Incidence and risk factors for sustained hepatic function toxicity 6 months after radioembolization: analysis of the radiation-emitting sir-spheres in non-resectable liver tumor (RESIN) registry

Abstract

Background: To quantify rates and risk factors for toxicity after hepatic radioembolization using resin yttrium-90 microspheres.Methods: Radiation-Emitting SIR-Spheres in Non-resectable liver tumor (RESIN) registry enrollees were reviewed with 614 patients included. Mean patient age was 63.1±12.5 years. The majority of patients were male (n=375, 61%) and white (n=490, 80%). Common tumor types were hepatocellular (n=197, 32%), colorectal (n=187, 30%) and neuroendocrine (n=56, 9%). Hepatotoxicity was measured using the Common Terminology Criteria for Adverse Events (CTCAE v 5). Potential risk factors for hepatotoxicity were tested using the Kruskal-Wallis or Pearson Chi-squared tests, and multivariate linear regressions.Results: At 6 months, 115 patients (18.7%) died (n=91, 14.8%), entered hospice (n=20, 3.3%) or sought treatment elsewhere (n=4, 4%). Seven (1.1%) deaths were from liver decompensation. Grade 3 toxicity rates were: bilirubin (n=85, 13.8%), albumin (n=28, 4.6%), ALT (n=26, 4.2%) and AST (n=37, 6.0%). For each of these liver function test components, baseline abnormal labs predicted Grade 3 toxicity at followup by Kruskal-Wallis test (P<0.001) and linear regression (all P<0.03). Other significant factors predicting toxicity at regression included elevated Body-Mass Index (albumin P=0.0056), whole liver treatment (bilirubin P=0.046), and lower tumor volume (ALT and INR, P<0.035 for both).Conclusions: Baseline liver function abnormalities prior to radioembolization is the strongest predictor of post-treatment Grade 3 toxicity with rates as high as 13.8%. Toxicity rates for specific lab values are affected by large volume treatments especially with low tumor volumes.

Prognostic Factors for Effectiveness Outcomes After Transarterial Radioembolization in Metastatic Colorectal Cancer: Results From the Multicentre Observational Study CIRT

“…Other studies evaluating safety data observed that the occurrence of SAEs can range from 3% to 15% (29)(30)(31)(32)(33). The dataset from the French prospective multicentre observational study CIRSE Registry for SIR-Spheres in France (CIRT-FR) reported 27% SAE occurrence in 63 mCRC patients treated with TARE (data forthcoming).…”

Predictive Factors for Adverse Event Outcomes After Transarterial Radioembolization with Yttrium-90 Resin Microspheres in Europe: Results from the Prospective Observational CIRT Study

“…Prior studies that identified prognostic factors for AEs were based on small retrospective cohorts [ 27 – 29 ]. The exception was the RESIN study, which included 614 patients with various indications and reported on predictors for AEs within 6 months after treatment [ 30 ].…”

Cost-effectiveness analysis of personalised versus standard dosimetry for selective internal radiation therapy with TheraSphere in patients with hepatocellular carcinoma

“…Another point relates to the impact of disease severity or risk factors on the cost-effectiveness of personalised dosimetry. The good safety profile of the tailored approach is probably the result of accurate patient selection, with the inclusion of patients with good liver function and a hepatic reserve of at least 30% after selective internal radiation therapy ( 8 ); on the other side, baseline liver function abnormalities, prior to radioembolisation, have shown to be predictors of post-treatment toxicities ( 48 ). Also, the amount of activity administered to target the liver volume can be considered a risk factor of experiencing SIRT-related side effects ( 49 ).…”