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• W2243269075 abstract "7102 Background: Weekly (DOC) is active and well tolerated in elderly or PS2 patients with advanced NSCLC. Cyclooxygenase-2 (COX-2) promotes tumor growth through the production of prostaglandin E2 (PGE2) and the induction of vascular endothelial growth factor (VEGF). Pre-clinical data show that celecoxib (CEL), a COX-2 inhibitor, has antitumor activity and enhances taxane efficacy.Methods: We are conducting a phase II study of CEL plus weekly DOC in elderly or PS2 pts with stage IIIB (pleural effusion)/IV NSCLC. Eligibility criteria include: age ≥ 70 yrs (PS 0–2) or age < 70 yrs with PS2; normal hepatic, renal and bone marrow function. CEL 400 mg po bid (daily) is started 7 days before the first dose of DOC 36mg/m2 IV given on days 1, 8, 15 of a 28 day cycle. Blood is collected pre-treatment, on day 8 of CEL, and on days 8 and 29 after first dose of DOC for VEGF and PGE2 levels. Results: 21 eligible pts have been treated: Median age 73 yrs (51–79 yrs); Gender 17M:4F; PS2 - 11; ≥70 yrs-14;PS2–11;adenocarcinoma 11, squamous cell 4, BAC-1; stage IV-21. Fifty two cycles (range 1–6) of DOC have been administered. Two pts are not yet assessable for response. The confirmed response rate is 21% (4/19 - 1 CR, 3 PR) and 5 pts have had stable disease. There has been no grade 3–4 hematologic toxicity. Non-hematologic toxicity: grade 3 fatigue (3); Grade 1/2 toxicities: hepatic transaminitis (1), azotemia (2), edema (2), nausea (1), diarrhea (1), rash (1). One pt died of myocardial infarction after 5 months and one died after a stroke at 1 month. One pt developed pulmonary embolism. Ten tumors were analyzed for COX-2: 6-Inadequate for IHC; 3-positive;1- negative. VEGF levels in 6 pts show no consistent pattern. Median survival time (MST) in all pts is 5.6mo and TTP is 3.0mo. In pts ≥70yrs MST is 8.6mo and TTP is 3.9 mo. Conclusions:The combination of CEL and weekly DOC is well tolerated and has encouraging activity in this select population with advanced NSCLC. A total of 39 pts will be accrued. Supported by Aventis and Pfizer. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Pfizer Pfizer Pfizer Aventis Aventis Pharmaceuticals; Pfizer" @default.
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• W2243269075 date "2004-07-15" @default.
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• W2243269075 title "Celecoxib (CEL) and weekly docetaxel (DOC) in elderly or PS2 patients (pts) with advanced non-small cell lung cancer (NSCLC)" @default.
• W2243269075 doi "https://doi.org/10.1200/jco.2004.22.90140.7102" @default.
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