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Annals of Oncology 2006 17(Supplement 7):vii68-vii72; doi:10.1093/annonc/mdl955
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© 2006 European Society for Medical Oncology

symposium article

Gemcitabine and oxaliplatin combination chemotherapy in advanced biliary tract cancers

F. Verderame1,#, A. Russo2,*,#, R. Di Leo1, G. Badalamenti2, D. Santangelo1, G. Cicero2, M. R. Valerio2, G. Gulotta2, G. Tomasello2, N. Gebbia2 and F. Fulfaro2

1 Department of Medicine, Oncology Unit, Azienda Ospedaliera ‘Giovanni Paolo II’ Sciacca (AG); 2 Department of Surgical Oncology, Università di Palermo, Italy

* Correspondence to: Dr A. Russo, Section of Medical Oncology, Department of Oncology, Università di Palermo, Via del Vespro 127, 90127 Palermo, Italy. Tel: +39-091-6552500; Fax: +39-091-6554529; E-mail: lab-oncobiologia{at}usa.net

Background: Biliary tract cancers are uncommon tumors with a poor prognosis and most patients present with invasive and inoperable disease at diagnosis. Chemotherapy represents a palliative treatment, with poor response rates and a median survival of less than 6 months. Oxaliplatin and gemcitabine have shown an interesting activity as single agents in this group of patients.

Patients and methods: We carried out a multicenter phase II study to evaluate the efficacy and safety of combined oxaliplatin and gemcitabine in locally advanced and metastatic biliary tract carcinoma. The schedule of chemotherapy included oxaliplatin 100 mg/m2 on day 1 and gemcitabine 1000 mg/m2 on days 1 and 8, every 21 days.

Results: All the 24 patients were evaluable for response and toxicity. According to RECIST criteria we observed one complete response and 11 partial responses for an overall response rate of 50%. Overall survival for all the patients on study was 12 months (range 2–30). According to WHO criteria, three patients (12.5%) suffered grade 3 neutropenia and three patients (12.5%) grade 3 thrombocytopenia. Only two patients (8%) suffered grade 3 neuropathy.

Conclusions: Oxaliplatin and gemcitabine chemotherapy seems to be effective with a favorable safety profile in first-line chemotherapy of advanced biliary tract cancers.

Key words: advanced biliary tract cancer, oxaliplatin, combination therapy


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