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, Fernando; Sangro, Bruno; Lee, Rheun‐Chuan; Manas, Derek; Jeyarajah, Rohan; Donckier, Vincent; Maleux, Geert; Pinna, Antonio; Bester, Lourens; Morris, David L.; Iannitti, David A.; Chow, Pierce K. H.; Stubbs, Richard S.; Gow, Paul J; Masi, Gianluca; Fisher, K.T.; Lau, Wan Yee; Kouladouros, Konstantinos; Katsanos, Georgios; Ercolani, Giorgio; Rotellar, Fernando; Bilbao, José Ignacio; Schoen, Michael R.

doi:10.1245/s10434-017-5950-z

Cited by 47 publications

(38 citation statements)

References 45 publications

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“…Moreover, the reluctance of surgeons to operate on livers treated with 90 Y‐labelled resin microspheres, owing to uncertainties over the safety of such an approach, may also have reduced the resection rate in the SIRT arm of SIRFLOX. Recently published data have demonstrated that mortality and complication rates in patients undergoing liver surgery after SIRT appeared acceptable given the risk profile of those particular patients; although further data are needed, these results may reassure physicians regarding the feasibility of this approach.…”

Section: Discussionmentioning

confidence: 96%

Secondary technical resectability of colorectal cancer liver metastases after chemotherapy with or without selective internal radiotherapy in the randomized SIRFLOX trial

Garlipp

Gibbs

Hazel

et al. 2019

British Journal of Surgery

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BackgroundSecondary resection of initially unresectable colorectal cancer liver metastases (CRLM) can prolong survival. The added value of selective internal radiotherapy (SIRT) to downsize lesions for resection is not known. This study evaluated the change in technical resectability of CRLM with the addition of SIRT to FOLFOX‐based chemotherapy.MethodsBaseline and follow‐up hepatic imaging of patients who received modified FOLFOX (mFOLFOX6: fluorouracil, leucovorin, oxaliplatin) chemotherapy with or without bevacizumab (control arm) versus mFOLFOX6 (with or without bevacizumab) plus SIRT using yttrium‐90 resin microspheres (SIRT arm) in the phase III SIRFLOX trial were reviewed by three or five (of 14) expert hepatopancreatobiliary surgeons for resectability. Reviewers were blinded to one another, treatment assignment, extrahepatic disease status, and information on clinical and scanning time points. Technical resectability was defined as at least 60 per cent of reviewers (3 of 5, or 2 of 3) assessing a patient's liver metastases as surgically removable.ResultsSome 472 patients were evaluable (SIRT, 244; control, 228). There was no significant baseline difference in the proportion of technically resectable liver metastases between SIRT (29, 11·9 per cent) and control (25, 11·0 per cent) arms (P = 0·775). At follow‐up, significantly more patients in both arms were deemed technically resectable compared with baseline: 159 of 472 (33·7 per cent) versus 54 of 472 (11·4 per cent) respectively (P = 0·001). More patients were resectable in the SIRT than in the control arm: 93 of 244 (38·1 per cent) versus 66 of 228 (28·9 per cent) respectively (P < 0·001).ConclusionAdding SIRT to chemotherapy may improve the resectability of unresectable CRLM.

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Section: Discussionmentioning

confidence: 96%

Secondary technical resectability of colorectal cancer liver metastases after chemotherapy with or without selective internal radiotherapy in the randomized SIRFLOX trial

Garlipp

Gibbs

Hazel

et al. 2019

British Journal of Surgery

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“…[25,49,50]. A time interval of 2 to 3 months between the last RE application and hepatic resection is recommended as optimal timing for resection [51]. However, there is also evidence for feasible secondary liver resection even 20 months following RE (n = 12) with acceptable morbidity (50%) and 90-day mortality (8%) rates [52].…”

Section: Discussionmentioning

confidence: 99%

Contralateral Liver Hypertrophy and Oncological Outcome Following Radioembolization with 90Y-Microspheres: A Systematic Review

Birgin

Rasbach

Seyfried

et al. 2020

Cancers

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Radioembolization with 90Y-microspheres has been reported to induce contralateral liver hypertrophy with simultaneous ipsilateral control of tumor growth. The aim of the present systematic review was to summarize the evidence of contralateral liver hypertrophy and oncological outcome following unilateral treatment with radioembolization. A systematic literature search using the MEDLINE, EMBASE, and Cochrane libraries for studies published between 2008 and 2020 was performed. A total of 16 studies, comprising 602 patients, were included. The median kinetic growth rate per week of the contralateral liver lobe was 0.7% and declined slightly over time. The local tumor control was 84%. Surgical resection after radioembolization was carried out in 109 out of 362 patients (30%). Although the available data suggest that radioembolization prior to major hepatectomy is safe with a promising oncological outcome, the definitive role of radioembolization requires assessment within controlled clinical trials.

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“…(69)(70)(71)(72) Progress in interventional radiology, oncology, radiotherapy, and immunotherapy for the treatment of colorectal liver metastases makes it unlikely, however, Grat et al (63) that LT will evolve as a standard therapy even in patients with unresectable liver metastases. (3,73) Critical Appraisal…”

Section: Lt For Liver-only Metastatic Colorectal Cancermentioning

confidence: 99%

Con: Liver transplantation for expanded criteria malignant diseases

Schaefer¹,

Zoller²,

Schneeberger

2017

Liver Transpl

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Organ shortage requires policies and guidelines to aid organ allocation along the principles of urgency or utility. Identifying patients with significant benefit and withholding liver transplantation (LT) from patients too sick for transplantation are ongoing challenges, in particular in patients with malignancies. An arbitrary threshold of >50% 5-year overall survival (OS) is broadly considered a minimum standard for LT. In patients transplanted for intrahepatic cholangiocarcinoma (iCC), this was only achieved in select cases and when the tumor had a diameter of <2 cm. In patients with extrahepatic and hilar cholangiocarcinoma (CCC), strict selection criteria and combined preoperative radiotherapy/chemotherapy according to the Mayo protocol showed that acceptable longterm results can be achieved in a single high-volume center but are difficult to repeat elsewhere. Furthermore, only rigorously selected patients with neuroendocrine tumors (NETs) meeting the NET Milan criteria adopted by United Network for Organ Sharing can also have >50% 5-year OS. A prospective study in patients with unresectable colorectal cancer metastases in the liver has shown promising OS rates, but further prospective trials are warranted. Current evidence shows that none of the proposed expanded malignant criteria justify deviation of scarce donor organs to patients with hilar CCC, iCC > 2 cm, metastatic NET beyond NET Milan criteria, or metastatic colorectal cancer (CRC) outside clinical trials.Liver Transplantation 24 104-111 2018 AASLD.Received September 1, 2017; accepted October 4, 2017. Utility of Liver Transplantation for Malignant DiseasesListing, delisting, and allocation policies aim at selecting patients with a projected 5-year survival rate of over 50% and is referred to as rationing. (1) As a result, allocation and distribution policies are not restricted to the best interest of an individual patient. To avoid ethical conflicts and litigations for physicians, treatment guidelines and allocation policies have been introduced by national transplant programs. (2) These recommendations and policies are based on empirical data with the aim to allocate donor livers to patients with the greatest need and best utility to society. (1) Recent reports suggest that selected patients with hepatobiliary malignancies despite advanced tumor stage but favorable tumor biology can have outcomes that are at least equivalent or even better than patients meeting conventional listing criteria. Expanded CriteriaIndividual candidates with tumors exceeding these criteria or with neuroendocrine tumors (NETs) or

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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

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

Cited by 47 publications

References 45 publications

Secondary technical resectability of colorectal cancer liver metastases after chemotherapy with or without selective internal radiotherapy in the randomized SIRFLOX trial

Secondary technical resectability of colorectal cancer liver metastases after chemotherapy with or without selective internal radiotherapy in the randomized SIRFLOX trial

Contralateral Liver Hypertrophy and Oncological Outcome Following Radioembolization with 90Y-Microspheres: A Systematic Review

Con: Liver transplantation for expanded criteria malignant diseases

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