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) Ceritinib 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) The development of surrogate markers for locoregional therapies (LRTs) in hepatocellular carcinoma (HCC) is learn more desirable to improve treatment planning and accelerate design and endpoints in clinical trials. Before validation, early imaging surrogate markers face different challenges, including methodological considerations, reproducibility, accuracy to detect real treatment response, and, potentially most important, detection of a survival benefit. In comparison with survival, surrogate endpoints (time to progression [TTP] and progression-free survival) offer the advantage of potentially less-confounding effect by concomitant liver (i.e., cirrhosis, fibrosis) or systemic diseases as well as previous or subsequent locoregional or systemic
treatment.[1] The European Association for the Study of the Liver (EASL) guidelines (2011) advocate the use of enhancing tissue to assess imaging response of HCC.[2] Modified Response Evaluation Criteria in Solid Tumors (mRECIST) were stiripentol devised with keeping this concept in mind and are currently being proposed as the standard methodology of radiological response in HCC.[3] However, few radiological-pathological studies support these criteria; our research group has previously highlighted the relevance of these important correlative concepts for both chemo- and radioembolization.[4-6] Uni- and bidimensional measurements of the entire treated tumor (Response Evaluation Criteria in Solid Tumors [RECIST] and World Health Organization [WHO] criteria) are often criticized, given their lack of correlation with viable tumor.
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