Erlotinib for frontline treatment of advanced non-small cell lung cancer: a phase II study.
Giaccone, Giuseppe Gallegos Ruiz, Marielle Le Chevalier, Thierry Thatcher, Nick Smit, Egbert Rodriguez, Jose Antonio Janne, Pasi Oulid-Aissa, Dalila Soria, Jean-Charles
Giaccone, Giuseppe
Gallegos Ruiz, Marielle
Le Chevalier, Thierry
Thatcher, Nick
Smit, Egbert
Rodriguez, Jose Antonio
Janne, Pasi
Oulid-Aissa, Dalila
Soria, Jean-Charles
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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.
Description
Date
2006-10-15
Publisher
Collections
Keywords
Lung Cancer
Type
Article
Citation
Erlotinib for frontline treatment of advanced non-small cell lung cancer: a phase II study. 2006, 12 (20 Pt 1):6049-55 Clin. Cancer Res.