title: Transhepatic arterial chemoembolization with oxaliplatin-eluting microspheres (OEM-TACE) for unresectable hepatic tumors.
abstract: BACKGROUND
  While conventional transhepatic arterial chemoembolization (TACE) is accepted worldwide as an effective treatment for patients with unresectable hepatocellular carcinoma (HCC), its use in other hepatic tumors is not supported by randomized studies. Preliminary results have shown that new drug-eluting microspheres (DEM) seem to optimize TACE procedures. The aim of this study was to evaluate the capability of HepaSphere to load oxaliplatin and their pharmacokinetic outcome. The feasibility and safety of treatment with oxaliplatin-eluting microspheres (OEM-TACE) was also evaluated in patients with unresectable liver metastasis of colorectal cancer and unresectable intrahepatic cholangiocarcinoma.
  
  
  METHODS
  An inductively coupled plasma mass spectrometer (ICP-MS) was used to quantify the oxaliplatin bound to microspheres and the oxaliplatin in liver biopsies. Fifteen patients (8 with colorectal carcinoma liver metastases, 7 with intrahepatic cholangiocarcinoma) were treated with 27 sessions of OEM-TACE.
  
  
  RESULTS
  The data suggested that the microspheres can bind oxaliplatin entirely. The pharmacokinetic parameters were significantly different between the OEM-TACE patients and a control group of patients treated with oxaliplatin chemotherapy. The mean oxaliplatin concentration within the tumor was twenty-times higher than the extratumoral liver concentration in the OEM-TACE patients. According to response evaluating criteria in solid tumors (RECIST), stable disease was observed in 8 out of the 15 patients (53.3%), a partial response in 2 (13.3%) and intrahepatic or extrahepatic tumor progression in 5 out of the 15 patients (33.3%). No major adverse event (AE G3/4) occurred.
  
  
  CONCLUSIONS
  TACE with oxaliplatin-loaded microspheres is a safe and feasible treatment without major adverse events and with a favorable pharmacokinetic profile.
authors.affiliation: Departments of Oncology, University of Pavia, IRCCS Fondazione S. Maugeri, Istituto Scientifico di Pavia, Italy. guido.poggi@fsm.it
authors.forename: Guido
authors.initials: G
authors.lastname: Poggi
authors.forename: Pietro
authors.initials: P
authors.lastname: Quaretti
authors.forename: Claudio
authors.initials: C
authors.lastname: Minoia
authors.forename: Giovanni
authors.initials: G
authors.lastname: Bernardo
authors.forename: Mario Regazzi
authors.initials: MR
authors.lastname: Bonora
authors.forename: Raffaella
authors.initials: R
authors.lastname: Gaggeri
authors.forename: Anna
authors.initials: A
authors.lastname: Ronchi
authors.forename: Cesare Massa
authors.initials: CM
authors.lastname: Saluzzo
authors.forename: Andrea
authors.initials: A
authors.lastname: Azzaretti
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Rodolico
authors.forename: Michela
authors.initials: M
authors.lastname: Montagna
authors.forename: Alessio
authors.initials: A
authors.lastname: Amatu
authors.forename: Cristina
authors.initials: C
authors.lastname: Teragni
authors.forename: Ilaria
authors.initials: I
authors.lastname: Palumbo
authors.forename: Elena
authors.initials: E
authors.lastname: Traverso
authors.forename: Stefano
authors.initials: S
authors.lastname: Tonini
authors.forename: Laura
authors.initials: L
authors.lastname: Villani
authors.forename: Mario
authors.initials: M
authors.lastname: Scelsi
authors.forename: Paola
authors.initials: P
authors.lastname: Baiardi
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Felisi
authors.forename: Federico
authors.initials: F
authors.lastname: Sottotetti
authors.forename: Barbara
authors.initials: B
authors.lastname: Tagliaferri
authors.forename: Alberto
authors.initials: A
authors.lastname: Riccardi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry / Q000493:pharmacokinetics; D016461:Chemoembolization, Therapeutic / Q000009:adverse effects / Q000379:methods*; D018281:Cholangiocarcinoma / Q000378:metabolism / Q000628:therapy*; D016503:Drug Delivery Systems; D005240:Feasibility Studies; D005260:Female; D006499:Hepatic Artery; D006801:Humans; D008113:Liver Neoplasms / Q000378:metabolism / Q000628:therapy*; D008297:Male; D008863:Microspheres; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry / Q000493:pharmacokinetics; D000077150:Oxaliplatin; D015996:Survival Rate
chemical_list: D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin