title: Second-line Erlotinib or Intermittent Erlotinib plus Docetaxel in Male Ex-smokers with Squamous NSCLC: The TALISMAN Randomized Trial.
abstract: 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 received erlotinib 150 mg/day (arm A; n=36) or docetaxel 75 mg/m2on 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.
  
  
  
  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).
  
  
  
  Results do not support further investigation of the combination of erlotinib and docetaxel in this setting.
authors.affiliation: Division of Medical Oncology, S.G. Moscati Hospital, Avellino, Italy cgridelli@libero.it.
authors.forename: Cesare
authors.initials: C
authors.lastname: Gridelli
authors.affiliation: University Hospital, Pisa, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Chella
authors.affiliation: ASST Valtellina e Alto Lario, Sondrio, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Valmadre
authors.affiliation: Az-USL 5 Pisa, Pisa, Italy.
authors.forename: Giacomo
authors.initials: G
authors.lastname: Allegrini
authors.affiliation: Cremona Hospital, Cremona, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Brighenti
authors.affiliation: San Gerardo Hospital, Monza, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Bidoli
authors.affiliation: Division of Medical Oncology, S.G. Moscati Hospital, Avellino, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Rossi
authors.affiliation: Division of Medical Oncology, S.G. Moscati Hospital, Avellino, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Maione
authors.affiliation: San Camillo Hospital, Roma, Italy.
authors.forename: Maria Rita
authors.initials: MR
authors.lastname: Migliorino
authors.affiliation: San Camillo Hospital, Roma, Italy.
authors.forename: Serena
authors.initials: S
authors.lastname: Ricciardi
authors.affiliation: Thoracic Oncology Division, European Institute of Oncology (IEO), Milan, Italy.
authors.forename: Filippo
authors.initials: F
authors.lastname: DE Marinis
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D018572:Disease-Free Survival; D000077143:Docetaxel; D000069347:Erlotinib Hydrochloride / Q000008:administration & dosage*; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012907:Smoking; D043823:Taxoids / Q000008:administration & dosage*
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D000069347:Erlotinib Hydrochloride
keywords: Combination therapy; NSCLC; docetaxel; erlotinib; males; second-line treatment; smokers