Relationship of Tumor Radiation–absorbed Dose to Survival and                    Response in Hepatocellular Carcinoma Treated with Transarterial                    Radioembolization with <sup>90</sup>Y in the SARAH Study

Hermann, Anne-Laure; Dieudonné, Arnaud; Ronot, Maxime; Sanchez, Manuel Villa; Pereira, Héléna; Châtellier, Gilles; Garin, Étienne; Castéra, Laurent; Lebtahi, Rachida; Vilgrain, Valérie

doi:10.1148/radiol.2020191606

Cited by 144 publications

(94 citation statements)

References 28 publications

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“…Several studies on pre- and post-therapy imaging indicate the recommended threshold tumour dose [ 31 , 52 , 53 ] (R38, Table 2 ). In the SARAH trial (using BSA method), a post hoc analysis of putative delivered dose based on 99m Tc-MAA SPECT/CT showed that OS and disease control were significantly better with a tumour-absorbed dose ≥ 100 Gy [ 32 ]. The probability of disease control at 6 months was 72% (95% CI 46–89%) and 81% (95% CI 58–93%) with a tumour-absorbed dose of 100 Gy and 120 Gy, respectively.…”

Section: Resultsmentioning

confidence: 99%

International recommendations for personalised selective internal radiation therapy of primary and metastatic liver diseases with yttrium-90 resin microspheres

Levillain

Bagni

Deroose

et al. 2021

Eur J Nucl Med Mol Imaging

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173

136

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Purpose A multidisciplinary expert panel convened to formulate state-of-the-art recommendations for optimisation of selective internal radiation therapy (SIRT) with yttrium-90 (90Y)-resin microspheres. Methods A steering committee of 23 international experts representing all participating specialties formulated recommendations for SIRT with 90Y-resin microspheres activity prescription and post-treatment dosimetry, based on literature searches and the responses to a 61-question survey that was completed by 43 leading experts (including the steering committee members). The survey was validated by the steering committee and completed anonymously. In a face-to-face meeting, the results of the survey were presented and discussed. Recommendations were derived and level of agreement defined (strong agreement ≥ 80%, moderate agreement 50%–79%, no agreement ≤ 49%). Results Forty-seven recommendations were established, including guidance such as a multidisciplinary team should define treatment strategy and therapeutic intent (strong agreement); 3D imaging with CT and an angiography with cone-beam-CT, if available, and 99mTc-MAA SPECT/CT are recommended for extrahepatic/intrahepatic deposition assessment, treatment field definition and calculation of the 90Y-resin microspheres activity needed (moderate/strong agreement). A personalised approach, using dosimetry (partition model and/or voxel-based) is recommended for activity prescription, when either whole liver or selective, non-ablative or ablative SIRT is planned (strong agreement). A mean absorbed dose to non-tumoural liver of 40 Gy or less is considered safe (strong agreement). A minimum mean target-absorbed dose to tumour of 100–120 Gy is recommended for hepatocellular carcinoma, liver metastatic colorectal cancer and cholangiocarcinoma (moderate/strong agreement). Post-SIRT imaging for treatment verification with 90Y-PET/CT is recommended (strong agreement). Post-SIRT dosimetry is also recommended (strong agreement). Conclusion Practitioners are encouraged to work towards adoption of these recommendations.

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Section: Resultsmentioning

confidence: 99%

International recommendations for personalised selective internal radiation therapy of primary and metastatic liver diseases with yttrium-90 resin microspheres

Levillain

Bagni

Deroose

et al. 2021

Eur J Nucl Med Mol Imaging

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173

136

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“…Quality Assurance in Interventional Oncology is an initiative to improve quality assurance in interventional oncology, amongst which post-intervention follow-ups and imaging are one of the quality standards [70] Another limitation has been the timing of the study. In the last years, research on TARE has provided insights in the importance of biomarkers, genetic information and tumour absorbed dose on the oncological outcomes [39,[65][66][67][68][69]. As CIRT was designed before these insights were accepted and applied, data on these outcomes have not been included in the objectives of the study.…”

Section: Discussionmentioning

confidence: 99%

Clinical Application of Trans-Arterial Radioembolization in Hepatic Malignancies in Europe: First Results from the Prospective Multicentre Observational Study CIRSE Registry for SIR-Spheres Therapy (CIRT)

Helmberger

Golfieri

Pech

et al. 2020

Cardiovasc Intervent Radiol

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Purpose To address the lack of prospective data on the real-life clinical application of trans-arterial radioembolization (TARE) in Europe, the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) initiated the prospective observational study CIRSE Registry for SIR-Spheres® Therapy (CIRT). Materials and Methods Patients were enrolled from 1 January 2015 till 31 December 2017. Eligible patients were adult patients treated with TARE with Y90 resin microspheres for primary or metastatic liver tumours. Patients were followed up for 24 months after treatment, whereas data on the clinical context of TARE, overall survival (OS) and safety were collected. Results Totally, 1027 patients were analysed. 68.2% of the intention of treatment was palliative. Up to half of the patients received systemic therapy and/or locoregional treatments prior to TARE (53.1%; 38.3%). Median overall survival (OS) was reported per cohort and was 16.5 months (95% confidence interval (CI) 14.2–19.3) for hepatocellular carcinoma, 14.6 months (95% CI 10.9–17.9) for intrahepatic cholangiocarcinoma. For liver metastases, median OS for colorectal cancer was 9.8 months (95% CI 8.3–12.9), 5.6 months for pancreatic cancer (95% CI 4.1–6.6), 10.6 months (95% CI 7.3–14.4) for breast cancer, 14.6 months (95% CI 7.3–21.4) for melanoma and 33.1 months (95% CI 22.1–nr) for neuroendocrine tumours. Statistically significant prognostic factors in terms of OS include the presence of ascites, cirrhosis, extra-hepatic disease, patient performance status (Eastern Cooperative Oncology Group), number of chemotherapy lines prior to TARE and tumour burden. Thirty-day mortality rate was 1.0%. 2.5% experienced adverse events grade 3 or 4 within 30 days after TARE. Conclusion In the real-life clinical setting, TARE is largely considered to be a part of a palliative treatment strategy across indications and provides an excellent safety profile. Level of evidence Level 3. Trial registration ClinicalTrials.gov NCT02305459.

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“…In the original publication on the SARAH trial [47], no difference in survival was found between SIRT with resin 90 Y microspheres and sorafenib treatment. However, in this secondary analysis, a clear dose-response relationship has been found, as the highest disease control rate was found in patients of whom the predicted tumour dose exceeded 100 Gy and in whom there was an optimal agreement between 99m Tc-MAA SPECT and 90 Y-SPECT or 90 Y-PET post-treatment [38]. The second study is the DOSISPHERE-01 trial, which is the first prospective study in nuclear medicine therapy designed to elucidate the benefit of personalized dosimetric treatment planning, in this case, a personalized dose of glass 90 Y microspheres to patients with HCC.…”

Section: Hepatocellular Carcinoma (Hcc)mentioning

confidence: 78%

“…One study has attempted to make an estimation of the T/N ratio by incorporating the hypervascularization status (based on CT imaging) into a volumetric partition model [30]. A total of 11 studies have predicted the tumour doses based on 99m Tc-MAA SPECT [5,12,26,[31][32][33][34][35][36][37][38], four have imaged the microsphere distribution with 90 Y-SPECT [39][40][41][42], and six studies have utilized 90 Y-PET [3,12,[43][44][45][46]. This has also resulted in a very wide range of reported dose thresholds, varying from 61 Gy to 1000 Gy, with the majority being between 100 and 250 Gy (13/19 studies; 68%).…”

Section: Hepatocellular Carcinoma (Hcc)mentioning

confidence: 99%

To 1000 Gy and back again: a systematic review on dose-response evaluation in selective internal radiation therapy for primary and secondary liver cancer

Roosen¹,

Klaassen²,

Gotby³

et al. 2021

Eur J Nucl Med Mol Imaging

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Purpose To systematically review all current evidence into the dose-response relation of yttrium-90 and holmium-166 selective internal radiation therapy (SIRT) in primary and secondary liver cancer. Methods A standardized search was performed in PubMed (MEDLINE), Embase, and the Cochrane Library in order to identify all published articles on dose-response evaluation in SIRT. In order to limit the results, all articles that investigated SIRT in combination with other therapy modalities (such as chemotherapy) were excluded. Results A total of 3038 records were identified of which 487 were screened based on the full text. Ultimately, 37 studies were included for narrative analysis. Meta-analysis could not be performed due to the large heterogeneity in study and reporting designs. Out of 37 studies, 30 reported a ‘mean dose threshold’ that needs to be achieved in order to expect a response. This threshold appears to be higher for hepatocellular carcinoma (HCC, 100–250 Gy) than for colorectal cancer metastases (CRC, 40–60 Gy). Reported thresholds tend to be lower for resin microspheres than when glass microspheres are used. Conclusion Although the existing evidence demonstrates a dose-response relationship in SIRT for both primary liver tumours and liver metastases, many pieces of the puzzle are still missing, hampering the definition of standardized dose thresholds. Nonetheless, most current evidence points towards a target mean dose of 100–250 Gy for HCC and 40–60 Gy for CRC. The field would greatly benefit from a reporting standard and prospective studies designed to elucidate the dose-response relation in different tumour types.

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Relationship of Tumor Radiation–absorbed Dose to Survival and Response in Hepatocellular Carcinoma Treated with Transarterial Radioembolization with ⁹⁰Y in the SARAH Study

Cited by 144 publications

References 28 publications

International recommendations for personalised selective internal radiation therapy of primary and metastatic liver diseases with yttrium-90 resin microspheres

International recommendations for personalised selective internal radiation therapy of primary and metastatic liver diseases with yttrium-90 resin microspheres

Clinical Application of Trans-Arterial Radioembolization in Hepatic Malignancies in Europe: First Results from the Prospective Multicentre Observational Study CIRSE Registry for SIR-Spheres Therapy (CIRT)

To 1000 Gy and back again: a systematic review on dose-response evaluation in selective internal radiation therapy for primary and secondary liver cancer

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Relationship of Tumor Radiation–absorbed Dose to Survival and Response in Hepatocellular Carcinoma Treated with Transarterial Radioembolization with 90Y in the SARAH Study

Cited by 144 publications

References 28 publications

International recommendations for personalised selective internal radiation therapy of primary and metastatic liver diseases with yttrium-90 resin microspheres

International recommendations for personalised selective internal radiation therapy of primary and metastatic liver diseases with yttrium-90 resin microspheres

Clinical Application of Trans-Arterial Radioembolization in Hepatic Malignancies in Europe: First Results from the Prospective Multicentre Observational Study CIRSE Registry for SIR-Spheres Therapy (CIRT)

To 1000 Gy and back again: a systematic review on dose-response evaluation in selective internal radiation therapy for primary and secondary liver cancer

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Relationship of Tumor Radiation–absorbed Dose to Survival and Response in Hepatocellular Carcinoma Treated with Transarterial Radioembolization with ⁹⁰Y in the SARAH Study