- 作者：Yoshitaka 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
- 关键词：Hepatocellular carcinoma ; Transarterial chemoembolisation ; Platelet-derived growth factor ; TSU-68
- 刊名：European Journal of Cancer
- 出版年：2013
- 出版时间：September, 2013
- 年：2013
- 卷：49
- 期：13
- 页码：2832-2840
- 全文大小：1059 K
Background
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 200 mg 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 157.0 days (95 % confidence interval [CI], 124.0-230.0 days) in the TSU-68 group and 122.0 days (95 % CI, 73.0-170.0 days) 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.