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• W2241484927 abstract "4183 Background: Cyclo-oxygenase-2 (COX-2) is upregulated and may play an important pathogenetic role in both PDAC and BTC. The present study was aimed at evaluating the feasibility, toxicity, and preliminary activity of a selective COX-2 inhibitor (celecoxib) combined with infusional 5-FU as second-line treatment for advanced PDAC and BTC pts. Methods: Advanced PDAC and BTC pts with confirmed progressive disease after Gem-based chemotherapy were eligible for this exploratory phase II study. Treatment consisted of oral celecoxib (400 mg b.i.d.) and p.i.v.i. 5-FU (200 mg/m2/d), both given continuously for a maximum of 9 treatment months, in the absence of progression or unacceptable toxicity. Pts were examined weekly for toxicity and restaged every 6 to 8 wks for tumor assessment. Results: 20 pts (median age: 63 yrs, range: 35–80; M/F: 11/9; PDAC/BTC: 17/3; locally advanced/metastatic disease: 3/17; ECOG PS 0/1/2: 6/11/3) entered the study. The median number of treatment wks administered was 4 (range 2–33); all pts and 158 treatment wks were evaluable for toxicity. Asymptomatic transaminase elevation was the most common toxicity and reached grade 3/4 in 5 out of 158 (3.2%) treatment wks. No other hematological or non-hematological toxicity greater than grade 2 was observed. Four pts discontinued celecoxib due to upper gastrointestinal tract toxicity. Two confirmed PR (duration: 23 and 50+ wks, respectively) and 2 SD (duration: 10 and 13 wks, respectively) were observed for an ORR of 10% (95% C.I. 0–23%) in the intent-to-treat population. Significant (≥ 50%) decrease in serum CA19.9 levels was observed in 3 out of 9 evaluable pts. Median time to progression was 8 wks and median overall survival was 14 wks. Conclusions: The combination of celecoxib and p.i.v.i. 5-FU is feasible, well tolerated, and may induce durable objective responses even in far advanced, Gem-resistant/refractory PDAC or BTC pts. Further exploration of COX-2 inhibitor/fluropyrimidine combinations in these diseases is warranted. No significant financial relationships to disclose." @default.
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• W2241484927 date "2004-07-15" @default.
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• W2241484927 title "Exploratory phase II study of celecoxib and infusional fluorouracil as second-line treatment for advanced pancreatic (PDAC) and biliary tree cancer (BTC)" @default.
• W2241484927 doi "https://doi.org/10.1200/jco.2004.22.90140.4183" @default.
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