Clinical study on the efficacy and safety of erlotinib in treatment of advanced non-small cell lung cancer / 肿瘤

ABSTRACT

Objective: To investigate the efficacy and adverse reaction of erlotinib as a single agent in 2nd and 3rd treatment of advanced non-small cell lung cancer (NSCLC) patients. Methods: Patients with advanced NSCLC (III B/IV stage) were recruited in this study. They had recurrence after receiving at least one or two regimens of platinum-based chemotherapy from October 2005 to September 2006. Erlotinib was given orally to the patients at 150 mg/d, once daily until disease progression. The clinical outcome and adverse reaction were observed. Patients were followed up. Kaplan-Meier method was used to perform survival analysis. Results: Fifty NSCLC patients were enrolled into the study and followed up until September 20, 2007. The median follow-up period was 17 months and the follow-up ratio was 100%. The clinical outcome could not be evaluated in 3 patients. There was no patient with complete response (0%, 0/47), 38.3% patients with partial response (18/47), 44.7% patients with stable disease (21/47) and 17.0% patients with progressive disease (8/47). Disease control rate was 83.0% (39/47). Median time to progression and median overall survival period were 7.0 and 13.7 months, respectively. One year progression-free survival rate and 1-year overall survival rate were 30% and 56%, respectively. Patients with II to III grade skin rash had higher response rate and disease control rate than those with 0 to I grade. The patients with partial response and stable disease obtained superior survival benefit than those with progressed disease. The occurence rate of skin rash over grade III was 4% (2/50). Conclusion: Erlotinib as a single agent is effective in the treatment of advanced NSCLC patients after failure of chemotherapy. The tolerance is well. The survival time is not dependent on gender, smoking status, and pathological classification. The patients with severe skin rash (> grade II) achieves better.