RESUMO
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.
RESUMO
According to Barcelona Clinic Liver Cancer classification, transarterial chemoembolization (TACE) is preferred treatment for stage B and in certain cases for stage A hepatocellular carcinoma (HCC). Conventional TACE (c-TACE) and drug-eluting microspheres TACE (DEM-TACE) are available intraarterial therapies. Screening of patients with cirrhosis is of great importance for early detection of malignant liver nodules. Primary endpoint of this study was to compare DEM-TACE with c-TACE in terms of 12- and 24-month survival. Secondary endpoints were comparison of intensity and duration of the postembolization syndrome (PES) and severe adverse events. We randomized 60 patients with unresectable HCC one-to-one with c-TACE or DEM-TACE and followed them for at least 24 months or until death. TACE was repeated 'on-demand. Most patients underwent two TACE sessions and the median hospital stay was 3 days for c-TACE and 2 days for DEM-TACE group. The overall 12- and 24-month survival rates were 89.8 and 70.7%, respectively, precisely 85.7 and 63.6% after c-TACE and 90.2 and 75.8% after DEM-TACE, without any significant difference (P = 0.18). Median overall survival was 21.1 months. Significant difference in the overall 12- and 24-month survival was found in patients with Child-Pugh A compared to Child-Pugh B class (P = 0.001). Child-Pugh class, aspartate aminotransferase levels and ascites independently predicted survival (P = 0.003). Both, DEM-TACE and c-TACE showed excellent 12- and 24-month survival rates. No significant difference in terms of adverse events was found. PES was slightly more severe after c-TACE, because of elevated temperature. DEM-TACE requires shorter in-hospital stay.
