A MULTI-CENTER PHASE II STUDY OF INTRA-ARTERIAL CHEMOTHERAPY OF A FINE-POWDER FORMULATION OF CISPLATIN IN PATIENTS WITH ADVANCED INTRAHEPATIC CHOLANGIOCARCINOMA

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Abstract

Background

The aim of this study was to evaluate the efficacy and safety of intra-arterial chemotherapy with a fine-powder formulation of cisplatin in patients with advanced intrahepatic cholangiocarcinoma.

Methods

Eligibility criteria were as follows: histologically proven intrahepatic cholangiocarcinoma, unresectable or recurrent disease, having a measurable lesion in the liver, no history of chemotherapy with platinum, and an ECOG performance status (PS) of 0-1. A fine-powder formulation of cisplatin was administered at a dose of 65 mg/m2 into the hepatic artery over 20 min. The treatment was repeated every 4–6 weeks until a maximum of six courses, unless unacceptable toxicity or disease progression occurred. The primary end point was the response rate according to RECIST ver.1.0.

Results

Thirty-five patients were enrolled between June 2007 and July 2010. There were 22 men and 13 women with a median age of 63 years (range 42–77). Thirty and five were in PS 0 and 1, respectively. Fifteen patients had received prior chemotherapy. One, 2, 17 and 15 patients were in UICC stage I, II, III and IV, respectively. Treatment courses ranged from 1 to 8 with a median of 3. The partial response was observed in six patients (17.1%, 95% confidential interval: 6.6–33.7%), stable disease in 15 and progressive disease in 14. Median time to progression, median overall survival and 1-year survival rate were 3.3 months, 11.0 months and 41.9%, respectively. The main grade 3/4 toxic effects were neutropenia (5.7%), thrombocytopenia (11.4%), elevation of the serum levels of aspartate aminotransferase (20%) and alanine aminotransferase (28.6%), anorexia (5.7%) and fatigue (8.6%). These toxic effects were transient and well tolerated.

Conclusions

Intra-arterial chemotherapy with a fine-powder formulation of cisplatin failed to demonstrate a favorable tumor response in patients with advanced intrahepatic cholangiocarcinoma.

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