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Radiological‐pathological analysis of WHO, RECIST, EASL, mRECIST and DWI: Imaging analysis from a prospective randomized trial of Y90 ± sorafenib
Author(s) -
Vouche Michael,
Kulik Laura,
Atassi Rohi,
Memon Khairuddin,
Hickey Ryan,
Ganger Daniel,
Miller Frank H.,
Yaghmai Vahid,
Abecassis Michael,
Baker Talia,
Mulcahy Mary,
Nayar Ritu,
Lewandowski Robert J.,
Salem Riad
Publication year - 2013
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.26487
Subject(s) - medicine , hepatocellular carcinoma , response evaluation criteria in solid tumors , sorafenib , nuclear medicine , effective diffusion coefficient , clinical endpoint , necrosis , liver transplantation , progressive disease , radiology , randomized controlled trial , transplantation , magnetic resonance imaging , chemotherapy
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. (H EPATOLOGY 2013;58:1655–1666)