[Comparison of single-agent docetaxel versus docetaxel plus platinum combination agent in second-line treatment for advanced non-small cell lung cancer].

OBJECTIVE: To compare the therapeutic efficacies and toxicities of single-agent docetaxel or docetaxel plus platinum combination agent in patients with advanced non-small cell lung cancer (NSCLC) so as to provide rationales for standard second-line chemotherapy.

METHODS: The clinical data from 152 patients with NSCLC who were admitted into Chest Hospital Affiliated to Shanghai Jiaotong University, from January 2004 to May 2008 were retrospectively analyzed. Forty patients were treated with single-agent docetaxel (single-agent group, 16 and 24 patients with stages IIIb and IV disease respectively; 32 patients with PS score 0-1 before treatment and 8 patients with PS score 2 before treatment), and 112 patients were treated with docetaxel plus platinum combination agent (combination group, 29 and 83 patients with stage IIIb and IV disease respectively; 98 patients with PS score 0-1 before treatment and 14 patients with PS score 2 before treatment). Primary end point was overall survival (OS), and secondary end point were progression-free survival time (PFS), disease control rate (DCR), one-year survival, and drug toxicity. Survival analysis was evaluated by Kaplan-Meier. Single factor analysis and Cox regression model were done to analyze the relationship between the influencing factors and the prognosis of disease.

RESULTS: The median PFS of the single-agent group was 3.0 months, significantly shorter than that of the combination group (4.2 months, P = 0.048). However, no statistical differences were found in OS, DCR or one-year survival between the two groups (all P > 0.05). The most common grade 3 to 4 toxicities were leukopenia (32.5% for single-agent group, and 56.2% for combination group, P = 0.000), and gastro-intestinal toxicity (0 for single-agent group, and 4.5% for combination group, P = 0.000). Single factor analysis showed that the factors including radiotherapeutic history, operative history, PS score before treatment, clinical stage, and response to second-line treatment influenced the prognosis of NSCLC (all P < 0.05). Cox regression analysis demonstrated operative history (HR = 0.428, 95% CI: 0.261-0.701), PS score before treatment (HR = 1.919, 95% CI: 0.999-3.685), clinical stage (HR = 2.297, 95% CI: 1.427-3.696) and response to second-line treatment (HR = 0.318, 95% CI: 0.177-0.571) had effects on survival.

CONCLUSIONS: To those well-selected patients, docetaxel plus platinum combination agent as the second-line treatment of advanced NSCLC significantly prolongs the progression-free survival. But such a regimen is more toxic and does not improve the response rate and overall survival.