Phase I/II Study of Hepatic Arterial Infusion Chemotherapy With Gemcitabine in Patients With Unresectable Intrahepatic Cholangiocarcinoma (JIVROSG-0301)

Inaba, Yoshitaka; Yamaura, Hidekazu; Sato, Yozo; Najima, Mina; Aramaki, Takeshi; Sone, Miyuki; Kumada, Takashi; Tanigawa, Noboru; Anai, Hiroshi; Yoshioka, Tetsuya; Ikeda, Masafumi

doi:10.1097/coc.0b013e3181d2709a

Cited by 38 publications

(35 citation statements)

References 17 publications

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“…Hepatic arterial infusion chemotherapy (HAIC) has been used for treatment of advanced HCC with portal vein tumor thrombosis in Asian countries [67][68][69][70][71][72] . Traditionally, the presence of tumor thrombus is assumed to aggravate ischemic injuries after TACE, so alternative modalities were sought.…”

Section: Medical Therapiesmentioning

confidence: 99%

“…HAIC does not use embolic material, and the chemotherapeutic agent is infused into the hepatic artery via an implanted catheter, which reduces systemic side effects by firstpass effects and maximizes drug delivery to the tumor. Although this is considered an experimental treatment modality and is not recommended for treatment of HCC in Western countries, a large amount of clinical data on HAIC have been accumulated in Eastern countries [67][68][69][70][71][72] . A small retrospective study showed survival benefits of HAIC using low doses of cisplatin and 5-fluorouracil compared with systemic cytotoxic chemotherapy or supportive care (median survival, 6, 4, and 2 mo, respectively; P = 0.003) in cases of advanced HCC with portal vein tumor thrombosis [73] .…”

Section: Medical Therapiesmentioning

confidence: 99%

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Current management of hepatocellular carcinoma: An Eastern perspective

Yim¹

2015

WJG

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Section: Medical Therapiesmentioning

confidence: 99%

Section: Medical Therapiesmentioning

confidence: 99%

Current management of hepatocellular carcinoma: An Eastern perspective

Yim¹

2015

WJG

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“…van Riel et al 95 observed that gemcitabine given via a 24-h hepatic arterial infusion was well tolerated and resulted in significantly lower systemic gemcitabine plasma concentrations than intravenous infusion. However, Inaba et al 96 reported that the toxicity of 1000 mg/m 2 gemcitabine via transcatheter arterial infusion in patients with unresectable ICC was tolerable, but the desired efficacy could not be reached. A retrospective study by Kuhlmann et al 97 reported that progression-free survival and overall survival in transarterial chemoembolization with irinotecan-eluting beads were similar to those for systemic chemotherapy with oxaliplatin and gemcitabine (3.9 months versus 6.3 months, and 11.7 months versus 11.0 months, respectively), but were superior to rates in transarterial chemoembolization with mitomycin-C (progression-free survival of 1.8 months, overall survival of 5.7 months).…”

Section: Chemotherapymentioning

confidence: 99%

A review of the clinical diagnosis and therapy of cholangiocarcinoma

2013

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Cholangiocarcinoma (CCA) is the second most common primary hepatic malignancy worldwide. The incidence of intrahepatic CCA is increasing, whereas that of extrahepatic CCA is decreasing. This review looks at the new advances that have been made in the management of CCA, based on a PubMed and Science Citation Index search of results from randomized controlled trials, reviews, and cohort, prospective and retrospective studies. Aggressive interventional approaches and new histopathological techniques have been developed to make a histological diagnosis in patients with high risk factors or suspected CCA. Resectability of the tumour can now be assessed using multiple radiological imaging studies; the main prognostic factor after surgery is a histologically negative resection margin. Biliary drainage and/or portal vein embolization may be performed before extended radical resection, or liver transplantation may be undertaken in combination with neoadjuvant chemotherapy or chemoradiotherapy. Though many advances have been made in the management of CCA, the standard modality of treatment has not yet been established. This review focuses on the clinical options for different stages of CCA.

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“…The results were disappointing with only 16% objective responses, a median PFS of 6.5 months and a median OS of 13.5 months. Gemcitabine HAI was tested in a phase I trial in biliary tract cancer [21]. The dose recommended was 1, 000 mg/m 2 and toxicity was similar to that obtained using systemic injection.…”

Section: Discussionmentioning

confidence: 99%

Hepatic Arterial Infusion of Gemcitabine plus Oxaliplatin as Second-Line Treatment for Locally Advanced Intrahepatic Cholangiocarcinoma: Preliminary Experience

Ghiringhelli

Lorgis²,

Vincent³

et al. 2013

Chemotherapy

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Background: The aim of this study was to evaluate the efficacy and tolerability of hepatic arterial infusion (HAI) of gemcitabine plus oxaliplatin as second-line treatment for unresectable locally advanced intrahepatic cholangiocarcinoma. Patients and Methods: We retrospectively analyzed the outcome of 12 consecutive patients with unresectable locally advanced intrahepatic cholangiocarcinoma treated with HAI of gemcitabine (1,000 mg/m² over 30 min) followed by oxaliplatin (100 mg/m² over 2 h), which was repeated every 2 weeks. Results: All patients presented with disease limited to the liver and all had failed at least one line of chemotherapy with gemcitabine and oxaliplatin. The best tumor responses using RECIST criteria were partial responses in 8 patients and stable disease in 3 patients for at least 3 months; in 1 patient, disease progressed, resulting in a disease control rate of 91% (95% CI 45-100%). The median overall survival and time to progression were 9.1 months (95% CI 4.9-8.1) and 20.3 months (95% CI 13.2-49.7), respectively. Partial responses enabled R0 liver surgery in 2 patients and stereotactic radiation therapy in 3 patients. Grade 3/4 toxicities included neutropenia in 2 patients, thrombocytopenia in 2 patients, and oxaliplatin allergy in 2 patients. Conclusions: HAI combining gemcitabine and oxaliplatin showed promising efficacy and safety as second-line treatment for locally advanced intrahepatic cholangiocarcinoma.

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Phase I/II Study of Hepatic Arterial Infusion Chemotherapy With Gemcitabine in Patients With Unresectable Intrahepatic Cholangiocarcinoma (JIVROSG-0301)

Abstract: Whereas the toxicity of hepatic arterial infusion with 1000 mg/m GEM for ICC was tolerable, expected efficacy could not be obtained, thus suggesting only minimal activity.

Cited by 38 publications

References 17 publications

Current management of hepatocellular carcinoma: An Eastern perspective

Current management of hepatocellular carcinoma: An Eastern perspective

A review of the clinical diagnosis and therapy of cholangiocarcinoma

Hepatic Arterial Infusion of Gemcitabine plus Oxaliplatin as Second-Line Treatment for Locally Advanced Intrahepatic Cholangiocarcinoma: Preliminary Experience

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