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

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    Authors
    Giaccone, Giuseppe
    Gallegos Ruiz, Marielle
    Le Chevalier, Thierry
    Thatcher, Nick
    Smit, Egbert
    Rodriguez, Jose Antonio
    Janne, Pasi
    Oulid-Aissa, Dalila
    Soria, Jean-Charles
    Affiliation
    Department of Medical Oncology, Vrije Universiteit Medical Center, Amsterdam, the Netherlands. g.giaccone@vumc.nl
    Issue Date
    2006-10-15
    
    Metadata
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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.
    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.
    Journal
    Clinical Cancer Research
    URI
    http://hdl.handle.net/10541/72596
    DOI
    10.1158/1078-0432.CCR-06-0260
    PubMed ID
    17062680
    Type
    Article
    Language
    en
    ISSN
    1078-0432
    ae974a485f413a2113503eed53cd6c53
    10.1158/1078-0432.CCR-06-0260
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