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

2.50
Hdl Handle:
http://hdl.handle.net/10541/72596
Title:
Erlotinib for frontline treatment of advanced non-small cell lung cancer: a phase II study.
Authors:
Giaccone, Giuseppe; Gallegos Ruiz, Marielle; Le Chevalier, Thierry; Thatcher, Nick; Smit, Egbert; Rodriguez, Jose Antonio; Janne, Pasi; Oulid-Aissa, Dalila; Soria, Jean-Charles
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.
Affiliation:
Department of Medical Oncology, Vrije Universiteit Medical Center, Amsterdam, the Netherlands. g.giaccone@vumc.nl
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
Issue Date:
15-Oct-2006
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
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorGiaccone, Giuseppe-
dc.contributor.authorGallegos Ruiz, Marielle-
dc.contributor.authorLe Chevalier, Thierry-
dc.contributor.authorThatcher, Nick-
dc.contributor.authorSmit, Egbert-
dc.contributor.authorRodriguez, Jose Antonio-
dc.contributor.authorJanne, Pasi-
dc.contributor.authorOulid-Aissa, Dalila-
dc.contributor.authorSoria, Jean-Charles-
dc.date.accessioned2009-07-06T14:00:19Z-
dc.date.available2009-07-06T14:00:19Z-
dc.date.issued2006-10-15-
dc.identifier.citationErlotinib for frontline treatment of advanced non-small cell lung cancer: a phase II study. 2006, 12 (20 Pt 1):6049-55 Clin. Cancer Res.en
dc.identifier.issn1078-0432-
dc.identifier.pmid17062680-
dc.identifier.doi10.1158/1078-0432.CCR-06-0260-
dc.identifier.urihttp://hdl.handle.net/10541/72596-
dc.description.abstractPURPOSE: 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.en
dc.language.isoenen
dc.subjectLung Canceren
dc.subject.mesh1-Phosphatidylinositol 3-Kinase-
dc.subject.meshAdministration, Oral-
dc.subject.meshAdult-
dc.subject.meshAntineoplastic Agents-
dc.subject.meshCarcinoma, Non-Small-Cell Lung-
dc.subject.meshDNA Primers-
dc.subject.meshGenes, ras-
dc.subject.meshHumans-
dc.subject.meshIn Situ Hybridization-
dc.subject.meshLung Neoplasms-
dc.subject.meshProtein Kinase Inhibitors-
dc.subject.meshQuinazolines-
dc.subject.meshReceptor, Epidermal Growth Factor-
dc.subject.meshTablets-
dc.titleErlotinib for frontline treatment of advanced non-small cell lung cancer: a phase II study.en
dc.typeArticleen
dc.contributor.departmentDepartment of Medical Oncology, Vrije Universiteit Medical Center, Amsterdam, the Netherlands. g.giaccone@vumc.nlen
dc.identifier.journalClinical Cancer Researchen

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