Background: The standard treatment for advanced non-small cell lung cancer (NSCLC) currently consists of platinum-based, combination chemotherapy of limited efficacy and possible toxicity. The bi-weekly administration of docetaxel and gemcitabine for advanced NSCLC was evaluated in a phase II study (objective response rate, median survival, median duration of response and safety).
Patients and methods: A total of 170 cycles were administered to 31 patients with advanced NSCLC and a median age of 66 years (range 47-75 years). Patients received docetaxel 80 mg/m2 and gemcitabine 1000 mg/m2 on days 1 and 14 of a 28-day cycle.
Results: Sixteen patients achieved a PR (16/31, 55.2%), 3 patients had SD (3/31, 10.3%) and 10 (10/31, 34.5%) had PD. The median time to disease progression was 3 months (range 0-12 months) with a mean survival of 10 months (range 3-31 months). Haematological and non-haematological toxic effects were generally mild to moderate and manageable: Grade 3 neurotoxicity and allergy occurred in 2 patients (6.4%) and 1 patient (3.2%), respectively. Peripheral neuropathy, mostly grades 1 and 2, was reported in 24 patients (77.4%).
Conclusion: The bi-weekly administration of a docetaxel/gemcitabine combination with G-CSF support constitutes a tolerable and convenient regimen for the treatment of advanced NSCLC, with efficacy similar to that reported in other regimens.