Effectiveness of Sorafenib in Patients with Transcatheter Arterial Chemoembolization (TACE) Refractory and Intermediate-Stage Hepatocellular Carcinoma

Arizumi, Tadaaki; Ueshima, Kazuomi; Minami, Tomohiro; Kono, Masashi; Chishina, Hirokazu; Takita, Masahiro; Kitai, Satoshi; Inoue, Takamitsu; Yada, Norihisa; Hagiwara, Satoru; Minami, Yasunori; Sakurai, Toshiharu; Nishida, Naoshi; Kudo, Masatoshi

doi:10.1159/000367743

Cited by 185 publications

(187 citation statements)

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“…Two pivotal randomized phase III studies, namely the Sorafenib HCC Assessment Randomized Protocol study (7) and the Asian Pacific study (8), demonstrated that patients with unresectable HCC undergoing sorafenib therapy had significantly longer survival time compared with the placebo group. Although >5 years have elapsed since the introduction of sorafenib for the treatment of unresectable HCC in daily clinical practice, sorafenib is still regarded as first-line systemic chemotherapeutic agent for HCC (9)(10)(11). In addition, studies on prognostic factors in patients with HCC who underwent sorafenib therapy have mainly focused on tumor-associated factors, liver function, serum biomarkers and combination therapy with sorafenib (12)(13)(14)(15)(16)(17).…”

Section: Introductionmentioning

confidence: 99%

Prognostic significance of sarcopenia in patients with hepatocellular carcinoma undergoing sorafenib therapy

et al. 2017

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Abstract. The present study aimed to examine the impact of sarcopenia, defined as low muscle mass on computed tomography (CT), prior to sorafenib therapy on the clinical outcomes of patients with hepatocellular carcinoma (HCC) receiving sorafenib therapy. In total, 232 patients with unresectable HCC (median age, 72 years) were analyzed, and the extent of sarcopenia was assessed using CT. Cross-sectional areas (cm 2 ) of the skeletal muscles at the third lumbar vertebra level were determined by manual outlining on the CT images. The cross-sectional areas were normalized for height [skeletal rates, progression-free survival (PFS) rates and best treatment response of the sarcopenia group were retrospectively compared with those of the non-sarcopenia group, and the factors associated with OS and PFS were examined. Sarcopenia was observed in 151 patients (65.1%). There were 165 patients with Child-Pugh A and 67 with Child-Pugh B cirrhosis. In the sarcopenia group, the median treatment duration was 66 days, whereas in the non-sarcopenia group it was 103 days (P=0.001). The median OS time was 174 days in the sarcopenia group and 454 days in the non-sarcopenia group (P<0.0001). The median PFS was 77 days in the sarcopenia group and 106 days in the non-sarcopenia group (P=0.0131). Multivariate analysis identified sarcopenia to be an independent predictor of OS (hazard ratio, 0.365; P<0.0001). The objective response rate and disease control rate in the sarcopenia group were significantly lower, compared with those in the non-sarcopenia group (P=0.0146 and P=0.0151, respectively). In conclusion, sarcopenia may be an indicator of poor clinical course in patients with HCC receiving sorafenib. IntroductionHepatocellular carcinoma (HCC) is one of the major causes of cancer-associated mortality worldwide, accounting for 5.7% of all newly diagnosed malignancies (1-5). The annual incidence rates of HCC are the highest in East Asia and Sub-Saharan Africa, where >80% of all known cases develop (1-5). Advances in treatments for HCC during the last few decades markedly improved the prognosis of the disease (1,2,4,5). However, a curative therapy such as surgical resection may be applied to a limited number (<20%) of patients with HCC (5,6). Sorafenib is a multi-kinase inhibitor that suppresses cancer growth and cell proliferation (7,8). Two pivotal randomized phase III studies, namely the Sorafenib HCC Assessment Randomized Protocol study (7)

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Section: Introductionmentioning

confidence: 99%

Prognostic significance of sarcopenia in patients with hepatocellular carcinoma undergoing sorafenib therapy

et al. 2017

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“…Currently, sorafenib is the only treatment strategy available after failure of TACE [9,10] . However, in clinical practice, "progression" is not determined by development of a new small lesion, and switching from TACE to sorafenib or other therapies does not necessarily happen at this point.…”

Section: Introductionmentioning

confidence: 99%

The Overall Survival of Patients with Hepatocellular Carcinoma Correlates with the Newly Defined Time to Progression after Transarterial Chemoembolization

et al. 2017

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Aim/Background: The ultimate aim of any treatment for hepatocellular carcinoma (HCC) is to improve overall survival (OS); however, the clinical significance of time to progression (TTP) after transarterial chemoembolization (TACE) is unclear. This retrospective study examined the association between OS and the newly defined time to TACE progression (TTTP) to assess whether TTTP can be an alternative to OS in HCC patients with Barcelona Clinic Liver Cancer (BCLC) stage B. Methods: Between January 2006 and December 2013, 592 patients with HCC (BCLC B1, n = 118; BCLC B2, n = 170) underwent TACE. TTTP was then redefined as time to progression from the first image taken after TACE. The relationship between TTTP and OS was then examined based on survival time. Results: Survival analysis revealed significant differences in the OS of patients with BCLC B1 and those with BCLC B2 (median OS: 42.3 months, 95% confidence interval [CI] 34.4-50.7; and 29.3 months, 95% CI 26.1-37.6, respectively, p = 0.0348). The median TTTP values were 9.5 months (95% CI 7.0-10.9) and 5.3 months (95% CI 4.6-6.7), respectively ( p = 0.0078). There was a moderate positive correlation between OS and TTTP for both B1 ( R 2 = 0.6563, p = 0.0045) and B2 ( R 2 = 0.6433, p = 0.0052) substages. There was also a positive correlation between OS and TTTP for the combined B1 and B2 substages Conclusions: There was a moderate correlation between the TTTP and OS of patients with HCC after TACE therapy, where the patients with short TTTP represented short OS, indicating that TTTP is an alternative parameter for survival analysis of HCC patients with BCLC stage B tumors who undergo TACE.

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“…The OS of patients with B1, B2, and B3 HCC according to the Kinki criteria corresponds to that of patients with HCC of BCLC stages A, B, and C. In addition, patients with BCLC substage B2 HCC, especially those with multiple HCC tumors in both lobes, are not good candidates for TACE. For patients with intermediatestage HCC (BCLC-B) who do not respond to TACE, an early switch to sorafenib therapy (rather than repeat ineffective TACE) results in a better survival benefit; therefore, early identification of patients that are refractory to TACE is crucial [14][15][16][17] . These data underscore the importance of establishing globally recognized, common criteria for identifying TACE failure/ refractory patients in order to improve the survival of HCC patients [18] .…”

Section: Hcc (Bclc-c) Patients With Intermediate-stage Hcc (Bclc-b)mentioning

confidence: 99%

A New Era of Systemic Therapy for Hepatocellular Carcinoma with Regorafenib and Lenvatinib

Kudo¹

2017

Liver Cancer

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HCC (BCLC-C), patients with intermediate-stage HCC (BCLC-B)were included in the SHARP study and the Asia Pacific study; therefore, sorafenib is a widely approved agent for systemic therapy not only for advanced-stage HCC but also for unresectable HCC (including intermediate-stage HCC). In fact, sorafenib is often administered to patients with intermediate-stage HCC (BCLC-B) in clinical practice and to 16.4-19.6% of patients in clinical trials worldwide [3][4][5] .The population of patients with intermediate-stage HCC is extremely heterogeneous, comprising 3 main subpopulations: (1) patients with a good prognosis who can be treated with curative therapy, (2) those for whom transarterial chemoembolization (TACE) is indicated, and (3) those for whom TACE is not recommended. This subclassification of intermediate-stage HCC recently became a well-discussed issue, and the Kinki criteria are used to subclassify patients with intermediate-stage HCC [12,13] . The OS of patients with B1, B2, and B3 HCC according to the Kinki criteria corresponds to that of patients with HCC of BCLC stages A, B, and C. In addition, patients with BCLC substage B2 HCC, especially those with multiple HCC tumors in both lobes, are not good candidates for TACE. For patients with intermediatestage HCC (BCLC-B) who do not respond to TACE, an early switch to sorafenib therapy (rather than repeat ineffective TACE) results in a better survival benefit; therefore, early identification of patients that are refractory to TACE is crucial [14][15][16][17] . These data underscore the importance of establishing globally recognized, common criteria for identifying TACE failure/ refractory patients in order to improve the survival of HCC patients [18] .

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Effectiveness of Sorafenib in Patients with Transcatheter Arterial Chemoembolization (TACE) Refractory and Intermediate-Stage Hepatocellular Carcinoma

Cited by 185 publications

References 32 publications

Prognostic significance of sarcopenia in patients with hepatocellular carcinoma undergoing sorafenib therapy

Prognostic significance of sarcopenia in patients with hepatocellular carcinoma undergoing sorafenib therapy

The Overall Survival of Patients with Hepatocellular Carcinoma Correlates with the Newly Defined Time to Progression after Transarterial Chemoembolization

A New Era of Systemic Therapy for Hepatocellular Carcinoma with Regorafenib and Lenvatinib

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