Epidermal Growth Factor Receptor Mutation Status in Circulating Free DNA in Serum: From IPASS, a Phase III Study of Gefitinib or Carboplatin/Paclitaxel in Non-small Cell Lung Cancer

摘要: Introduction In IPASS (IRESSA Pan-Asia Study), clinically selected patients with pulmonary adenocarcinoma received first-line gefitinib or carboplatin/paclitaxel. This preplanned, exploratory analysis was conducted to increase understanding of the use surrogate samples, such as serum, versus tumor biopsy samples for determining EGFR mutation status in Japanese cohort ( n = 233). Methods mutations were assessed using tissue-derived DNA 91) and circulating free (cf) from pretreatment serum 194). Results Fewer positive when cfDNA (23.7%) (61.5%). results identified no false positives but a high rate negatives (56.9%). There significant interaction between treatment progression-free survival (PFS) p 0.045). PFS significantly longer objective response (ORR) higher than carboplatin/paclitaxel mutation-positive subgroup (PFS: hazard ratio [HR], 0.29; 95% confidence interval [CI], 0.14–0.60; 0.40). slight numerical advantage ORR over mutation-negative subgroup, likely due within this subgroup. Conclusions These merit further investigation determine whether alternative sources DNA, could be used future; currently, where sample is available, material recommended.