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. 2012 Mar;1(1):5–13. doi: 10.3978/j.issn.2218-6751.2011.12.01

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).