TUEBINGEN, Germany- Oral capecitabine(Drug information on capecitabine) (Xeloda) plus oxaliplatin(Drug information on oxaliplatin) (Eloxatin) is a "highly active" outpatient therapy for advanced biliary system adenocarcinomas, reported Oliver Nehls, MD, a postdoctoral research fellow, Department of Internal Medicine I, University Hospital Tübingen, Germany, citing results from a phase II multicenter study (abstract 4091). Outcomes were poorer in intrahepatic vs gallbladder/extrahepatic tumors, but overall, the capecitabine/ oxaliplatin (XELOX) combination "has a favorable safety profile and is more convenient than infusional regimens, avoiding the need for indwelling devices and frequent hospital visits," Dr. Nehls said. "There's a difference in the entities on the one hand, but on the other hand, [XELOX is] a highly active therapy for extrahepatic and gallbladder carcinomas," Dr. Nehls said. While biliary system carcinomas are relatively rare, he told ONI, about 7,000 new cases are expected in the US each year. Currently, surgery is the only curative treatment option, but most patients are in advanced stages of the disease and thus unresectable. While chemotherapy can play a palliative role, no standard-of-care treatment exists. Accordingly, Dr. Nehls and his colleagues wanted to determine the activity and toxicity of the XELOX regimen in this patient population. The investigation included 58 patients (33 female, median age 63 years) who received a total of 274 cycles. The treatment consisted of oxaliplatin (130 mg/m2, on day 1) plus capecitabine (1,000 mg/m2 twice daily, on days 1-14) administered every 3 weeks for gallbladder (22 cases), extrahepatic (20 cases), or intrahepatic (16 cases) cholangiocarcinoma. Dr. Nehls reported on 51 patients evaluable for both response and toxicity. Of this group, 35 patients had gallbladder/extrahepatic disease and 16 had intrahepatic disease. Complete responses were seen in 2 patients (6%) with gallbladder/extrahepatic disease and no patients in the intrahepatic group. The overall disease control rate was 72% for gallbladder and 82% for extrahepatic carcinoma, but only 25% for intrahepatic carcinoma. Likewise, survival was poorer in the intrahepatic group (see Table 1). Toxicities were generally mild; most serious toxicities were grade 3. The most common serious toxicities were peripheral sensory neuropathy (eight cases grade 3, or 14%; two cases grade 4, or less than 1%), and thrombocytopenia (four cases grade 3, or 1%). Two patients were discontinued from the study owing to allergic reactions related to oxaliplatin. One patient with intrahepatic carcinoma died from sepsis after the first treatment cycle. Previously, Dr. Nehls and colleagues had reported on the combination of oxaliplatin plus fluorouracil(Drug information on fluorouracil)/ leucovorin in patients with biliary system carcinomas (Br J Cancer 87(7):702-704, 2002). Results of the prospective phase II showed a 56% disease control rate and a median overall survival time of 9.5 months. However, the XELOX regimen was chosen for this study because it had the potential to "improve efficacy and offer a more convenient treatment option for patients," Dr. Nehls said. To confirm the "encouraging results" of this trial, a randomized study has been planned, he added.