Comparison of Therapeutic Effect of Miriplatin Suspension Versus Miriplatin Emulsion in Transcatheter Arterial Chemoembolization of Hepatocellular Carcinoma: A Prospective Evaluation

Hiroki Sanda, Nobuyuki Kawai, Morio Sato, Hiroki Minamiguchi, Motoki Nakai, Hinako Sakaguchi, Kouhei Nakata, Akira Ikoma, Fumihiro Tanaka, Hirotatsu Sato, Tetsuo Sonomura

Abstract


AIM: To compare miriplatin plus lipiodol (viscous mixture; miriplatin suspension) with miriplatin plus lipiodol with contrast medium (less-viscous mixture; oil-in-water miriplatin emulsion), in terms of lipiodol (Lp) accumulation in hepatocellular carcinoma (HCC) nodules immediately after transcatheter arterial chemoembolization, adverse events, treatment effect (TE), and overall tumor response. METHODS: This study was designed as a single-center, prospective, randomized controlled trial. Patients with unresectable hypervascular HCC confined to the liver were assigned to either the miriplatin suspension group or miriplatin emulsion group. We evaluated radiographic response (modified Response Evaluation Criteria in Solid Tumors) at 3 months as the primary endpoint; secondary endpoints were Lp accumulation immediately after (Grade I, lipiodol accumulation of 100% or greater), lesion TE (Liver Cancer Study Group of Japan), and safety (Common Terminology Criteria for Adverse Events v4.0). RESULTS: Twenty-nine patients with 71 nodules were randomized to the suspension group and 32 patients with 84 nodules to the emulsion group. No significant difference in HCC patient background was found between the groups. Grade I Lp accumulation immediately after, TE4, and overall tumor response (partial response plus complete response) of the suspension vs. emulsion groups were 70% vs. 66.7%, 39.4% vs. 39.3%, and 51.7% vs. 46.9%, respectively, with no significant difference. There was no significant difference in adverse events between the groups. CONCLUSION: There was no significant difference between the miriplatin suspension and miriplatin emulsion groups regarding Lp accumulation, TE, overall tumor response at 3 months, and adverse events.

Keywords


Hepatocellular carcinoma; Lipiodol; Miriplatin emulsion; miriplatin suspension; Overall tumor response; Prospective study; Transcatheter arterial chemoembolization

References


Kawai S, Tani M, Okamura J, Ogawa M, Ohashi Y, Monden

M, Hayashi S, Inoue J, Kawarada Y, Kusano M, Kubo Y,

Kuroda C, Sakata Y, Shimamura Y, Jinno K, Takahashi A,

Takayasu K, Tamura K, Nagasue N, Nakanishi Y, Makino

M, Masuzawa M, Yumoto Y, Mori T, Oda T. Prospective

and randomized trial of lipiodol-transcatheter arterial

chemoembolisation for treatment of hepatocellular

carcinoma: a comparison of epirubicin and doxorubicin

(second cooperative study). The Cooperative Study Group

for Liver Cancer Treatment of Japan. Semin Oncol 1997; 24:

S6-38–S6-45

Sasaki Y, Imaoka S, Kasugai H, Fujita M, Kawamoto S,

Ishiguro S, Kojima J, Ishikawa O, Ohigashi H, Furukawa

H. A new approach to chemoembolization therapy for

hepatoma using ethiodized oil, cisplatin, and gelatin

sponge. Cancer 1987; 60: 1194–1203

Kasugai H, Kojima J, Tatsuta M, Okuda S, Sasaki Y,

Imaoka S, Fujita M, Ishiguro S. Treatment of hepatocellular

carcinoma by transcatheter arterial embolization combined

with intraarterial infusion of a mixture of cisplatin and

ethiodized oil. Gastroenterology 1989; 97: 965–971

Konno T, Maeda H, Iwai K, Tashiro S, Maki S, Morinaga

T, Mochinaga M, Hiraoka T, Yokoyama I. Effect of arterial

administration of high molecular weight anticancer agent

SMANCS with lipid lymphographic agent on hepatoma: A

preliminary report. Eur J Cancer Clin Oncol 1983; 19: 1053–

Kamada K, Nakani shi T, Ki t amoto M, Aika t a H,

Kawakami Y, Ito K, Asahara T, Kajiyama G. Long-term

prognosis of patients undergoing transcatheter arterial

chemoembolization for unresectable hepatocellular

carcinoma: Comparison of cisplatin lipiodol suspension and

doxorubicin hydrochloride emulsion. J Vasc Interv Radiol

; 12: 847–854

Ono Y, Yoshimasu T, Ashikaga R, Inoue M, Shindou H,

Fuji K, Araki Y, Nishimura Y. Long-term results of lipiodoltranscatheter

arterial embolization with cisplatin or

doxorubicin for unresectable hepatocellular carcinoma. Am

J Clin Oncol 2000; 23: 564–568

Sahara S, Kawai N, Sato M, Minamiguchi H, Nakai M,

Takasaka I, Nakata K, Ikoma A, Sawa N, Sonomura T,

Shirai S. Prospective comparison of transcatheter arterial

chemoembolization with lipiodol-epirubicin and lipiodolcisplatin

for treatment of recurrent hepatocellular

carcinoma. Jpn J Radiol 2010; 28: 362–368

Maeda S, Shibata J, Fujiyama S, Tanaka M, Noumaru S,

Sato K, Tomita K. Long-term follow-up of hepatic arterial

chemoembolization with cisplatin suspended in iodized oil

for hepatocellular carcinoma. Hepatogastroenterology 2003;

: 809–913

© 2013 ACT. All rights reserved. 778

Sanda H et al . TACE with miriplatin suspension and emulsion

Uyama N, Hatano N, Maetani Y, Isoda H, Shibata T,

Taura K, Oe S, Naito M, Yasuchika K, Fujii H, Ikai I,

Uemoto S. Efficacy and toxicity of transcatheter arterial

chemoembolization with Cisplatin suspended in lipiodol

for unresectable hepatocellular carcinoma. Jpn J Cancer

Chemother 2008; 35: 775–780

Chang JM, Tzeng WS, Pan HB, Yang CF, Lai KH.

Transcatheter arterial embolization with or without

cisplatin treatment of hepatocellular carcinoma. A

randomized controlled study. Cancer 1994; 74: 2449–2453

Sahara S, Kawai N, Sato M, Tanaka T, Ikoma A, Nakata K,

Sanda H, Minamiguchi H, Nakai M, Shirai S, Sonomura

T. Prospective evaluation of transcatheter arterial

chemoembolization (TACE) with multiple anti-cancer

drugs (epirubicin, cisplatin, mitomycin C, 5-fluorouracil)

compared with TACE with epirubicin for treatment for

hepatocellular carcinoma. Cardiovasc Intervent Radiol 2012;

: 1363–1371

Maeda M, Uchida NA, Sasaki T. Liposoluble platinum (II)

complexes with antitumor activity. Jpn J Cancer Res 1986;

: 523–525

Ki shimoto S, Fukui M, Fukushima S, Nakano M.

Application of a lipophilic platinum derivative contained

in an oily lymphographic agent to intrahepatic arterial

chemotherapy. Reg Cancer Treat 1992; 1: 25–29

Fujiyama S, Shibata J, Maeda S, Tanaka M, Noumaru

S, Sato K, Tomita K. Phase I clinical study of a novel

lipophilic platinum complex (SM-11355) in patients with

hepatocellular carcinoma refractory to cisplatin/lipiodol.

British J Cancer 2003; 89: 1614–1619

Okusaka T, Okada, Nakanishi T, Fujiyama S, Kubo Y.

Phase II trial of intra-arterial chemotherapy using a novel

lipophilic platinum derivative (SM-11355) in patients with

hepatocellular carcinoma. Invest New Drugs 2004; 22: 169–176

de Baere T, Zhang X, Aubert B, Harry G, Lagrange C, Ropers

J, Dufaux J, Lumbroso J, Rougier P, Ducreux M, Roche

A.K. Quantification of tumor uptake of iodized oils and

emulsions of iodized oils: experimental study. Radiology

; 201: 731–735

Demachi H, Matsui O, Abo H, Tatsu H. Simulation model

based on non-newtonian fluid mechanics applied to the

evaluation of the embolic effect of emulsions of iodized oil

and anticancer drug. Cardiovasc Intervent Radiol 2000; 23:

–290

Liver Cancer Study Group of Japan, The general rules for

the clinical and pathological study of primary liver cancer.

Third English edition, revised version. 2010

Lencioni R, Llovet JM. Modified RECIST (mRECIST)

assessment for hepatocellular carcinoma. Semin Liver Dis

; 30: 52–60

Takara S, Higashihara H, Urakawa H, Masima S, Nou A,

Yosimitu K. Thermo-effect of miriplatin-lipiodol emulsion. J

New Rem & Clin 2011; 60: 994–998

Okabe K, Beppu T, Haraoka K, Oh-Uchida Y, Yamamura S,

Tomiyasu S, Yamanaka T, Sano O, Masuda T, Chikamoto

A, Fujiyama S, Baba H. Safety and short-term therapeutic

effects of miriplatin-lipiodol suspension in transarterial

chemoembolization (TACE) for hepatocellular carcinoma.

Anticancer Res 2011; 31: 2983–2988

Imai N, Ikeda K, Kawamura Y, Sezaki H, Hosaka T, Akuta

N, Kobayashi M, Saitoh S, Suzuki F, Suzuki Y, Arase Y,

Kumada H. Transcatheter arterial chemotherapy using

miriplatin-lipiodol suspension with or without embolization

for unresectable hepatocellularcarcinoma. Jpn J Clin Oncol

; 42: 175–182

Aramaki T, Moriguchi M, Bekku E, Asakura K, Sawada

A, Endo M. Comparison of epirubicin hydrochloride and

miriplatin hydrate as anticancer agents for transcatheter

arterial chemoembolization of hepatocellular carcinoma.

Hepatol Res 2012 Sep 3

Araki T, Okada T, Kimura K, Sawada E, Sano K, Araki T.

Adverse events and therapeutic efficacy associated with

TACE for hepatocellular carcinoma with a miriplatinlipiodol

suspension in comparison with a cisplatin-lipiodol

suspension. IVR 2012; 27: 33–40

Miyayama S, Yamashiro M, Shibata Y, Hashimoto M,

Yoshida M, Tsuji K, Toshima F, Matsui O. Comparison of

local control effects of superselective transcatheter arterial

chemoembolization using epirubicin plus mitomycin C and

miriplatin for hepatocellular carcinoma. Jpn J Radiol 2012;

: 263-270

Ikoma A, Kawai N, Sato M, Minamiguchi H, Nakai M,

Nakata K, Tanaka T, Sonomura T. Comparison of blood

dynamics of anticancer drugs (cisplatin, mitomycin C,

epirubicin) in treatment groups of hepatic arterial infusion,

hepatic arterial infusion with lipiodol, hepatic arterial

chemoembolization with lipiodol plus gelatin sponge

particles in a swine model. Hepatol Res 2012 May 8

Sahara S, Tanihata H, Sato M, Kawai N, Takasaka I,

Minamiguchi H, Nakai M, Sonomura T. Effects of hepatic

artery chemoembolization using cisplatin-lipiodol

suspension with gelatin sponge particles on swine liver. J

Vasc Interv Radiol 2009; 20: 1359–1364


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