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.
Pardo F (1), Sangro B (2), Lee RC (3), Manas D (4,5), Jeyarajah R (6), Donckier V (7), Maleux G (8), Pinna AD (9), Bester L (10), Morris DL (11), Iannitti D (12), Chow PK (13), Stubbs R (14), Gow PJ (15), Masi G (16), Fisher KT (17), Lau WY (18), Kouladouros K (19), Katsanos G (20), Ercolani G (21), Rotellar F (22), Bilbao JI (23), Schoen M (19).
(1) HPB and Transplant Surgery, Clinica Universidad de Navarra, IDISNA, Pamplona, Navarra, Spain.
(2) Liver Unit, Clinica Universidad de Navarra, IDISNA, CIBEREHD, Pamplona, Navarra, Spain.
(3) Radiology, Taipei Veterans General Hospital and National Yang-Ming University School of Medicine, Taipei, Taiwan.
(4) Institute of Transplantation, University of Newcastle Upon Tyne, Newcastle Upon Tyne, UK.
(5) Newcastle NHS Trust, Newcastle Upon Tyne, UK.
(6) Surgical Oncology, Methodist Dallas Medical Center, Dallas, TX, USA.
(7) Department of Surgery, Institut Jules Bordet, Université Libre de Bruxelles and Centre de Chirurgie Hépato-Biliaire de l'ULB, Brussels, Belgium.
(8) Radiology, University Hospitals Leuven, Louvain, Belgium.
(9) Hepatobiliary and Transplant Surgery, S. Orsola-Malpighi, University of Bologna, Bologna, Italy.
(10) Interventional Radiology, St Vincent's Hospital, Sydney, NSW, Australia.
(11) Department of Surgery, St George Hospital, University of New South Wales, Kogarah, NSW, Australia.
(12) HPB Surgery, Carolinas Medical Center, Charlotte, NC, USA.
(13) Surgical Oncology, National Cancer Center, Singapore, Singapore.
(14) Hepatobiliary Surgery, Wakefield Clinic, Wellington, New Zealand.
(15) Transplant Hepatology, Austin Hospital, Heidelberg, VIC, Australia.
(16) Medical Oncology, Ospedale Santa Chiara, Pisa, Italy.
(17) Department of Surgery, Saint Francis Hospital, Tulsa, OK, USA.
(18) Faculty of Medicine, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong SAR, Hong Kong.
(19) Klinikum Karlsruhe, Karlsruhe, Germany.
(20) Department of Abdominal Surgery, Hôpital Erasme, Université Libre de Bruxelles and Centre de Chirurgie Hépato-Biliaire de l'ULB, Brussels, Belgium.
(21) Hepatobiliary and Transplant Surgery, Sant'Orsola Hospital, University of Bologna, Bologna, Italy.
(22) HPB and Transplant Surgery, Clinica Universidad de Navarra, IDISNA, Pamplona, Navarra, Spain.
(23) Interventional Radiology, Clinica Universidad de Navarra, IDISNA, Pamplona, Navarra, Spain.
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.
CITATION Ann Surg Oncol. 2017 Jun 26. doi: 10.1245/s10434-017-5950-z