Comparing docetaxel with gemcitabine as second-line chemotherapy in patients with advanced non-small cell lung cancer: A single institute randomized phase II study

Background: Platinum-based doublet chemotherapy is the backbone of treatment in advanced non-small cell lung cancer (NSCLC) however second-line treatment options are controversial particularly in patients with borderline performance status (PS) of 2. The aim of this study was to compare efficacy and toxicity of weekly docetaxel versus gemcitabine in this clinical setting. Patients and methods: A total of 70 patients with advanced (stage IIIB, IV) NSCLC entered this single institute study. Cases of this study had experienced disease progression after the first-line platinum-based doublet chemotherapy, with PS 0- 2 in “Eastern Cooperative Oncology Group” scale. They were randomly assigned by stratified blocks to receive docetaxel 35 mg/m2 (Arm A, n=34) or gemcitabine 1000 mg/m2 (Arm B, n=36) days 1, 8 and 15, every three weeks, for up to six cycles. Primary end point was progression free survival (PFS) and secondary end points were objective response rate, disease control rate, median overall survival (OS) and toxicity. Dose modification was permitted upon clinician’s discretion for each individual patient. Results: Median of PFS was 2.02 months in arm A and 2.63 months in arm B (HR= 1.279; 95% CI: 0.710-2.304, P= 0.551). Although median OS for arm A was numerically greater (9.2 months) than arm B (8.3 months) it was statistically non-significant (HR= 1.384; 95% CI: 0.632 to 2.809, P= 0.59). Objective response was higher in Arm B than that in Arm A (P= 0.20) but disease control rates were statistically different in both arms (P= 0.034). Statistically significant differences in term of leukopenia was seen in arm B (P= 0.013). Conclusion: This study, with limited number of cases, indicates that in advanced NSCLC, weekly docetaxel and gemcitabine are reasonable second-line treatment options with statistically similar effectiveness in terms of PFS and median OS with manageable toxicities in patients with PS 0-2