Abstract | PURPOSE: METHODS: Patients were randomized to either low-dose XT ( capecitabine 825 mg/m2 twice daily, days 1-14; docetaxel 60 mg/m2, day 1 every 3 weeks) or docetaxel (70 mg/m2, day 1 every 3 weeks). The primary objective was to demonstrate superior progression-free survival (PFS) with low-dose XT versus single-agent docetaxel. Overall survival (OS) and safety were secondary endpoints. RESULTS: In total, 162 patients were treated. Median PFS was 10.5 months with low-dose XT and 9.8 months with single-agent docetaxel (hazard ratio [HR] 0.62 [95% confidence interval (CI) 0.40-0.97]; p = 0.03). The OS HR was 0.89 (95% CI 0.52-1.53; p = 0.68). Grade ≥3 treatment-related toxicities occurred in 74% of XT-treated patients and 76% of docetaxel-treated patients. The main differences in grade ≥3 treatment-related toxicities were hand-foot syndrome (7.3% of XT-treated patients vs 0% receiving docetaxel), fatigue/malaise (2.4 vs 10.0%), and peripheral edema (1.2 vs 7.5%). Dose modifications were required in 100% of low-dose XT and 49% of docetaxel patients. Toxicity-related treatment discontinuations occurred in 18 and 33%, respectively. CONCLUSION: The improved PFS with low-dose XT versus docetaxel alone is consistent with higher-dose XT phase III experience, but the safety profile was more favorable and manageable.
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Authors | Daigo Yamamoto, Nobuaki Sato, Yoshiaki Rai, Yutaka Yamamoto, Mitsue Saito, Hiroji Iwata, Norikazu Masuda, Shoji Oura, Junichiro Watanabe, Satoshi Hattori, Yoshimasa Matsuura, Katsumasa Kuroi |
Journal | Breast cancer research and treatment
(Breast Cancer Res Treat)
Vol. 161
Issue 3
Pg. 473-482
(02 2017)
ISSN: 1573-7217 [Electronic] Netherlands |
PMID | 28005247
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Anthracyclines
- Taxoids
- Docetaxel
- Capecitabine
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Topics |
- Adult
- Aged
- Anthracyclines
(therapeutic use)
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Breast Neoplasms
(drug therapy, mortality, pathology)
- Capecitabine
(administration & dosage)
- Docetaxel
- Female
- Humans
- Middle Aged
- Neoplasm Staging
- Quality of Life
- Retreatment
- Survival Analysis
- Taxoids
(administration & dosage, therapeutic use)
- Treatment Outcome
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