© 2006 European Society for Medical Oncology
symposium article |
Gemcitabine and cisplatin for inoperable and/or metastatic biliary tree carcinomas: a multicenter phase II study of the Gruppo Oncologico dell'Italia Meridionale (GOIM)
1 Division of Medical Oncology, National Institute of Oncology, Bari; 2 Department of Experimental Oncology, University of Palermo; 3 Division of Medical Oncology, Casa di Cura Sollievo della Sofferenza, San Giovanni Rotondo; 4 Division of Medical Oncology, Ospedale Buccheri La Ferla, Palermo, Italy
* Correspondence to: Dr V. Gebbia, Via Alessandro Paternostro n. 48, 90133 Palermo, Italy. Fax: +39-091-6806906; E-mail: vittorio.gebbia{at}tin.it
Background: The aim of the study was to test the clinical efficacy and toxicity profile of gemcitabine (GEM) in combination with cisplatin (CDDP) in a series of patients affected by unresectable and/or metastatic biliary tree carcinoma (BTC) previously untreated with chemotherapy.
Patients and methods: Overall 38 consecutive patients who satisfied eligibility criteria (10 with gall-bladder carcinoma and 28 with bile duct carcinoma) were included in this phase II study. Median age was 61 years with median PS 1. Treatment included GEM 1000 mg/m2/week as 30 min i.v. on days 1 and 8, and CDDP 75–80 mg/m2 on day 1 with adequate hydration protocol and forced diuresis. Treatment was repeated every 3 weeks for three cycles before first re-evaluation of disease status.
Results: According to an intent-to-treat analysis a complete response (CR) was achieved in 1 patient (3%) with duration of 8 months. A partial response (PR) was recorded in 11 cases (29%; 95% CI 6% to 48%) with a median duration of 6.4 months (range 5–11 months) for an overall response rate (ORR) of 32%. Stable disease (SD) was seen in eight cases (21%), while the remaining 18 patients showed progressive disease (PD). Tumor growth control rate was 53%. Objective responses were recorded at loco-regional disease, liver and nodal metastases. Lung and peritoneal metastases did not respond. Time-to-progression was 4 months (range 2–11 months) and median overall survival was 8+ months (range 2–15 months). Side-effects were mild with few cases of grade 4 hematological toxicity. Transient and reversible liver toxicity was recorded in nearly one-quarter of patients. Infection without severe grade 4 neutropenia was observed in three cases. In no case was chemotherapy withdrawn for toxicity.
Conclusion: The GEM/CDDP regimen is active against advanced and/or metastatic BTC with a favourable toxicity profile. This regimen represents a reasonable therapeutic choice for palliation of advanced BTC. Inferences concerning overall survival are difficult to draw due to the phase II nature of the study.
Key words: biliary tree carcinoma, gemcitabine, cisplatin, chemotherapy