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).

ASCO SIGN IN

Username:

Create an account

Why Be A Member?

Password:

Remember me

Forgot your username or password?

The Remember Me feature is an automatic login process which creates a cookie on the hard drive of your computer containing a unique identifier which ASCO.org will utilize to remember you by, thereby avoiding the need to enter username and password upon subsequent visits to ASCO.org. DO NOT select this option if you share this computer with others since transactional, personal, or member only information will be accessible by other users.

To activate the Remember Me option, click the empty check box when signing in to the site. The Remember Me functionality is deactivated at the logout.

For additional information please review our Privacy Policy.

ASCO Home

Meetings

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. Molecular and clinical predictors of outcome for cetuximab in non-small cell lung cancer (NSCLC): Data from the FLEX study. Meeting: 2009 ASCO Annual Meeting Abstract No: 8007 First Author: K. J. O'Byrne Category: Lung Cancer--Metastatic Lung Cancer - Metastatic Lung Cancer
		2. MSH2 and adjuvant cisplatin-based chemotherapy in non-small cell lung cancer. Meeting: 2009 ASCO Annual Meeting Abstract No: CRA7502 First Author: P. Fouret Category: Lung Cancer--Local-Regional and Adjuvant Therapy - Adjuvant Therapy
		3. Prognostic factors in advanced NSCLC: Experience from the FLEX trial. Meeting: 2009 ASCO Annual Meeting Abstract No: 8083 First Author: R. Pirker Category: Lung Cancer--Metastatic Lung Cancer - Metastatic Lung Cancer
		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 :

No items found.