Randomized, placebo-controlled study of vinorelbine plus cisplatin with celecoxib and serum VEGF before treatment as a biomarker for patients with advanced non-small cell lung cancer.

e19066 Background: Cyclooxygenase-2 (COX-2) protein expression in patients with non-small-cell lung cancer (NSCLC) has been proved a prognostic marker for COX-2 inhibition. But we need a feasible predictive factor to instruct the COX-2 inhibition treatment. We hypothesized that high serum VEGF at the start of treatment was associated with shorter survival and that celecoxib, a potent COX-2 inhibitor, improved tumor response and survival. Methods: A study was performed in patients with stage IIIb/IV NSCLC who had pathologic confirmation, no prior chemotherapy, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, and adequate organ function. Treatment consisted of vinorelbine and cisplatin every 4 weeks for four cycles. Patients were randomly assigned to receive celecoxib 400 mg or placebo twice daily. Primary end point was overall survival (OS). Serum VEGF levels of all patients were detected at onset and endpoint of treatment. Results: From April 2010 to October 2012, 81 patients were r...