SARAH: a randomised controlled trial comparing efficacy and safety of selective internal radiation therapy (with yttrium-90 microspheres) and sorafenib in patients with locally advanced hepatocellular carcinoma

Vilgrain, Valérie; Benameur, M.; Sibert, Annie; Lebtahi, Rachida; Ronot, Maxime; Pageaux, Georges Philippe; Guiu, Boris; Barraud, Hélène; Silvain, Christine; Gerolami, René; Oberti, Frédéric; Raoul, J.L.; Costentin, Charlotte; Samuel, Didier; Dinut, Aurélia; Pereira, Héléna; Châtellier, Gilles; Castéra, Laurent

doi:10.1016/s0168-8278(17)30436-1

Cited by 58 publications

(77 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Our observed lack of significant lung shunting in patients with limited disease (T1‐T3) may permit the consideration of Y90 without mandated lung shunt study, further reducing time to treatment and cost. Although two recent trials have reported on Y90 compared to sorafenib, neither study is publicly available for comprehensive peer review, and the inability of these trials to reach their endpoint in advanced disease should not be conflated with the clear antitumoral effect and clinical applicability of Y90 in nonadvanced T1‐T4a disease . Although speculative, the lack of personalized dosimetry may have contributed to the negative trials.…”

Section: Discussionmentioning

confidence: 99%

Institutional decision to adopt Y90 as primary treatment for hepatocellular carcinoma informed by a 1,000‐patient 15‐year experience

et al. 2018

View full text Add to dashboard Cite

show abstract

Section: Discussionmentioning

confidence: 99%

Institutional decision to adopt Y90 as primary treatment for hepatocellular carcinoma informed by a 1,000‐patient 15‐year experience

et al. 2018

View full text Add to dashboard Cite

show abstract

“…Recently, the results of two trials comparing SIRT to sorafenib in advanced HCC (SARAH trial [NCT01482442] and the SIRveNIB trial [NCT NCT01135056]), have been released [6,7]. Both were designed to demonstrate superiority of SIRT over sorafenib, and failed to meet their primary endpoint: median overall survival was comparable between both treatment groups: 8.0 months with SIRT compared to 9.9 months with sorafenib in the SARAH trial ( p = 0.179), 8.8 months with SIRT compared to 10 months with sorafenib in the SIRveNIB trial ( p = 0.36).…”

Section: Ongoing Research and Future Developmentmentioning

confidence: 99%

“…Indeed, recent data suggest that HCC with MVI might benefit from locoregional therapies alone, or the combination of locoregional and systemic treatments. However, two phase III trials comparing selective internal radiation therapy to sorafenib (SAHAH and SIRveNIB trials) recently failed to meet their primary endpoint to improve survival [6,7]. …”

Section: Introductionmentioning

confidence: 99%

Hepatocellular Carcinoma with Macrovascular Invasion: Defining the Optimal Treatment Strategy

Costentin

Ferrone²,

Arellano

et al. 2017

Liver Cancer

View full text Add to dashboard Cite

Background: Tumoral macrovascular invasion (MVI) of hepatic and/or portal vein branches is a common phenomenon in hepatocellular carcinoma (HCC) and is associated with poorer prognosis when compared to HCC without MVI. Summary: Current international guidelines for the management of HCC recommend sorafenib as the only treatment option in case of MVI. Despite guideline recommendations, several alternative options have been tested to manage HCC with MVI: surgery, transarterial chemoembolization, external or internal radiation, hepatic arterial infusion chemotherapy, percutaneous treatment, cryotherapy, or the combination of two or more of these strategies, with or without sorafenib. Here we will provide a comprehensive state-of-the-art review for the management of this challenging clinical entity based on the most recent available data. Key Messages: There is a growing body of evidence suggesting that alternative strategies to standard-of-care sorafenib might improve survival in patients with advanced HCC with MVI but the level of evidence remains weak. Randomized phase III trials are ongoing and will hopefully provide information leading towards a more personalized treatment algorithm.

show abstract

“…More recently, the initial report from the randomized SARAH trial also suggested similar efficacy of SIRT and sorafenib (median OS 8.0 and 9.9 months in the SIRT and sorafenib groups, respectively, P=0.179), but with patients receiving SIRT having a better quality of life and experiencing fewer AEs than patients receiving sorafenib (82 and 111 treatment-related serious AEs, respectively). Objective response rate was 19.0% and 11.6% (P=0.042) with SIRT and sorafenib, respectively (64). SIRveNIB, with a similar design and patient eligibility to SARAH but conducted in South-East Asia, reported a very similar result (65).…”

Section: Rationale and Recommendationsmentioning

confidence: 90%

Safety of selective internal radiation therapy (SIRT) with yttrium-90 microspheres combined with systemic anticancer agents: expert consensus

Kennedy

Brown

Feilchenfeldt

et al. 2017

J. Gastrointest. Oncol.

View full text Add to dashboard Cite

Selective internal radiation therapy (SIRT) with microspheres labelled with the β-emitter yttrium-90 (Y-90) enables targeted delivery of radiation to hepatic tumors. SIRT is primarily used to treat inoperable primary or metastatic liver tumors. Eligible patients have usually been exposed to a variety of systemic anticancer therapies, including cytotoxic agents, targeted biologics, immunotherapy and peptide receptor radionuclide therapy (PRRT). All these treatments have potential interactions with SIRT; however, robust evidence on the safety of these potential combinations is lacking. This paper provides current clinical experiences and expert consensus guidelines for the use of SIRT in combination with the anticancer treatment agents likely to be encountered in clinical practice. It was agreed by the expert panel that precautions need to be taken with certain drugs, but that, in general, systemic therapies do not necessarily have to be stopped to perform SIRT. The authors recommend stopping vascular endothelial growth factor inhibitors 4-6 weeks before SIRT, and restart after the patient has recovered from the procedure. It may also be prudent to stop potent radiosensitizers such as gemcitabine therapy 4 weeks before SIRT, and restart treatment at least 2-4 weeks later. Data from phase III studies combining SIRT with fluorouracil (5FU) or folinic acid/5FU/oxaliplatin (FOLFOX) suggest that hematological toxicity is more common from the combination than it is from chemotherapy without SIRT. There is no evidence to suggest that chemotherapy increases SIRT-specific gastro-intestinal or liver toxicities.

show abstract

SARAH: a randomised controlled trial comparing efficacy and safety of selective internal radiation therapy (with yttrium-90 microspheres) and sorafenib in patients with locally advanced hepatocellular carcinoma

Cited by 58 publications

References 0 publications

Institutional decision to adopt Y90 as primary treatment for hepatocellular carcinoma informed by a 1,000‐patient 15‐year experience

Institutional decision to adopt Y90 as primary treatment for hepatocellular carcinoma informed by a 1,000‐patient 15‐year experience

Hepatocellular Carcinoma with Macrovascular Invasion: Defining the Optimal Treatment Strategy

Safety of selective internal radiation therapy (SIRT) with yttrium-90 microspheres combined with systemic anticancer agents: expert consensus

Contact Info

Product

Resources

About