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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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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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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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Journal Article
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
2014
Overview
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/m
2
on day 1 every 3 weeks, or docetaxel 60 mg/m
2
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.
Publisher
Springer US,Springer,Springer Nature B.V
Subject
/ 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
/ Biological and medical sciences
/ Breast Neoplasms - drug therapy
/ Drugs
/ Female
/ Gynecology. Andrology. Obstetrics
/ Humans
/ Indoles - administration & dosage
/ Medicine
/ Multiple tumors. Solid tumors. Tumors in childhood (general aspects)
/ Oncology
/ Patients
/ Pharmacology. Drug treatments
/ Propionates - administration & dosage
/ Propionates - adverse effects
/ Taxoids - administration & dosage
/ Toxicity
/ Tumors
/ Vascular endothelial growth factor
/ Women
