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Annals of Surgical Oncology

, Volume 24, Issue 9, pp 2465–2473 | Cite as

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

  • Fernando PardoEmail author
  • Bruno Sangro
  • Rheun-Chuan Lee
  • Derek Manas
  • Rohan Jeyarajah
  • Vincent Donckier
  • Geert Maleux
  • Antonio D. Pinna
  • Lourens Bester
  • David L. Morris
  • David Iannitti
  • Pierce K. Chow
  • Richard Stubbs
  • Paul J. Gow
  • Gianluca Masi
  • Kevin T. Fisher
  • Wan Y. Lau
  • Konstantinos Kouladouros
  • Georgios Katsanos
  • Giorgio Ercolani
  • Fernando Rotellar
  • José I. Bilbao
  • Michael Schoen
Hepatobiliary Tumors

Abstract

Background

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).

Methods

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.

Results

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.

Conclusions

In 100 patients undergoing liver surgery after receiving SIRT, mortality and complication rates appeared acceptable given the risk profile of the recruited patients.

Notes

Acknowledgments

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.

Funding

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.

Disclosure

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.

Supplementary material

10434_2017_5950_MOESM1_ESM.docx (31 kb)
Supplementary material 1 (DOCX 30 kb)

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Copyright information

© Society of Surgical Oncology 2017

Authors and Affiliations

  • Fernando Pardo
    • 1
    Email author
  • Bruno Sangro
    • 2
  • Rheun-Chuan Lee
    • 3
  • Derek Manas
    • 4
    • 5
  • Rohan Jeyarajah
    • 6
  • Vincent Donckier
    • 7
  • Geert Maleux
    • 8
  • Antonio D. Pinna
    • 9
  • Lourens Bester
    • 10
  • David L. Morris
    • 11
  • David Iannitti
    • 12
  • Pierce K. Chow
    • 13
  • Richard Stubbs
    • 14
  • Paul J. Gow
    • 15
  • Gianluca Masi
    • 16
  • Kevin T. Fisher
    • 17
  • Wan Y. Lau
    • 18
  • Konstantinos Kouladouros
    • 19
  • Georgios Katsanos
    • 20
  • Giorgio Ercolani
    • 21
  • Fernando Rotellar
    • 1
  • José I. Bilbao
    • 22
  • Michael Schoen
    • 19
  1. 1.HPB and Transplant SurgeryClinica Universidad de Navarra, IDISNAPamplonaSpain
  2. 2.Liver UnitClinica Universidad de Navarra, IDISNA, CIBEREHDPamplonaSpain
  3. 3.RadiologyTaipei Veterans General Hospital and National Yang-Ming University School of MedicineTaipeiTaiwan
  4. 4.Institute of TransplantationUniversity of Newcastle Upon TyneNewcastle Upon TyneUK
  5. 5.Newcastle NHS TrustNewcastle Upon TyneUK
  6. 6.Surgical OncologyMethodist Dallas Medical CenterDallasUSA
  7. 7.Department of Surgery, Institut Jules BordetUniversité Libre de Bruxelles and Centre de Chirurgie Hépato-Biliaire de l’ULBBrusselsBelgium
  8. 8.RadiologyUniversity Hospitals LeuvenLouvainBelgium
  9. 9.Hepatobiliary and Transplant Surgery, S. Orsola-MalpighiUniversity of BolognaBolognaItaly
  10. 10.Interventional RadiologySt Vincent’s HospitalSydneyAustralia
  11. 11.Department of Surgery, St George HospitalUniversity of New South WalesKogarahAustralia
  12. 12.HPB SurgeryCarolinas Medical CenterCharlotteUSA
  13. 13.Surgical OncologyNational Cancer CenterSingaporeSingapore
  14. 14.Hepatobiliary SurgeryWakefield ClinicWellingtonNew Zealand
  15. 15.Transplant HepatologyAustin HospitalHeidelbergAustralia
  16. 16.Medical OncologyOspedale Santa ChiaraPisaItaly
  17. 17.Department of SurgerySaint Francis HospitalTulsaUSA
  18. 18.Faculty of MedicineThe Chinese University of Hong KongShatinHong Kong
  19. 19.Klinikum KarlsruheKarlsruheGermany
  20. 20.Department of Abdominal Surgery, Hôpital ErasmeUniversité Libre de Bruxelles and Centre de Chirurgie Hépato-Biliaire de l’ULBBrusselsBelgium
  21. 21.Hepatobiliary and Transplant Surgery, Sant’Orsola HospitalUniversity of BolognaBolognaItaly
  22. 22.Interventional RadiologyClinica Universidad de Navarra, IDISNAPamplonaSpain

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