CIRT

Status: closed

Study summary | Endpoints | Methods | Patient enrolment | Outcomes | Steering Committee | Publications

Study summary

The CIRSE Registry for SIR-Spheres Therapy (CIRT) was a European-wide prospective observational study on the clinical application and outcomes of radioembolisation with SIR-Spheres therapy. It was initiated in 2014 as a result of the lack of clinical data on the use of SIR-Spheres in the real-life context and was the first study to be completely sponsored and executed by the CIRSE Society. Over a period of 3 years, more than 1000 patients with primary and metastatic liver cancer were included in the study and were followed-up for at least 24 months, whereby data on survival, adverse events and quality of life have been collected.

The first data publication came out in 2020 (see below) and further indication-specific analyses are currently being performed. The CIRT Steering Committee is thrilled to share these outcomes with the IR community and the medical community as a whole.

Endpoints

Primary end point

The primary objective is to observe the real-life clinical application of SIRT with SIR-Spheres Y-90 resin microspheres and the impact of the treatment in clinical practice. Patients will be classified according to the following categories:

• type of liver cancer
• intention of treatment
• prior hepatic procedures
• associated systemic therapy
• post-SIRT hepatic procedures

Secondary end points

In addition to observing the real-life application of CIRT, the Steering Committee is also very interested in data on the safety and effectiveness of the treatment. Furthermore, to observe the palliative aspect of SIRT, a quality of life questionnaire has been included in the study.

Safety

• adverse events

Effectiveness

• overall Survival (OS)
• progression free survival (PFS) by investigator
• liver specific PFS by investigator
• imaging response

Quality of life

• measured with EORTC’s QLQ-C30 with HCC module

Methods

CIRT was a prospective, multicentre, single-device, observational study of patients with hepatic malignancies treated with TARE with Y90 resin microspheres as standard of care. Sites were invited if they met the minimum selection criteria of at least 40 treatments in total, with a minimum of ten procedures within 12 months prior to invitation. From August 2014 to April 2017, 27 sites were enrolled and included patients. Data was collected prospectively from medical centres in Europe via an electronic data capture (EDC) system.

Patient enrolment

As of December 31, 2019 data collection has been completed. 1,027 patients have been included in the study, representing 8 countries and 27 hospitals. Patients have been followed up for 24 months. Data is now under review by the Steering Committee. Publications can be expected in the third quarter of 2020.

Outcomes

The full report on the outcomes of CIRT can be found here.

During the observation period, 495 (48.2%) patients died and 349 (33.9%) were lost to follow up. 26 (2.5%) patients had less than 2 years of follow-up but no recorded reason for non-completion. 157 (15.3%) patients were alive and completed the 2-year follow-up period.

Median overall survival for patients following TARE was 16.5 months (95% CI 14.2–19.3) for HCC and 14.7 months (95% CI 10.9–17.9) for ICC. For liver metastases, median OS for mCRC was 9.8 months (95% CI 8.3–12.9), 5.6 months (95% CI 4.1–6.6) for pancreatic cancer metastases, 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% 22.1–nr) for neuroendocrine tumours. Univariable analyses showed that extra-hepatic disease, ECOG status ≥0, presence of cirrhosis and ascites were associated with a lower survival rate. Unilateral malignancies had a better survival outcome than bilobar malignancies and a higher tumour burden was negatively associated with overall survival.

Across the entire cohort, the 30-day mortality rate of patients that received TARE was 1.0% (n = 10). Serious adverse events (SAE, grade 3 and 4) within 30 days of treatment were found in less than 2.5% of the patients. SAEs such as gastritis, gastrointestinal ulcerations, radiation cholecystitis and radioembolization-induced liver disease (REILD) occurred in less than 0.3% of the total patient cohort.

Steering Committee

Helmberger T, Arnold D, Bilbao JI, de Jong N, Maleux G, Nordlund A, Peynircioglu B, Sangro B, Sharma RA, Walk A, Clinical Application of Radioembolization in Hepatic Malignancies: Protocol for a Prospective Multicenter Observational Study, JMIR Res Protoc 2020;9(4):e16296, DOI: 10.2196/16296, PMID: 32319960.

Helmberger, T, Golfieri, R, Pech, M, et al. 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). Cardiovasc Intervent Radiol (2020). DOI: 10.1007/soo270-020-02642-y, PMID: 32959085