Radiological-pathological analysis of WHO, RECIST, EASL, mRECIST and DWI: Imaging analysis from a prospective randomized trial of Y90 ± sorafenib

Authors

  • Michael Vouche,

    1. Department of Radiology, Section of Interventional Radiology and Division of Interventional Oncology, Northwestern University, Chicago, IL
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  • Laura Kulik,

    1. Department of Medicine, Division of Hepatology, Northwestern University, Chicago, IL
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  • Rohi Atassi,

    1. Department of Radiology, Section of Interventional Radiology and Division of Interventional Oncology, Northwestern University, Chicago, IL
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  • Khairuddin Memon,

    1. Department of Radiology, Section of Interventional Radiology and Division of Interventional Oncology, Northwestern University, Chicago, IL
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  • Ryan Hickey,

    1. Department of Radiology, Section of Interventional Radiology and Division of Interventional Oncology, Northwestern University, Chicago, IL
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  • Daniel Ganger,

    1. Department of Medicine, Division of Hepatology, Northwestern University, Chicago, IL
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  • Frank H. Miller,

    1. Department of Radiology, Section of Interventional Radiology and Division of Interventional Oncology, Northwestern University, Chicago, IL
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  • Vahid Yaghmai,

    1. Department of Radiology, Section of Interventional Radiology and Division of Interventional Oncology, Northwestern University, Chicago, IL
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  • Michael Abecassis,

    1. Department of Surgery, Division of Transplantation, Northwestern University, Chicago, IL
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  • Talia Baker,

    1. Department of Surgery, Division of Transplantation, Northwestern University, Chicago, IL
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  • Mary Mulcahy,

    1. Department of Medicine, Division of Medical Oncology, Northwestern University, Chicago, IL
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  • Ritu Nayar,

    1. Department of Surgical Pathology, Northwestern University, Chicago, IL
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  • Robert J. Lewandowski,

    1. Department of Radiology, Section of Interventional Radiology and Division of Interventional Oncology, Northwestern University, Chicago, IL
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  • Riad Salem

    Corresponding author
    1. Department of Radiology, Section of Interventional Radiology and Division of Interventional Oncology, Northwestern University, Chicago, IL
    2. Department of Surgery, Division of Transplantation, Northwestern University, Chicago, IL
    3. Department of Medicine, Division of Medical Oncology, Northwestern University, Chicago, IL
    • Address reprint requests to: Riad Salem, M.D., M.B.A., Department of Radiology, Northwestern University, 676 North St. Clair, Suite 800, Chicago, IL 60611. E-mail: r-salem@northwestern.edu; fax: 312-695-0654.

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  • Potential conflict of interest: L.K. and R.S. are advisors to Nordion and Bayer/Onyx. L.K. is on the speakers- bureau and received grants from Bayer/Onyx. M.M. received grants from Nordion. R.S. consults for and received grants from Nordion and consults for Bayer/Onyx.

Abstract

The aim of this study was to compare radiological and pathological changes and test the adjunct efficacy of Sorafenib to Y90 as a bridge to transplantation in hepatocellular carcinoma (HCC). 15 patients with 16 HCC lesions were randomized to Y90 without (Group A, n = 9) or with Sorafenib (Group B, n = 7). Size (WHO, RECIST), enhancement (EASL, mRECIST) and diffusion-weighted imaging criteria (apparent diffusion coefficient, ADC) measurements were obtained at baseline, then at 1 and every 3 months after treatment until transplantation. Percentage necrosis in explanted tumors was correlated with imaging findings. 100%, 50%-99% and <50% pathological necrosis was observed in 6 (67%), 1 (11%), and 2 (22%) tumors in Group A and 3 (42%), 2 (28%), and 2 (28%) in Group B, respectively (P = 0.81). While ADC (P = 0.46) did not change after treatment, WHO (P = 0.06) and RECIST (P = 0.08) response at 1 month failed to reach significance, but significant responses by EASL (P < 0.01/0.03) and mRECIST (P < 0.01/0.03) at 1 and 3 months were observed. Response was equivalent by EASL or mRECIST. No difference in response rates was observed between groups A and B at 1 and 3 months by WHO, RECIST, EASL, mRECIST or ADC measurements. Despite failing to reach significance, smaller baseline size was associated with complete pathological necrosis (CPN) (RECIST: P = 0.07; WHO: P = 0.05). However, a cut-off size of 35 mm was predictive of CPN (P = 0.005). CPN could not be predicted by WHO (P = 0.25 and 0.62), RECIST (P = 0.35 and 0.54), EASL (P = 0.49 and 0.46), mRECIST (P = 0.49 and 0.60) or ADC (P = 0.86 and 0.93). Conclusion: The adjunct of Sorafenib did not augment radiological or pathological response to Y90 therapy for HCC. Equivalent significant reduction in enhancement at 1 and 3 months by EASL/mRECIST was noted. Neither EASL nor mRECIST could reliably predict CPN. (HEPATOLOGY 2013;58:1655–1666)

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