Zeka, B. (Bleranda)
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- A multicentre, international, observational study on transarterial chemoembolisation in colorectal cancer liver metastases: Design and rationale of CIREL(Elsevier, 2020) Pellerin, O. (Olivier); Kaufmann, N. (Nathalie); Iezzi, R. (Roberto); Arnold, D. (Dirk); Taieb, J. (Julien); Bauer, R. (Robert); Sangro, B. (Bruno); Maleux, G. (Geert); Nordlund, A. (Anders); Baere, T. (T.) de; Helmberger, T. (Thomas); Pereira, P.L. (Philippe L.); Prenen, H. (Hans); Zeka, B. (Bleranda); Gómez, F. (F.)Background: About 70–80% of patients with colorectal liver metastases appear as ineligible for a curative treatment approach. Transarterial chemoembolisation (TACE) using irinotecan-eluting beads has emerged as a promising treatment option in cases with irresectable liver metastases. Despite being in clinical practice for years, little is known about the treatment characteristics and outcomes when used as per routine hospital practice. Methods: Patients with hepatic metastases from colorectal cancer origin, admitted to contributing centres to receive TACE with drug-eluting LifePearl® Microspheres loaded with irinotecan, as part of their standard care, will be consecutively added to the registry. Data will be collected until the end of study, loss to follow-up or death. Primary endpoint is the characterisation of the treatment usage at the selected sites in Europe. Secondary endpoints include outcome parameters, safety and toxicity, as well as quality of life. Conclusion and AIMS: This multicentre, international, prospective observational study conducted in European centres plans to collect real-life data. This data will form an evidence-base from which conclusions can be drawn on how to improve patient selection and optimise treatment protocols when treating with TACE using irinotecan-eluting microspheres.
- Prognostic factors for effectiveness outcomes after transarterial radioembolization in metastatic colorectal cancer: results from the multicentre observational study CIRT(2022) Pfammatter, T. (Thomas); Peynircioglu, B. (Bora); Munneke, G. (Graham); Pereira, H. (Helena); Soydal, C. (Cigdem); Sangro, B. (Bruno); Arnold, D. (Dick); Grözinger, G. (Gerd); Kolligs, F. (Frank); Pech, M. (Maciej); Maleux, G. (Geert); Jong, N. (Niels) de; Helmberger, T. (Thomas); Zeka, B. (Bleranda); Schaefer, N. (Niklaus)This study explored factors that can predict effectiveness outcomes after transarterial radioembolization in colorectal liver metastases in the liver. In a cohort of 237 patients, among other factors, we found that an Aspartate transaminase to Platelet Ratio Index (APRI) value of > 0.40 was a particularly strong independent predictor of worse overall survival, progression-free survival and hepatic progression-free survival outcomes. Background: Transarterial radioembolisation (TARE) with Yttrium-90 resin microspheres is a treatment option for patients with metastatic colorectal cancer in the liver (mCRC). A better understanding of the prognostic factors and treat-ment application can improve survival outcomes. Methods: We analysed the safety and effectiveness of 237 mCRC patients included in the prospective observational study CIRSE Registry for SIR-Spheres Therapy (CIRT) for indepen-dent prognostic factors for overall survival (OS), progression-free survival (PFS) and hepatic progression-free survival (hPFS) using the Cox proportional-hazard model. Results: The median OS was 9.8 months, median PFS was 3.4 months and median hPFS was 4.2 months. Independent prognostic factors for an improved overall survival were the absence of extra-hepatic disease ( P = .0391), prior locoregional procedures ( P = .0037), an Aspartate transaminase to Platelet Ratio Index (APRI) value of <= 0.40 ( P < .0001) and Inter national Nor malized Ratio (INR) <= 1 ( P = .0078). Partition model dosimetry resulted in improved OS outcomes compared to the body surface area model ( P = .0120). Independent predictors for PFS were APRI > 0.40 ( P = .0416) and prior ablation ( P = .0323), and for hPFS these were 2 to 5 tumor nodules ( P = .0148), Albumin-bilirubin (ALBI) grade 3 ( P = .0075) and APRI > 0.40 ( P = .0207). During the study, 95 of 237 (40.1%) patients experienced 197 adverse events, with 28 of 237 (11.8%) patients having a grade 3 or higher adverse events. Conclusion: Including easy-to-acquire laboratory markers INR, APRI, ALBI and using partition model dosimetry can identify mCRC patients that may benefit from TARE.
- Factors impacting survival after transarterial radioembolization in patients with hepatocellular carcinoma: Results from the prospective CIRT study(2023) Ronot, M. (Maxime); Pfammatter, T. (Thomas); Peynircioglu, B. (Bora); Golfieri, R. (Rita); Munneke, G. (Graham); Arnold, D. (Dirk); Pereira, H. (Helena); Sangro, B. (Bruno); Kolligs, F. (Frank); Pech, M. (Maciej); Maleux, G. (Geert); Jong, N. (Niels) de; Helmberger, T. (Thomas); Zeka, B. (Bleranda); Schaefer, N. (Niklaus)Background & aims: Transarterial radioembolization (TARE) with Yttrium-90 resin microspheres is an established treatment option for patients with hepatocellular carcinoma (HCC). However, optimising treatment application and patient selection remains challenging. We report here on the effectiveness, safety and prognostic factors, including dosing methods, associated with TARE for HCC in the prospective observational CIRT study. Methods: We analysed 422 patients with HCC enrolled between Jan 2015 and Dec 2017, with follow-up visits every 3 months for up to 24 months after first TARE. Patient characteristics and treatment-related data were collected at baseline; adverse events and time-to-event data (overall survival [OS], progression-free survival [PFS] and hepatic PFS) were collected at every 3-month follow-up visit. We used the multivariable Cox proportional hazard model and propensity score matching to identify independent prognostic factors for effectiveness outcomes. Results: The median OS was 16.5 months, the median PFS was 6.1 months, and the median hepatic PFS was 6.7 months. Partition model dosimetry resulted in improved OS compared to body surface area calculations on multivariable analysis (hazard ratio 0.65; 95% CI 0.46-0.92; p = 0.0144), which was confirmed in the exact matching propensity score analysis (hazard ratio 0.56; 95% CI 0.35-0.89; p = 0.0136). Other independent prognostic factors for OS were ECOG-performance status >0 (p = 0.0018), presence of ascites (p = 0.0152), right-sided tumours (p = 0.0002), the presence of portal vein thrombosis (p = 0.0378) and main portal vein thrombosis (p = 0.0028), ALBI grade 2 (p = 0.0043) and 3 (p = 0.0014). Adverse events were recorded in 36.7% of patients, with 9.7% of patients experiencing grade 3 or higher adverse events. Conclusions: This large prospective observational dataset shows that TARE is an effective and safe treatment in patients with HCC. Using partition model dosimetry was associated with a significant improvement in survival outcomes. Impact and implications: Transarterial radioembolization (TARE) is a form of localised radiation therapy and is a potential treatment option for primary liver cancer. We observed how TARE was used in real-life clinical practice in various European countries and if any factors predict how well the treatment performs. We found that when a more complex but personalised method to calculate the applied radiation activity was used, the patient responded better than when a more generic method was used. Furthermore, we identified that general patient health, ascites and liver function can predict outcomes after TARE. Clinical trial number: NCT02305459.
- Predictive factors for adverse event outcomes after transarterial radioembolization with Yttrium-90 resin microspheres in Europe: results from the prospective observational CIRT study(2023) Albrecht, T. (Thomas); Peynircioglu, B. (Bora); Munneke, G. (Graham); Arnold, D. (Dirk); Pereira, H. (Helena); Bargellini, I. (Irene); Sangro, B. (Bruno); Kolligs, F. (Frank); Bilbao, J.I. (José I.); Maleux, G. (Geert); Cianni, R. (Roberto); Jong, N. (Niels) de; Helmberger, T. (Thomas); Zeka, B. (Bleranda); Schaefer, N. (Niklaus)BackgroundUsing data collected in the prospective observational study CIRSE Registry for SIR-Spheres Therapy, the present study aimed at identifying predictors of adverse events (AEs) following transarterial radioembolization (TARE) with Yttrium-90 resin microspheres for liver tumours.MethodsWe analysed 1027 patients enrolled between January 2015 and December 2017 and followed up for 24 months. Four hundred and twenty-two patients with hepatocellular carcinoma (HCC), 120 with intrahepatic carcinoma (ICC), 237 with colorectal liver metastases and 248 with liver metastases from other primaries were included. Prognostic factors were calculated with a univariable analysis by using the overall AEs burden score (AEBS).ResultsAll-cause AEs were reported in 401/1027 (39.1%) patients, with AEs associated with TARE, such as abdominal pain (16.6%), fatigue (17%), and nausea (11.7%) reported most frequently. Grade 3 or higher AEs were reported in 92/1027 (9%) patients. Reports on grade >= 3 gastrointestinal ulcerations (0.4%), gastritis (0.3%), radiation cholecystitis (0.2%) or radioembolization-induced liver disease (0.5%) were uncommon. Univariable analysis showed that in HCC, AEBS increased for Eastern Cooperative Oncology Group (ECOG) 0 (p = 0.0045), 1 tumour nodule (0.0081), > 1 TARE treatment (p = 0.0224), no prophylactic embolization (p = 0.0211), partition model dosimetry (p = 0.0007) and unilobar treatment target (0.0032). For ICC, > 1 TARE treatment was associated with an increase in AEBS (p = 0.0224), and for colorectal liver metastases, ECOG 0 (p = 0.0188), > 2 prior systemic treatments (p = 0.0127), and 1 tumour nodule (p = 0.0155) were associated with an increased AEBS.ConclusionOur study confirms that TARE is a safe treatment with low toxicity and a minimal impact on quality of life.