Current Status of Hepatic Arterial Infusion Chemotherapy

Obi, Shuntaro; Sato, Shinpei; Kawai, Toshihiro

doi:10.1159/000367746

Cited by 106 publications

(83 citation statements)

References 47 publications

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“…However, in previous combination studies with TACE, the median OS ranged from 18 months (shortest) to 32 months (longest) ( Table 1 ), suggesting that the duration of the study needs to be extremely long when evaluating OS as a primary endpoint. In clinical studies that are terminated early because of tumor progression or adverse effects, patients often receive various post-trial treatments, such as hepatic artery infusion chemotherapy [20][21][22] , ablation [23][24][25] , or systemic therapy [26][27][28][29] . In such cases, post-trial treatment likely affects OS, making it difficult to evaluate treatment outcomes using OS, especially in studies of TACE in patients with intermediate-stage HCC.…”

Section: Proposal Of a New Primary Endpoint In Tace Combination Trialsmentioning

confidence: 99%

Transarterial Chemoembolization in Combination with a Molecular Targeted Agent: Lessons Learned from Negative Trials (Post-TACE, BRISK-TA, SPACE, ORIENTAL, and TACE-2)

Kudo

Arizumi²

2017

Oncology

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sessment Randomized Protocol (SHARP) and Asia-Pacific studies [1,2] . In 2007, sorafenib was approved in the EU and USA, where it became a first-line agent for unresectable advanced HCC. Transarterial chemoembolization (TACE) is the first-line treatment option for intermediate-stage HCC [3][4][5][6] ; however, repeated TACE sessions tend to impair liver functional reserve. Reducing the frequency of TACE, which is generally repeated upon tumor progression, is a challenging issue in the treatment of patients with intermediate-stage HCC. To address this issue, previous trials combined molecular targeted agents with TACE; however, the safety and efficacy of this combination could not be demonstrated, and none of the combination therapies is currently recommended.In the SHARP study, subanalysis showed that the hazard ratio (HR) for overall survival (OS) in patients with HCC with no vascular invasion or extrahepatic spread, which are regarded as good indications for TACE, was 0.52 and, thus, extremely good in the sorafenib group. The median survival of these patients was extended approximately 1.5-fold [7] , suggesting that the addition of sorafenib as adjuvant therapy to TACE improves prognosis. The combination of TACE with sorafenib does not simply represent the administration of 2 types of treatment; the combination is expected to extend the period during which TACE controls tumor progression because sorafenib strongly suppresses post-TACE tumor recur- AbstractThe multikinase inhibitor sorafenib is the first oral molecular targeted agent with proven prognostic benefit in unresectable advanced hepatocellular carcinoma (HCC). However, as with other drugs, sorafenib has its limitations, and various clinical trials have been conducted to develop novel molecular targeted agents for use alone or in combination with existing locoregional therapies. Despite this, clinical trials of molecular targeted agents combined with transarterial chemoembolization (TACE) have not reported major treatment outcomes to date. In this review, we describe previous clinical trials of combination therapy with TACE and a molecular targeted agent in patients with unresectable HCC.

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Section: Proposal Of a New Primary Endpoint In Tace Combination Trialsmentioning

confidence: 99%

Transarterial Chemoembolization in Combination with a Molecular Targeted Agent: Lessons Learned from Negative Trials (Post-TACE, BRISK-TA, SPACE, ORIENTAL, and TACE-2)

Kudo

Arizumi²

2017

Oncology

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“…According to this algorithm, sorafenib is indicated for patients diagnosed with Child-Pugh class A HCC with extrahepatic spread or vascular invasion. Sorafenib is also recommended for patients with Child-Pugh class A HCC where transcatheter arterial chemoembolization (TACE) [7][8][9][10][11] and hepatic arterial infusion chemotherapy [12,13] are not indicated. In the present study, we examined the efficacy of sorafenib treatment and the clinical outcome in 314 patients at 5 general hospitals in Kagawa Prefecture, Japan.…”

Section: Introductionmentioning

confidence: 99%

Hand-Foot Syndrome and Post-Progression Treatment Are the Good Predictors of Better Survival in Advanced Hepatocellular Carcinoma Treated with Sorafenib: A Multicenter Study

et al. 2017

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87.3-170.7) and the median overall survival (OS) was 392 days (95% CI: 316.0-468.0). The OS of the patients with ChildPugh class A HCC was significantly better than that of the patients with Child-Pugh class B HCC ( p < 0.0001). The survival curves for Child-Pugh class A-5 points and class A-6 points were significantly different, with that for class A-5 points being better ( p < 0.0001). A significant difference was observed between the patients who exhibited HFS and those who did not, with the former exhibiting a better survival rate ( p < 0.001). In addition, the survival rate of the patients who received post-progression treatment after sorafenib therapy was significantly better than that of the patients who did not ( p < 0.001). Conclusion: In sorafenib therapy, patients with HFS and those who received post-progression treatment exhibited good OS. © 2017 S. Karger AG, BaselKeywords Hepatocellular carcinoma · Sorafenib · Hand-foot syndrome Abstract Objective: To determine the relationship between treatment outcomes and hand-foot syndrome (HFS), and the relationship between survival rate and post-progression treatment after sorafenib therapy. Methods: The study assessed 314 patients with advanced hepatocellular carcinoma (HCC) treated with sorafenib at 5 general hospitals in Kagawa Prefecture, Japan. Results: At the start of sorafenib therapy, 23.6% of the patients had HCC of a Child-Pugh class other than A. The initial sorafenib dose was 800 mg in 9.2% of the patients and 400 mg in 64.3%. Time to progression was 129 days (95% CI:

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“…These reports suggested that surgical resection could be the best option for HCC patients with BCLC stage B disease. Furthermore, in some patients, TACE resistance due to the repeated TACE procedure should end up in the selection of other treatment strategies, including sorafenib and hepatic arterial infusion chemotherapy (HAIC) [15,16,17,18,19,20,21]. Although TACE is the most frequently selected treatment for the patients in BCLC stage B, other treatment options should be applied depending on the condition of individual patients in the clinical setting.…”

Section: Introductionmentioning

confidence: 99%

Validation of Kinki Criteria, a Modified Substaging System, in Patients with Intermediate Stage Hepatocellular Carcinoma

Arizumi

Ueshima

Iwanishi

et al. 2016

Dig Dis

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Background: The standard treatment option that is available for patients with Barcelona Clinic Liver Cancer (BCLC) stage B hepatocellular carcinoma (HCC) is transarterial chemoembolization (TACE). However, the condition of the patients with BCLC stage B disease is heterogeneous showing different tumor statuses and Child-Pugh scores; treatment strategies other than TACE are frequently employed for the patients in this stage. Based on the subclassification system proposed by Bolondi et al. [Semin Liver Dis 2012;32:348-359], we developed the Kinki criteria focusing on a substaging for BCLC stage B disease, which is simpler and should be more suitable in actual clinical setting in Japan. In this study, we evaluated the performance of Kinki criteria. Summary: This study included 1,633 HCC patients who received first-line treatment at the Kindai University Hospital. Patients were classified into subgroups based on the Kinki criteria and the survival time was estimated for each group. There were 156 (33.3%) patients in subclass B1, 278 (59.3%) in B2, and 35 (7.4%) in B3. The median overall survival times and 95% CI for BCLC B subclasses B1, B2, and B3 were 4.3 years (3.7-4.9), 2.9 years (2.2-3.4), and 1.1 years (0.5-1.8), respectively (p < 0.001). Key Messages: Classification of HCC patients in BCLC stage B based on the Kinki criteria showed statistically significant differences in survival, indicating the performance of Kinki criteria, which takes Child-Pugh score and tumor status into account for determining treatment options for HCC in BCLC stage B.

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Current Status of Hepatic Arterial Infusion Chemotherapy

Cited by 106 publications

References 47 publications

Transarterial Chemoembolization in Combination with a Molecular Targeted Agent: Lessons Learned from Negative Trials (Post-TACE, BRISK-TA, SPACE, ORIENTAL, and TACE-2)

Transarterial Chemoembolization in Combination with a Molecular Targeted Agent: Lessons Learned from Negative Trials (Post-TACE, BRISK-TA, SPACE, ORIENTAL, and TACE-2)

Hand-Foot Syndrome and Post-Progression Treatment Are the Good Predictors of Better Survival in Advanced Hepatocellular Carcinoma Treated with Sorafenib: A Multicenter Study

Validation of Kinki Criteria, a Modified Substaging System, in Patients with Intermediate Stage Hepatocellular Carcinoma

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