trial studies combination transarterial chemoembolization (TACE) and Stereotactic Body Radiation Therapy (SBRT) for BCLC A patients with HCC from 4-7 cm. Materials/Methods: Patients were eligible if they were BCLC A, Child-Pugh score 7, had a single HCC from 4-7 cm, no evidence of macrovascular invasion, no evidence of metastatic disease, ECOG 0, and were not suitable for resection or liver transplantation. Treatment consisted of drug-eluting bead (DEB)-TACE at time 0 and 1 month followed by SBRT completed within 2-3 weeks following TACE. Each DEB-TACE treatment utilized 1 vial of 100-300 micron LC Beads (BTG) loaded with 50mg of doxorubicin. SBRT was delivered from 35-50 Gy in 5 fractions. The primary end-point of the study was best objective response by mRECIST (measured 1 month post-treatment and every 3 months thereafter). Secondary endpoints were progression free survival (PFS), cancer specific survival (CSS), overall survival (OS) assessed using the Kaplan-Meier method.Results: From 2014-2018, 25 patients were enrolled in a single institution with a median follow of 18 months (range 1-47). Baseline patient characteristics are shown in Table 1. Every patient completed the protocol as planned except one who only received DEB-TACEx1 before SBRT. 24 patients had at least one post treatment scan to assess mRECIST response (one patient lost to follow up). Best objective response in the target lesion was 92%: 64% complete response (nZ16), 28% partial response (nZ7), 0%stable disease, and 4% progression of disease (nZ1). Median time to CR was 3 months (range 1-17). 1-and 2-year OS was 80% and 67%, respectively. 1-and 2-year PFS was 67% and 52%, respectively. CSS was 91% at 1 year and 83% at 2 years. Conclusion: Preliminary results from this Phase II trial show very promising response rates when combining TACE+SBRT in large, unresectable HCC with excellent OS, PFS, and CSS. These preliminary data are currently being confirmed in an expanded cohort.
para-aortic nodal involvement (but not VA or SQA indices) were predictors of worse OS on multivariable analysis. Patients with sarcopenia did not have more treatment-related grade 2 and above (48.2% vs 45.7%, p Z 0.84) or grade 3 and above toxicities (24.7% vs 25.7%, p Z 1.0); however, low VA and SQA indices were both associated with increased grade 3 and higher treatment-related toxicities (p Z 0.02 and p<0.01, respectively). Conclusion: Sarcopenia is an independent risk factor for worse OS and PFS among patients treated with CRT for LACC, but does not appear to increase treatment-related toxicity. In contrast, increased VA and SQA may be protective from treatment-related toxicities. While these body composition factors are not easily modifiable at time of cancer diagnosis, they can help guide prognosis. Disruptions in body composition may warrant interventions such as dietary modification or exercise. Prospective studies are needed to investigate tailored treatment planning in terms of radiotherapy volumes, dose, and fractionation in the setting of sarcopenia and low VA and SQA.
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