PMID- 22187203
OWN - NLM
STAT- MEDLINE
DCOM- 20130403
LR  - 20240330
IS  - 1573-0646 (Electronic)
IS  - 0167-6997 (Print)
IS  - 0167-6997 (Linking)
VI  - 30
IP  - 5
DP  - 2012 Oct
TI  - A randomized phase II trial of intra-arterial chemotherapy using SM-11355 
      (Miriplatin) for hepatocellular carcinoma.
PG  - 2015-25
LID - 10.1007/s10637-011-9776-4 [doi]
AB  - BACKGROUND: SM-11355 is a platinum complex developed to treat hepatocellular 
      carcinoma (HCC) via administration into the hepatic artery as a sustained-release 
      suspension in iodized oil. We conducted a multicenter phase II trial in patients 
      with HCC to evaluate the efficacy and safety of SM-11355, using a Zinostatin 
      stimalamer suspension in iodized oil as a reference. METHODS: Patients with 
      unresectable HCC were randomized 2:1 to receive administration of the SM-11355 or 
      Zinostatin stimalamer suspension into the hepatic artery. A second injection was 
      given 4-12 weeks later. Efficacy was evaluated by CT 3 months after treatment and 
      categorized as therapeutic effect (TE) V to I, where TE V was defined as 
      disappearance or 100% necrosis of all treated tumors. RESULTS: A total of 122 
      patients were evaluated for efficacy and toxicity (SM-11355, n = 83; Zinostatin 
      stimalamer, n = 39). Baseline characteristics were similar in the two groups. The 
      TE V rates were 26.5% (22/83) and 17.9% (7/39) in the SM-11355 and Zinostatin 
      stimalamer groups, respectively. In the SM-11355 group,the most frequent 
      drug-related adverse events (AEs) of >/= grade 3 were elevated AST, elevated ALT, 
      thrombocytopenia, and hyperbilirubinemia. The AEs with the largest difference 
      between the two groups (SM-11355 vs. Zinostatin stimalamer) were hepatic vascular 
      injury (0 vs. 48.4%) and eosinophilia (84.3 vs. 41.0%). The 2-year and 3-year 
      survival rates were 75.9% vs. 70.3% and 58.4% vs. 48.7%, respectively. 
      CONCLUSIONS: The results suggest that SM-11355 in iodized oil has similar 
      efficacy to Zinostatin stimalamer and that repeated dosing of SM-11355 is 
      possible without hepatic vascular injury in cases of relapse.
FAU - Okusaka, Takuji
AU  - Okusaka T
AD  - Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, 
      5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. tokusaka@ncc.go.jp
FAU - Kasugai, Hiroshi
AU  - Kasugai H
FAU - Ishii, Hiroshi
AU  - Ishii H
FAU - Kudo, Masatoshi
AU  - Kudo M
FAU - Sata, Michio
AU  - Sata M
FAU - Tanaka, Katsuaki
AU  - Tanaka K
FAU - Shioyama, Yasukazu
AU  - Shioyama Y
FAU - Chayama, Kazuaki
AU  - Chayama K
FAU - Kumada, Hiromitsu
AU  - Kumada H
FAU - Yoshikawa, Masaharu
AU  - Yoshikawa M
FAU - Seki, Toshihito
AU  - Seki T
FAU - Saito, Hidetugu
AU  - Saito H
FAU - Hayashi, Naoaki
AU  - Hayashi N
FAU - Shiratori, Keiko
AU  - Shiratori K
FAU - Okita, Kiwamu
AU  - Okita K
FAU - Sakaida, Isao
AU  - Sakaida I
FAU - Honda, Masao
AU  - Honda M
FAU - Kusumoto, Yukio
AU  - Kusumoto Y
FAU - Tsutsumi, Takuya
AU  - Tsutsumi T
FAU - Sakata, Kenji
AU  - Sakata K
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20111221
PL  - United States
TA  - Invest New Drugs
JT  - Investigational new drugs
JID - 8309330
RN  - 0 (Organoplatinum Compounds)
RN  - 780F0P8N4I (miriplatin)
SB  - IM
MH  - Aged
MH  - Carcinoma, Hepatocellular/*drug therapy/metabolism
MH  - Drug Administration Schedule
MH  - Female
MH  - Hepatic Artery
MH  - Humans
MH  - Infusions, Intra-Arterial/methods
MH  - Liver Neoplasms/*drug therapy/metabolism
MH  - Male
MH  - Middle Aged
MH  - Organoplatinum Compounds/*administration & dosage/adverse 
      effects/pharmacokinetics
MH  - Survival Rate
PMC - PMC3432786
EDAT- 2011/12/22 06:00
MHDA- 2013/04/04 06:00
PMCR- 2011/12/21
CRDT- 2011/12/22 06:00
PHST- 2011/10/10 00:00 [received]
PHST- 2011/11/27 00:00 [accepted]
PHST- 2011/12/22 06:00 [entrez]
PHST- 2011/12/22 06:00 [pubmed]
PHST- 2013/04/04 06:00 [medline]
PHST- 2011/12/21 00:00 [pmc-release]
AID - 9776 [pii]
AID - 10.1007/s10637-011-9776-4 [doi]
PST - ppublish
SO  - Invest New Drugs. 2012 Oct;30(5):2015-25. doi: 10.1007/s10637-011-9776-4. Epub 
      2011 Dec 21.