Second-line Erlotinib or Intermittent Erlotinib plus Docetaxel in Male Ex-smokers with Squamous NSCLC: The TALISMAN Randomized Trial.

Background/aim: The TArceva and docetaxeL In former-Smokers MAle patients with recurrent non-small cell lung cancer (TALISMAN) phase II, open-label randomized trial evaluates the combination of erlotinib with docetaxel in the second-line therapy of ex-smoker males with advanced squamous non-small cell lung cancer (NSCLC).

Patients And Methods: Patients received erlotinib 150 mg/day (arm A; n=36) or docetaxel 75 mg/m on day 1 of each 3-week cycle and erlotinib 150 mg/day on days 2-16 of each cycle (arm B; n=38). The primary end-point was progression-free rate (PFR) at 6 months.

Results: The study was prematurely interrupted due to slow enrolment. Three (8.3%) patients in arm A and 3 (8.1%) in arm B remained progression-free at 6 months. Median progression-free survival (PFS) was 2.3 months in arm A and 2.8 months in arm B. Median overall survival (OS) was 5.6 and 8.9 months, respectively. Overall, 77.8% of patients in arm A and 89.2% in arm B experienced treatment-related adverse events (AEs).

Conclusion: Results do not support further investigation of the combination of erlotinib and docetaxel in this setting.