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The potential predictive value of cyclooxygenase-2 expression and increased risk of gastrointestinal hemorrhage in advanced non-small cell lung cancer patients treated with erlotinib and celecoxib
Clinical Cancer Research, 04/03/08

Fidler MJ et al. – Erlotinib/celecoxib combination is not superior to erlotinib alone in unselected pts; however, longer progression-free survival (PFS) with high-tumor COX-2 expression may warrant trials of epidermal growth factor receptor (EGFR) and cyclooxygenase-2 (COX-2) inhibitors; upper GI bleeding (GIB) supports excluding pts with peptic ulcer disease history or pts with therapeutic anticoagulation from these studies

Methods

Phase II trial to evaluate efficacy and safety of erlotinib plus celecoxib in advanced NSCLC
Administration of celecoxib (400 mg orally twice daily) and erlotinib (150 mg/day orally) until disease progression in previously treated stage IIIB/IV NSCLC pts
EGFR analysis and COX-2 immunohistochemistry

Results

Of 26 pts (17 men, 9 women; median age, 66 yr), 18 and 21 pts had tissue available for EGFR analysis and COX-2 immunohistochemistry, respectively
Median PFS: 2 mo; overall survival: 9.2 mo
Of 21 pts, 11 had increased tumor COX-2 expression, which was strongly associated with prolonged PFS
Of pts on anticoagulation or with peptic ulcer disease history, 4 had grade 3/4 GIB; thus early study closure
Of GIB pts, 3 had peptic ulcers on endoscopy

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