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 ofTACE 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.
RCT Entities:
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 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.
Authors: Jeeyun Lee; Sang Joon Shin; Ik Joo Chung; Tae Won Kim; Hoo-Geun Chun; Dong Bok Shin; Yeul Hong Kim; Hong Suk Song; Sae-Won Han; Jong Gwang Kim; Sun Young Kim; Young Jin Choi; Hyun Cheol Chung Journal: Invest New Drugs Date: 2014-02-27 Impact factor: 3.850
Authors: W Koizumi; K Yamaguchi; H Hosaka; Y Takinishi; N Nakayama; T Hara; K Muro; H Baba; Y Sasaki; T Nishina; N Fuse; T Esaki; M Takagi; M Gotoh; T Sasaki Journal: Br J Cancer Date: 2013-09-17 Impact factor: 7.640
Authors: Mohamed R Akl; Poonam Nagpal; Nehad M Ayoub; Betty Tai; Sathyen A Prabhu; Catherine M Capac; Matthew Gliksman; Andre Goy; K Stephen Suh Journal: Oncotarget Date: 2016-07-12