CIRT Registry: A Good Start for a Much-Needed Evolution in Interventional Oncology

In this study, Maleux et al. analyzed the prospective observational CIRT registry that included patients from 27 centres performing high volume yttrium-90 resin microsphere radioembolization for primary and secondary hepatic malignancies [1]. Frequencies of individual adverse events (AEs) were reported and risk factors for a cumulative adverse event burden score (AEBS) were assessed. This study confirms the safety of yttrium-90 transarterial radioembolization (TARE) performed at specialized centres. The vast majority of observed adverse events were mild and the incidence of grade 3 or more serious complications related to non-target radioembolization was low. In addition, the incidence of radioembolization-induced liver disease was very low (0.5%), as previously reported in several studies.

There is wide variability of oncologic outcomes including patient survival after TARE for primary and metastatic disease, even when treating the same pathology and at similar disease stages [2]. This has been shown to be affected by factors such as tumour differentiation, presence of extrahepatic disease, liver disease volume, levels of albumin and bilirubin, patient performance status, extent of prior treatments, as well as tumour specific biomarkers [2]. Such patient and tumour variables were assessed as factors contributing to post-TARE morbidity in the current study [1]. Several of these factors, found to be significant predictors of increased AEBS, also represent factors that determine patient eligibility for TARE and our ability to perform TARE in a safe and effective manner. These factors include the patient performance status as reflected by the ECOG classification, the malignant disease volume replacing liver parenchyma as reflected by the presence of solitary tumor contrary to multifocal liver disease. Thus, it is not surprising that the same factors affecting the oncologic outcomes also impact the AEBS, as determined in this analysis. Other factors that have been identified as impacting the incidence of AEs are related to the interventional techniques used during the mandatory arteriography and mapping. These include the application of prophylactic embolization for example, the actual administration of the Y90 microspheres through unilobar treatment to one or more targets or the use of the partition model dosimetry that includes radiation segmentectomy and selective administrations. These methods are correlated to the disease volume and the relative technical challenges that impact the effective and safe TARE administration. The authors acknowledge that data pertaining to the treated liver volume and the absorbed liver/tumor dose was not captured in this study. Thus, there is a high probability that the increased incidence of mild and self-limiting AEs captured in the AEBS represents the cost of improved tumor control and resulting overall survival when radioembolization is performed with personalized ablative dosimetry or higher tumor absorbed dose, both for primary and secondary malignancies [3,4,5].

Prospective, multicenter registries are important tools in generating high-quality, real-world data for treatment safety, efficacy, and oncologic outcomes. The authors clearly need be congratulated for undertaking this important and challenging work. The Radiation-Emitting SIR-Spheres in Non-resectable (RESiN) Liver Tumor registry have also produced such data [6]. It is of paramount importance to intensify our efforts in building such registries across multiple interventional treatments and conditions, especially in oncology, similarly to our medical, surgical and radiation oncology colleagues. This would further strengthen the evidence for the value proposition of image-guided, minimally invasive treatments offered within the practice of interventional oncology (IO). This is particularly valuable for the less frequent cancer pathologies (24% of patients in the current study). It is time for the global IO community to join forces beyond geographic boundaries and embark in the creation of global registries to better determine the real-life use of IO therapies, their oncologic outcomes, and AEs, as well as their impact on patient quality of life. The need to provide the evidence regarding the value and benefits of IO therapies will only continue to increase in the current healthcare environment.

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