Bi-weekly administration of docetaxel and gemcitabine as first-line therapy for non-small cell lung cancer: A phase II study

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 NSCL C was evaluated in a phase If 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/m(2) and gemcitabine 1000 mg/m(2) on days I and 14 of a 28-day cycle. Results: Sixteen patients achieved a PR (16131, 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 I 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. Hence, this non-platinum-based regimen appears promising and warrants further evaluation.