Oza AM et al. – Erlotinib is well tolerated with an overall objective response rate of 12.5%; molecular analysis did not identify epidermal growth factor receptor (EGFR) mutations in responders or correlation of response with gene amplification Methods
Multinomial design 2-stage phase II study of single-agent activity of erlotinib in women with advanced endometrial cancer with recurrent or metastatic disease who were chemotherapy naïve with ≤1 line of prior hormonal therapy
Erlotinib administered at dose of 150 mg/day
immunohistochemistry (IHC) analysis for EGFR expression and fluorescence in situ hybridization (FISH) for gene amplification in archival tumor tissue
Mutational status of EGFR determined in responders
Results
Treatment was well tolerated with infrequent severe toxicity; only grade 4 toxicity was elevated AST
Of 32 assessable pts, partial responses (PRs) of 2-36 mo duration in 4 pts; stable disease (SD) with median duration 3.7 mo (range, 2-12 mo) in 15 pts
EGFR expression analyzed in 30 pts; 19 positive, 9 negative, 2 not assessable
Of EGFR+ 19 pts, 3 had PR, 7 SD, 8 progressive disease, 1 not assessable
No mutations identified in responders
FISH showed no correlation of response with gene amplification
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