Table 1.
Targeted therapies
| First name STUDY |
Primary Endpoint/objective | n | PLACE OF STUDY | PHASE/ Programme |
STAGE OF NSCLC | TREATMENT |
EGFR positive | PATIENTS pre-treatment | OBJECTIVE RESPONSE RATE (ORR) % |
MEDIAN OVERALL SURVIVAL (OS) | MEDIAN PROGRESSION -FREE SURVIVAL (PFS) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Kris et al 2003 | symptomatic and radiographic response | 221 | USA | II | IIIB or IV | gefitinib | No | Pretreated/ platinum- or taxane-based CT | 22 | 6-7 | - |
| Simon et al 2003 | OS | 183 | USA | prospective landmark analysis | advanced | gefitinib | No | Pretreated | 3.8 | 8.8 | 3.6 |
| Gaafar et al 2011 (EORTC study 08021/ILCP 01/03) |
OS | 173 | Egypt | III | advanced | gefitinib | No | Pretreated/platinum-based CT | - | 10.9 | 4.1 |
| Wang et al 2006 | OS | 151 | China | Expanded Access Programme | IIIb or IV | gefitinib | No | Pretreated/ platinum- or taxane-based CT | 29.8 | 15.3 | 12.0 |
| Fukuoka et al 2003 (The IDEAL 1 Trial) |
efficacy and tolerability of two doses | 210 | Japan | II | advanced NSCLC | Gefitinib (250-mg) | No | Pretreated/platinum- or taxane-based CT | 18.4 | 8.0 | 2.8 |
| Thatcher et al 2005 ISEL |
OS | 1692 | UK | III | IIIB or IV | gefitinib | No | pretreated/platinum- or taxane-based CT | - | 5.6 | 3 |
| Giaccone et al 2004 (INTACT 1) |
OS | 1093 | The Netherlands | III | III or IV | Gefitinib + gemcitabine and cisplatin | No | untreated | 49.7 | 9.9 | 5.5 |
| Herbst et al 2004 (INTACT 2) |
OS | 1037 | USA | III | III or IV | Gefitinib + paclitaxel and carboplatin | No | untreated | 8.7 | ||
| Mitsudomi et al 2010 (WJTOG3405) | PFS | 177 | Japan | III | III or IV | Gefitinib vs cisplatin and docetaxel | Yes | untreated | 62.1 | 30.9 | 9.2 |
| Fukuoka et al 2011 (IPAS) |
OS | 1217 | Japan | III | III or IV | gefitinib vs carboplatin/paclitaxel | Yes | untreated | 43 | 18.8 | 5.7 |
| Mok et al 2009 | PFS | 609 | Asia | III | III or IV | gefitinib | Yes | untreated | 71.2 | 18.6 | 5.7 |
| Maemondo et al 2010 | PFS | 230 | Japan | - | III or IV | gefitinib or carboplatin-paclitaxel. | Yes | untreated | 73.7 | 30.5 | 10.8 |
| Shepherd et al 2005 (BR21) | OS | 731 | Canada | III | IIIB or IV | erlotinib | No | pretreated | 8.9 | 6.7 | 2.2 |
| Zhou et al 2011 (OPTIMAL, CTONG-0802) | PFS | 154 | China | III | IIIB or IV | erlotinib vs gemcitabine plus carboplatin | Yes | untreated | 83 | - | 13.1 |
| Rosell et al 2012 (EURTAC) | PFS | 174 | Europe | III | Advanced NSCLC | erlotinib vs platinum-based CT | Yes | untreated | 54.4 | 22.9 | 9.4 |
| Pallis et al 2012 | PFS | 49 | Greece | II | IIIB/IV | erlotinib | No | untreated | 24.5 | 15.5 | 6.7 |
| Ramalingam et al 2012 | PFS | 188 | USA | II | advanced | erlotinib vs dacomitinib | Yes | pretreated | - | 7.44 | 1.91 |
| Cufer et al 2006 (SIGN) |
assessment of symptom improvement | 141 | Slovenia | II | advanced NSCLC | gefitinib vs docetaxel | No | pretreated/platinum- or taxane-based | 13.2 | 7.5 | 3.0 |
| Miller et al 2012 (LUX-Lung 1) | OS | 697 | USA | IIb/III | IIIB or IV | afatinib | Yes | pretreated | - | 10.8 | 3.3 |
| Yang et al 2012 (LUX-Lung 2) |
ORR | 129 | Taiwan | II | stage IIIb with pleural effusion or stage IV/adenocarcinoma | afatinib | Yes | Pretreated platinum- or taxane-based | 61 | 24.8 | 10.1 |
| Sequist et al 2013 (LUX-Lung 3) |
PFS | 1269 | - | III | IIIB/IV lung adenocarcinoma | afatinib | yes | untreated | - | - | 11.1 |
| Sequist et al 2010 | ORR | 167 | USA | II | advanced | neratinib | Yes | pretreated | 54 | - | 15.3weeks |
| Butts et al 2007 | RR | 131 | Canada | II | IIIB / IV | cetuximab | No | pretreated gemcitabine/platinum | 27.7 | 11.99 | 5.09 |
| Rosell et al 2008 | activity, safety and pharmacokinetics | 86 | Spain | II | advanced | cetuximab | Yes | pretreated cisplatin and vinorelbine | 38 | 8.3 | 5.0 |
| Lynch et al 2010 (BMS099) | PFS | 676 | USA | III | IIIB / IV | cetuximab | No | Pretreated taxane/carboplatin | 25.7% | 9.69 | 4.40 |
| Pirker et al 2009 (FLEX) |
OS | 1125 | Austria | III | IIIB / IV | cetuximab | No | pretreated cisplatin and vinorelbine | - | 11.3 | 4.8 |
| Hanna et al 2006 | RR | 66 | USA | II | advanced | cetuximab | Yes | Pretreated taxane/carboplatin | 5% | 8.9 | 2.3 |
| Ramalingam et al 2011 | 12-week PFS | 172 | USA | II | advanced | Erlotinib + R1507 16 mg/kg | No | Pretreated/ taxane/carboplatin | - | 12.1 | 44% |
| Maruyama et al 2010 V-15-32 | OS | 489 | Japan | III | advanced/metastatic | gefitinib versus docetaxel | No | Pretreated/ taxane/carboplatin | 22.5 | - | 2 |
| Lee et al 2010 | PFS | 161 | Korea | III | advanced/metastatic | gefitinib versus docetaxel | No | Pretreated platinum-based CT | 28.1% | - | - |
| Kim et al 2008 (INTEREST) |
OS | 1466 | USA | III | advanced | gefitinib versus docetaxel | No | Pretreated platinum-based regimen | 9.1 | 7.6 | 2.2 |
| Herbst et al 2005 TRIBUTE |
OS | 1059 | USA | III | IIIB/IV | erlotinib + carboplatin and paclitaxel | No | untreated | 21.5 | 10.6 | - |
| Wheatley-Price et al 2008 BR21 | PFS, OS, RR, QOL | 731 | Canada | III | advanced | erlotinib | No | Elderly pretreated 1st line | 8.9 | 6.7 | 2.2 |
| VEGF | |||||||||||
| LeCaer et al (GFPC 0505) |
TTP2 | 100 | France | II | IIIB/IV | gemcitabine (G) followed by erlotinib | No | Untreated/elderly | 13.6 | 4.4 | - |
| Niho et al 2012 (JO19907) |
PFS | 180 | Japan | II | IIIB, IV or recurrentnon-squamous | bevacizumab | No | Pretreated carboplatin-paclitaxel | 60.7 | 22 | - |
| Reck et al 2009 (AVAIL) |
OS to PFS | 1043 | Germany. | III | advanced nonsquamous | bevacizumab | No | Pretreated cisplatin/gemcitabine | 30.4 | 6.7 | 13.6 |
| Takeda et al 2012 (WJOG 5910L) |
PFS | Japan | II | advanced nonsquamous | bevacizumab | No | Pretreated 1st line bevacizumab +a platinum-based doublet | 40 | 13.0 | 5.6 | |
| Heymach et al 2007 | PFS | 127 | USA | II | IIIB/IV | vandetanib plus docetaxel | No | Pretreated 1st line platinum-based CT | 32 | - | 11.5 |
| de Boer et al 2011 | PFS | 534 | Australia | III | advanced | vandetanib plus pemetrexed | No | Pretreated-failure 1st line treatment | 19 | 10.5 | 17.6 |
| Lee et al 2012 (ZEPHYR) |
OS | 924 | Korea | III | advanced | Vandetanib | No | Pretreated-treatment failure with an EGFR TKI | 2.6 | 8.5 | 1.9 |