A phase II study of 5-FU (CVI) and low-dose consecutive CDDP (LFP) therapy in advanced gallbladder carcinoma

Abstract

4261 Background: Unresectable and recurrent gallbladder carcinoma (GBca) are known to be poor prognosis. In Japan 5-FU alone or modified FAM therapy was once tried to these malignancies, but no objective response was aquired. By the way, 5-FU and CDDP combination chemotherapy (FP) has been widely used as standard chemotherapy for gastrointestinal cancer, and in Japan FP therapy was modified into 5-FU (CVI) and low-dose consecutive CDDP (LFP) Therapy from 1990. Because of low toxicity and relatively high response rate, LFP therapy has been widely used for the treatment of gastrointestinal cancers in Japan. We are conducted a single arm phase II study of LFP therapy in patients with advanced GBca. Methods: Patients with advanced or recurrent bile duct carcinoma received LFP therapy. 5-FU (160mg/m2/day) was continuously infused over 24 hours using an implantable port and CDDP (3mg/ m2/day) was infused for half an hour. The administration schedule consisted of 5-FU for 7 consecutive days and drip infusion of CDDP twice a week for each four weeks according to response and tolerance. RESIST criteria was used to assess tumor response. The toxicity was estimated by NCI-CTC (ver.3). Median survival time (MST) and median time to treatment failure (TTF) was calculated by the Kaplan-Meier method. Results: Between May 1996 and September 2003, 13 patients were entered into this trial. Information is available for all patients. Characteristics were: mean age 69.4±5.0: male 6: locally advanced 10, postoperative recurrence 3. Overall, most common toxicity was appetite loss occurring 38.5% of patients. Hematological toxicity (up to grade 2) was occurring in 23.1% of patients. No grade 4 toxicity occurred. All the patients are evaluable for effects with an over all response rates of 46.2% (6 PR, 2 NC, 5 PD). Estimated MST is 150 days. 1-year and 2-year survival rate were 16.8% and 0.0%, respectively. Estimated median TTF is 85 days. Conclusions: This study resulted in high response rate and tolerable adverse effect. This outpatient-basis LFP therapy promises to advance the quality of life of the cancer patients and to be useful in the clinical management of advanced or recurrent GBca tract malignancy for first line chemotherapy. No significant financial relationships to disclose.