A phase II trial of erlotinib as front-line treatment in clinically selected patients with non-small-cell lung cancer.

Abstract

BACKGROUND:

The purpose of this study was to evaluate the efficacy of erlotinib as front-line treatment in clinically selected patients with non-small-cell lung cancer (NSCLC).

PATIENTS AND METHODS:

Forty-nine previously untreated white patients who had stage IIIB/IV pulmonary adenocarcinoma or bronchoalveolar carcinoma and who were nonsmokers or former light smokers were treated with erlotinib 150 mg daily, irrespective of the EGFR mutation status.

RESULTS:

In an intention-to-treat analysis, the overall response rate (ORR) was 24.5%. The median progression-free survival (PFS) was 6.7 months, the median overall survival (OS) was 15.5 months, and the 1-year survival rate was 61.3%. Among the 36 patients for whom tumor material was available, 9 (25%) had activating EGFR mutations. The ORR was 66.7% in patients with activating EGFR mutations and 14.8% in patients with wild-type EGFR (2P = .006). In patients with activating EGFR mutations, the OS has not been reached, whereas it was 12.9 months in patients with EGFR wild type (2P = .045). Twenty-four patients had a PFS of > 6 months; 11 (45.8%) of them had EGFR wild type and 7 (29.1%) had EGFR mutation.

CONCLUSIONS:

The selection of patients for treatment with EGFR-directed tyrosine kinase inhibitors (TKIs) should be based on mutation testing. However use of clinical (smoking status) and pathologic (adenocarcinoma) criteria may identify a subgroup of patients with advanced/metastatic NSCLC who can benefit from front-line treatment with erlotinib when mutation testing is not feasible.

• Authors: Athanasios G Pallis, Alexandra Voutsina, Nikolaos Kentepozidis, Stylianos Giassas, Pavlos Papakotoulas, Sofia Agelaki, Kostas Tryfonidis, Athanasios Kotsakis, Lambros Vamvakas, Nikolaos Vardakis, Vassilis Georgoulias
• Journal: Clinical lung cancer (Clin Lung Cancer) Vol. 13 Issue 2 Pg. 129-35 (Mar 2012) ISSN: 1938-0690 [Electronic] United States
• PMID: 22000696 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2012 Elsevier Inc. All rights reserved.

Chemical References

• Protein Kinase Inhibitors
• Quinazolines
• Erlotinib Hydrochloride
• EGFR protein, human
• ErbB Receptors

Topics

• Adenocarcinoma (drug therapy, genetics, mortality)
• Adenocarcinoma, Bronchiolo-Alveolar (drug therapy, genetics, mortality)
• Adult
• Aged
• Aged, 80 and over
• Carcinoma, Non-Small-Cell Lung (drug therapy, genetics, mortality)
• ErbB Receptors (antagonists & inhibitors, genetics)
• Erlotinib Hydrochloride
• Female
• Follow-Up Studies
• Humans
• Lung Neoplasms (drug therapy, genetics, mortality)
• Male
• Middle Aged
• Mutation (genetics)
• Neoplasm Staging
• Prognosis
• Protein Kinase Inhibitors (therapeutic use)
• Quinazolines (therapeutic use)
• Survival Rate