Safety, Feasibility and Technical Considerations from a Prospective, Observational Study—CIREL: Irinotecan-TACE for CRLM in 152 Patients

Abstract

CIREL, a prospective, Europe-wide, observational study aimed to assess the real-world feasibility and tolerability of irinotecan-based transarterial chemoembolization (LP-irinotecan TACE) for unresectable colorectal cancer liver metastases with regard to the treatment plan and adverse events (AEs). CIREL enrolled 152 eligible patients (≥18 years) with liver-only or dominant metastases treated with LP-irinotecan TACE following a multidisciplinary tumor board decision. Data were prospectively collected for baseline, the number of planned and performed sessions, and technical information and safety according to CTCAE 4.03/5.0. Results from 351 analyzed treatment sessions showed technical success for 99% of sessions, and 121 patients (79%) completed all planned sessions. Further, 60% of sessions were performed using opioids, 4% intra-arterial anesthetics, and 25% both. Additionally, 60% of patients experienced at least one peri-interventional AE of any grade; 8% of grade 3–4. Occurrence of AEs was related to larger liver-involvement (p < 0.001), bi-lobar disease (p = 0.002), and larger beads (p < 0.001). Using corticosteroids together with antiemetics showed reduced and lower grade vomiting (p = 0.01). LP-irinotecan TACE was tolerated well and had a high proportion of completed treatment plans. This minimally invasive locoregional treatment can be used together with concomitant systemic therapy or ablation.

The Value of Local Therapies in Advanced Adrenocortical Carcinoma

“…Although the reported toxicity appears to be limited, it is important to recognise that our study may tend to underestimate negative effects due to its retrospective nature. However, data from other studies investigating LTs in advanced ACC, but also larger studies in other tumour entities, suggest that most local treatment modalities have acceptable toxicity levels [42][43][44][57][58][59]. Another limitation concerns the diversity in LT modalities and varying group sizes.…”

Research in interventional oncology: How sound is the evidence base?

“…An orchestrated effort is required to conduct more well‐designed, large observational cohort studies, as well as RCTs. To this end, the Cardiovascular and Interventional Radiological Society of Europe (CIRSE), has created an in‐house research infrastructure to facilitate research projects that generate evidence of level II or higher 64,66,67 …”

“…To this end, the Cardiovascular and Interventional Radiological Society of Europe (CIRSE), has created an in-house research infrastructure to facilitate research projects that generate evidence of level II or higher. 64,66,67 An additional issue is that when faced with the prospect of being randomised into receiving systemic chemotherapy or surgery versus a minimally invasive locoregional treatment, patients might refuse to be randomised. 68,69 Patient contact and collection of follow-up data.…”

Interventional Radiology in the Treatment of Pancreatic Adenocarcinoma: Present and Future Perspectives

“…The usefulness of TACE is because the drug is significantly more locally concentrated, with a consequent sparing of the remaining liver, and with a reduction of systemic side effects. The embolizing effect reduces blood flow within the lesion, leading to ischaemia, thereby prolonging the dwell time of the chemotherapic agent in the metastasis and further decreasing the systemic side effects of the drug [ 75 , 76 , 77 ].…”