Phase II trial of Gemcitabine Plus Cisplatin in Patients with Locally Advanced or Metastatic Non-Small-Cell Lung Cancer

초록

Purpose: As one of the third generation chemotherapeutic agents, gemcitabine is widely used in combination with cisplatin in the treatment of advanced non-snall-cell lung cancer (NSCLC). In this study, we evaluated the efficacy, tolerance, and survival of this combination in patients with locally advanced and metastatic NSCLC. Patients and Methods: Patients received gemcitabine 1200 mg/m2 on days 1 and 8, cisplatin 75 mg/m2 on day 1 of a 21-day cycle, for a maximum of nine cycles. Results: Between January 2000 and March 2002, 140 untreated NSCLC patients were enrolled; 27(19.3%) had stage IIIA, 53(37.9%) had stage IIIB, and 60(42.9%) had stage IV diseases. Sixty-four percent of patients had a performance status (PS) of 0 or 1. The median number of cycles administered was 4(range, two to nine cycles). Grade three or four hematologic toxicities were noted in 49 patients (35%) during the chemotherapy, but there was no treatment related death. Thirty-four patients received palliative radiotherapy, and eleven patients operation before chemotherapy. One-year survival was 60.5%, and median survival was 14.3 months for patients with a PS of 0 or 1 and 13.3 months for patients with a PS of 2 (p=0.11). The overall response rate was 67.9% among the evaluated 109 patients after two cycles of chemotherapy. The median survival time of the responders was significantly longer than that of the non-responders (17.5 months vs. 10.4 months, p=0.0001). Conclusions: A three weekly gemcitabine/cisplatin regimen was relatively well tolerated, with an acceptable response rate and a reasonable median survival in locally advanced or metastatic NSCLC.