| treatment |
|
comparator |
death (overall survival) | progression or death (progression free survival PFS) | objective response (ORR) |
|
|
| Cetuximab | lung cancer (metastatic), in all type of patients | vs CT | NS | NS | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.89 [0.75 1.05] | p=1.00 | 0 | -18 | 1 | Lynch, | | progression or death (progression free survival PFS) | 0.90 [0.76 1.07] | p=1.00 | 0 | -18 | 1 | Lynch, | | objective response (ORR) | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| Lynch, 2010 | cetuximab (400 mg/m(2) on day 1, 250 mg/m(2) weekly) was administered until progression or unacceptable toxicity plus taxane/carboplatin | paclitaxel (225 mg/m(2)) or docetaxel (75 mg/m(2)), at the investigators discretion, and carboplatin (area under the curve = 6) on day 1 every 3 weeks for < or = six cycles | chemotherapy-naïve patients with stage IIIB (pleural effusion) or IV NSCLC, without restrictions by histology or epidermal growth factor receptor expression |
|
| Cetuximab | lung cancer (metastatic), in all type of patients | vs CT alone | by 13% | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.87 [0.76 1.00] | p=0.04 | 0 | 1125 | 1 | FLEX (Pirker), | | progression or death (progression free survival PFS) | no data | | objective response (ORR) | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| FLEX (Pirker), 2009 | Cetuximab-at a starting dose of 400 mg/m(2) intravenous infusion over 2 h on day 1, and from day 8 onwards at 250 mg/m(2) over 1 h per week-was continued after the end of chemotherapy until disease progression or unacceptable toxicity + CT | cisplatin 80 mg/m(2) intravenous infusion on day 1, and vinorelbine 25 mg/m(2) intravenous infusion on days 1 and 8 of every 3-week cycle) for up to six cycles | chemotherapy-naive patients with advanced EGFR-expressing histologically or cytologically proven stage wet IIIB or stage IV non-small-cell lung cancer | | Rosell, 2008 | cetuximab treatment (initial dose 400 mg/m(2), followed by 250 mg/m(2) weekly thereafter) + same CT | for a maximum of eight cycles, patients received three-weekly cycles of cisplatin (80 mg/m(2), day 1) and vinorelbine (25 mg/m(2) on days 1 and 8) alone | first-line therapy in EGFR-expressing advanced non-small-cell lung cancer | | Butts, 2007 | cetuximab (400 mg/m2 i.v | cisplatin (75 mg/m2 i.v., every 3 weeks) or carboplatin (area under the concentration-versus-time curve of 5 intravenously [i.v.], every 3 weeks), and gemcitabine (1,250 or 1,000 mg/m2 i.v., days 1 and 8) | chemotherapy-naïve patients with recurrent/metastatic NSCLC (stage IV or stage IIIB with malignant pleural effusion) |
|
| Afatinib | lung cancer (metastatic), in all type of patients | vs cisplatin-based chemotherapy | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | objective response (ORR) | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| LUX-LUNG 3, 2015 | | | EGFR mutation-positive lung adenocarcinoma | | LUX-LUNG 6, 2015 | | | EGFR mutation-positive lung adenocarcinoma |
|
| Dacomitinib | lung cancer (metastatic), in all type of patients | vs gefitinib | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | objective response (ORR) | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| ARCHER 1050, | dacomitinib | gefitinib | Patients (pts) with newly diagnosed stage IIIB/IV/ recurrent NSCLC harboring an EGFR- activating mutation (exon 19 del or exon 21 L858R mu +/- exon 20 T790M mu) |
|
| Erlotinib | lung cancer (metastatic), in all type of patients | vs Platinum-based CT | by 10% | by 28% | by 30% | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.90 [0.83 0.98] | p=0.04 | 0 | -144 | 8 | TITAN, TRIBUTE (Herbst), Mok , SATURN (Cappuzzo), Boutsikou, Lee , Stinchcombe, FASTACT-2 (Wu) , | | progression or death (progression free survival PFS) | 0.72 [0.67 0.78] | p=0.04 | 0 | -126 | 7 | OPTIMAL , EUTRAC, Gatzemeier , Mok , Lee , Stinchcombe, FASTACT-2 (Wu) , | | objective response (ORR) | 1.30 [1.14 1.47] | p=0.04 | 0 | -108 | 6 | TRIBUTE (Herbst), Gatzemeier , Mok , Lee , Stinchcombe, FASTACT-2 (Wu) , |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| OPTIMAL , | oral erlotinib (150 mg/day) until disease progression or unacceptable toxic effects | up to four cycles of gemcitabine plus carboplatin | Patients older than 18 years with histologically confirmed stage IIIB or IV NSCLC and a confirmed activating mutation of EGFR (exon 19 deletion or exon 21 L858R point mutation) | | EUTRAC, | oral erlotinib 150 mg per day | 3 week cycles of standard intravenous chemotherapy of cisplatin 75 mg/m(2) on day 1 plus docetaxel (75 mg/m(2) on day 1) or gemcitabine (1250 mg/m(2) on days 1 and 8). | adults (> 18 years) with NSCLC and EGFR mutations (exon 19 deletion or L858R mutation in exon 21) with no history of chemotherapy for metastatic disease (neoadjuvant or adjuvant chemotherapy ending ¡Ý 6 months before study entry was allowed) | | TITAN, | erlotinib 150 mg/day | chemotherapy (standard docetaxel or pemetrexed regimens, at the treating investigators discretion) until unacceptable toxicity, disease progression, or death | second-line treatment of patients with advanced, non-small-cell lung cancer with poor prognosis | | TRIBUTE (Herbst), | erlotinib 150 mg/d combined with up to six cycles of carboplatin and paclitaxel, followed by maintenance monotherapy with erlotinib | placebo combined with up to six cycles of carboplatin and paclitaxel, followed by maintenance monotherapy with erlotinib | patients with good performance status and previously untreated advanced (stage IIIB/IV) NSCLC | | Gatzemeier , | Erl 150 mg/day plus (Gem 1,250 mg/m2 D1,8 and Cis 80 mg/m2 D1)*6 cycles | Gem 1,250 mg/m2 D1,8 and Cis 80 mg/m2 D1)*6 cycles | first-line treatment for advanced non-small-cell lung cancer | | Mok , | Erl 150 mg/day plus (Gem 1,250 mg/m2 D1,8 and either Cis75 mg/m2 D1 or Car AUC = 5, D1) | Gem 1,250 mg/m2 D1,8 and either | first-line treatment for advanced non-small-cell lung cancer | | SATURN (Cappuzzo), | Erl 150 mg/day plus select one of seven standard chemotherapy regimens | Cis75 mg/m2 D1 or Car AUC = 5, D1 | maintenance treatment in advanced non-small-cell lung cancer | | Boutsikou, | Erl 150 mg/day plus (Doc 100 mg/ m 2 and Car AUC = 5.5 q28d*4) | Doc 100 mg/m2 and Car AUC = 5.5 q28d*4 | first-line treatment of patients with NSCLC | | Lee , | Erl 150 mg/day plus Pem 500 mg/ m 2 D1 q21d | Pem 500 mg/m2 D1 q21d | second-line treatment for never-smokers with non-squamous non-small cell lung cancer | | Stinchcombe, | Erl 150 mg/day plus Gem 1,200 mg/m2 D1,8 q21d | Gem 1,200 mg/m2 D1,8 q21d | elderly patients (age ¡Ý70 years) with stage IIIB or IV non-small cell lung cancer | | FASTACT-2 (Wu) , | Erl 150 mg/day plus Gem 1,250 mg/m2 D1,8, six cycles and Car AUC = 5 or Cis 75 mg/ m 2,D1 | Gem 1,250 mg/m2, d1,8, six cycles and Car AUC = 5 or Cis 75 mg/ m 2,D1 | patients with untreated stage IIIB/IV non-small-cell lung cancer |
|
| Gefitinib | lung cancer (metastatic), in all type of patients | vs | - | by 96% | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | 1.96 [1.38 2.79] | p=0.04 | 0 | -18 | 1 | CTONG0806 (Yang), | | objective response (ORR) | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| West Japan, | | | | | Northeast Japan, | | | | | CTONG0806 (Yang), 2013 | | | |
|
| Gefitinib | lung cancer (metastatic), in all type of patients | vs carboplatin-paclitaxel | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | objective response (ORR) | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| NEJ002, 2013 | | | chemo-naïve non-small cell lung cancer with sensitive EGFR gene mutations | | Maemondo, 2010 | | | patients with metastatic, non-small-cell lung cancer and EGFR mutations who had not previously received chemotherapy | | IPASS (Mok), 2009 | | | previously untreated patients in East Asia who had advanced pulmonary adenocarcinoma and who were nonsmokers or former light smokers |
|
| Gefitinib | lung cancer (metastatic), in all type of patients | vs carboplatin/paclitaxel | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | objective response (ORR) | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| IPASS, | | | previously untreated never-smokers and light ex-smokers with advanced pulmonary adenocarcinoma |
|
| Gefitinib | lung cancer (metastatic), in all type of patients | vs cisplatin plus docetaxel | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | objective response (ORR) | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| WJTOG3405 (Mitsudomi), 2010 | | | patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor |
|
| Gefitinib | lung cancer (metastatic), in all type of patients | vs continued platinum-doublet chemotherapy | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | objective response (ORR) | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| WJTOG0203 (Takeda), 2010 | | | Japanese patients with advanced non-small-cell lung cancer |
|
| Gefitinib | lung cancer (metastatic), in all type of patients | vs docetaxel | NS | NS | by 49% | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 1.02 [0.92 1.12] | p=1.00 | 0 | -72 | 4 | ISTANA (Lee), V-15-32 (Maruyama), INTEREST (Kim), SIGN (Cufer), | | progression or death (progression free survival PFS) | 0.97 [0.88 1.07] | p=1.00 | 0 | -72 | 4 | ISTANA (Lee), V-15-32 (Maruyama), INTEREST (Kim), SIGN (Cufer), | | objective response (ORR) | 1.49 [1.17 1.91] | p=0.04 | 0 | -72 | 4 | ISTANA (Lee), V-15-32 (Maruyama), INTEREST (Kim), SIGN (Cufer), |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| ISTANA (Lee), 2010 | | | previously treated advanced nonsmall-cell lung cancer | | V-15-32 (Maruyama), 2008 | | | previously treated advanced nonsmall-cell lung cancer | | INTEREST (Kim), 2008 | | | previously treated advanced nonsmall-cell lung cancer | | SIGN (Cufer), 2006 | | | previously treated advanced nonsmall-cell lung cancer | | IFCT-0301 study (Morère), 2010 | | | patients with advanced non-small-cell lung cancer and a performance status of 2 or 3 |
|
| Gefitinib | lung cancer (metastatic), in all type of patients | vs gefitinib | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | objective response (ORR) | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| Kris, 2003 | | | Patients either stage IIIB or IV NSCLC for which they had received at least 2 chemotherapy regimens |
|
| Gefitinib | lung cancer (metastatic), in all type of patients | vs gemcitabine and cisplatin | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | objective response (ORR) | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| First Signal, | gefitinib (250 mg daily) | GP chemotherapy (gemcitabine 1,250 mg/m(2) on days 1 and 8; cisplatin 80 mg/m(2) on day 1 every 3 weeks, for up to nine courses | first-line therapy of never-smokers with adenocarcinoma of the lung |
|
| Gefitinib | lung cancer (metastatic), in all type of patients | vs paclitaxel and carboplatin | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | objective response (ORR) | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| INTACT 2, 2004 | gefitinib plus paclitaxel and carboplatin | paclitaxel 225 mg/m(2) and carboplatin area under concentration/time curve of 6 mg/min/mL (day 1 every 3 weeks) | chemotherapy-naive patients with advanced NSCLC |
|
| Gefitinib | lung cancer (metastatic), in all type of patients | vs placebo | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | objective response (ORR) | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| NCIC CTG BR19 (Goss), 2013 | gefitinib 250 mg per day | placebo | completely resected non-small-cell lung cancer | | INFORM; C-TONG 0804, 2012 | | | maintenance therapy in patients with locally advanced or metastatic non-small-cell lung cancer | | EORTC 08021/ILCP 01/03, 2011 | | | patients with advanced NSCLC, non-progressing after first line platinum-based chemotherapy | | Goss, 2009 | | | chemotherapy-naive patients with advanced non-small-cell lung cancer and poor performance status | | SWOG S0023 (Kelly), 2008 | | | inoperable stage III non-small-cell lung cancer | | ISEL, 2006 | | | patients of Asian origin with refractory advanced non-small cell lung cancer | | Tsuboi, 2005 | | | patients with completely resected non-small cell lung cancer |
|
| Gefitinib | lung cancer (metastatic), in all type of patients | vs placebo + gemcitabine / cisplatin | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | objective response (ORR) | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| INTACT 1., | gefitinib 500 mg/d, gefitinib 250 mg/d, | placebo | chemotherapy-naive patients with unresectable stage III or IV NSCLC |
|
| Gefitinib | lung cancer (metastatic), in all type of patients | vs vinorelbine | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | objective response (ORR) | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| INVITE (Crinò), 2008 | | | chemotherapy-naive elderly patients with advanced non-small-cell lung cancer |
|
| Gefitinib | lung cancer (metastatic), in first line | vs carboplatin-paclitaxel | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | objective response (ORR) | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| NEJ002, 2013 | | | chemo-naïve non-small cell lung cancer with sensitive EGFR gene mutations | | IPASS (Mok), 2009 | | | previously untreated patients in East Asia who had advanced pulmonary adenocarcinoma and who were nonsmokers or former light smokers |
|
| Gefitinib | lung cancer (metastatic), in first line | vs carboplatin/paclitaxel | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | objective response (ORR) | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| IPASS, | | | previously untreated never-smokers and light ex-smokers with advanced pulmonary adenocarcinoma |
|
| Gefitinib | lung cancer (metastatic), in first line | vs gemcitabine and cisplatin | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | objective response (ORR) | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| First Signal, | gefitinib (250 mg daily) | GP chemotherapy (gemcitabine 1,250 mg/m(2) on days 1 and 8; cisplatin 80 mg/m(2) on day 1 every 3 weeks, for up to nine courses | first-line therapy of never-smokers with adenocarcinoma of the lung |
|
| Gefitinib | lung cancer (metastatic), in first line | vs paclitaxel and carboplatin | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | objective response (ORR) | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| INTACT 2, 2004 | gefitinib plus paclitaxel and carboplatin | paclitaxel 225 mg/m(2) and carboplatin area under concentration/time curve of 6 mg/min/mL (day 1 every 3 weeks) | chemotherapy-naive patients with advanced NSCLC |
|
| Gefitinib | lung cancer (metastatic), in first line | vs placebo + gemcitabine / cisplatin | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | objective response (ORR) | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| INTACT 1., | gefitinib 500 mg/d, gefitinib 250 mg/d, | placebo | chemotherapy-naive patients with unresectable stage III or IV NSCLC |
|
| Gefitinib | lung cancer (metastatic), in first line | vs vinorelbine | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | objective response (ORR) | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| INVITE (Crinò), 2008 | | | chemotherapy-naive elderly patients with advanced non-small-cell lung cancer |
|
| Gefitinib | lung cancer (metastatic), in second line | vs carboplatin-paclitaxel | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | objective response (ORR) | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| Maemondo, 2010 | | | patients with metastatic, non-small-cell lung cancer and EGFR mutations who had not previously received chemotherapy |
|
| Gefitinib | lung cancer (metastatic), in second line | vs docetaxel | NS | NS | by 49% | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 1.02 [0.92 1.12] | p=1.00 | 0 | -72 | 4 | ISTANA (Lee), V-15-32 (Maruyama), INTEREST (Kim), SIGN (Cufer), | | progression or death (progression free survival PFS) | 0.97 [0.88 1.07] | p=1.00 | 0 | -72 | 4 | ISTANA (Lee), V-15-32 (Maruyama), INTEREST (Kim), SIGN (Cufer), | | objective response (ORR) | 1.49 [1.17 1.91] | p=0.04 | 0 | -72 | 4 | ISTANA (Lee), V-15-32 (Maruyama), INTEREST (Kim), SIGN (Cufer), |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| ISTANA (Lee), 2010 | | | previously treated advanced nonsmall-cell lung cancer | | V-15-32 (Maruyama), 2008 | | | previously treated advanced nonsmall-cell lung cancer | | INTEREST (Kim), 2008 | | | previously treated advanced nonsmall-cell lung cancer | | SIGN (Cufer), 2006 | | | previously treated advanced nonsmall-cell lung cancer |
|
| Gefitinib | lung cancer (metastatic), in second line | vs gefitinib | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | objective response (ORR) | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| Kris, 2003 | | | Patients either stage IIIB or IV NSCLC for which they had received at least 2 chemotherapy regimens |
|
| Gefitinib | lung cancer (metastatic), in second line | vs placebo | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | objective response (ORR) | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| EORTC 08021/ILCP 01/03, 2011 | | | patients with advanced NSCLC, non-progressing after first line platinum-based chemotherapy | | ISEL, 2006 | | | patients of Asian origin with refractory advanced non-small cell lung cancer |
|
| Osimertinib | lung cancer (metastatic), in all type of patients | vs placebo | - | by 55% | by 37% | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.45 [0.36 0.56] | p=0.04 | 0 | 556 | 1 | FLAURA, | | objective response (ORR) | 0.63 [0.45 0.88] | p=0.04 | 0 | 556 | 1 | FLAURA, |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| FLAURA, 2017 | osimertinib (AZD9291) (80 mg or 40 mg orally, once daily) | first-line standard-of-care treatment erlotinib or gefitinib | previously untreated patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation–positive non–small cell lung cancer |
|
| Osimertinib | lung cancer (metastatic), in all type of patients | vs platinum-based therapy plus pemetrexed | - | by 70% | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.30 [0.22 0.40] | p=0.04 | 0 | -18 | 1 | AURA 3, | | objective response (ORR) | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| AURA 3, 2017 | oral osimertinib (at a dose of 80 mg once daily) | intravenous pemetrexed (500 mg per square meter of body-surface area) plus either carboplatin (target area under the curve, 5 [AUC5]) or cisplatin (75 mg per square meter) every 3 weeks for up to six cycles | patients with EGFR T790M mutation-positive, locally-advanced or metastatic NSCLC, whose disease had progressed after 1st-line EGFR tyrosine kinase inhibitor (TKI) therapy. |
|
| Osimertinib | lung cancer (metastatic), in second line | vs platinum-based therapy plus pemetrexed | - | by 70% | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.30 [0.22 0.40] | p=0.04 | 0 | -18 | 1 | AURA 3, | | objective response (ORR) | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| AURA 3, 2017 | oral osimertinib (at a dose of 80 mg once daily) | intravenous pemetrexed (500 mg per square meter of body-surface area) plus either carboplatin (target area under the curve, 5 [AUC5]) or cisplatin (75 mg per square meter) every 3 weeks for up to six cycles | patients with EGFR T790M mutation-positive, locally-advanced or metastatic NSCLC, whose disease had progressed after 1st-line EGFR tyrosine kinase inhibitor (TKI) therapy. |
|
| Osimertinib | lung cancer (metastatic), in first line | vs placebo | - | by 55% | by 37% | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.45 [0.36 0.56] | p=0.04 | 0 | 556 | 1 | FLAURA, | | objective response (ORR) | 0.63 [0.45 0.88] | p=0.04 | 0 | 556 | 1 | FLAURA, |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| FLAURA, 2017 | osimertinib (AZD9291) (80 mg or 40 mg orally, once daily) | first-line standard-of-care treatment erlotinib or gefitinib | previously untreated patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation–positive non–small cell lung cancer |
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