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)

Abstract

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.

Transarterial Radioembolization of Hepatocellular Carcinoma, Liver-Dominant Hepatic Colorectal Cancer Metastases, and Cholangiocarcinoma Using Yttrium90 Microspheres: Eight-Year Single-Center Real-Life Experience

“…It might have an impact on the response tumor and survival. However, our study reports real-life experience with Y90 TARE in a tertiary academic French center, and results are in accordance with those of previous registries [ 36 , 43 ].…”

“…Several ongoing prospective studies have produced encouraging intermediate results and may confirm the role for TARE in the therapeutic arsenal for CCA [ 34 , 35 ]. Indeed, the first results from the CIRSE registry in Europe using SIR-Spheres therapy recently reported and analyzed 1027 patients in real-life conditions [ 36 ]. Overall, 68.2% of the intention of treatment was palliative.…”

“…Median OS was reported per cohort and was 16.5 months for HCC, 14.6 months for CCA. For mCRC patients, median OS was 9.8 months [ 36 ]. Better timeline management may improve OS.…”

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

“…Our series included 13.9% inoperable iCC patients treated with SIRT in 2020. Multiple retrospective and prospective series reported good tolerability and objective response rates, with 12–14 months median OS [ 31 , 32 ], comparable to the data reported after TACE [ 33 ]. The role of SIRT in iCC is yet not well-defined [ 7 ].…”

Locoregional therapies in patients with intrahepatic cholangiocarcinoma: A systematic review and pooled analysis

“…Results of randomised trials for SIRT (SIRCCA randomised phase II trial, clinicaltrials.gov identifier NCT02807181) and for EBRT (ABC-07 randomised phase II trial, ISRCTN identifier 10639376) are awaited, but the early closure of SIRCCA might lead to insufficient power. Interestingly, different publications reported secondary resection following downsizing with IAT of initially unresectable iCC, evaluated in the pooled analysis as 14.6% of patients treated with systemic chemotherapy in the first-line setting [14][15][16][17][18][19][20], with a potential for long-term survival for these patients [21]. Analysis of landmark survival of patients with BTC treated with systemic chemotherapy suggested that patients treated with combination therapy, for iCC and with locallyadvanced disease had higher probability of further survival [22].…”