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

Cesare Gridelli, Antonio Chella, Giuseppe Valmadre, Giacomo Allegrini, Matteo Brighenti, Paolo Bidoli, Antonio Rossi, Paolo Maione, Maria Rita Migliorino, Serena Ricciardi, Filippo DE Marinis

Research output: Contribution to journalArticlepeer-review

Abstract

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(2) 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.

Original languageEnglish
Pages (from-to)6535-6540
Number of pages6
JournalAnticancer Research
Volume36
Issue number12
DOIs
Publication statusPublished - Dec 2016

Keywords

  • Aged
  • Antineoplastic Combined Chemotherapy Protocols
  • Carcinoma, Non-Small-Cell Lung
  • Disease-Free Survival
  • Erlotinib Hydrochloride
  • Humans
  • Lung Neoplasms
  • Male
  • Middle Aged
  • Smoking
  • Taxoids
  • Journal Article
  • Randomized Controlled Trial

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