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01.12.2014 | Original Article—Liver, Pancreas, and Biliary Tract | Ausgabe 12/2014 Open Access

Journal of Gastroenterology 12/2014

Comparison of systems for assessment of post-therapeutic response to sorafenib for hepatocellular carcinoma

Zeitschrift:
Journal of Gastroenterology > Ausgabe 12/2014
Autoren:
Tadaaki Arizumi, Kazuomi Ueshima, Haruhiko Takeda, Yukio Osaki, Masahiro Takita, Tatsuo Inoue, Satoshi Kitai, Norihisa Yada, Satoru Hagiwara, Yasunori Minami, Toshiharu Sakurai, Naoshi Nishida, Masatoshi Kudo
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1007/​s00535-014-0936-0) contains supplementary material, which is available to authorized users.

Abstract

Background

To test the hypothesis that use of the response evaluation criteria in cancer of the liver (RECICL), an improved evaluation system designed to address the limitations of the response evaluation criteria in solid tumors 1.1 (RECIST1.1) and modified RECIST (mRECIST), provides for more accurate evaluation of response of patients with hepatocellular carcinoma (HCC) to treatment with sorafenib, a molecularly targeted agent, as assessed by overall survival (OS).

Methods

The therapeutic response of 156 patients with advanced HCC who had been treated with sorafenib therapy for more than 1 month was evaluated using the RECIST1.1, mRECIST, and RECICL. After categorization as showing progressive disease (PD), stable disease (SD), or objective response, the association between OS and categorization was examined using the Kaplan–Meier method to develop survival curves. The 141 cases categorized as PD or SD by the RECIST1.1, but objective response by the mRECIST and RECICL, were further analyzed for determination of the association between OS and categorization.

Results

Only categorization using the RECICL was found to be significantly correlated with OS (p = 0.0033). Among the patients categorized as SD or PD by the RECIST1.1, reclassification by the RECICL but not the mRECIST was found to be significantly associated with OS and allowed for precise prediction of prognosis (p = 0.0066).

Conclusions

Only the use of the RECICL allowed for identification of a subgroup of HCC patients treated with sorafenib with improved prognosis. The RECICL should, therefore, be considered a superior system for assessment of therapeutic response.

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Zusatzmaterial
Supplementary material 1 (TIFF 836 kb) Supplementary Fig. 1. Inconsistency in assessment of response of hypovascular tumor by the RECIST1.1 and by the mRECIST and RECICL. CE-CT images of a representative case of tumor necrosis at baseline (A, C, E) and serial follow-up (B, D, F) for which response to sorafenib was evaluated by the RECIST1.1 (A, B), mRECIST (C, D), and RECICL (E, F). The arrows in the panel show the direction of the measurement of tumor size. While the response to sorafenib was evaluated as PR by the mRECIST and RECICL due to the presence of necrotic lesions, which both systems consider a sign of response, it was evaluated as SD by the RECIST1.1 due to the lack of change in the size of the target lesion between baseline and post treatment. CE-CT images were obtained during the arterial (40 s) and portal (70 s) phases using 120 ml of iomeprol at a flow rate of 3 ml/second. Dynamic MRI images were obtained by performing Gd-EOB-DTPA-enhanced MRI during the arterial (22–35 s post injection) and portal venous (70 s post injection) phases using a T1-weighted high-resolution sequence in a single breath hold
535_2014_936_MOESM1_ESM.tif
Supplementary material 2 (TIFF 429 kb) Supplementary Fig. 2. Inconsistency in assessment of response of hypovascular tumor by the mRECIST and by the RECIST1.1 and RECICL. CE-CT images of a tumor during the arterial phase (A) and the portal venous phase (B) before sorafenib treatment (baseline) and at 1 month and 2 months after initiation of sorafenib treatment in which the hypovascular area appears enlarged after treatment. While the response to sorafenib was evaluated as PR by the mRECIST due to the decrease in the size of the enhanced area, it was classified as PD by the RECIST1.1 and RECICL due to the increase in the size of the target area by more than 25 %
535_2014_936_MOESM2_ESM.tif
Supplementary material 3 (TIFF 566 kb) Supplementary Fig. 3. Inconsistency in measurement of tumor size or area by the RECIST1.1, mRECIST, and RECICL. CE-CT images of a tumor at baseline (A, C, E) and after sorafenib treatment (B, D, F). The arrows in the panel show the direction of the measurement of tumor size. While the response to sorafenib was classified as PR by RECICL (E, F) due to the 50 % decrease in the size of the enhanced area, it was classified as SD by the RECIST1.1 (A, B) and mRECIST (C, D) due to the lack of change in the size of the tumor between baseline and post-treatment
535_2014_936_MOESM3_ESM.tif
Supplementary material 4 (DOCX 33 kb)
535_2014_936_MOESM4_ESM.docx
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