Table 1. Phase III studies comparing gefitinib or erlotinib versus a standard platinum-based doublet in the first line treatment of advanced NSCLC patients selected based on the presence of EGFR mutation.
Study | EGFR-TKI | No. of patients | Type of EGFR mutation | Population | RR (EGFR-TKI vs. chemotherapy) | PFS (EGFR-TKI vs. chemotherapy) | OS (EGFR-TKI vs. chemotherapy) | Quality of life (EGFR-TKI vs. chemotherapy) |
---|---|---|---|---|---|---|---|---|
WJTOG 3405 (19) | Gefitinib | 172 | del19 or L858R | Asiatic | 62.1% vs.32.2%† P<0.0001 | 9.2 vs. 6.3 months P<0.0001 | Not available | Not assessed |
NEJ002 (20,34) | Gefitinib | 228 | Any‡ | Asiatic | 73.7% vs. 30.7% P<0.001 | 10.4 vs. 5.5 months P<0.001 | 30.5 vs. 23.6 months P=0.31 | Significant less deterioration§ |
OPTIMAL (21) | Erlotinib | 154 | del19 or L858R | Asiatic | 83% vs. 36% P<0.0001 | 13.1 vs. 4.6 months P<0.0001 | Not available | Significant improvement¶ |
EURTAC (22) | Erlotinib | 173 | del19 or L858R | Caucasian | 58% vs. 15% P<0.05 | 9.7 vs. 5.2 months P<0.0001 | Not available | Not available |
EGFR-TKI, epidermal growth factor receptor-tyrosine kinase inhibitor; No., number; OS, overall survival; PFS, progression-free survival; RR, response rare. †Only patients with measurable disease considered. ‡Excluded the T790M resistant mutation. §As assessed by a Care Notebook (QOL Res 2005, http://homepage3.nifty.com/care-notebook/) questionnaire. ¶As assessed with the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire and the Lung Cancer Subscale (LCS).