A three-week schedule of gemcitabine-cisplatin in advanced non-small-cell lung cancer with two different cisplatin dose levels: A phase II randomizedtrial

Background: To explore a new schedule of gemcitabine-cisplatin (GP) combina tion therapy using two different cisplatin doses in patients with advanced non-small-cell lung cancer (NSCLC). Patients and methods: From May to December 1997, 92 chemonaive patients ent ered the study and 88 (28 with locally advanced and 60 with disseminated NS CLC) were evaluable for response and toxicity (45 in arm A and 43 in arm B) . Patients were randomly assigned to arm A or arm B. Gemcitabine 1000 mg/m( 2) was given on days 1-8 plus cisplatin 100 mg/m(2) in arm A and cisplatin 70 mg/m(2) in arm B on day 2 of every 21-day cycle. Results: The overall response rates in arms A and B were 42% (95% confidenc e interval (CI): 27.8%-56.7%) and 47% (95% CI: 31.6%-61.5%), respectively. Median duration of response was 9.7 months (range 1.8 to 30.9 months; 13.1 and 9.5 months for arm A and B, respectively), and median survival was 12 m onths (range 0.2 to 31.1 months; 15.4 and 11.5 months for arm A and B, resp ectively). Major WHO grade 3-4 toxicities in arm A vs. arm B included: thro mbocytopenia (23% vs. 17% of courses), leukopenia (15% vs. 4% of courses), anemia (7% vs. 6% of courses), and nausea-vomiting (20% vs. 7% of patients) . Grade 1-2 nephrotoxicity occurred in 20% of patients in arm A and in 7% o f patients in arm B, with one grade 4 episode in arm A. Six patients discon tinued treatment because of toxicities, 5 in arm A and 1 in arm B. Conclusions: Results of this trial indicate that both schedules are feasibl e and active, with a milder toxicity in the arm with the lower cisplatin do se.