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Background: Hyperbilirubinaemia is a common disease effect in patients pts ith metastatic pancreatic cancer mPC . As clinical trials often exclude them, data on management of these pts are rare. In the frameork of a German observational multicenter study QoliXane , quality of life and therapy data are currently being collected in pts ith mPC receiving a combination of nab-paclitaxel and gemcitabine. This is an interim analysis on hyperbilirubinaemia management. Methods: Pts ere included to this analysis if they entered the trial ith a bilirubin level 1.5 mgdl and completed at least 1 cycle. Bilirubin levels ere documented for up to 4 cycles and methods of hyperbilirubinaemia management have been assessed. A both descriptive and explorative analysis as performed using IBM SPSS V 23. Results: 20 of 219 pts 9.1 percent ere included. Mean bilirubin level as 4.4 mgdl range 1.5-12.9 at baseline and dropped considerably by the 2nd cycle to 1.8 range 0.35-14.1; p=0.031 . Bilirubin levels decreased in 13 65 percent and increased in 2 10 percent pts upon treatment start. 14 70 percent pts started treatment ith standard dosage, 6 30 percent ith a reduced regime. 11 55 percent pts underent additional intervention: either stenting 7 pts, 35 percent or bile duct anastomosis 4 pts, 20 percent . Mean bilirubin values dropped from 5.32 to 0.48 in pts ith and from 3.27 to 0.53 in pts ithout additional intervention. Grade 34 toxicity as seen in 70 percent of pts and most common 34 events ere leukopenia, anemia, and fever, each observed in 20 percent of pts. Conclusions: Data sho that bilirubin levels drop considerably after start of nab-pacgem therapy. The treatment seems to be feasible, although considerable rates of leukopenia and fever ere observed. Clinical trial information: AIO-LQ-0214.ltcaption class=mtgabstract-table-title Mean bilirubin levels1.BaselineCycle 1Cycle 2Cycle 3Cycle 4All pts n=20 4.404.701.800.700.50No add. intervention n=9 3.273.812.620.70.53Any add. intervention n=11 5.325.291.150.630.48Add. stenting n=7 5.202.011.320.720.43Add. bile duct anastomosis n=4 5.5211.00.870.470.53p all pts 20.0310.0020.012ltfn id=TF-170512-001-1 ltp class=mtgabstract-table-fn 1 nx0027;s indicate of pts at baseline 2 Wilcoxon test to baseline related samples , level of significance p = .05lttable-rap-foot ,J Clin Oncol 34, 2016 suppl; abstr e15739 ,AIO-LQ-0214Publication Only Gastrointestinal Noncolorectal Cancer
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