Abstract | BACKGROUND: METHODS: Patients with previously untreated metastatic, recurrent, or inoperable biliary tract cancer were enrolled. Eligible patients were screened as following: (1) histologically confirmed, (2) age between 18 and 75 years, (3) at least one measurable lesion according to RECIST criteria, (4) ECOG performance status <or=2, (5) a life expectancy of at least 3 months, and (6) adequate laboratory values. Patients received capecitabine (2,500 mg/m2/day, days 1 to 14) and cisplatin (60 mg/m2, day 1) every 3 weeks. Response was assessed for every two cycles of chemotherapy and treatment was stopped when tumor had progressed or stable with no further response. RESULTS: Thirty-two patients were enrolled, 20 (62.5%) were male and 12 (37.5%) were female and the median age was 54 years (33-71 years). Fifteen patients (46.9%) had gallbladder cancer, 13 (40.6%) had intrahepatic cholangiocarcinoma, and 4 (12.5%) had extrahepatic biliary cancer. The most frequent metastatic sites were lymph nodes (20/32, 62.5%) and liver (28/32, 56.3%). No complete response was observed and partial response was observed in 13/32 patients. By the intent-to-treat analysis, the overall response rate was 40.6% (95% CI, 23.7-59.4) with 0 CR and 13 PRs. Stable disease was observed in 3 patients (9.4%), and 11 patients (34.4%) had progressive disease. The median time to progression was 3.5 months (95% CI, 1.3-5.8), and the median overall survival was 12.4 months (95% CI, 6.3-18.5) after the median follow-up duration of 9.5 months (4.8-26.1 months). A total of 108 cycles of chemotherapy was delivered. Grade 3 hematologic toxicities included neutropenia (5, 15.6%), anemia (1, 3.1%), and thrombocytopenia (1, 3.1%) per patient, and no grade 4 hematologic toxicities were observed. Grade 3 non-hematologic toxicities included hyperbilirubinemia (2, 6.3%), increase of alkaline phosphatase (2, 6.3%), hand-foot syndrome (2, 6.3%), anorexia, and diarrhea (1, 3.1%) per patient, respectively. There was no treatment-related death. CONCLUSION:
|
Authors | Yong Sang Hong, Jeeyun Lee, Sang Cheol Lee, In Gyu Hwang, Seong-Ho Choi, Jin-Seok Heo, Joon Oh Park, Young Suk Park, Ho Yeong Lim, Won Ki Kang |
Journal | Cancer chemotherapy and pharmacology
(Cancer Chemother Pharmacol)
Vol. 60
Issue 3
Pg. 321-8
(Aug 2007)
ISSN: 0344-5704 [Print] Germany |
PMID | 17143602
(Publication Type: Clinical Trial, Phase III, Journal Article)
|
Chemical References |
- Deoxycytidine
- Capecitabine
- Cisplatin
- Fluorouracil
|
Topics |
- Adult
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use, toxicity)
- Biliary Tract Neoplasms
(drug therapy, mortality, pathology)
- Capecitabine
- Cisplatin
(administration & dosage)
- Deoxycytidine
(administration & dosage, analogs & derivatives)
- Disease Progression
- Drug Administration Schedule
- Female
- Fluorouracil
(administration & dosage, analogs & derivatives)
- Humans
- Male
- Middle Aged
- Neoplasm Metastasis
- Recurrence
- Survival Analysis
|
|
Join CureHunter, for free Research Interface BASIC access!
Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease.
Find out why thousands of doctors, pharma researchers and patient activists
around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!
|