title: Radiological-pathological analysis of WHO, RECIST, EASL, mRECIST and DWI: Imaging analysis from a prospective randomized trial of Y90 ± sorafenib.
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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Radiology, Section of Interventional Radiology and Division of Interventional Oncology, Northwestern University, Chicago, IL.
authors.forename: Michael
authors.initials: M
authors.lastname: Vouche
authors.forename: Laura
authors.initials: L
authors.lastname: Kulik
authors.forename: Rohi
authors.initials: R
authors.lastname: Atassi
authors.forename: Khairuddin
authors.initials: K
authors.lastname: Memon
authors.forename: Ryan
authors.initials: R
authors.lastname: Hickey
authors.forename: Daniel
authors.initials: D
authors.lastname: Ganger
authors.forename: Frank H
authors.initials: FH
authors.lastname: Miller
authors.forename: Vahid
authors.initials: V
authors.lastname: Yaghmai
authors.forename: Michael
authors.initials: M
authors.lastname: Abecassis
authors.forename: Talia
authors.initials: T
authors.lastname: Baker
authors.forename: Mary
authors.initials: M
authors.lastname: Mulcahy
authors.forename: Ritu
authors.initials: R
authors.lastname: Nayar
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Lewandowski
authors.forename: Riad
authors.initials: R
authors.lastname: Salem
mesh_terms: D000368:Aged; D006528:Carcinoma, Hepatocellular / Q000473:pathology / Q000628:therapy*; D038524:Diffusion Magnetic Resonance Imaging / Q000379:methods*; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000473:pathology / Q000628:therapy; D008297:Male; D008863:Microspheres; D008875:Middle Aged; D009536:Niacinamide / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000627:therapeutic use*; D011446:Prospective Studies; D000077157:Sorafenib; D013668:Technetium Tc 99m Aggregated Albumin / Q000008:administration & dosage; D014944:World Health Organization; D015021:Yttrium Radioisotopes / Q000627:therapeutic use*
chemical_list: D010671:Phenylurea Compounds; D013668:Technetium Tc 99m Aggregated Albumin; D015021:Yttrium Radioisotopes; D009536:Niacinamide; D000077157:Sorafenib