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

Author:

Lee Rheun‐Chuan12ORCID,Liang Po‐Chin34,Liang Huei‐Lung5,Chen Yung‐Fang6,Yu Chun‐Yen78,Cheng Pin‐Nan9ORCID,Hung Chien‐Fu810,Hsia Cheng‐Yuan211,Lai Hsueh‐Chou12,Ho Ming‐Chih13ORCID,Cheng Yu‐Fan78,Liu Yi‐Sheng14,Chao Yee215,Chen Chien‐Hung1617ORCID

Affiliation:

1. Department of Radiology Taipei Veterans General Hospital Taipei Taiwan

2. Institute of Clinical Medicine National Yang Ming Chiao Tung University School of Medicine Taipei Taiwan

3. Department of Medical Imaging National Taiwan University Hospital and College of Medicine Taipei Taiwan

4. Department of Medical Imaging National Taiwan University Hospital Hsin‐Chu Branch Hsin‐Chu Taiwan

5. Department of Radiology Kaohsiung Veterans General Hospital Kaohsiung Taiwan

6. Department of Radiology China Medical University Hospital Taichung Taiwan

7. Department of Diagnostic Radiology Kaohsiung Chang Gung Memorial Hospital Kaohsiung Taiwan

8. College of Medicine Chang Gung University Taoyuan Taiwan

9. Department of Internal Medicine National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University Tainan Taiwan

10. Department of Medical Imaging and Intervention New Taipei City Tucheng Hospital Taoyuan Taiwan

11. Department of Surgery Taipei Veterans General Hospital Taipei Taiwan

12. Department of Internal Medicine China Medical University Hospital, China Medical University Taichung Taiwan

13. Department of Surgery National Taiwan University Hospital and College of Medicine Taipei Taiwan

14. Department of Medical Imaging National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University Tainan Taiwan

15. Department of Oncology Taipei Veterans General Hospital Taipei Taiwan

16. Department of Internal Medicine National Taiwan University Hospital and College of Medicine Taipei Taiwan

17. Department of Medicine National Taiwan University Cancer Center Taipei Taiwan

Abstract

AbstractBackground and AimThe REgistry of Selective Internal radiation therapy in AsiaNs (RESIN) was a multicenter, single‐arm, prospective, observational study of 90Y 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 90Y resin microspheres.MethodsAdults with HCC or mCRC scheduled to receive SIRT with 90Y 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).ResultsOf 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.ConclusionsSafety and efficacy outcomes with the routine use of SIRT with 90Y resin microspheres in Taiwan are consistent with published data.

Funder

Sirtex Medical

Publisher

Wiley

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