Maintenance erlotinib improves clinical outcomes of unresectable advanced non-small cell lung cancer: A meta-analysis of randomized controlled trials.

The aim of this study was to evaluate the efficacy and safety of erlotinib as maintenance therapy in patients with unresectable non-small cell lung cancer (NSCLC) by evidence-based methodology. Six eligible studies including 4,372 patients were analyzed. Erlotinib was administered to 2,191 patients as maintenance treatment, while the remaining patients received a placebo or observation only. The meta-analysis was performed using Reviewer Manager Version 5.12 software. Compared with the control group, maintenance erlotinib improved progression-free survival (PFS) and overall survival (OS) with moderate heterogeneity. Results from the random effects model analysis for OS were not in concordance with the difference observed in the fixed effects model analysis. Administration of erlotinib only after chemotherapy obtained a higher objective response rate (ORR). Safety analyses indicated a slight increase in side-effects. The most common adverse events (AEs) were diarrhea and rash, which were usually manageable. There was no significant difference in treatment-related deaths. Erlotinib produced significant clinical benefits with acceptable toxicity as a maintenance strategy in patients with unresectable NSCLC, particularly when sequentially administered with chemotherapy. However, more well-designed randomized control trials (RCTs) are required to identify patients that may derive greater benefits from maintenance with erlotinib, and whether the use of erlotinib as maintenance therapy is more efficient than second-line treatment should also be investigated.