Objective:To compare the efficacy and safety of docetaxel versus epidermal growth factor receptor tyrosine kinase inhibitors (EFGR-TKIs: gefitinib,erlotinib or icotinib) in the second-line treatment for patients with advanced non-small-cell lung cancer(NSCLC).Methods:The clinical data of 100 advanced NSCLC patients who received second-line therapy in Guangxi Medical University Affiliated Tumor Hospital from January 2009 to June 2013 were retrospectively analyzed. Fifty-two patients were treated with EGFR-TKIs(TKIs group) and 48 patients with docetaxel(DOC group).The progression-free survival (PFS),overall survival(OS), were estimated by Kaplan-Meier method. Differences of survival between groups were compared by log-rank test. Single factor analysis and Cox regression model were done to analysis the relationship between the influencing factors and prognosis of disease.Results:(1) Response Rates:the Tumour objective responses for EGFR-TKIs and docetaxel was 23.1% and 6.3% respectively, with a statistically significant difference(P=0.038). (2) Survival Time:The progression-free survival was significantly longer in patients given EGFR-TKIs than in those given docetaxel (median progression-free survival 6.0 months [95% CI 4.5-7.5] vs.3.0 months [95% CI 1.8-4.1];p=0.021).The median survival time was 16 months (95% CI 13.3-18.7) for the EGFR-TKIs group and 10 months (95% CI 8.0-12.0) for the DOC group, P=0.068, without any statistical difference. (3) Cox regression analysis demonstrated ECOG PS score before treatment (HR=1.885; 95% CI 1.071-3.316; p=0.028) and EGFR status (HR= 1.476; 95% CI 1.032-2.113; P=0.033) are independent prognostic factors for patients with advanced non-small-cell lung cancer. (4) Toxicity:Grade 3 to 4 leukopenia, neutropenia, and febrile neutropenia were significantly more frequent with docetaxel compared with erlotinib (none v 47.92%,2.08% ν 62.5%, and none ν 25%, respectively; all P=0.000).Conclusion:EGFR-TKIs show PFS benefit and a favorable safety profile comparing with docetaxel in the second-line treatment for selected advanced NSCLC patients who has high potential of EGFR sensitive mutation. |