Paclitaxel, carboplatin, and G-CSF in advanced non-small-cell lung cancer:: A phase I/II study

Background: Despite the introduction of new chemotherapeutic agents, the overall prognosis of patients with advanced non-small-cell lung cancer (NSCLC) remains poor. A very promising approach is the use of paclitaxel (Taxol(R)), which has shown efficacy in phase I/II studies. In an outpatient setting, we investigated the combination of paclitaxel, carboplatin, and G-CSF in patients with NSCLC stage III/IV disease and evaluated the response with respect to the histological subtype. Patients and Methods: A total of 29 patients (stage IV: 28 patients) were enrolled. Paclitaxel was given at day 1 as a 3-hour infusion, beginning at a dose of 150 mg/m(2). Escalation occurred by increments of 25 mg/m2. Carboplatin was administered immediately after paclitaxel at a dose of 300 mg/m(2) as a 1-hour infusion. G-CSF was applied after chemotherapy starting on day 6 until recovery of neutrophils. Chemotherapy was repeated every 21 days for at least 6 cycles unless there was Progression of disease. Results: Toxicity was generally mild with WHO grade III/IV leukocytopenia in 6 cycles (5.1%), grade III thrombocytopenia in 1 cycle (0.8%) and grade III anemia in 2 cycles (1.7%), respectively. Neurotoxicity (WHO grade III) occurred in 1 patient (paclitaxel 175 mg/m(2)). The recommended dose for paclitaxel in this combination was evaluated with 200 mg/m(2) Of 25 patients evaluable for response, I patient reached a complete remission (4%), 9 patients achieved a partial response (36%), 5 patients showed no change (20%) and 10 patients progressed (40%). 2/12 patients with adenocarcinoma responded to the regimen as compared with 8/13 patients with other histological subtypes of NSCLC (p = 0.029). The median progression-free survival time was 42 weeks, the 1-year survival rate was 40.9%. Conclusion: The regimen can be given safely in an outpatient setting and is effective in NSCLC except adenocarcinoma.