BACKGROUND: Docetaxel has been the only single agent with proven activityand documented survival benefit in the second-line treatment of advanced/refractory non-small cell lungcancer (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 improvethe results over single-agent docetaxel in relapsed/refractory NSCLC.MATERIAL/METHODS: Given the establishedactivity of single-agent docetaxel in two recent large randomized phase III trials against best supportivecare or versus single-agent Vinorelbine or Ifosfamide in patients with platinum pretreated NSCLC, andthe proven activity of single-agent gemcitabine in this setting, combination regimens employing thesetwo agents in various doses and schedules have recently been initiated. Adequately designed phase IIstudies using standard criteria of efficacy and safety, with peer-review based publication, were selectedfrom the literature.RESULTS: The gemcitabine/docetaxel combination in various schedules with or withoutG-CSF support as salvage therapy of NSCLC pre-treated with platinum+paclitaxel-based regimens has beenevaluated in four recently published phase II clinical studies, and has been shown to represent a tolerableand 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-relatedsymptoms has outweighed toxicity in all these studies.CONCLUSIONS: Randomized studies are warranted,comparing the gemcitabine/docetaxel combination to single-agent gemcitabine or docetaxel, drugs currentlyrecommended in the second-line treatment of advanced NSCLC.

Keywords: Antineoplastic Combined Chemotherapy Protocols, Clinical Trials, Phase II, Deoxycytidine, paclitaxel, Salvage Therapy, Taxoids