Table 2. Qualitative analyses of trials according to EGFR mutation status and laboratory methods used to confirm EGFR mutation status.
| Study [ref.] | ||||||||
| NEJ002 [12, 23] | WJTOG3405 [13, 25] | IPASS# [8, 14] | EURTAC [9] | LUX-Lung 3 [15] | OPTIMAL [10] | LUX-Lung 6 [16] | ENSURE [17] | |
| Included patient group | EGFR mutant and absence of T790M | Del19 and L8585R | Nonsmoker or former light smoker (no EGFR status required) | Del19 or L858R | EGFR mutation-positive | Del19 or L858R | EGFR mutation-positive | Del19 or L858R |
| EGFR mutations that could be included | Del19 L858R Other (not described) | Del19 L858R | Del19 (19 different deletions) L858R T790M L861Q G719X S768I Three insertions in exon 20 | Del19 L858R | Del19 (19 different deletions) L858R T790M L861Q G719X S768I Three insertions in exon 20 | Del19 L858R | Del19 (19 different deletions) L858R T790M L861Q G719X S768I Three insertions in exon 20 | Del19 or L858R |
| Testing methodology used | Peptide nucleic acid-locked nucleic acid PCR clamp method | For those tested centrally, detection by fragment analysis for Del19 and by cycleave for L858R; confirmed by direct sequencing | Detection by Therascreen EGFR29 in central laboratory | Sanger sequencing confirmed by PNAClamp for Del19 and by TaqMan assay for L858R | Standardised allele-specific quantitative real-time PCR kit (Therascreen EGFR 29) in central laboratory | PCR-based direct sequencing in central laboratory | TheraScreen EGFR RGQ PCR kit in central laboratory | Not reported |
| Specificity | 100% [28] | Direct sequencing: 100% [29] | 100% [29] | 100% [28] | 100% [29] | 100% [29] | 100% [29] | |
| Sensitivity | 89% [28] | Direct sequencing: 40–89% [29] | 40–67% [29] | 89% for PNAClamp [28] 99% for TaqMan | 40–67% [29] | 40–89% [29] | 40–67% [29] | |
EGFR: epidermal growth factor receptor; WJTOG: West Japan Thoracic Oncology Group; NEJ002: North East Japan 002; IPASS: Iressa Pan-Asia Study; EURTAC: European Randomised Trial of Tarceva versus Chemotherapy #: all patients. Therascreen EGFR 29 and TheraScreen EGFR RGQ PCR kit are manufactured by Qiagen (Manchester, UK); TaqMan is manufactured by Life Technologies Europe BV (Bleiswijk, the Netherlands); PNAClamp is manufactured by Panagene Inc. (Daejeon, Korea).