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A Randomized, Placebo-Controlled, Multicenter, Biomarker-Selected, Phase 2 Study of Apricoxib in Combination with Erlotinib in Patients with Advanced Non–Small-Cell Lung Cancer

A Randomized, Placebo-Controlled, Multicenter, Biomarker-Selected, Phase 2 Study of Apricoxib in... BRIEF REPORT A Randomized, Placebo-Controlled, Multicenter,  Biomarker-Selected, Phase 2 Study of Apricoxib in  Combination with Erlotinib in Patients with Advanced  Non–Small-Cell Lung Cancer Barbara J. Gitlitz, MD,* Eric Bernstein, MD,† Edgardo S. Santos, MD,‡ Greg A. Otterson, MD,§ Ginger Milne, PhD,║ Mary Syto, MS,¶ Francis Burrows, PhD¶ and Sara Zaknoen, MD¶ strategy. Although AP/E seemed to improve TTP and overall sur- Abstract: Cyclooxygenase-2 (COX-2) overexpression is asso- vival in a subset of patients aged 65 years or younger, the primary ciated with a poor prognosis in non–small-cell lung cancer endpoint of the trial was not met. (NSCLC) and may promote resistance to epidermal growth factor receptor inhibitors. This randomized phase 2 trial evaluated apri- Key Words: Non–small-cell lung cancer, Apricoxib, Erlotinib, coxib, a novel COX-2 inhibitor, in combination with erlotinib in Cyclooxygenase-2 inhibitor, Prostaglandin E metabolite. biomarker-selected patients. Patients with stage IIIB/IV NSCLC (J Thorac Oncol. 2014;9: 577–582) previously treated with platinum-based chemotherapy were ran- domized (2:1) to 400 mg/day apricoxib plus 150 mg/day erlotinib (AP/E) or placebo plus erlotinib (P/E) in 21-day cycles until disease progression or unacceptable toxicity. The primary endpoint was pidermal growth factor receptor (EGFR) tyrosine kinase time to progression (TTP). A decrease of 50% or more from baseline Einhibitors such as erlotinib and gefitinib have demon- urinary prostaglandin E metabolite after http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Thoracic Oncology Wolters Kluwer Health

A Randomized, Placebo-Controlled, Multicenter, Biomarker-Selected, Phase 2 Study of Apricoxib in Combination with Erlotinib in Patients with Advanced Non–Small-Cell Lung Cancer

Zaknoen, Sara
Journal of Thoracic Oncology , Volume 9 (4) – Apr 1, 2014
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Copyright
Copyright © 2013 by the International Association for the Study of Lung Cancer
ISSN
1556-0864
DOI
10.1097/JTO.0000000000000082
pmid
24736085
Publisher site
See Article on Publisher Site

Abstract

BRIEF REPORT A Randomized, Placebo-Controlled, Multicenter,  Biomarker-Selected, Phase 2 Study of Apricoxib in  Combination with Erlotinib in Patients with Advanced  Non–Small-Cell Lung Cancer Barbara J. Gitlitz, MD,* Eric Bernstein, MD,† Edgardo S. Santos, MD,‡ Greg A. Otterson, MD,§ Ginger Milne, PhD,║ Mary Syto, MS,¶ Francis Burrows, PhD¶ and Sara Zaknoen, MD¶ strategy. Although AP/E seemed to improve TTP and overall sur- Abstract: Cyclooxygenase-2 (COX-2) overexpression is asso- vival in a subset of patients aged 65 years or younger, the primary ciated with a poor prognosis in non–small-cell lung cancer endpoint of the trial was not met. (NSCLC) and may promote resistance to epidermal growth factor receptor inhibitors. This randomized phase 2 trial evaluated apri- Key Words: Non–small-cell lung cancer, Apricoxib, Erlotinib, coxib, a novel COX-2 inhibitor, in combination with erlotinib in Cyclooxygenase-2 inhibitor, Prostaglandin E metabolite. biomarker-selected patients. Patients with stage IIIB/IV NSCLC (J Thorac Oncol. 2014;9: 577–582) previously treated with platinum-based chemotherapy were ran- domized (2:1) to 400 mg/day apricoxib plus 150 mg/day erlotinib (AP/E) or placebo plus erlotinib (P/E) in 21-day cycles until disease progression or unacceptable toxicity. The primary endpoint was pidermal growth factor receptor (EGFR) tyrosine kinase time to progression (TTP). A decrease of 50% or more from baseline Einhibitors such as erlotinib and gefitinib have demon- urinary prostaglandin E metabolite after

Journal

Journal of Thoracic Oncology – Wolters Kluwer Health

Published: Apr 1, 2014

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