Erlotinib treatment in pretreated patients with non-small cell lung cancer: A Phase II study

Erlotinib is an oral, small-molecule targeting therapy that inhibits epidermal growth factor tyrosine kinase receptors Eilotinib has been administered for the treatment of advanced pancreatic cancer and non-small cell lung cancer In the present trial, erlotinib was administered as second-line monotherapy in pretreated patients with advanced non-small cell lung cancer Our objectives were to determine response, survival and toxicity Fifty-four patients pretreated with cisplatin or its analogue-based combinations were evaluated The disease stage of the patients was IIIB and IV Thirty-eight patients were male, 16 were female, the median age was 65 years, and the WHO performance status was 0-2 Twenty-five cases were adenocarcinomas, 19 squamous cell carcinomas and 10 were undifferentiated Erlotinib was administered at a dose of 150 mg daily In case of intolerable adverse reactions, the dose was either reduced to 100 mg daily or treatment was interrupted for a maximum of two weeks A partial response was observed in 10 (18 52%) and stable disease in 40 (74 07%) patients The median time to disease progression was 3 months (95% CI 1 7-10 3), and the median survival was 6 months Concerning toxicity, 53 patients (98 15%) developed a grade 1-2 skin rash, and 1 (1 85%) grade 3 Diarrhea occurred in 9 (16 67%) patients, nausea and vomiting in 4 (741%) and gastritis in 2 (370%) The majority of patients tolerated the erlotinib treatment Of note were the 18 52% response rate and 74 07% stable disease