phase ii study of gemcitabine and cisplatin regimen in advanced non-small cell lung cancer (nsclc).

background: cisplatin-based chemotherapy is the standard treatment for advanced non-small cell lung cancer (nsclc). many novel drugs, including gemcitabine, vinorelbine, paclitaxel and docetaxel have been used in combination with cisplatin in this setting. of these drugs, gemcitabine is reported to have a high response rate and acceptable toxicity. the aim of this study was to evaluate the efficacy and safety of gemcitabine & cisplatin combination. methods: twenty-three patients with nsclc, who met inclusion criteria, were enrolled from january 2001 till september 2003. all of them were confirmed by histology and were in advanced stages, i.e. stage iiib or stage iv. cisplatin with a dose of 70mg/m2 was given every 21 days, in combination with gemcitabine at a dose of 1250mg/m2 administered on days 1and 8 of a 21-day cycle. results: of the 23 patients, 1 showed complete remission, 5 achieved partial remission, 7 had stable disease and 2 patients showed progressive disease, while 8 patients were not evaluable for response. the overall response in 15 evaluable patients was 40% (95% ci), median survival was 13.5 months (95% ci, 3.5-27.4 months), and median progression free survival (pfs)was 11 months (95% ci, 1.04-20.9 months). hematological toxicities included who grade 3, 4 anemia, neutropenia and thrombocytopenia 10%, 7% and 2% respectively. non-hematological toxicities included nausea/vomiting who grade 1,2 & peripheral neuropathy who grade 1,2. skin rashes were mild.six patients developed grade 2 toxicity. renal impairment was mild. one case developed acute respiratory distress syndrome (ards) after first dose of chemotherapy, another case developed transient acute psychosis under therapy. conclusions: the regimen of combined gemcitabine with cisplatin is safe and effective and well toler ated in patients. some rare but important toxicity such as ards may occur occasionally. in this com bination, a lower dose of cisplatin seems to have an efficacy similar to that of in previous reports.