Phase II study of capecitabine plus cisplatin as first-line chemotherapy in advanced biliary cancer.

Abstract

BACKGROUND:

A phase II study was conducted to assess the efficacy and tolerability of substituting capecitabine for 5-fluorouracil in combination with cisplatin in patients with advanced biliary cancer.

PATIENTS AND METHODS:

Patients with previously untreated metastatic or unresectable measurable biliary adenocarcinoma received oral capecitabine 1250 mg/m(2) twice daily on days 1-14, and intravenous cisplatin 60 mg/m(2) on day 1. This cycle was repeated every 21 days.

RESULTS:

Forty-two patients were enrolled in this study. Of these, 38 were assessable for efficacy and 41 were assessable for safety. A median of three cycles of treatment (range one to eight) were administered. One patient achieved a complete response, and eight had partial responses, giving an overall response rate of 21.4% in the intention-to-treat population (95% confidence interval 9.1% to 33.9%). The median response duration was 5.1 months. The median time to progression and median overall survival were 3.7 and 9.1 months, respectively. The most common grade 3/4 adverse events were neutropenia (20% of patients), vomiting (12%), diarrhea (7%) and stomatitis (5%). There were no treatment-related deaths.

CONCLUSIONS:

The combination of capecitabine and cisplatin has promising antitumor activity and is well tolerated in patients with advanced biliary cancer.

• Authors: T W Kim, H M Chang, H J Kang, J R Lee, M H Ryu, J H Ahn, J H Kim, J S Lee, Y K Kang
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 14 Issue 7 Pg. 1115-20 (Jul 2003) ISSN: 0923-7534 [Print] England
• PMID: 12853355 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Deoxycytidine
• Capecitabine
• Cisplatin
• Fluorouracil

Topics

• Administration, Oral
• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Bile Duct Neoplasms (drug therapy, pathology)
• Capecitabine
• Cisplatin (administration & dosage)
• Deoxycytidine (administration & dosage, analogs & derivatives)
• Disease Progression
• Female
• Fluorouracil (analogs & derivatives)
• Gallbladder Neoplasms (drug therapy, pathology)
• Humans
• Infusions, Intravenous
• Male
• Middle Aged
• Neutropenia (chemically induced)
• Survival Analysis
• Treatment Outcome