A multicenter phase II study of capecitabine plus oxaliplatin (CapOx) in advanced biliary system adenocarcinomas

Abstract

4091 Background: To evaluate the feasibility of capecitabine and oxaliplatin combination therapy (CapOx) in unresectable or metastatic adenocarcinomas of the biliary system. Patients 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 oxaliplatin (130 mg/m2, d1) plus capecitabine (2000 mg/m2, d 1–14) were administered 3 weekly for gallbladder carcinoma (GBC) (20 pts), extrahepatic (20 pts), and intrahepatic (16 pts) cholangiocarcinoma (CCC). Pts were assessed for response according to WHO standard criteria. Clinical outcome was determined separately for pts with either GBC/extrahepatic CCC or intrahepatic CCC (mass-forming type), because these two distinct presentations have been supposed to differ substantially from each other according to clinical behaviour. Results: Grade 4 toxicities (WHO) were diarrhea in 1 pt (1% of cycles), thrombocytopenia in 1 pt (1%), leukopenia in 1 pt (1%), and fever in 2 pts (1%); grade 3 toxicities were: diarrhea in 2 pts (1%), thrombocytopenia in 3 pts (2%), and fever in 1 pt (1%). Grade 3/4 peripheral sensory neuropathy (Lévis scale) was found in 10 pts (15%). Two pts were removed from study due to oxaliplatin-related allergic reactions. One patient harboring intrahepatic CCC died with septic shock after the first treatment cycle. On 31 evaluable pts with GBC or extrahepatic CCC 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 progressive disease (PD). In contrast, in 16 evaluable pts with intrahepatic mass-forming CCC no CR or PR was observed, but 4 pts (25%) were found to have NC, and in 12 pts (75%) PD was encountered. Conclusions: Our preliminary data suggest the CapOx regimen to be well tolerable and highly active for advanced GBC and extrahepatic CCC (disease-control rate: 77%), whereas outcome might be poorer in intrahepatic CCC. Survival data will be presented at the meeting. No significant financial relationships to disclose.