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A randomised phase II study of TSU-68 in patients with hepatocellular carcinoma treated by transarterial chemoembolisation.

AbstractBACKGROUND:
TSU-68 is an antitumour drug that acts by inhibiting angiogenesis. We evaluated the efficacy and safety of TSU-68 in combination with transarterial chemoembolisation (TACE) in patients with intermediate-stage hepatocellular carcinoma (HCC).
PATIENTS AND METHODS:
In this multicenter, open-label phase II study, we randomised patients with HCC who had been treated with a single session of TACE to receive either 200mg TSU-68 twice daily or no medication. The primary end-point was progression-free survival (PFS).
RESULTS:
A total of 103 patients were enrolled. Median PFS was 157.0days (95% confidence interval [CI], 124.0-230.0days) in the TSU-68 group and 122.0days (95% CI, 73.0-170.0days) in the control group. The hazard ratio was 0.699 (95% CI, 0.450-1.088). Fatigue, elevated aspartate aminotransferase (AST), elevated alkaline phosphatase, oedema and anorexia were more frequent in the TSU-68 group than in the control group. The most frequent grade 3/4 adverse events were AST elevation (46% of patients in the TSU-68 group and 12% of controls) and alanine aminotransferase elevation (26% of patients in the TSU-68 group and 8% of controls). Two deaths, grade 5 hepatic failure and melena were noted in the TSU-68 group.
CONCLUSION:
This exploratory study shows a trend towards prolonged PFS with TSU-68 treatment after a single session of TACE, but this observation was not statistically significant. The two deaths were related to the study treatment. These results suggest that further examination of the study design is necessary to determine whether TSU-68 has any clinical benefits when combined with TACE.
AuthorsYoshitaka Inaba, Fumihiko Kanai, Takeshi Aramaki, Takanobu Yamamoto, Toshihiro Tanaka, Koichiro Yamakado, Shuichi Kaneko, Masatoshi Kudo, Kazuho Imanaka, Shinichi Kora, Norifumi Nishida, Nobuyuki Kawai, Hiroshi Seki, Osamu Matsui, Hitoshi Arioka, Yasuaki Arai
JournalEuropean journal of cancer (Oxford, England : 1990) (Eur J Cancer) Vol. 49 Issue 13 Pg. 2832-40 (Sep 2013) ISSN: 1879-0852 [Electronic] England
PMID23764238 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2013 Elsevier Ltd. All rights reserved.
Chemical References
  • Angiogenesis Inhibitors
  • Indoles
  • Oxindoles
  • Propionates
  • Pyrroles
  • orantinib
Topics
  • Aged
  • Angiogenesis Inhibitors (adverse effects, therapeutic use)
  • Carcinoma, Hepatocellular (drug therapy, mortality, therapy)
  • Chemoembolization, Therapeutic (adverse effects)
  • Disease-Free Survival
  • Female
  • Humans
  • Indoles (adverse effects, therapeutic use)
  • Japan
  • Kaplan-Meier Estimate
  • Liver Neoplasms (drug therapy, mortality, therapy)
  • Male
  • Middle Aged
  • Oxindoles
  • Propionates (adverse effects, therapeutic use)
  • Proportional Hazards Models
  • Pyrroles
  • Time Factors
  • Treatment Outcome

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