UNASSIGNED: 4091 Background: To evaluate the feasibility of @entity416 and @entity901 combination therapy (CapOx) in unresectable or metastatic @entity420 of the biliary system. @entity1 AND METHODS: 56 pts (25M, 31F) were included (median age, 63 yrs). Major eligibility: histologic proven, measurable disease, age 18-75 yrs, ECOG PS 0-2. A total number of 250 cycles (median: 5; range 1-16) of @entity901 (130 mg/m2, d1) plus @entity416 (2000 mg/m2, d 1-14) were administered 3 weekly for @entity1086 ( @entity1086 ) (20 pts), extrahepatic (20 pts), and intrahepatic (16 pts) @entity201 ( @entity201 ). Pts were assessed for response according to WHO standard criteria. Clinical outcome was determined separately for pts with either @entity1086 /extrahepatic @entity201 or intrahepatic @entity201 (mass-forming type), because these two distinct presentations have been supposed to differ substantially from each other according to clinical behaviour. RESULTS: Grade 4 @entity137 (WHO) were @entity294 in 1 pt (1% of cycles), @entity882 in 1 pt (1%), @entity1431 in 1 pt (1%), and fever in 2 pts (1%); grade 3 @entity137 were: @entity294 in 2 pts (1%), @entity882 in 3 pts (2%), and fever in 1 pt (1%). Grade 3/4 @entity1897 (L  vis scale) was found in 10 pts (15%). Two pts were removed from study due to @entity901 -related @entity56 . One @entity1 harboring intrahepatic @entity201 died with @entity326 after the first treatment cycle. On 31 evaluable pts with @entity1086 or extrahepatic @entity201 the response-rate was as follows: complete response (CR), 2 pts (6% of the pts); partial response (PR), 7 pts (23%); stable disease (NC) 15 pts (48%). Thus, the overall disease control rate (CR + PR + NC) was 77%, whereas 7 pts (23%) had @entity74 ( @entity74 ). In contrast, in 16 evaluable pts with intrahepatic mass-forming @entity201 no CR or PR was observed, but 4 pts (25%) were found to have NC, and in 12 pts (75%) @entity74 was encountered. CONCLUSIONS: Our preliminary data suggest the CapOx regimen to be well tolerable and highly active for advanced @entity1086 and extrahepatic @entity201 (disease-control rate: 77%), whereas outcome might be poorer in intrahepatic @entity201 . Survival data will be presented at the meeting. No significant financial relationships to disclose.

A multicenter phase II study of XXXX plus @entity901 (CapOx) in advanced biliary system @entity420 .

@entity901 :: ('MESH:C030110', 'Chemical') :: ['oxaliplatin'] @entity1 :: ('9606', 'Species') :: ['patient', 'PATIENTS'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicities'] @entity416 :: ('MESH:C110904', 'Chemical') :: ['capecitabine'] @entity882 :: ('MESH:D013921', 'Disease') :: ['thrombocytopenia'] @entity326 :: ('MESH:D012772', 'Disease') :: ['septic shock'] @entity294 :: ('MESH:D003967', 'Disease') :: ['diarrhea'] @entity1897 :: ('MESH:D010523', 'Disease') :: ['peripheral sensory neuropathy'] @entity201 :: ('MESH:D018281', 'Disease') :: ['cholangiocarcinoma', 'CCC'] @entity56 :: ('MESH:D004342', 'Disease') :: ['allergic reactions'] @entity1431 :: ('MESH:D007970', 'Disease') :: ['leukopenia'] @entity74 :: ('MESH:D030342', 'Disease') :: ['PD', 'progressive disease'] @entity1086 :: ('MESH:D005706', 'Disease') :: ['GBC', 'gallbladder carcinoma'] @entity420 :: ('MESH:D000230', 'Disease') :: ['adenocarcinomas']
@entity416 :: (MESH:C110904,Chemical) :: ['capecitabine']
