A phase II study of oxaliplatin (O) and gemcitabine (G) first line chemotherapy in patients with advanced biliary tract cancers

Abstract

Background: Biliary tract cancers are uncommon tumors with a poor prognosis and most patients (pts) present with invasive and inoperable disease at diagnosis. Chemotherapy represents a palliative treatment, but single or combination-drug schedules have demonstrated poor response rates with a median survival less than 6 months. Recently O and G have showed an interesting activity as single agents in this group of pts. Methods: We carried out a multicenter phase II study to evaluate the efficacy and safety of combined O and G in locally advanced and metastatic biliary tract carcinoma. The schedule of chemotherapy included O 100 mg/m2 on day 1 and G 1000 mg/m2 on days 1 and 8, every 21 days. Inclusion Criteria were: histological diagnosis of biliary tract carcinoma, age <75, Performance Status (PS)<=2, normal kidney and liver function, absence of brain symptomatic metastases, informed consent.Median patient age was 68 years (range 59 -73). At present 24 pts, 15 males and 9 females, have been enrolled. Nine pts had carcinoma of the gallbladder, 7 cholangiocarcinoma and 8 extrahepatic biliary system disease. Locally advanced 14 pts, metastatic 10 pts. Thirteen pts had a PS =0, 7 pts had a PS=1, 4 pts had a PS=2. Results: All the 24 pts were evaluable for response and toxicity. According RECIST criteria we observed 1 CR and 11 PR for an overall response rate of 50%. Five SD and 7 PD also occurred. The responders (PR+CR) demonstrated a TTP of 10 months (range 6–24) and an overall survival of 14 months (range 6 - 28), while the overall survival for all the pts on study was 10 months (range 2–28). According WHO criteria, 6 pts (25%) suffered grade 2–3 neutropenia, and 3 pts (12.5%) grade 2 thrombocytopenia. One third of pts developed grade 1–2- peripheral neuropathy, only 2 pts (8%) suffered grade 3 neuropathy. Nausea & vomiting G1–2 was present in 6 pts (25%). Conclusions: From these preliminary data O and G combination seems to be effective with a favorable safety profile in first line chemotherapy of advanced biliary tract cancers.