PMID- 28777459 OWN - NLM STAT- MEDLINE DCOM- 20171212 LR - 20171212 IS - 1097-4652 (Electronic) IS - 0021-9541 (Linking) VI - 233 IP - 3 DP - 2018 Mar TI - Iodixanol versus iopromide in cancer patients: Evidence from a randomized clinical trial. PG - 2572-2580 LID - 10.1002/jcp.26132 [doi] AB - To assess the safety profile of iso-osmolar contrast medium (CM) versus low osmolar CM in cancer patients with an estimated glomerular filtration rate (eGFR) >60 ml/min. In this multicenter, blind trial of patients seeking a chest-abdomen-pelvis contrast enhanced computed tomography (CT) with iodated CM, participants were centrally randomized to iodixanol or iopromide. Contrast induced nephropathy (CIN) at 24 and/or 72 hr were our primary outcomes. We further considered irreversible CIN, average eGFR percentage variation (%Delta), and adverse events (AEs). Overall, 607 patients were enrolled. Among them, 497 eligible patients were randomized to iodixanol (N: 247) or iopromide (N: 250). No differences emerged by descriptive characteristics. Seven and 3 CIN at 24 hr (p = 0.34) and 8 and 2 CIN at 72 hr (p = 0.11) occurred in the iopromide and iodixanol group, respectively. Within the subgroup of individual patients who developed CIN (N: 17), the event rate was higher in the iopromide arm (p = 0.045). No cases of permanent CIN or significant differences in terms of AEs or GFR %Delta were observed. Our results suggest a more favorable safety profile of iodixanol versus iopromide. Adequately sized trials with similar design are warranted to confirm our findings and clarify the underlying biological mechanisms. CI - (c) 2017 Wiley Periodicals, Inc. FAU - Terrenato, Irene AU - Terrenato I AUID- ORCID: 0000-0002-0187-9323 AD - Biostatistic Unit, Regina Elena National Cancer Institute, Rome, Italy. FAU - Sperati, Francesca AU - Sperati F AD - Biostatistic Unit, Regina Elena National Cancer Institute, Rome, Italy. FAU - Musicco, Felice AU - Musicco F AD - Service of Pharmacovigilance, Regina Elena National Cancer Institute, Rome, Italy. FAU - Pozzi, Anna F AU - Pozzi AF AD - AUSL di Bologna, Bologna, Italy. FAU - di Turi, Annunziata AU - di Turi A AD - Scientific Direction, Regina Elena National Cancer Institute, Rome, Italy. FAU - Caterino, Mauro AU - Caterino M AD - Department of Diagnostic Imaging, Regina Elena National Cancer Institute, Rome, Italy. FAU - de Lutio di Castelguidone, Elisabetta AU - de Lutio di Castelguidone E AD - Department of Diagnostic Imaging, Radiant and Metabolic Therapy, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy. FAU - Setola, Sergio V AU - Setola SV AD - Department of Diagnostic Imaging, Radiant and Metabolic Therapy, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy. FAU - Bellomi, Massimo AU - Bellomi M AD - Department of Medical Imaging and Radiation Sciences, European Institute of Oncology, Milan, Italy. AD - Department of Oncology and Hematology-Oncology, University of Milan, Milan, Italy. FAU - Neumaier, Carlo E AU - Neumaier CE AD - Diagnostic Imaging and Senology, IRCCS-A.O.U., San Martino-IST, Genoa, Italy. FAU - Conti, Laura AU - Conti L AD - Departement of Clinical Patology, Regina Elena National Cancer Institute, Rome, Italy. FAU - Cigliana, Giovanni AU - Cigliana G AD - Departement of Clinical Patology, Regina Elena National Cancer Institute, Rome, Italy. FAU - Merola, Roberta AU - Merola R AD - Departement of Clinical Patology, Regina Elena National Cancer Institute, Rome, Italy. FAU - Antenucci, Anna AU - Antenucci A AD - Departement of Clinical Patology, Regina Elena National Cancer Institute, Rome, Italy. FAU - Orlandi, Giulia AU - Orlandi G AD - Departement of Clinical Patology, Regina Elena National Cancer Institute, Rome, Italy. FAU - Giordano, Antonio AU - Giordano A AD - Department of Medicine, Surgery and Neuroscience, University of Siena and Istituto Toscano Tumori (ITT), Siena, Italy. AD - Department of Biology, Sbarro Institute for Cancer Research and Molecular Medicine, College of Science and Technology, Temple University, Philadelphia, Pennsylvania. FAU - Barba, Maddalena AU - Barba M AD - Scientific Direction, Regina Elena National Cancer Institute, Rome, Italy. AD - Division of Medical Oncology 2, Regina Elena National Cancer Institute, Rome, Italy. FAU - Canitano, Stefano AU - Canitano S AD - Department of Diagnostic Imaging, Regina Elena National Cancer Institute, Rome, Italy. LA - eng PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20170912 PL - United States TA - J Cell Physiol JT - Journal of cellular physiology JID - 0050222 RN - 0 (Contrast Media) RN - 0 (Triiodobenzoic Acids) RN - 4419T9MX03 (Iohexol) RN - 712BAC33MZ (iopromide) RN - HW8W27HTXX (iodixanol) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Contrast Media/administration & dosage/*adverse effects MH - Female MH - Glomerular Filtration Rate/drug effects MH - Humans MH - Iohexol/administration & dosage/adverse effects/*analogs & derivatives MH - Italy MH - Kidney/*drug effects/physiopathology MH - Kidney Diseases/*chemically induced/diagnosis/physiopathology MH - Male MH - Middle Aged MH - Neoplasms/*diagnostic imaging/pathology MH - Patient Safety MH - Predictive Value of Tests MH - Risk Factors MH - Time Factors MH - *Tomography, X-Ray Computed/adverse effects MH - Triiodobenzoic Acids/administration & dosage/*adverse effects MH - Young Adult OTO - NOTNLM OT - cancer patients OT - contrast induced nephropathy OT - low-osmolar/iso-osmolar contrast medium EDAT- 2017/08/05 06:00 MHDA- 2017/12/13 06:00 CRDT- 2017/08/05 06:00 PHST- 2017/08/01 00:00 [received] PHST- 2017/08/03 00:00 [accepted] PHST- 2017/08/05 06:00 [pubmed] PHST- 2017/12/13 06:00 [medline] PHST- 2017/08/05 06:00 [entrez] AID - 10.1002/jcp.26132 [doi] PST - ppublish SO - J Cell Physiol. 2018 Mar;233(3):2572-2580. doi: 10.1002/jcp.26132. Epub 2017 Sep 12.