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Breast Cancer
Published in: Breast Cancer 4/2010

01-10-2010 | Original Article

Phase II study of 4-weekly capecitabine monotherapy in advanced/metastatic breast cancer

Authors: Mikihiro Kusama, Tadashi Nomizu, Kenjiro Aogi, Masataka Yoshimoto, Noboru Horikoshi, Toshio Tabei, Shinzaburo Noguchi, Shigeto Miura, Norio Yoshimura, Morihiko Kimura, Kazushige Toyama, Eisei Shin

Published in: Breast Cancer | Issue 4/2010

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Abstract

Background

A multicenter, phase II study was conducted to evaluate the efficacy and safety of the Japanese intermittent 4-week regimen of capecitabine in patients with advanced/metastatic breast cancer.

Methods

Fifty patients who had received no more than one prior chemotherapy regimen for advanced/metastatic disease were enrolled from 23 centers and received at least two 4-weekly cycles of capecitabine (828 mg/m2 orally twice daily for 3 weeks followed by a 1-week rest period).

Results

The overall response rate assessed by the Independent Review Committee (standard population, n = 46) was 28.3% (95% confidence interval 16.0–43.5%), including complete responses in 6.5%. Stable disease was observed in 20 patients and maintained for more than 6 months in 10 patients. The median duration of response in 13 evaluable responders was 5.3 months. Among evaluable patients (n = 47), median time to disease progression was 5.1 months. Median overall survival was 20.2 months. The most common treatment-related adverse events (all grades) were hand–foot syndrome (66%), nausea (26%), stomatitis (22%) and diarrhea (20%). Grade 3/4 treatment-related adverse events were seen in 23 patients (46%). The most common grade 3/4 adverse events were lymphocytopenia (22%), hand–foot syndrome (18%) and hyperbilirubinemia (10%).

Conclusions

Although the target overall response rate was not reached, the Japanese intermittent 4-week regimen of capecitabine was shown to be an effective and well-tolerated first- or second-line therapy for advanced/metastatic breast cancer.
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Metadata
Title
Phase II study of 4-weekly capecitabine monotherapy in advanced/metastatic breast cancer
Authors
Mikihiro Kusama
Tadashi Nomizu
Kenjiro Aogi
Masataka Yoshimoto
Noboru Horikoshi
Toshio Tabei
Shinzaburo Noguchi
Shigeto Miura
Norio Yoshimura
Morihiko Kimura
Kazushige Toyama
Eisei Shin
Publication date
01-10-2010
Publisher
Springer Japan
Published in
Breast Cancer / Issue 4/2010
Print ISSN: 1340-6868
Electronic ISSN: 1880-4233
DOI
https://doi.org/10.1007/s12282-009-0137-5

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