Multicenter evaluation of the safety and efficacy of selective internal radiation therapy with yttrium‐90 resin microspheres in Taiwan: data from the RESIN registry

Abstract Background and Aim The RE gistry of S elective I nternal radiation therapy in Asia N s (RESIN) was a multicenter, single‐arm, prospective, observational study of 90 Y resin microspheres in patients with hepatocellular carcinoma (HCC) or metastatic colorectal cancer (mCRC) from Taiwan. RESIN is the first real‐life clinical study of this therapy in an Asian cohort. Study objectives were to evaluate the safety and efficacy of 90 Y resin microspheres. Methods Adults with HCC or mCRC scheduled to receive SIRT with 90 Y resin microspheres were included. Primary endpoints were best overall response rate (ORR), adverse events, and changes from baseline in liver function. Secondary efficacy endpoints included overall survival (OS). Results Of 107 enrolled patients, 83 had HCC, and 24 had mCRC. ORR was 55.41% (HCC) and 33.33% (mCRC). Of 58 HCC patients with 6‐month post‐SIRT data, 13.79% ( n = 8) had resection, transplantation, transarterial chemoembolization, or radiofrequency ablation as the result of down‐staging or down‐sizing of their lesions. One hundred and ten treatment emergent adverse events (TEAEs) were reported in 51 patients, and five serious adverse events (SAEs) were reported in five patients. The most frequent TEAEs were abdominal pain, nausea and decreased appetite (HCC), and abdominal pain, decreased appetite, fatigue, and vomiting (mCRC). Two deaths due to SAEs (probably related to SIRT) were reported, both in patients with extensive HCC, active hepatitis infection, and other comorbidities. Median OS was 24.07 (HCC) and 12.66 (mCRC) months. Conclusions Safety and efficacy outcomes with the routine use of SIRT with 90 Y resin microspheres in Taiwan are consistent with published data.