Chemotherapy with gemcitabine and oxaliplatin in patients with advanced biliary tract cancer: a single-institution experience.
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.


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.
Manzione
Luigi
L
Medical Oncology, A.O. San Carlo, Potenza, Italy.
Romano
Rosangela
R
Germano
Domenico
D
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use* / Q000633:toxicity; D001661:Biliary Tract Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000633:toxicity; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000633:toxicity; D000077150:Oxaliplatin; D014057:Tomography, X-Ray Computed; D000093542:Gemcitabine
D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000093542:Gemcitabine