Phase Ii Trial Of Gemcitabine And Cisplatin As First-Line Treatment Of Advanced Non-Small Cell Lung Cancer (Nsclc).

7326 Background: The prognosis of patients with advanced non-small-cell lung cancer (NSCLC) is extremely poor. Many prospective randomized trials on patients with advanced NSCLC suggested systemic chemotherapy improves both the survival and quality of life. A phase II trial was conducted to evaluate the efficacy and safety profile of the combination chemotherapy of gemcitabine and cisplatin in advanced NSCLC. Methods: Forty-four patients with locally advanced or metastatic NSCLC were enrolled. The patients received a cisplatin, 75 mg/m2, infusion over 30 minutes on days 1, followed by a gemcitabine, 1,250 mg/m2, infusion over 30 minutes on days 1 and 8 every 3 weeks. Results: The median age of the patients was 64 years (range: 27∼75). Forty-one patients were assessable for response and toxicity analyses. The overall response rate was 53.6%, but with no complete remissions. The median time to progression was 5.6 months (range: 1∼15.4). The median survival was 14.2 months (95% confidence interval (CI), 13.8∼22.5). A total of 179 cycles were administered, with a median of 4 cycles of chemotherapy, ranging from 2 to 9 cycles. The most common hematological toxicities were NCI grades 3/4 neutropenia (24%) and thrombocytopenia (7.8%). The most common non-hematological toxicity was fatigue (42.4%). There were no life-threatening toxicity or treatment related mortalities. The median duration of follow up was 9.4 months, ranging from 1.6 to 30.3 months. Conclusions: In this trial, the combination of gemcitabine and cisplatin showed significant activity, with acceptable and manageable toxicities as a first-line regimen for patients with advanced NSCLC. No significant financial relationships to disclose.