Additional holmium-166 radioembolisation after lutetium-177-dotatate in patients with neuroendocrine tumour liver metastases (HEPAR PLuS): a single-centre, single-arm, open-label, phase 2 study

Braat, Arthur J. A. T.; Bruijnen, R.; Rooij, Rob van; Braat, Manon N.G.J.A.; Wessels, Frank J.; Leeuwaarde, Rachel S van; Treijen, Mark J C van; Herder, Wouter W. de; Hofland, Johannes; Tesselaar, Margot E.T.; Jong, Hugo W. A. M. de; Lam, Marnix G. E. H.

doi:10.1016/s1470-2045(20)30027-9

Cited by 58 publications

(37 citation statements)

References 25 publications

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“…Another advantage is that 166 Homicrospheres can be visualized by both MRI and SPECT/CT (5). The safety and efficacy of 166 Horadioembolization was determined in the HEPAR and SIM studies (6)(7)(8)(9). In these studies, activity calculation was based on a whole-liver absorbed dose of 60 Gy.…”

Section: Introductionmentioning

confidence: 99%

Dose–Effect Relationships of ¹⁶⁶Ho Radioembolization in Colorectal Cancer

et al. 2020

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INTRODUCTION Radioembolization is a treatment option for colorectal cancer (CRC) patients with inoperable, chemorefractory hepatic metastases. Personalized treatment requires established dose thresholds. Hence, the aim of this study was to explore the relation between dose and effect (i.e. response and toxicity) in CRC patients treated with holmium-166 (166 Ho) radioembolization. MATERIALS AND METHODS CRC patients treated in the HEPAR II and SIM studies were analyzed. Absorbed doses were estimated using the activity distribution on post-treatment 166 Ho-SPECT/CT. Metabolic response was assessed using the change in total lesion glycolysis on 18 FDG-PET/CT between baseline and threemonths follow-up. Toxicity between treatment and three months was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5, and its relation with parenchymalabsorbed dose was assessed using linear models. The relation between tumor-absorbed dose and patient-and tumor-level response was analyzed using linear mixed-models. Using a threshold of 100% sensitivity for response, the threshold for a minimal mean tumor-absorbed dose was determined and its impact on survival was assessed. RESULTS Forty patients were included. The median parenchymalabsorbed dose was 37 Gy (range 12-55 Gy). New CTCAE grade ≥3 clinical and laboratory toxicity were present in eight and seven patients, respectively. For any clinical toxicity (highest grade per patient), the mean difference in parenchymal dose (Gy) per step increase in CTCAE grade category was 5.75 (95% confidence interval (CI) 1.18-10.32). On a patient level, metabolic response was: complete response (CR) n=1, partial response (PR) n=11, stable disease (StD) n=17 and progressive disease (PD) n=8. The mean tumor-absorbed dose was 84% higher in patients with CR/PR than in patients with PD (95%CI: 20-180%). Survival for patients with a mean tumor-absorbed dose >90 Gy was significantly better than for patients with a mean tumor-absorbed dose <90 Gy (hazard ratio=0.16, 95%CI 0.06-0.511). CONCLUSION A significant dose-response relationship in CRC patients treated with 166 Ho-radioembolization was established and a positive association between toxicity and parenchymal dose was found. For future patients, it is advocated to use 166 Ho-scout to select patients and personalize the administered activity targeting a mean tumor-absorbed dose of >90 Gy and a parenchymal dose <55 Gy.

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Section: Introductionmentioning

confidence: 99%

Dose–Effect Relationships of ¹⁶⁶Ho Radioembolization in Colorectal Cancer

et al. 2020

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“…Numerous radiosensitive metastatic lesions may be treated with SIRT, alone or in combination with personalized therapies [ 35 ].…”

Section: Discussionmentioning

confidence: 99%

Management of Liver Tumors during the COVID-19 Pandemic: The Added Value of Selective Internal Radiation Therapy (SIRT)

Bargellini¹,

Boni

Traino

et al. 2021

JCM

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Background: In the context of the coronavirus disease 2019 (COVID-19) pandemic, liver-directed therapies (LDTs) may offer minimally invasive integrative tools for tumor control. Among them, selective internal radiation therapy (SIRT) represents a safe, flexible and effective treatment. Purpose of this study is to present our experience with SIRT during the first wave of COVID-19 pandemic and provide an overview of the indications and challenges of SIRT in this scenario. Methods: We retrospectively analyzed the number of patients evaluated by Multidisciplinary Liver Tumor Board (MLTB) and who were undergoing LDTs between March and July 2020 and compared it with 2019. For patients treated with SIRT, clinical data, treatment details and the best radiological response were collected. Results: Compared to 2019, we observed a 27.5% reduction in the number of patients referred to MLTB and a 28.3% decrease in percutaneous ablations; transarterial chemoembolizations were stable, while SIRT increased by 64%. The majority of SIRT patients (75%) had primary tumors, mostly HCC. The best objective response and disease control rates were 56.7% and 72.2%, respectively. Conclusion: The first wave of the COVID-19 pandemic was characterized by an increased demand for SIRT, which represents a safe, flexible and effective treatment, whose manageability will further improve by simplifying the treatment workflow, developing user-friendly and reliable tools for personalized dosimetry and improving interdisciplinary communication.

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“…17 The development of quality of life after treatment was confirmed in the HEPAR PLUS study, again showing a significant decrease in quality of life early after treatment (i.e., 3 weeks) with rapid recovery thereafter. 12 Apart from a temporary significant decrease in the role functioning scale, only nonsignificant temporary decreases were noticed after 166 Ho-microsphere radioembolization. Also, a temporary significant increase in the fatigue scale was noticed, in line with the findings from the clinical toxicity data.…”

Section: Quality Of Lifementioning

confidence: 93%

“…A total of 34 patients were assessed for eligibility. 12 Thirtyone patients received treatment and 30 (97%) patients were available for primary endpoint assessment and completed 6 months of follow-up. Three (9%) patients were excluded at screening and one (3%) patient was treated and died before the primary endpoint and was replaced.…”

Section: Studiesmentioning

confidence: 99%

Holmium-166 Radioembolization

Lam

Smits

Bruijnen

et al. 2021

Digestive Disease Interventions

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Radioembolization is usually performed with microspheres containing yttrium-90 (90Y). Holmium-166 (166Ho)-microspheres were developed as an alternative new product for radioembolization. The unique characteristics of 166Ho-microspheres allow for improved imaging possibilities. They can be visualized and quantified, already at low numbers and activities, to predict treatment distribution using 166Ho-microspheres at scout quantity during pre-treatment simulation. The option to reliably predict the distribution of microspheres provides physicians control over the treatment, allowing them to select and treat patients with a personalized treatment plan. Safety and efficacy were established in several clinical studies. 166Ho-microspheres radioembolization aims to optimize individualized treatment planning in order to improve treatment outcomes.

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Additional holmium-166 radioembolisation after lutetium-177-dotatate in patients with neuroendocrine tumour liver metastases (HEPAR PLuS): a single-centre, single-arm, open-label, phase 2 study

Cited by 58 publications

References 25 publications

Dose–Effect Relationships of ¹⁶⁶Ho Radioembolization in Colorectal Cancer

Dose–Effect Relationships of ¹⁶⁶Ho Radioembolization in Colorectal Cancer

Management of Liver Tumors during the COVID-19 Pandemic: The Added Value of Selective Internal Radiation Therapy (SIRT)

Holmium-166 Radioembolization

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Additional holmium-166 radioembolisation after lutetium-177-dotatate in patients with neuroendocrine tumour liver metastases (HEPAR PLuS): a single-centre, single-arm, open-label, phase 2 study

Cited by 58 publications

References 25 publications

Dose–Effect Relationships of 166Ho Radioembolization in Colorectal Cancer

Dose–Effect Relationships of 166Ho Radioembolization in Colorectal Cancer

Management of Liver Tumors during the COVID-19 Pandemic: The Added Value of Selective Internal Radiation Therapy (SIRT)

Holmium-166 Radioembolization

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Dose–Effect Relationships of ¹⁶⁶Ho Radioembolization in Colorectal Cancer

Dose–Effect Relationships of ¹⁶⁶Ho Radioembolization in Colorectal Cancer