New Data Supporting Modified RECIST (mRECIST) for Hepatocellular Carcinoma

Lencioni, Riccardo

doi:10.1158/1078-0432.ccr-12-3796

Cited by 112 publications

(71 citation statements)

References 12 publications

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“…Modified-RECIST criteria proposed by the European Association for Study of Liver (EASL) were also used to evaluate response as a secondary endpoint of this study. 8 …”

Section: Methodsmentioning

confidence: 99%

A phase II study of TRC105 in patients with hepatocellular carcinoma who have progressed on sorafenib

et al. 2015

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Background: Endoglin is an endothelial cell membrane receptor essential for angiogenesis and highly expressed on the vasculature of many tumor types, including hepatocellular carcinoma (HCC). TRC105 is a chimeric IgG1 anti-CD105 monoclonal antibody that inhibits angiogenesis and tumor growth by endothelial cell growth inhibition, ADCC and apoptosis, and complements VEGF inhibitors. Objective: The aim of this phase II study was to evaluate the efficacy of anti-endoglin therapy with TRC105 in patients with advanced HCC, post-sorafenib. Methods: Patients with HCC and compensated liver function (Childs-Pugh A/B7), ECOG 0/1, were enrolled to a single-arm, phase II study of TRC105 15 mg/kg IV every two weeks. Patients must have progressed on or been intolerant of prior sorafenib. A Simon optimal two-stage design was employed with a 50% four-month PFS target for progression to the second stage. Correlative biomarkers evaluated included DCE-MRI as well as plasma levels of angiogenic biomarkers and soluble CD105. Results: A total accrual of 27 patients was planned. However, because of lack of efficacy and in accordance with the Simon two-stage design, 11 patients were enrolled. There were no grade 3/4 treatment-related toxicities. Most frequent toxicities were headache (G2; N ¼ 3) and epistaxis (G1; N ¼ 4). One patient had a confirmed partial response by standard RECIST criteria and biologic response on DCE-MRI but the four-month PFS was insufficient to proceed to the second stage of the study. Conclusions: TRC105 was well tolerated in this HCC population following sorafenib. Although there was evidence of clinical activity, this did not meet prespecified criteria to proceed to the second stage. TRC105 development in HCC continues as combination therapy with sorafenib.

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“…Modified-RECIST criteria proposed by the European Association for Study of Liver (EASL) were also used to evaluate response as a secondary endpoint of this study. 8 …”

Section: Methodsmentioning

confidence: 99%

A phase II study of TRC105 in patients with hepatocellular carcinoma who have progressed on sorafenib

et al. 2015

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“…(2) For contrast-enhanced CT/MRI, we evaluated the tumor response according to the modified response evaluation criteria in solid tumors (mRECIST) protocol [13].…”

Section: Measurementsmentioning

confidence: 99%

Transarterial chemoembolization for huge hepatocellular carcinoma with diameter over ten centimeters: a large cohort study

et al. 2015

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Patients with huge hepatocellular carcinoma >10 cm in diameter represent a special subgroup for treatment. To date, there are few data and little consensus on treatment strategies for huge hepatocellular carcinoma. In this study, we summarized the effects and safety of transarterial chemoembolization for huge hepatocellular carcinoma. A retrospective study was performed based on a large cohort of patients (n = 511) with huge hepatocellular carcinoma who underwent serial transarterial chemoembolization between January 2008 to December 2011 and were followed up until March 2013. We found median survival time was 6.5 months. On multivariate analysis, Child-Pugh class (A versus B) (p < 0.0001), alpha-fetoprotein (≤400 µg/L) (p = 0.002), Barcelona Clinic Liver Cancer stage (B versus C) (p = 0.013), and other treatments after transarterial chemoembolization such as surgical resection (p = 0.008), radiation (p = 0.018), and local radiofrequency ablation (p = 0.002) were factors significantly associated with better overall patient survival after chemoembolization. Twenty-nine percent of these patients showed a tumor response after serial transarterial chemoembolization. Severe complications were few (4.9%), including oncolytic syndrome (n = 3), tumor rupture (n = 3), gastrointestinal bleeding (n = 4), deep venous thrombosis (n = 3), acute cholecystitis (n = 4), femoral artery pseudoaneurysm (n = 1), acute pancreatitis (n = 1), and acute hepatic failure (n = 6). In conclusion, transarterial chemoembolization is a safe and effective treatment for selected patients with huge hepatocellular carcinoma and is recommended as a component of combination therapy. In addition, patients with good liver function and low alpha-fetoprotein levels may acquire greater survival benefits from transarterial chemoembolization.

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“…As such, numerous radiologic-pathologic studies were conducted with the goal of comparing enhancement-based uni- and bidimensional (one- and two-dimensional) criteria with pathologically estimated tumor necrosis (8,13–15). An important benefit of these techniques is the simplicity and reproducibility of measurements, specifically when using modified Response Evaluation Criteria in Solid Tumors (16). However, by nature of one- and two-dimensional measurements, these methods assume that three-dimensional (3D) tumor growth or response to treatment occurs in a symmetric, spheric manner.…”

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confidence: 99%

Radiologic-Pathologic Analysis of Contrast-enhanced and Diffusion-weighted MR Imaging in Patients with HCC after TACE: Diagnostic Accuracy of 3D Quantitative Image Analysis

Chapiro¹,

et al. 2014

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Purpose To evaluate the diagnostic performance of three-dimensional (3D) quantitative enhancement-based and diffusion-weighted volumetric magnetic resonance (MR) imaging assessment of hepatocellular carcinoma (HCC) lesions in determining the extent of pathologic tumor necrosis after transarterial chemoembolization (TACE). Materials and Methods This institutional review board–approved retrospective study included 17 patients with HCC who underwent TACE before surgery. Semiautomatic 3D volumetric segmentation of target lesions was performed at the last MR examination before orthotopic liver transplantation or surgical resection. The amount of necrotic tumor tissue on contrast material–enhanced arterial phase MR images and the amount of diffusion-restricted tumor tissue on apparent diffusion coefficient (ADC) maps were expressed as a percentage of the total tumor volume. Visual assessment of the extent of tumor necrosis and tumor response according to European Association for the Study of the Liver (EASL) criteria was performed. Pathologic tumor necrosis was quantified by using slide-by-slide segmentation. Correlation analysis was performed to evaluate the predictive values of the radiologic techniques. Results At histopathologic examination, the mean percentage of tumor necrosis was 70% (range, 10%–100%). Both 3D quantitative techniques demonstrated a strong correlation with tumor necrosis at pathologic examination (R2 = 0.9657 and R2 = 0.9662 for quantitative EASL and quantitative ADC, respectively) and a strong intermethod agreement (R2 = 0.9585). Both methods showed a significantly lower discrepancy with pathologically measured necrosis (residual standard error [RSE] = 6.38 and 6.33 for quantitative EASL and quantitative ADC, respectively), when compared with non-3D techniques (RSE = 12.18 for visual assessment). Conclusion This radiologic-pathologic correlation study demonstrates the diagnostic accuracy of 3D quantitative MR imaging techniques in identifying pathologically measured tumor necrosis in HCC lesions treated with TACE.

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New Data Supporting Modified RECIST (mRECIST) for Hepatocellular Carcinoma

Cited by 112 publications

References 12 publications

A phase II study of TRC105 in patients with hepatocellular carcinoma who have progressed on sorafenib

A phase II study of TRC105 in patients with hepatocellular carcinoma who have progressed on sorafenib

Transarterial chemoembolization for huge hepatocellular carcinoma with diameter over ten centimeters: a large cohort study

Radiologic-Pathologic Analysis of Contrast-enhanced and Diffusion-weighted MR Imaging in Patients with HCC after TACE: Diagnostic Accuracy of 3D Quantitative Image Analysis

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