S-Space College of Medicine/School of Medicine (의과대학/대학원) Preventive Medicine (예방의학전공) Journal Papers (저널논문_예방의학전공)
Phase II trial of gemcitabine combined with cisplatin in patients with inoperable biliary tract carcinomas
- Lee, Jeeyun; Kim, Tae-You; Lee, Myung Ah; Ahn, Myung Ju; Kim, Hoon-Kyo; Lim, Ho Yeong; Lee, Nam Su; Park, Byung Joo; Kim, Jun Suk
- Issue Date
- Springer Verlag
- Cancer Chemother Pharmacol. 2008 ;61(1):47-52.
- Adenocarcinoma/*drug therapy/pathology; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use; Biliary Tract Neoplasms/*drug therapy/pathology; Cisplatin/administration & dosage; Deoxycytidine/administration & dosage/analogs & derivatives; Disease Progression; Female; Humans; Infusions, Intravenous; Liver Neoplasms/secondary; Male; Middle Aged; Nausea/chemically induced; Neoplasm Metastasis; Neoplasm Recurrence, Local; Neoplasm Staging; Survival Rate; Treatment Outcome; Vomiting/chemically induced
- OBJECTIVES: The aim of this phase II study was to evaluate the response rate to gemcitabine combined with cisplatin in patients with locally advanced, metastatic or recurrent biliary tract cancer who had received no prior chemotherapy. METHODS: The treatment consisted of cisplatin 70 mg/m(2) in intravenous infusion followed by gemcitabine 1,250 mg/m(2) in 30-min intravenous infusion on days 1 and 8, repeated every 3 weeks until disease progression, unacceptable toxicity, patient's refusal or up to 8 cycles. RESULTS: Thirty-nine patients with advanced biliary cancer were enrolled between March 2003 and August 2003. Fourteen patients (40%) had gall bladder cancer and 20 patients (57%) had cholangiocarcinoma. Thirty-two patients (91%) had metastatic disease at study entry with liver being the most commonly involved site of metastasis. About 84.5 and 94.2% of the initially planned dose were administered for gemcitabine and cisplatin, respectively. In the ITT population (n = 35), six partial responses were observed for an objective response rate of 17.1% (95% CI; 4.7-29.6%). Ten patients (28.6%) had stable disease, 16 (45.7%) progressed, and three (8.6%) were not evaluable. For the 35 patients in the ITT population, the median overall survival time was 8.6 months (95% CI; 6.1-10.4 months). The median time to disease progression was 3.2 months (95% CI; 2.3-4.9 months) and the median time to treatment failure was 3.1 months (95% CI; 1.9-4.1 months). Among the six tumor responders, the median duration of tumor response was 7.3 months (95% CI; 5.6-11.0 months). The most common grade 3/4 maximum toxicities were nausea (3.4%) and vomiting (2.7%). CONCLUSION: The combination chemotherapy with gemcitabine and cisplatin in this trial demonstrated moderate antitumor activity with favorable toxicity profile.
- 0344-5704 (Print)
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