Medline ® Abstract for Reference 25
of 'Systemic therapy for advanced cholangiocarcinoma'
Chemotherapy with gemcitabine and oxaliplatin in patients with advanced biliary tract cancer: a single-institution experience.
Manzione L, Romano R, Germano D
Oncology. 2007;73(5-6):311. Epub 2008 May 21.
BACKGROUND: Biliary tract cancers are uncommon tumors with a poor prognosis. Since most patients present with invasive and inoperable disease at diagnosis, treatment consists of palliative chemotherapy, with poor response rates and a median survival of less than 6 months. Oxaliplatin and gemcitabine have shown interesting activity as single agents in this patient group.
OBJECTIVE: A single-institution phase II study was performed to evaluate the efficacy and safety of combination therapy with oxaliplatin and gemcitabine in locally advanced and metastatic biliary tract carcinomas.
PATIENTS AND METHODS: Combination chemotherapy consisted of gemcitabine 1,000 mg/m(2) on day 1 and oxaliplatin 100 mg/m(2) on day 2 every 2 weeks. Treatment was administered until disease progression, unacceptable toxicity or patient refusal. Thirty-five consecutive patients with advanced biliary tract carcinoma, aged 18-80 years, with Eastern Cooperative Oncology Group performance status<or =2 were entered into our study from November 2003.
RESULTS: Thirty- four patients were evaluable for response and toxicity. According to RECIST criteria, 2 patients had a complete response and 12 had a partial response, with an overall response rate of 41%. Overall survival in our patients was 10 months (range 2-30). According to WHO criteria, 3 patients (9%) suffered from grade 3 neutropenia and 7 patients (21%) from grade 3 thrombocytopenia. Only 3 patients (9%) had grade 3 neuropathy.
CONCLUSIONS: The GEMOX combination seems to be active with a favorable safety profile in first-line chemotherapy of advanced biliary tract cancers.
Medical Oncology, A.O. San Carlo, Potenza, Italy.