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Combination of docetaxel and TSU-68, an oral antiangiogenic agent, in patients with metastatic breast cancer previously treated with anthracycline: Randomized phase II multicenter trial

 Sung-Bae Kim  ;  Changhoon Yoo  ;  Jungsil Ro  ;  Seock-Ah Im  ;  Young-Hyuck Im  ;  Jee Hyun Kim  ;  Jin-Hee Ahn  ;  Kyung Hae Jung  ;  Hong Suk Song  ;  Seok Yun Kang  ;  Hee Sook Park  ;  Hyun-Cheol Chung 
 INVESTIGATIONAL NEW DRUGS, Vol.32(4) : 753-761, 2014 
Journal Title
Issue Date
Adult ; Aged ; Angiogenesis Inhibitors/administration & dosage ; Angiogenesis Inhibitors/adverse effects ; Anthracyclines/therapeutic use ; Antineoplastic Agents/administration & dosage ; Antineoplastic Agents/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Breast Neoplasms/drug therapy* ; Disease-Free Survival ; Female ; Humans ; Indoles/administration & dosage ; Indoles/adverse effects ; Middle Aged ; Propionates/administration & dosage ; Propionates/adverse effects ; Taxoids/administration & dosage ; Taxoids/adverse effects
TSU-68 ; Breast cancer ; Angiogenesis ; Docetaxel
The novel oral antiangiogenic agent TSU-68 was investigated in patients with metastatic breast cancer. Patients with anthracycline-pretreated metastatic breast cancer were randomly assigned to receive either TSU-68 400 mg twice daily on days 1–21 plus docetaxel 60 mg/m2 on day 1 every 3 weeks, or docetaxel 60 mg/m2 on day 1 every 3 weeks. The primary endpoint was progression-free survival. Between November 2006 and December 2007, 81 patients were included in this study (41 for TSU-68 plus docetaxel and 40 for docetaxel alone). Median progression-free survival was 6.8 months (95 % confidence interval [CI] = 5.4–12.5 months) in the TSU-68 plus docetaxel group and 8.1 months (95 % CI = 4.0–13.7 months) in the docetaxel-alone group (hazard ratio [HR] = 1.0; 95 % CI = 0.6–1.8; p = 0.95). There were no significant differences in the overall response rates and overall survival between groups (p = 0.29 and p = 0.42, respectively). In subgroup analysis, TSU-68 plus docetaxel was associated with better overall survival than docetaxel alone in anthracycline-resistant patients (HR = 0.3; 95 % CI = 0.1–0.8; p = 0.02). The most frequent adverse events were neutropenia and anorexia in both arms. Although both regimens were well tolerated, grade 3/4 non-hematologic toxicity was more frequently observed in the TSU-68 plus docetaxel group. Combination of TSU-68 and docetaxel is well tolerated but failed to demonstrate superior efficacy over docetaxel alone in anthracycline-pretreated breast cancer patients. As TSU-68 was associated with better survival in the anthracycline-resistant subgroup, it should be further explored in this subgroup.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Chung, Hyun Cheol(정현철) ORCID logo https://orcid.org/0000-0002-0920-9471
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