Paclitaxel and gemcitabine vs carboplatin and gemcitabine. A multicenter, phase III randomized trial in patients with advanced inoperable non-small cell lung cancer (NSCLC).

7000 Background: This phase III study was designed to compare the combination paclitaxel - gemcitabine (PG) versus carboplatin - gemcitabine (CG) in patients with advanced inoperable NSCLC.,Chemotherapy - naïve patients with performance status (PS) of 0 or 1 were randomized to gemcitabine 1gm/m on days 1 and 8 plus either paclitaxel 200mg/m on day 1 (arm A) or Carboplatin at an area under the concentration - time curve of 6 on day 1 (arm B) every 3 weeks. Primary endpoint was overall survival (OS). Secondary endpoints included objective response (OR), time to progression (TTP) and toxicity. For a two-sided test at the 5% level of significance and power of 80%, the number of patients required to detect a 10% difference in survival rate was 417.,A total of 512 patients were enrolled and 445 evaluable (arm A, 222; arm B, 223) were analyzed. All characteristics were well balanced. As shown in the table below with a median follow-up time 23 mos (0.1 - 48.16) there was no difference in the OS, one-year survival, OR and TTP. However, statistically significant differences were seen in toxicity.,The two regimens are equally active. Myelotoxicity is worse in the CG group whereas alopecia, myalgia and neurotoxicity worse in the PG group. [Figure: see text] No significant financial relationships to disclose.