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. Methods: Chemotherapy - naïve patients with performance status (PS) of 0 or 1 were randomized to gemcitabine 1gm/m2 on days 1 and 8 plus either paclitaxel 200mg/m2 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. Results: 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. Conclusions: The two regimens are equally active. Myelotoxicity is worse in the CG group whereas alopecia, myalgia and neurotoxicity worse in the PG group. No significant financial relationships to disclose.