Background: Docetaxel has been the only single agent with proven activity and documented survival benefit in the second-line treatment of advanced/refractory non-small cell lung cancer (NSCLC). Combinations of docetaxel with other active agents in this setting, such as gemcitabine, besides their popularity as front-line treatment, are currently being explored in an attempt to improve the results over single-agent docetaxel in relapsed/refractory NSCLC.
Material/methods: Given the established activity of single-agent docetaxel in two recent large randomized phase III trials against best supportive care or versus single-agent Vinorelbine or Ifosfamide in patients with platinum pretreated NSCLC, and the proven activity of single-agent gemcitabine in this setting, combination regimens employing these two agents in various doses and schedules have recently been initiated. Adequately designed phase II studies using standard criteria of efficacy and safety, with peer-review based publication, were selected from the literature.
Results: The gemcitabine/docetaxel combination in various schedules with or without G-CSF support as salvage therapy of NSCLC pre-treated with platinum+paclitaxel-based regimens has been evaluated in four recently published phase II clinical studies, and has been shown to represent a tolerable and active regimen in this setting, yielding a 10-33% response rate, improvement of disease-related symptoms, and meaningful median and 1-year survival figures in the range of 20-32%. Improvement of disease-related symptoms has outweighed toxicity in all these studies.
Conclusions: Randomized studies are warranted, comparing the gemcitabine/docetaxel combination to single-agent gemcitabine or docetaxel, drugs currently recommended in the second-line treatment of advanced NSCLC.