Phase II Clinical Trial Data with the Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Erlotinib (OSI-774) in Non–Small-Cell Lung Cancer

摘要: Erlotinib (OSI-774; Tarceva) is an orally available, highly specific epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. The results of 3 phase II studies with erlotinib in non-small-cell lung cancer (NSCLC) are reviewed herein: (1) patients chemotherapy-resistant, HER1/EGFR-expressing NSCLC all histologies, (2) bronchoalveolar carcinoma previously untreated or treated chemotherapy, and (3) as first-line therapy elderly histologies. These have evaluated tumor response, survival, symptom improvement. was given oral, continuous daily dose 150 mg. drug well tolerated; drug-related cutaneous rash diarrhea were observed approximately two thirds patients. Withdrawals caused by toxicity rare. response rates 12.3%, 25%, 13.3%, respectively. Mature survival data available for the first trial. median 8.4 months, 1-year rate 40%. All responding second trials presented skin rash. In addition, correlated occurrence severity No on correlation between third trials. active tolerated first- second-line therapy. Cutaneous appears to be a surrogate marker clinical benefit, but this finding needs confirmed ongoing future studies.