PMID- 37337059 OWN - NLM STAT- MEDLINE DCOM- 20230707 LR - 20230726 IS - 1432-086X (Electronic) IS - 0174-1551 (Linking) VI - 46 IP - 7 DP - 2023 Jul TI - Prospective Series of Transarterial Chemoembolization of Metastatic Colorectal Cancer to the Liver with 30-60 mum Microspheres Loaded with Irinotecan. PG - 880-890 LID - 10.1007/s00270-023-03446-6 [doi] AB - PURPOSE: To describe safety and clinical outcomes among patients with metastatic colorectal cancer (mCRC) to the liver treated with transarterial chemoembolization with HepaSphere Microspheres 30-60 mum loaded with irinotecan (IotaRI-HEP-TACE). MATERIAL AND METHODS: In this prospective study (NCT04866290), 100 adults with confirmed mCRC to the liver who were ineligible for resection were enrolled and followed up to 24 months or death. Study outcomes among Salvage (patients not tolerating more cycles of chemotherapy) and Non-salvage patients included overall survival (OS), progression-free survival (PFS), objective response (OR), objective response rate (ORR), best tumor response (BTR), adverse events (AEs), and pharmacokinetics of irinotecan and its active metabolite, 7-ethyl-10-hydroxy-camptothecin (SN38). RESULTS: The median age was 66 years (range: 31-89). Median OS was 15.08 months (95% confidence interval [CI]: 12.33-17.25). PFS was 8.52 months (95% CI: 6.0-9.0; p < 0.001). ORR was 42.2% (95% CI: 31.57-53.50) and 35.9% (95% CI: 25.57-47.62) based on modified RECIST (Response Evaluation Criteria in Solid Tumors) and RECIST 1.1 criteria. BTR was not significantly different between mRECIST and RECIST (p = 0.745). The Non-salvage group had a statistically significant difference in median OS relative to the Salvage group (15.3 vs. 3 months; p < 0.001). Pharmacokinetic analyses demonstrated no correlation of OS with plasma concentration of irinotecan and SN38 (all p > 0.05). Most AEs were Grade 2 (257/279), the most common AE was right upper abdominal pain (180/279). One major AE (tumor rupture) was reported. CONCLUSION: IRI-HEP-TACE is an alternative treatment for patients with Non-salvage mCRC to the liver. CI - (c) 2023. Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE). FAU - Malagari, K AU - Malagari K AUID- ORCID: 0000-0002-1391-0965 AD - Department of Radiology, Medical School, National and Kapodistrian University of Athens, 19 Monis Kyccou, 15 669 Papagou, Athens, Greece. kmalag@otenet.gr. AD - Evgenidion and Attikon University Hospitals, Chaidari, Greece. kmalag@otenet.gr. FAU - Kiakidis, Th AU - Kiakidis T AD - Department of Radiology, Medical School, National and Kapodistrian University of Athens, 19 Monis Kyccou, 15 669 Papagou, Athens, Greece. AD - Evgenidion and Attikon University Hospitals, Chaidari, Greece. FAU - Moschouris, H AU - Moschouris H AD - Interventional Radiology Department, Tzanion General Hospital, Piraeus, Athens, Greece. FAU - Charokopakis, A AU - Charokopakis A AD - Department of Radiology, Medical School, National and Kapodistrian University of Athens, 19 Monis Kyccou, 15 669 Papagou, Athens, Greece. AD - Evgenidion and Attikon University Hospitals, Chaidari, Greece. FAU - Vergadis, C AU - Vergadis C AD - Laikon General Hospital, Athens, Greece. FAU - Alevisopoulos, N AU - Alevisopoulos N AD - Evangelismos Hospital, Athens, Greece. FAU - Kartsouni, V AU - Kartsouni V AD - Department of Interventional Radiology, Agios Savvas Anticancer Hospital, Athens, Greece. FAU - Panagiotou, Ir AU - Panagiotou I AD - Department of Internal Medicine, Agios Savvas Anticancer Hospital, Alphathens, Greece. FAU - Pellerin, O AU - Pellerin O AD - Interventional Radiology, Universite de Paris-Cite, PARCC, INSERM, 75006, Service de Radiologie Interventionnelle Assistance Publique - Hopitaux de Paris Hopital Europeen Georges Pompidou, Paris, France. FAU - Glantzounis, G AU - Glantzounis G AD - Ioannina University Hospital, Ioannina, Greece. FAU - Filippiadis, D K AU - Filippiadis DK AD - Department of Radiology, Medical School, National and Kapodistrian University of Athens, 19 Monis Kyccou, 15 669 Papagou, Athens, Greece. AD - Evgenidion and Attikon University Hospitals, Chaidari, Greece. FAU - Emmanouil, E AU - Emmanouil E AD - Department of Radiology, Amalia Fleming Hospital, Athens, Greece. FAU - Tsavaris, N AU - Tsavaris N AD - Laikon Hospital, Athens, Greece. FAU - Psarros, G AU - Psarros G AD - ASTAT-Statistics in Clinical Research, 166 75, Athens, Greece. FAU - Delicha, E AU - Delicha E AD - ASTAT-Statistics in Clinical Research, 166 75, Athens, Greece. FAU - Kelekis, N AU - Kelekis N AD - Department of Radiology, Medical School, National and Kapodistrian University of Athens, 19 Monis Kyccou, 15 669 Papagou, Athens, Greece. AD - Evgenidion and Attikon University Hospitals, Chaidari, Greece. LA - eng PT - Clinical Study PT - Journal Article DEP - 20230619 PL - United States TA - Cardiovasc Intervent Radiol JT - Cardiovascular and interventional radiology JID - 8003538 RN - 7673326042 (Irinotecan) SB - IM MH - Adult MH - Aged MH - Humans MH - *Carcinoma, Hepatocellular/therapy MH - *Chemoembolization, Therapeutic/adverse effects MH - *Colonic Neoplasms MH - *Colorectal Neoplasms/pathology MH - Irinotecan/therapeutic use MH - *Liver Neoplasms/drug therapy/pathology MH - Microspheres MH - Prospective Studies MH - *Rectal Neoplasms/therapy MH - Middle Aged MH - Aged, 80 and over OTO - NOTNLM OT - Drug-eluting microspheres OT - HepaSphere microspheres 30-60 mum OT - Irinotecan OT - Liver metastatic colorectal cancer (mCRC) EDAT- 2023/06/20 01:09 MHDA- 2023/07/07 06:42 CRDT- 2023/06/19 23:25 PHST- 2022/10/10 00:00 [received] PHST- 2023/04/13 00:00 [accepted] PHST- 2023/07/07 06:42 [medline] PHST- 2023/06/20 01:09 [pubmed] PHST- 2023/06/19 23:25 [entrez] AID - 10.1007/s00270-023-03446-6 [pii] AID - 10.1007/s00270-023-03446-6 [doi] PST - ppublish SO - Cardiovasc Intervent Radiol. 2023 Jul;46(7):880-890. doi: 10.1007/s00270-023-03446-6. Epub 2023 Jun 19.