1. 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)
- Author
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Helmberger T., Golfieri R., Pech M., Pfammatter T., Arnold D., Cianni R., Maleux G., Munneke G., Pellerin O., Peynircioglu B., Sangro B., Schaefer N., de Jong N., Bilbao J. I., Pelage J. -P., Manas D. M., Kolligs F. T., Ezziddin S., Peters R., Albrecht T., D'Archambeau O., Balli T., Bilgic S., Bloom A., Cioni R., Fischbach R., Flamen P., Gerard L., Grozinger G., Katoh M., Koehler M., Kroger J. R., Kuhl C., Orsi F., Ozgun M., Reimer P., Ronot M., Schmid A., Vit A., Helmberger T., Golfieri R., Pech M., Pfammatter T., Arnold D., Cianni R., Maleux G., Munneke G., Pellerin O., Peynircioglu B., Sangro B., Schaefer N., de Jong N., Bilbao J.I., Pelage J.-P., Manas D.M., Kolligs F.T., Ezziddin S., Peters R., Albrecht T., D'Archambeau O., Balli T., Bilgic S., Bloom A., Cioni R., Fischbach R., Flamen P., Gerard L., Grozinger G., Katoh M., Koehler M., Kroger J.R., Kuhl C., Orsi F., Ozgun M., Reimer P., Ronot M., Schmid A., Vit A., University of Zurich, On behalf of the CIRT Steering Committee, On behalf of the CIRT Principal Investigators, Pelage, J.P., Manas, D.M., Kolligs, F.T., Ezziddin, S., Peters, R., Albrecht, T., D'Archambeau, O., Balli, T., Bilgic, S., Bloom, A., Cioni, R., Fischbach, R., Flamen, P., Gerard, L., Grözinger, G., Katoh, M., Koehler, M., Kröger, J.R., Kuhl, C., Orsi, F., Ozgun, M., Reimer, P., Ronot, M., Schmid, A., and Vit, A.
- Subjects
Male ,Registrie ,SIR-Spheres ,Yttrium-90 ,Cardiac & Cardiovascular Systems ,Tare weight ,Colorectal cancer ,Hepatocellular carcinoma ,medicine.medical_treatment ,Metastasi ,Radioisotope brachytherapy ,COLORECTAL-CANCER ,Metastasis ,030218 nuclear medicine & medical imaging ,0302 clinical medicine ,Observational study ,Medicine ,Yttrium Radioisotopes ,Prospective Studies ,Registries ,SALVAGE THERAPY ,Y-90 RADIOEMBOLIZATION ,10042 Clinic for Diagnostic and Interventional Radiology ,Incidence ,Mortality rate ,Radiology, Nuclear Medicine & Medical Imaging ,Liver Neoplasms ,CANCER LIVER METASTASES ,Middle Aged ,Embolization, Therapeutic ,Microspheres ,Europe ,Trans-arterial radioembolization ,Liver ,SAFETY ,030220 oncology & carcinogenesis ,Female ,Cardiology and Cardiovascular Medicine ,Life Sciences & Biomedicine ,medicine.medical_specialty ,Carcinoma, Hepatocellular ,610 Medicine & health ,Context (language use) ,Therapeutic embolization ,03 medical and health sciences ,Breast cancer ,GLASS MICROSPHERES ,ADVANCED HEPATOCELLULAR-CARCINOMA ,Pancreatic cancer ,Internal medicine ,INTRAHEPATIC CHOLANGIOCARCINOMA ,Humans ,Radiology, Nuclear Medicine and imaging ,Clinical Investigation ,Retrospective Studies ,Science & Technology ,INTERNAL RADIATION-THERAPY ,business.industry ,EFFICACY ,medicine.disease ,Radiography ,Cardiovascular System & Cardiology ,business - 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.
- Published
- 2021