Development of a prognostic score to predict response to Yttrium-90 radioembolization for hepatocellular carcinoma with portal vein invasion

Spreafico, Carlo; Sposito, Carlo; Vaiani, Marta; Cascella, Tommaso; Bhoori, Sherrie; Morosi, Carlo; Lanocita, Rodolfo; Romito, Raffaele; Chiesa, Carlo; Maccauro, Marco; Marchianò, Alfonso; Mazzaferro, Vincenzo

doi:10.1016/j.jhep.2017.12.026

Cited by 105 publications

(75 citation statements)

References 39 publications

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“…60 A prognostic model was prospectively constructed in patients with HCC and PVT (excluding main PVT) to select appropriate candidates for TARE based on anticipated OS after TARE. 61 This model is comprised of 3 distinct clinical variables that are assigned points: bilirubin (≤1. This prognostic score importantly identifies a subset of patients in whom the expected median OS is inferior to systemic therapy and therefore Y90 should be deferred.…”

Section: Key Pointmentioning

confidence: 99%

“…Additionally, both trials were conducted in geographic locations where the availability of TARE was limited outside the context of a clinical trial, whereas the most encouraging results have come from single centres with significant experience with TARE. 61,69 There was no use of boosted radiation, which has thus far been limited to glass microspheres. Lastly, OS was calculated from time of randomisation.…”

Section: Key Pointmentioning

confidence: 99%

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Role of locoregional therapies in the wake of systemic therapy

Palmer

Malagari

Kulik

2020

Journal of Hepatology

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Multiple systemic agents have recently been approved in the first-and second-line setting for hepatocellular carcinoma (HCC), increasing the therapeutic options for patients and treating physicians. The randomised controlled trials that led to these approvals were predominantly conducted in a population comprised of patients with advanced HCC. However, these trials also included a subset of patients who had progressed after locoregional therapies (LRTs), mostly transarterial chemoembolisation. With a greater number of systemic agents available, the role of LRTs has become a topic of debate, specifically regarding when to transition to systemic therapy in unresectable HCC and the potential opportunities for combining locoregional and systemic therapies. Trials of immuno-oncology agents (notably T cell checkpoint inhibitors) are ongoing in the advanced disease setting and these agents also present opportunities for combination therapies, both with other systemic agents and with LRTs in earlier stage disease. This article will review strategies to guide patient selection for LRT as well as the development of locoregional-systemic combinations based on scientific rationale and the challenges of clinical trial design in this setting.

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Section: Key Pointmentioning

confidence: 99%

Section: Key Pointmentioning

confidence: 99%

Role of locoregional therapies in the wake of systemic therapy

Palmer

Malagari

Kulik

2020

Journal of Hepatology

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“…Furthermore, an increase in intratumoral pressure, resulting from elevated temperature during the ablation process, might induce the release of tumor cells to the peritoneum. Given that portal venous tumor thrombus and peritoneal dissemination were poor prognostic factors and their treatments are limited, patients with uncontrollable tumors by RFA should be surgically resected before tumor development into the portal vein. In addition, due to a wide range and dense adhesion of the liver surface after RFA, combined resection with adjacent organs, such as the diaphragm, might be necessary.…”

Section: Discussionmentioning

confidence: 99%

Liver resection for recurrent hepatocellular carcinoma after radiofrequency ablation therapy

Yamagishi

Midorikawa

Nakayama

et al. 2019

Hepatology Research

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Aim: Although radiofrequency ablation (RFA) is an effective local treatment of hepatocellular carcinoma (HCC), local recurrence is relatively frequent. We aimed to elucidate the validity of salvage liver resection for recurrent HCC after RFA.Methods: Patients who underwent liver resection for recurrent HCC after RFA (LR after RFA) and those who underwent second liver resection for recurrent HCC (second LR) were included. The short-term outcomes were compared between the two groups. The survival rates between the two groups were compared after propensity-score matching to adjust for the variables, including patient background, liver function, and tumor status.Results: Major resection was frequently carried out in the LR after RFA group, but there was no significant difference both in operative data and complication rate between LR after RFA (n = 54) and second LR (n = 266) groups. After a median followup period of 1.8 years (range, 0.2-10.5), the median overall survival was 4.4 years (95% confidence interval [CI], 2.2not applicable) and 5.6 years (95% CI, 4.5-7.3; P = 0.023) in the LR after RFA group (n = 54) and second LR group (n = 54), respectively, and recurrence-free survival was 1.3 years (0.4-2.2) and 1.2 years (0.5-1.8, P = 0.469), respectively. The only independent factor for overall survival of the LR after RFA group was local recurrence (hazard ratio, 2.73; 1.06-9.00). Conclusions: Salvage liver resection of recurrent HCC afterRFA could be recommended due to the safety of the procedure, especially in patients without local tumor progression after RFA.

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“…Treatment of HCC associated with PVTT would be a good indication for TheraSphere microspheres because the small size and number of TheraSphere microspheres administered makes them less embolic than other devices, and the ensuing effect on vascular dynamics is smaller than with other devices [ 43 - 45 ]. TARE with TheraSphere microspheres was found to be tolerable and effective in HCC patients with branch or lobar PVTT [ 44 , 46 , 47 ].…”

Section: Discussionmentioning

confidence: 99%

Intra-Arterial TheraSphere Yttrium-90 Glass Microspheres in the Treatment of Patients With Unresectable Hepatocellular Carcinoma: Protocol for the STOP-HCC Phase 3 Randomized Controlled Trial

Chauhan¹,

Bukovcan²,

Boucher³

et al. 2018

JMIR Res Protoc

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BackgroundGlobally, hepatocellular carcinoma is the second most common cause of cancer deaths. It remains challenging to intensify cancer treatment without impairing liver function.ObjectiveThe objective of the TheraSphere in the Treatment of Patients with Unresectable Hepatocellular Carcinoma (STOP-HCC) study is to examine the hypothesis that transarterial radioembolization (TheraSphere yttrium-90 glass microspheres) combined with standard first-line treatment with sorafenib will improve outcomes over treatment with sorafenib alone in unresectable hepatocellular carcinoma. The STOP-HCC study is the largest international, multicenter, prospective study of intra-arterial treatment in combination with sorafenib in unresectable hepatocellular carcinoma. Here we report the study design.MethodsSTOP-HCC is a prospective, phase 3, open-label, randomized controlled study conducted across up to 105 sites in North America, Europe, and Asia. Eligible adults have unresectable hepatocellular carcinoma and a life expectancy of at least 12 weeks, 1 or more unidimensional measurable lesions, Child-Pugh score 7 points or less, and Eastern Cooperative Oncology Group Performance Status score 1 or lower, and are candidates for treatment with sorafenib. Presence of branch portal vein tumor thrombosis is permitted. Patients were randomly assigned in a 1:1 ratio to receive either sorafenib alone or transarterial radioembolization followed by sorafenib within 2 to 6 weeks. The primary outcome is overall survival. Secondary outcomes are time to progression, time to untreatable progression, time to symptomatic progression, tumor response, quality of life, and adverse event occurrence. The study is an adaptive trial, comprising a group-sequential design with 2 interim analyses with 520 patients, and an option to increase the sample size to 700 patients at the second interim analysis. The sample size of 520 patients allows for 417 deaths to give 80% power to detect an increase in median overall survival from 10.7 months for the sorafenib group (based on the Sorafenib Hepatocellular Carcinoma Assessment Randomized Protocol [SHARP] trial) to 14.2 months for the transarterial radioembolization+sorafenib group (hazard ratio 0.754) with 2-sided alpha of .05. The increased sample size of 700 patients allows for 564 deaths to give 80% power to detect a smaller difference in median overall survival from 10.7 months for the sorafenib group to 13.7 months for the transarterial radioembolization+sorafenib group (hazard ratio 0.781).ResultsEnrollment for the study completed in September 2017. Results of the first and second interim analyses were reviewed by the Independent Data Monitoring Committee. The recommendation of the committee, at both interim analyses, was to continue the study without any changes.ConclusionsThe STOP-HCC study will contribute toward the establishment of the role of combination therapy with transarterial radioembolization and sorafenib in the treatment of unresectable hepatocellular carcinoma with and without branch portal vein...

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Development of a prognostic score to predict response to Yttrium-90 radioembolization for hepatocellular carcinoma with portal vein invasion

Cited by 105 publications

References 39 publications

Role of locoregional therapies in the wake of systemic therapy

Role of locoregional therapies in the wake of systemic therapy

Liver resection for recurrent hepatocellular carcinoma after radiofrequency ablation therapy

Intra-Arterial TheraSphere Yttrium-90 Glass Microspheres in the Treatment of Patients With Unresectable Hepatocellular Carcinoma: Protocol for the STOP-HCC Phase 3 Randomized Controlled Trial

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