| Abstract | 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. |
| Authors | Luigi Manzione, Rosangela Romano, Domenico Germano
(Affiliation: Medical Oncology, A.O. San Carlo, Potenza, Italy.)
|
| Journal | Oncology
(Oncology)
Vol. 73
Issue 5-6
Pg. 311-5
( 2007)
ISSN: 1423-0232 Switzerland |
| PMID | 18493158
(Publication Type: Clinical Trial, Phase II, Journal Article)
|
| Copyright | 2008 S. Karger AG, Basel. |
| Chemical References |
- Organoplatinum Compounds
- gemcitabine
- oxaliplatin
- Deoxycytidine
|
| Topics |
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use, toxicity)
- Biliary Tract Neoplasms
(drug therapy, pathology, radiography)
- Deoxycytidine
(administration & dosage, analogs & derivatives, toxicity)
- Drug Administration Schedule
- Female
- Humans
- Male
- Middle Aged
- Neoplasm Staging
- Organoplatinum Compounds
(administration & dosage, toxicity)
- Tomography, X-Ray Computed
|
