Τίτλος:
Chemoembolization of Hepatocellular Carcinoma with Hepasphere 30-60 μm. Safety and Efficacy Study
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Background: This study examined the safety, pharmacokinetics, and efficacy of transarterial chemoembolization of hepatocellular carcinoma (HCC) using a newly developed size of a superabsorbent polymer drug-eluting embolic material. Methods: Forty-five patients with documented HCC (Child-Pugh score A/B: 55.5 %/44.5 %) were embolized with HepaSphere microspheres 30-60 μm with escalation of lesion, dose, and frequency of re-embolization. Local response was evaluated with modified response evaluation criteria in solid tumors (mRECIST). Plasma levels of doxorubicin were measured in 24 patients at baseline and at 5, 20, 40, 60, and 120 min, at 6, 24, and 48 h, and at 7 days, respectively, to determine doxorubicin in plasma (Cmax) and area under the curve (AUC). Measurements of three patients who underwent lipiodol-based conventional chemoembolization (c-TACE) were also performed. Results: TACE with HepaSphere was well tolerated with an acceptable safety profile and no 30-day mortality. Response rates were calculated on intention-to-treat basis with complete response (CR) in 17.8 % reaching 22.2 % for the target lesion. Overall partial response (PR) was seen in 51.1 %, stable disease in 20 %, and progressive disease in 11.1 % of patients. Overall objective response (CR + PR), including patients treated at all dosages of doxorubicin, was seen in 68.9 % of cases. After a median follow-up of 15.6 months, 1-year survival is 100 %. Doxorubicin AUC was significantly lower in patients with HepaSphere 30-60 μm (35,195 ± 27,873 ng × min/ml) than in patients with conventional TACE (103,960 ± 16,652 ng × min/ml; p = 0.009). Cmax was also significantly lower with HepaSphere 30-60 μm (83.9 ± 32.1 ng/ml) compared with c-TACE (761.3 ± 58.8 ng/ml; p = 0.002). Conclusion: HepaSphere 30-60 μm is an effective drug-eluting embolic material with a favourable pharmacokinetic profile. © 2013 The Author(s).
Συγγραφείς:
Malagari, K.
Pomoni, M.
Moschouris, H.
Kelekis, A.
Charokopakis, A.
Bouma, E.
Spyridopoulos, T.
Chatziioannou, A.
Sotirchos, V.
Karampelas, T.
Tamvakopoulos, C.
Filippiadis, D.
Karagiannis, E.
Marinis, A.
Koskinas, J.
Kelekis, D.A.
Περιοδικό:
CardioVascular and Interventional Radiology
Λέξεις-κλειδιά:
alanine aminotransferase; aspartate aminotransferase; bilirubin; cefuroxime; codeine; dexamethasone; doxorubicin; iodinated poppyseed oil; metronidazole; microsphere; ondansetron; paracetamol; pethidine; ranitidine; antineoplastic agent; contrast agent BR1; contrast medium; doxorubicin; drug carrier; ethiodized oil; microsphere; phospholipid; polymer; sulfur hexafluoride, adult; aged; alanine aminotransferase blood level; area under the curve; article; ascites; aspartate aminotransferase blood level; bilirubin blood level; cancer mortality; cancer survival; chemoembolization; cholecystitis; clinical article; comparative study; complication; conventional chemoembolization; drug blood level; drug fever; female; follow up; human; intention to treat analysis; length of stay; limit of quantitation; liver cell carcinoma; liver necrosis; male; maximum plasma concentration; middle aged; pain; postembolization syndrome; priority journal; prospective study; safety; survival rate; treatment duration; treatment response; unspecified side effect; very elderly; Carcinoma, Hepatocellular; chemoembolization; diagnostic imaging; diagnostic use; liver function test; Liver Neoplasms; procedures; treatment outcome, Aged; Aged, 80 and over; Antineoplastic Agents; Carcinoma, Hepatocellular; Chemoembolization, Therapeutic; Contrast Media; Diagnostic Imaging; Doxorubicin; Drug Carriers; Ethiodized Oil; Female; Humans; Liver Function Tests; Liver Neoplasms; Male; Microspheres; Middle Aged; Phospholipids; Polymers; Prospective Studies; Sulfur Hexafluoride; Survival Rate; Treatment Outcome
DOI:
10.1007/s00270-013-0777-x
