chemo | Chemo | P | 250 mg + Chemo | Chemo | P | 250 mg + Chemo | Chemo | P |
| 1st line | |||||||||
| Giaccone 2004 | 51.2 | 47.2 | NS | 5.8 | 6 | NS | 9.9 | 10.9 | NS |
| Herbst 2004 | 30.4 | 28.7 | NS | 5.3 | 5 | NS | 9.8 | 9.9 | NS |
| Takeda 2010 (Asian) | 34.2 | 29.3 | NS | 4.3 | 4.6 | < 0.001 | 12.9 | 13.7 | NS |
| Yu 2014 (Asian) | 47.4 | 50 | NS | 7.9 | 7 | NS | 25.4 | 20.5 | NS |
| 2nd line | |||||||||
| Soria 2015 IMPRESS (EGFR mutation positive) | 32 | 34 | NS | 5.4 | 5.4 | NS | 14.8 | 17.2 | NS |
Chemo: chemotherapy G: gefitinib NS: non‐significant ORR: overall response rate OS: overall survival PFS: progression‐free survival