A Phase II Trial of Erlotinib As Front-Line Treatment in Clinically Selected Patients With Non-Small-Cell Lung Cancer

作者：Pallis Athanasios G^*; Voutsina Alexandra; Kentepozidis Nikolaos; Giassas Stylianos; Papakotoulas Pavlos; Agelaki Sofia; Tryfonidis Kostas; Kotsakis Athanasios; Vamvakas Lambros; Vardakis Nikolaos; Georgoulias Vassilis

来源：Clinical Lung Cancer, 2012, 13(2): 129-135.

DOI：10.1016/j.cllc.2011.08.004

• EGFR
• Erlotinib
• First line
• KRAS
• Mutations
• NSCLC

The purpose of this study was to evaluate the efficacy of erlotinib as first-line treatment in NSCLC. The primary endpoint was ORR. With a target OAR > 40%, 50 patients were required (the Simon 2-stage design). In the whole cohort, OAR was 24.5%. In patients with activating EGFR mutations, the OAR was 66.7%. The selection of patients for treatment with TKIs should be based on mutation testing.
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 (OAR) 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 OAR 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. Clinical Lung Cancer, Vol. 13, No.

• 出版日期2012-3