Table 1.
Study (phase, ethnicity) | Sample size (No); median age | Female (%) | EGFR mutation | Intervention arm | Control arm | Reported outcomes | |
---|---|---|---|---|---|---|---|
Exon 19 deletion | Leu858Arg | ||||||
NEJ026 201935 (III, Asian) | 114/114; 67/68 | 63.4/65.2 | 50/48 | 50/50 | Erlotinib 150 mg once a day + bevacizumab 15 mg/kg every 3 weeks | Erlotinib 150 mg once a day | Progression free survival†, objective response rate, grade ≥3 AEs |
SWOGS1403 201836 (II, NG) | 86/84; NG | NG | NG | NG | Afatinib 40 mg once a day + cetuximab 500 mg/m2 every 2 weeks | Afatinib 40 mg once a day | Progression free survival, overall survival |
NEJ009 201824 (III, Asian) | 170/172; 64.1/64.8* | 62.8/67.1 | NG | NG | Gefitinib 250 mg once a day + PbCT (carboplatin AUC 5 + pemetrexed 500 mg/m2 every 3 weeks (4-6 cycles) + pemetrexed 500 mg/m2 every 3 weeks) | Gefitinib 250 mg once a day | Progression free survival, overall survival, objective response rate, grade ≥3 AEs |
FLAURA 201826 (III, multiple) | 279/277; 64.0/64.0 | 64.0/62.0 | 63/63 | 37/37 | Osimertinib 80 mg once a day | Gefitinib 250 mg once a day | Progression free survival†, overall survival, objective response rate, grade ≥3 AEs |
63/63 | 37/37 | Osimertinib 80 mg once a day | Erlotinib 150 mg once a day | ||||
ARCHER1050 201738 48 (III, multiple) | 227/225; 62.0/61.0 | 64.0/56.0 | 59/59 | 41/41 | Dacomitinib 45 mg once a day | Gefitinib 250 mg once a day | Progression free survival†, overall survival†, objective response rate, grade ≥3 AEs |
CONVINCE 201737 (III, Asian) | 148/137; 56.0/56.0 | 70.9/69.3 | 50/50 | 43/39 | Icotinib 125 mg three times a day | PbCT (cisplatin 75 mg/m2 + pemetrexed 500mg/m2 every 3 weeks (4 cycles) + pemetrexed 500 mg/m2 every 3 weeks) | Progression free survival†, overall survival†, grade ≥3 AEs |
Han et al 201725 (II, Asian) | 40/40; NG | 62.5/57.5 | 53/50 | 48/50 | Gefitinib 250 mg once a day + PbCT (carboplatin AUC=5 + pemetrexed 500 mg/m2 every 4 weeks (6 cycles) + pemetrexed 500 mg/m2 every 4 weeks) | PbCT (carboplatin AUC=5 + pemetrexed 500 mg/m2 every 4 weeks (6 cycles) + pemetrexed 500 mg/m2 every 4 weeks) | Progression free survival†, overall survival, objective response rate |
40/41; NG | 62.5/56.1 | 53/51 | 48/49 | Gefitinib + PbCT | Gefitinib 250 mg once a day | ||
41/40; NG | 56.1/57.5 | 51/50 | 49/50 | Gefitinib | PbCT | ||
CTONG0901 201739 (III, Asian) | 81/84; NG | 46.9/53.1 | 58/58 | 42/42 | Erlotinib 150 mg once a day | Gefitinib 250 mg once a day | Progression free survival, overall survival, objective response rate, grade ≥3 AEs |
JMIT 201623 49 (II, Asian) | 126/65; 62.0/62.0 | 65.0/63.0 | 52/62 | 41/35 | Gefitinib 250 mg once a day + pemetrexed 500 mg/m2 every 3 weeks | Gefitinib 250 mg once a day | Progression free survival†, overall survival, objective response rate, grade ≥3 AEs |
LUX-Lung7 201641 50 (IIB, multiple) | 160/159; 63.0/63.0 | 57.0/67.0 | 58/58 | 42/42 | Afatinib 40 mg once a day | Gefitinib 250 mg once a day | Progression free survival†, overall survival†, objective response rate, grade ≥3 AEs |
ENSURE 201513 (III, Asian) | 110/107; 57.5/56.0 | 61.8/60.7 | 52/57 | 48/43 | Erlotinib 150 mg once a day | PfCT (gemcitabine 1250 mg/m2 + cisplatin 75 mg/m2 every 3 weeks (≤4 cycles)) | Progression free survival†, overall survival†, objective response rate, grade ≥3 AEs |
JO25567 201442 51 (II, Asian) | 75/77; 67.0/67.0 | 60.0/66.0 | 53/52 | 47/48 | Erlotinib 150 mg once a day + bevacizumab 15 mg/kg every 3 weeks | Erlotinib 150 mg once a day | Progression free survival†, overall survival†, objective response rate, grade ≥3 AEs |
LUX-Lung6 201443 (III, Asian) | 242/122; 58.0/58.0 | 64.0/68.0 | 51/51 | 38/38 | Afatinib 40 mg once a day | PfCT (gemcitabine 1000 mg/m2 + cisplatin 75 mg/m2 every 3 weeks (≤6 cycles)) | Progression free survival†, overall survival†, objective response rate, grade ≥3 AEs |
LUX-Lung3 201312 (III, multiple) | 230/115; 61.5/61.0 | 63.9/67.0 | 49/50 | 40/41 | Afatinib 40 mg once a day | PbCT (cisplatin 75 mg/m2 + pemetrexed 500mg/m2 every 3 weeks (≤6 cycles)) | Progression free survival†, overall survival†, objective response rate, grade ≥3 AEs |
EURTAC 201244 (III, non-Asian) | 86/87; 65.0/65.0 | 67.0/78.0 | 66/67 | 34/33 | Erlotinib 150 mg once a day | PfCT (cisplatin 75 mg/m2 + docetaxel 75 mg/m2/gemcitabine 1250 mg/m2 every 3 weeks) | Progression free survival†, overall survival†, objective response rate, grade ≥3 AEs |
OPTIMAL 201145 52 (III, Asian) | 83/72; 57.0/59.0 | 59.0/60.0 | 52/54 | 48/46 | Erlotinib 150 mg once a day | PfCT (gemcitabine 1000 mg/m2 + cisplatin AUC=5 every 3 weeks (≤4 cycles)) | Progression free survival†, overall survival†, objective response rate, grade ≥3 AEs |
NEJ002 201046 53 (III, Asian) | 114/110; 63.9/62.6* | 63.2/64.0 | 51/54 | 43/44 | Gefitinib 250 mg once a day | PfCT (paclitaxel 200 mg/m2 + carboplatin AUC=6 every 3 weeks (≥3 cycles)) | Progression free survival†, overall survival†, objective response rate, grade ≥3 AEs |
WJTOG3405 200947 54 (III, Asian) | 86/86; 64.0/64.0 | 68.6/69.8 | 58/43 | 42/47 | Gefitinib 250 mg once a day | PfCT (cisplatin 80 mg/m2 + docetaxel 60 mg/m2 every 3 weeks (3-6 cycles)) | Progression free survival†, overall survival†, objective response rate |
Data are expressed as intervention/control unless indicated otherwise. AE=adverse events; NG=not given; AUC=area under the concentration-time curve; PbCT=pemetrexed based chemotherapy; PfCT=pemetrexed free chemotherapy.
Mean age was given instead of median age.
Information of outcomes for exon 19 deletion and Leu858Arg mutation subgroups are also reported in trials.