The Post-SIR-Spheres Surgery Study (P4S): Retrospective Analysis of Safety Following Hepatic Resection or Transplantation in Patients Previously Treated with Selective Internal Radiation Therapy with Yttrium-90 Resin Microspheres
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Reports show that selective internal radiation therapy (SIRT) may downsize inoperable liver tumors to resection or transplantation, or enable a bridge-to-transplant. A small-cohort study found that long-term survival in patients undergoing resection following SIRT appears possible but no robust studies on postsurgical safety outcomes exist. The Post-SIR-Spheres Surgery Study was an international, multicenter, retrospective study to assess safety outcomes of liver resection or transplantation following SIRT with yttrium-90 (Y-90) resin microspheres (SIR-Spheres®; Sirtex).
Data were captured retrospectively at participating SIRT centers, with Y-90 resin microspheres, surgery (resection or transplantation), and follow-up for all eligible patients. Primary endpoints were perioperative and 90-day postoperative morbidity and mortality. Standard statistical methods were used.
The study included 100 patients [hepatocellular carcinoma: 49; metastatic colorectal cancer (mCRC): 30; cholangiocarcinoma, metastatic neuroendocrine tumor, other: 7 each]; 36% of patients had one or more lines of chemotherapy pre-SIRT. Sixty-three percent of patients had comorbidities, including hypertension (44%), diabetes (26%), and cardiopathy (16%). Post-SIRT, 71 patients were resected and 29 received a liver transplant. Grade 3+ peri/postoperative complications and any grade of liver failure were experienced by 24 and 7% of patients, respectively. Four patients died <90 days postsurgery; all were trisectionectomies (mCRC: 3; cholangiocarcinoma: 1) and typically had one or more previous chemotherapy lines and presurgical comorbidities.
In 100 patients undergoing liver surgery after receiving SIRT, mortality and complication rates appeared acceptable given the risk profile of the recruited patients.
The authors acknowledge the editorial assistance provided by Martin Gilmour of ESP Bioscience, Crowthorne, UK, funded by Sirtex, during the preparation of this manuscript. The guidelines issued by the International Committee of Medical Journal Editors and Good Publication Practice-3 were adhered to for the development of the manuscript.
This study was sponsored by Sirtex, with set funding provided for each study entrant, assuming 80% of the required data were collected. The authors received no payment for their involvement as authors of this manuscript.
Independently of P4S, the authors declare the following additional conflicts. Fernando Pardo has received lecture and consulting fees from Sirtex Medical; Bruno Sangro has received lecture and consulting fees from Sirtex Medical; Derek Manas has received support for travel to meetings, as well as honoraria for lecturing and attendance at advisory boards from Sirtex Medical; Pierce K. Chow has received honoraria and research grants from Sirtex Medical; Fernando Rotellar has received travel support and lecture and consulting fees from Sirtex Medical; IB has received lecture fees from Sirtex Medical. Paul J. Gow, Geert Maleux,Gianluca Masi, Lourens Bester, David L. Morris, Wan Y. Lau, Konstantinos Kouladouros, Georgios Katsanos, and Giorgio Ercolani have no conflict of interest to declare.
- 11.Gulec SA, Pennington K, Hall M, Fong Y. Preoperative Y-90 microsphere selective internal radiation treatment for tumor downsizing and future liver remnant recruitment: a novel approach to improving the safety of major hepatic resections. World J Surg Oncol. 2009;7:6.CrossRefPubMedPubMedCentralGoogle Scholar
- 13.13. Inarrairaegui M, Pardo F, Bilbao JI, et al. Response to radioembolization with yttrium-90 resin microspheres may allow surgical treatment with curative intent and prolonged survival in previously unresectable hepatocellular carcinoma. Eur J Surg Oncol. 2012;38:594–601.CrossRefPubMedGoogle Scholar
- 42.Yankol Y, Mecit N, Kanmaz T, et al. Lessons learned from review of a single center experience with 500 consecutive liver transplants in a region with insufficient deceased-donor support. Exp Clin Transpl 2016;14(2):191–200.Google Scholar