CISPLATIN-GEMCITABINE COMBINATION IN ADVANCED NON-SMALL-CELL LUNG-CANCER - A PHASE-II STUDY

Purpose: The nucleoside analog, gemcitabine, has shown activity as a s ingle agent in the treatment of metastatic non-small-cell lung cancer (NSCLC), Its combination with cisplatin in preclinical models suggeste d synergy between the two drugs. The aim of the study was to evaluate the clinical efficacy and toxicity of the cisplatin-gemcitabine combin ation in advanced NSCLC, Patients and Methods: Forty-eight consecutive previously untreated NSCLC patients entered the trial from January to June 1994. The median age was 60 years (range, 37 to 70) and performa nce status (PS) was 0 or 1; 22 patients had unresectable stage III dis ease (21 stage IIIB and one stage IIIA) and 26 had stage IV disease. G emcitabine 1 g/m(2) was administered weekly (days 1, 8, and 15) follow ed by a 1-week rest and cisplatin 100 mg/m(2) on day 2 of each 28-day cycle. Survival and response were determined in accordance with the in tention-to-treat principle in all enrolled patients. Results: Of 48 as sessable patients, one (stage IV) had a complete response (CR) and 25 achieved a partial response (PR), The overall response rate was 54% (9 5% confidence interval [CI], 40% to 68%). Thrombocytopenia was the mai n side effect, with 52% of patients experiencing grade III to IV toxic ity, which was usually short-lived and responsible for the omission of gemcitabine administration on day 15 in 50% of chemotherapy courses. The median survival time wets 61.5 weeks (95% CI, 40 to 71), Conclusio n: The combination of gemcitabine and cisplatin induced a high respons e rate in both stage IIIB and IV NSCLC, with modest side effects, The regimen deserves further careful evaluation in a phase III prospective randomized trial. (C) 1997 by American Society of Clinical Oncology.