Efficacy and safety of irinotecan drug-eluting CalliSpheres beads in treating unresectable gastrointestinal cancer liver metastases

Abstract

Abstract Background Drug eluting beads transarterial chemoembolization (DEB-TACE) is considered as an effective and safe method in treating hepatocellular carcinoma. CalliSpheres beads (CB) is a novel microsphere product in China. Currently, few studies reported efficacy and safety of DEB-TACE with irinotecan-eluting CB in treating unresectable gastrointestinal cancer liver metastases (GRLM). This study aimed to evaluate the clinical outcomes of DEB-TACE with irinotecan-eluting CB in treating unresectable GRLM. Methods From May 2016 to May 2022, 28 patients with unresectable GRLM who were treated with DEB-TACE with irinotecan-eluting CB procedures were studied. Objective response rate (ORR) and disease control rate (DCR) were primary endpoints, Overall survival and progression-free survival (PFS) were the minor endpoints. Other indexes such as Child-Pugh class, systemic treatments and adverse events were assessed before or after procedure. Results ORR and DCR were 18.2% and 86.4%, respectively, at 1 month; were 27.8% and 61.1%, respectively, at 3 months; then were 21.4% and 50.0%, respectively at 6 months. As for survival profiles, 1-year overall survival was 70.0%; 3-year overall survival was 37.5%; the median overall survival and PFS were 15.2 months and 5.2 months, respectively. No severe adverse events were observed during and after DEB-TACE. The most common complication was abdominal pain (n = 13). Besides, nausea, fever, vomiting were observed in 5, 4 and 5 patients, respectively. Conclusions DEB-TACE with irinotecan-eluting CB is effective and safe, with good tolerance in treating unresectable GRLM.