RT Journal Article SR Electronic T1 Second-line Erlotinib or Intermittent Erlotinib plus Docetaxel in Male Ex-smokers with Squamous NSCLC: The TALISMAN Randomized Trial JF Anticancer Research JO Anticancer Res FD International Institute of Anticancer Research SP 6535 OP 6540 VO 36 IS 12 A1 CESARE GRIDELLI A1 ANTONIO CHELLA A1 GIUSEPPE VALMADRE A1 GIACOMO ALLEGRINI A1 MATTEO BRIGHENTI A1 PAOLO BIDOLI A1 ANTONIO ROSSI A1 PAOLO MAIONE A1 MARIA RITA MIGLIORINO A1 SERENA RICCIARDI A1 FILIPPO DE MARINIS YR 2016 UL http://ar.iiarjournals.org/content/36/12/6535.abstract AB 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/m2 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.