FLEX: A randomized, multicenter, phase III study of cetuximab in combination with cisplatin/vinorelbine (CV) versus CV alone in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC).

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Abstracts

2008 ASCO Annual Meeting

FLEX: A randomized, multicenter, phase III study of cetuximab in combination with cisplatin/vinorelbine (CV) versus CV alone in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC).

Sub-category:

Metastatic Lung Cancer

Category:

Lung Cancer--Metastatic Lung Cancer

Meeting:

2008 ASCO Annual Meeting

Session Type and Session Title:

null, General Session XIII: Lung Cancer - Non-Small Cell Carcinoma
Plenary Presentation, Plenary Session including Science of Oncology Award and Lecture

Abstract No:

Citation:

J Clin Oncol 26: 2008 (May 20 suppl; abstr 3)

Author(s):

R. Pirker, A. Szczesna, J. von Pawel, M. Krzakowski, R. Ramlau, K. Park, U. Gatzemeier, E. Bajeta, M. Emig, J. R. Pereira

Abstract:

Background: Epidermal growth factor receptor (EGFR) dysregulation is common in NSCLC and is associated with poorer prognosis. This phase III study assessed the efficacy and safety of the EGFR-targeted monoclonal antibody cetuximab in combination with cisplatin/vinorelbine (CV) compared with CV alone in advanced NSCLC. Methods: Patients with EGFR-detectable advanced NSCLC were randomized 1:1 to cetuximab (400 mg/m²initial dose, then 250 mg/m²/wk) plus C (80 mg/m² d1) and V (25 mg/m² d1, d8) q3w (arm A) or CV alone (arm B). The primary endpoint was overall survival (OS); secondary endpoints were progression-free survival, tumor response, disease control, and safety. Randomization was stratified by ECOG performance status (0/1 vs 2) and tumor stage (wet IIIb vs IV). Results: 1,125 patients were randomized: 557 to arm A, 568 to arm B, 70% male, median age 59 (18-83) years, 94% stage IV, 47% adenocarcinoma (AC), 34% squamous cell carcinoma (SCC), 83% ECOG 0/1. Survival analysis was performed after 868 events had occurred. OS was significantly improved in arm A (stratified log-rank test). Preliminary results of prespecified subgroup analyses suggest a greater benefit in Caucasians independent of histology and a general better prognosis in Asians. Analyses of secondary endpoints are ongoing. Conclusions: Cetuximab plus CV demonstrated superior survival over CV alone in patients with advanced EGFR-detectable NSCLC. There was a remarkable difference between the outcome of Asian and Caucasian patients. This is the first study to demonstrate a survival benefit of an EGFR-targeted agent in combination with platinum-based chemotherapy in advanced first-line NSCLC irrespective of histology and confirms the clinical relevance of cetuximab in NSCLC.

	Median OS (mo) Arm A	Median OS (mo) Arm B	HR [95% CI]	p-value
All (n=1125)	11.3	10.1	0.871 [0.762- 0.996]	0.0441
Caucasians (n=945)	10.5	9.1	0.800 [0.692-0.924]	0.0025
with AC (n=412)	12.0	10.2	0.809 [0.644-1.016]	0.0673
with SCC (n=347)	10.2	8.9	0.794 [0.626-1.007]	0.0567
Asians (n=121)	17.6	20.4	1.179 [0.730- 1.905]	0.4992
HR, hazard ratio

Abstract Disclosures

Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy and are designated with a caret symbol (^) here and in the print version.

Associated Presentation(s):

1. FLEX: A randomized, multicenter, phase III study of cetuximab in combination with cisplatin/vinorelbine (CV) versus CV alone in the first-line treatment of patients with advanced nonsmall-cell lung cancer (NSCLC)

Meeting: 2008 Best of ASCO Boston
Speaker: R. Pirker
Session: General Session XIII: Lung Cancer - Non-Small Cell Carcinoma

2. FLEX: A randomized, multicenter, phase III study of cetuximab in combination with cisplatin/vinorelbine (CV) versus CV alone in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC).

Meeting: 2008 ASCO Annual Meeting
Presenter: Robert Pirker, MD
Session: Plenary Session including Science of Oncology Award and Lecture (Plenary Presentation)

Other Abstracts in this Sub-Category:

		1. Characterization of NSCLC patients responding to anti-IGF-IR therapy. Meeting: 2008 ASCO Annual Meeting Abstract No: 8000 First Author: A. Gualberto Category: Lung Cancer--Metastatic Lung Cancer - Metastatic Lung Cancer
		2. Molecular and clinical subgroup analyses from a phase III trial comparing gefitinib with docetaxel in previously treated non-small cell lung cancer (INTEREST). Meeting: 2008 ASCO Annual Meeting Abstract No: 8001^ First Author: J. Douillard Category: Lung Cancer--Metastatic Lung Cancer - Metastatic Lung Cancer
		3. Reproducibility of computed tomography (CT) measurements of lung cancer. Meeting: 2008 ASCO Annual Meeting Abstract No: 8002 First Author: L. P. James Category: Lung Cancer--Metastatic Lung Cancer - Metastatic Lung Cancer
		More...

Abstracts by R. Pirker :

		1. Clinical recommendations for EGFR mutation testing in non-small cell lung cancer (NSCLC): Results from a European workshop. Meeting: 2010 ASCO Annual Meeting Abstract No: e18038 First Author: R. Pirker Category: Lung Cancer - Metastatic - Metastatic
		2. D-dimer levels and prediction of overall survival in cancer patients. Meeting: 2010 ASCO Annual Meeting Abstract No: 10587 First Author: C. Ay Category: Tumor Biology - Prognostic Factors
		3. First-cycle rash as a clinical marker in patients with advanced non-small cell lung cancer (NSCLC) receiving first-line chemotherapy (CT) plus cetuximab: Efficacy by histology. Meeting: 2010 ASCO Annual Meeting Abstract No: 7556 First Author: K. J. O'Byrne Category: Lung Cancer - Metastatic - Metastatic
		More...

Presentations by R. Pirker :

		1. Prognostic factors in advanced NSCLC: Experience from the FLEX trial. Meeting: 2009 ASCO Annual Meeting Presenter: Robert Pirker Session: Lung Cancer - Metastatic (General Poster Session)
		2. Molecular Markers of Response to Cetuximab in Lung Cancer (FLEX Study) Meeting: 2008 Molecular Markers Speaker: Robert Pirker, MD Session: General Session II: Identifying Patients for EGFR Inhibitor Therapy: Markers of Response and Resistance (General Session)
		3. Cetuximab Plus Platinum-based Chemotherapy Sets a New Standard in Patients with Newly Diagnosed Advanced Lung Cancer Meeting: 2008 ASCO Annual Meeting Participant: Robert Pirker, MD Session: Screening and Treatment Advances Press Briefing (Press Program)
		More...

Educational Book Manuscripts by R. Pirker :

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