Transhepatic arterial chemoembolization with oxaliplatin-eluting microspheres (OEM-TACE) for unresectable hepatic tumors.
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.
Poggi
Guido
G
Departments of Oncology, University of Pavia, IRCCS Fondazione S. Maugeri, Istituto Scientifico di Pavia, Italy. guido.poggi@fsm.it
Quaretti
Pietro
P
Minoia
Claudio
C
Bernardo
Giovanni
G
Bonora
Mario Regazzi
MR
Gaggeri
Raffaella
R
Ronchi
Anna
A
Saluzzo
Cesare Massa
CM
Azzaretti
Andrea
A
Rodolico
Giuseppe
G
Montagna
Michela
M
Amatu
Alessio
A
Teragni
Cristina
C
Palumbo
Ilaria
I
Traverso
Elena
E
Tonini
Stefano
S
Villani
Laura
L
Scelsi
Mario
M
Baiardi
Paola
P
Felisi
Maria Grazia
MG
Sottotetti
Federico
F
Tagliaferri
Barbara
B
Riccardi
Alberto
A
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
D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin