First-cycle rash and survival in patients with advanced non-small-cell lung cancer receiving cetuximab in combination with first-line chemotherapy: A subgroup analysis of data from the FLEX phase 3 study

Ulrich Gatzemeier, Joachim von Pawel, Ihor Vynnychenko, Petr Zatloukal, Filippo de Marinis, Wilfried E E Eberhardt, Luis Paz-Ares, Karl Maria Schumacher, Thomas Goddemeier, Kenneth J. O'Byrne, Robert Pirker

Research output: Contribution to journalArticle

Abstract

Background: The randomised phase 3 First-Line Erbitux in Lung Cancer (FLEX) study showed that the addition of cetuximab to cisplatin and vinorelbine significantly improved overall survival compared with chemotherapy alone in the first-line treatment of advanced non-small-cell lung cancer (NSCLC). The main cetuximab-related side-effect was acne-like rash. Here, we assessed the association of this acne-like rash with clinical benefit. Methods: We did a subgroup analysis of patients in the FLEX study, which enrolled patients with advanced NSCLC whose tumours expressed epidermal growth factor receptor. Our landmark analysis assessed if the development of acne-like rash in the first 21 days of treatment (first-cycle rash) was associated with clinical outcome, on the basis of patients in the intention-to-treat population alive on day 21. The FLEX study is registered with ClinicalTrials.gov, number NCT00148798. Findings: 518 patients in the chemotherapy plus cetuximab group-290 of whom had first-cycle rash-and 540 patients in the chemotherapy alone group were alive on day 21. Patients in the chemotherapy plus cetuximab group with first-cycle rash had significantly prolonged overall survival compared with patients in the same treatment group without first-cycle rash (median 15·0 months [95% CI 12·8-16·4] vs 8·8 months [7·6-11·1]; hazard ratio [HR] 0·631 [0·515-0·774]; p

Original languageEnglish
Pages (from-to)30-37
Number of pages8
JournalThe Lancet Oncology
Volume12
Issue number1
DOIs
Publication statusPublished - Jan 2011

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Exanthema
Non-Small Cell Lung Carcinoma
Drug Therapy
Survival
Acne Vulgaris
Cetuximab
Epidermal Growth Factor Receptor
Cisplatin
Lung Neoplasms
Therapeutics
Population
Neoplasms

ASJC Scopus subject areas

  • Oncology

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First-cycle rash and survival in patients with advanced non-small-cell lung cancer receiving cetuximab in combination with first-line chemotherapy : A subgroup analysis of data from the FLEX phase 3 study. / Gatzemeier, Ulrich; von Pawel, Joachim; Vynnychenko, Ihor; Zatloukal, Petr; de Marinis, Filippo; Eberhardt, Wilfried E E; Paz-Ares, Luis; Schumacher, Karl Maria; Goddemeier, Thomas; O'Byrne, Kenneth J.; Pirker, Robert.

In: The Lancet Oncology, Vol. 12, No. 1, 01.2011, p. 30-37.

Research output: Contribution to journalArticle

Gatzemeier, Ulrich ; von Pawel, Joachim ; Vynnychenko, Ihor ; Zatloukal, Petr ; de Marinis, Filippo ; Eberhardt, Wilfried E E ; Paz-Ares, Luis ; Schumacher, Karl Maria ; Goddemeier, Thomas ; O'Byrne, Kenneth J. ; Pirker, Robert. / First-cycle rash and survival in patients with advanced non-small-cell lung cancer receiving cetuximab in combination with first-line chemotherapy : A subgroup analysis of data from the FLEX phase 3 study. In: The Lancet Oncology. 2011 ; Vol. 12, No. 1. pp. 30-37.
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AU - von Pawel, Joachim

AU - Vynnychenko, Ihor

AU - Zatloukal, Petr

AU - de Marinis, Filippo

AU - Eberhardt, Wilfried E E

AU - Paz-Ares, Luis

AU - Schumacher, Karl Maria

AU - Goddemeier, Thomas

AU - O'Byrne, Kenneth J.

AU - Pirker, Robert

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