Personalised versus standard dosimetry approach of selective internal radiation therapy in patients with locally advanced hepatocellular carcinoma (DOSISPHERE-01): a randomised, multicentre, open-label phase 2 trial

Garin, Étienne; Edeline, Julien; Robert, Corentin; Sourd, Samuel Le; Palard, Xavier; Laffont, Sophie; Campillo‐Gimenez, Boris; Rolland, Yan; Pracht, Marc; Ardisson, Valérie; Lenoir, L.; Boudjéma, Karim; Tselikas, Lambros; Baère, Thierry De; Terroir-Cassou-Mounat, Marie; Hollebecque, Antoine; Grimaldi, Séréna; Deschamps, Frédèric; Ducreux, Michel; Gelli, Maximiliano; Vibert, Éric; Guiu, Boris; Piron, Lauranne; Kafrouni, Marilyne; Fourcade, Marjolaine; Assenat, Éric; Mariano‐Goulart, Denis; Cassinotto, Christophe; Allimant, Carole; Chalaye, Julia; Regnault, Hélène; Amaddeo, Giuliana; Sommacale, Danièle; Kobeiter, Hicham; Tacher, Vania; Bonnot-Lours, Sophie; Marie, Margarita; Itti, Emmanuel; Lerman, Lionel; Abulizi, Mukedaisi; Luciani, Alain; Costentin, Charlotte; Milliner, Milan

doi:10.1016/s2468-1253(20)30290-9

Cited by 407 publications

(425 citation statements)

References 31 publications

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“…In many cases, the choice is made for a phase II trial with fixed activity at the maximum tolerable activity from phase I in order to simplify the clinical protocol. However, without absorbed doses available, it is impossible to build knowledge on doseeffect relationships and prospective clinical trials based on individually absorbed doses are crucial [67].…”

Section: Investigating Therapeutic Radiation Effects In Nuclear Medicinementioning

confidence: 99%

EANM position paper on the role of radiobiology in nuclear medicine

Aerts

Eberlein

Holm

et al. 2021

Eur J Nucl Med Mol Imaging

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Executive SummaryWith an increasing variety of radiopharmaceuticals for diagnostic or therapeutic nuclear medicine as valuable diagnostic or treatment option, radiobiology plays an important role in supporting optimizations. This comprises particularly safety and efficacy of radionuclide therapies, specifically tailored to each patient. As absorbed dose rates and absorbed dose distributions in space and time are very different between external irradiation and systemic radionuclide exposure, distinct radiation-induced biological responses are expected in nuclear medicine, which need to be explored. This calls for a dedicated nuclear medicine radiobiology. Radiobiology findings and absorbed dose measurements will enable an improved estimation and prediction of efficacy and adverse effects. Moreover, a better understanding on the fundamental biological mechanisms underlying tumor and normal tissue responses will help to identify predictive and prognostic biomarkers as well as biomarkers for treatment follow-up. In addition, radiobiology can form the basis for the development of radiosensitizing strategies and radioprotectant agents. Thus, EANM believes that, beyond in vitro and preclinical evaluations, radiobiology will bring important added value to clinical studies and to clinical teams. Therefore, EANM strongly supports active collaboration between radiochemists, radiopharmacists, radiobiologists, medical physicists, and physicians to foster research toward precision nuclear medicine.

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Section: Investigating Therapeutic Radiation Effects In Nuclear Medicinementioning

confidence: 99%

EANM position paper on the role of radiobiology in nuclear medicine

Aerts

Eberlein

Holm

et al. 2021

Eur J Nucl Med Mol Imaging

View full text Add to dashboard Cite

show abstract

“…Reference lists of all included studies after full-text screening were used for manual cross-referencing. In between the completion and submission of this review, the results of the DOSISPHERE-01 trial were published [26]. As this is the only level 1 evidence available, it was decided to incorporate this study as well.…”

Section: Search Strategymentioning

confidence: 99%

“…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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“…For example, selective internal radiotherapy (SIRT) by intra-arterial injection of 90Y microspheres is a therapeutic alternative for inoperable primary and secondary liver cancers [56]. The most recent studies highlight the importance of the tumor absorbed dose, significantly associated with overall survival, but also of the dose delivered to healthy organs, a source of radiation-induced side effects [57].…”

Section: Imaging Of Tracer With Low Abundance Emission And/or Long Half-lifementioning

confidence: 99%

Clinical perspectives for the use of total body PET/CT

Abgral

Bourhis

Salaun

2021

Eur J Nucl Med Mol Imaging

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Personalised versus standard dosimetry approach of selective internal radiation therapy in patients with locally advanced hepatocellular carcinoma (DOSISPHERE-01): a randomised, multicentre, open-label phase 2 trial

Abstract: HAL is a multi-disciplinary open access archive for the deposit and dissemination of scientific research documents, whether they are published or not. The documents may come from teaching and research institutions in France or abroad, or from public or private research centers.

Cited by 407 publications

References 31 publications

EANM position paper on the role of radiobiology in nuclear medicine

EANM position paper on the role of radiobiology in nuclear medicine

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

Clinical perspectives for the use of total body PET/CT

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