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Open Access Research article

A phase II study of LFP therapy (5-FU (5-fluorourasil) continuous infusion (CVI) and Low-dose consecutive (Cisplatin) CDDP) in advanced biliary tract carcinoma

Kazuma Kobayashi16*, Akihito Tsuji4, Sojiro Morita2, Tadashi Horimi3, Tetsuhiko Shirasaka5 and Takashi Kanematsu6

Author Affiliations

1 Internal medicine, Clinical Oncology Group, Kochi Municipal Central Hospital, Kochi, Japan

2 Radiology, Clinical Oncology Group, Kochi Municipal Central Hospital, Kochi, Japan

3 Surgery, Clinical Oncology Group, Kochi Municipal Central Hospital, Kochi, Japan

4 Department of Clinical Oncology, Kochi Health Science Center, Kochi, Japan

5 Kitasato Institute for Life Sciences, Kitasato University, Tokyo, Japan

6 Department of Transplantation and Digestive Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan

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BMC Cancer 2006, 6:121  doi:10.1186/1471-2407-6-121

Published: 6 May 2006

Abstract

Background

Unresectable biliary tract carcinoma is known to demonstrate a poor prognosis. We conducted a single arm phase II study of LFP therapy (5-FU (5-fluorourasil) continuous infusion (CVI) and Low-dose consecutive (Cisplatin) CDDP) for advanced biliary tract malignancies basically on an outpatient basis.

Methods

Between February 1996 and September 2003, 42 patients were enrolled in this trial.

LFP therapy

By using a total implanted CV-catheter system, 5-FU (160 mg/m2/day) was continuously infused over 24 hours for 7 consecutive days and CDDP (6 mg/m2/day) was infused for 30 minutes twice a week as one cycle. The administration schedule consisted of 4 cycles as one course. RESIST criteria (Response evaluation criteria for solid tumors) and NCI-CTC (National Cancer Institute-Common Toxicity Criteria) (ver.3.0) were used for evaluation of this therapy. The median survival time (MST) and median time to treatment failure (TTF) were calculated by the Kaplan-Meier method.

Results

Patients characteristics were: mean age 66.5(47–79): male 24 (54%): BDca (bile duct carcinoma) 27 GBca (Gallbladder carcinoma) 15: locally advanced 26, postoperative recurrence 16. The most common toxicity was anemia (26.2%). Neither any treatment related death nor grade 4 toxicity occurred. The median number of courses of LFP Therapy which patients could receive was two (1–14). All the patients are evaluable for effects with an over all response rates of 42.9% (95% confidence interval C.I.: 27.7–59.0) (0 CR, 18 PR, 13 NC, 11 PD). There was no significant difference regarding the anti tumor effects against both malignant neoplasms. Figure 2 Shows the BDca a longer MST and TTF than did GBca (234 vs 150, 117 vs 85, respectively), but neither difference was statistically significant.

The estimated MST and median TTF were 225 and 107 days, respectively. The BDca had a longer MST and TTF than GBca (234 vs 150, 117 vs 85, respectively), but neither difference was statistically significant.

Conclusion

LFP therapy appears to be useful modality for the clinical management of advanced biliary tract malignancy.