Erlotinib for frontline treatment of advanced non-small cell lung cancer: a phase II study. Academic Article uri icon

Overview

abstract

  • PURPOSE: Erlotinib has proven activity in pretreated patients with advanced non-small cell lung cancer (NSCLC). We evaluated erlotinib in the frontline treatment of advanced NSCLC and assessed biological predictors of outcome. EXPERIMENTAL DESIGN: In this phase II study, chemotherapy-naive patients with stage IIIB/IV NSCLC received oral erlotinib (150 mg/d) until disease progression or unacceptable toxicity occurred. Tumor response was assessed every 6 weeks, and samples were analyzed for potential molecular markers of treatment response and survival. The primary end point was the proportion of patients without disease progression after 6 weeks of treatment. RESULTS: Fifty-three patients were eligible. The overall rate of nonprogression at 6 weeks was 52.8% (28 of 53 patients). Tumor response rate was 22.7%, with 1 complete response, 11 partial responses, and 16 cases of stable disease. Responses were seen across most patient clinical characteristics. The median duration of tumor response was 333 days; median overall survival was 391 days; and median time to disease progression was 84 days. Erlotinib was well tolerated, the main treatment-related adverse events being mild-to-moderate rash and diarrhea. Histologic material for biological studies was available in 29 cases. Four of five responders and one patient with stable disease had a classic epidermal growth factor receptor tyrosine kinase mutation. Two progressing patients exhibited epidermal growth factor receptor point mutations (one with T790M mutation), and K-ras mutations were detected in 10 nonresponders. CONCLUSIONS: Erlotinib shows significant antitumor activity in the first-line treatment of advanced NSCLC and may be a viable alternative to chemotherapy. Patient selection cannot easily be based on clinical or biological variables.

authors

  • Giaccone, Giuseppe
  • Gallegos Ruiz, Marielle
  • Le Chevalier, Thierry
  • Thatcher, Nick
  • Smit, Egbert
  • Rodriguez, Jose Antonio
  • Janne, Pasi
  • Oulid-Aissa, Dalila
  • Soria, Jean-Charles

publication date

  • October 15, 2006

Research

keywords

  • Antineoplastic Agents
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Quinazolines

Identity

Scopus Document Identifier

  • 33750700477

Digital Object Identifier (DOI)

  • 10.1158/1078-0432.CCR-06-0260

PubMed ID

  • 17062680

Additional Document Info

volume

  • 12

issue

  • 20 Pt 1