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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

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Author(s)
Sung-Bae KimChanghoon YooJungsil RoSeock-Ah ImYoung-Hyuck ImJee Hyun KimJin-Hee AhnKyung Hae JungHong Suk SongSeok Yun KangHee Sook ParkHyun-Cheol Chung
Keimyung Author(s)
Song, Hong Suk
Department
Dept. of Internal Medicine (내과학)
Journal Title
Investigational New Drugs
Issued Date
2014
Volume
32
Issue
4
Abstract
Summary 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 eventswere neutropenia
and anorexia in both arms. Although both regimens were well
tolerated, grade 3/4 non-hematologic toxicity wasmore 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.
Keywords TSU-68 . Breast cancer . Angiogenesis .
Docetaxel
Keimyung Author(s)(Kor)
송홍석
Publisher
School of Medicine
Citation
Sung-Bae Kim et al. (2014). 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. Investigational New Drugs, 32(4), 753–761. doi: 10.1007/s10637-014-0093-6
Type
Article
ISSN
0167-6997
Source
https://link.springer.com/article/10.1007%2Fs10637-014-0093-6
DOI
10.1007/s10637-014-0093-6
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/36030
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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