TY - JOUR
T1 - Randomized study of orally administered fluorinated pyrimidines (capecitabine versus S-1) in women with metastatic or recurrent breast cancer
T2 - Japan Breast Cancer Research Network 05 Trial
AU - Yamamoto, D.
AU - Iwase, S.
AU - Tsubota, Y.
AU - Ariyoshi, K.
AU - Kawaguchi, T.
AU - Miyaji, T.
AU - Sueoka, N.
AU - Yamamoto, C.
AU - Teramoto, S.
AU - Odagiri, H.
AU - Kitamura, K.
AU - Nagumo, Y.
AU - Yamaguchi, T.
N1 - Publisher Copyright:
© 2015 Springer-Verlag Berlin Heidelberg.
PY - 2015/6/26
Y1 - 2015/6/26
N2 - Purpose: Capecitabine and S-1 are orally administered fluorinated pyrimidines with high-level activity against metastatic breast cancer (MBC). This randomized, multicenter, phase II study compared the activities and safeties of the oral fluoropyrimidines, capecitabine and S-1, in breast cancer patients. Methods: Patients with MBC were randomly assigned to receive capecitabine 825 g/m2 twice daily on days 1-21 every 4 weeks or S-1 40-60 mg twice daily, according to body surface area, on days 1-28 every 6 weeks. The primary endpoint was progression-free survival (PFS). Results: A total of 142 patients were enrolled and randomized to either capecitabine (N = 73) or S-1 (N = 69). Median PFS (progression-free survival) was 1.2 years for capecitabine and 1.3 years for S-1, with a hazard ratio (S-1/capecitabine) of 0.85 (95 % confidence interval [CI] 0.52-1.38) (P = 0.48 by log-rank). The confirmed objective response rates were 24.0 % for capecitabine and 23.1 % for S-1 (P = 0.938). The most common treatment-related adverse events were grade 1-2 in intensity. Thrombocytopenia (S-1: 9.2 %, capecitabine: 1.4 %; P = 0.040) and nausea (S-1: 26.2 %, capecitabine: 14.1 %; P = 0.079) were more frequent in the S-1 group, while hand-foot syndrome occurred more often in the capecitabine group (S-1: 10.8 %, capecitabine: 25.4 %; P = 0.029). Conclusions: The results of the current study demonstrate that both S-1 and capecitabine are effective and well-tolerated treatments in patients with MBC, while their adverse events were different. They are both convenient, orally administered drugs, making them attractive agents for use in outpatient treatment.
AB - Purpose: Capecitabine and S-1 are orally administered fluorinated pyrimidines with high-level activity against metastatic breast cancer (MBC). This randomized, multicenter, phase II study compared the activities and safeties of the oral fluoropyrimidines, capecitabine and S-1, in breast cancer patients. Methods: Patients with MBC were randomly assigned to receive capecitabine 825 g/m2 twice daily on days 1-21 every 4 weeks or S-1 40-60 mg twice daily, according to body surface area, on days 1-28 every 6 weeks. The primary endpoint was progression-free survival (PFS). Results: A total of 142 patients were enrolled and randomized to either capecitabine (N = 73) or S-1 (N = 69). Median PFS (progression-free survival) was 1.2 years for capecitabine and 1.3 years for S-1, with a hazard ratio (S-1/capecitabine) of 0.85 (95 % confidence interval [CI] 0.52-1.38) (P = 0.48 by log-rank). The confirmed objective response rates were 24.0 % for capecitabine and 23.1 % for S-1 (P = 0.938). The most common treatment-related adverse events were grade 1-2 in intensity. Thrombocytopenia (S-1: 9.2 %, capecitabine: 1.4 %; P = 0.040) and nausea (S-1: 26.2 %, capecitabine: 14.1 %; P = 0.079) were more frequent in the S-1 group, while hand-foot syndrome occurred more often in the capecitabine group (S-1: 10.8 %, capecitabine: 25.4 %; P = 0.029). Conclusions: The results of the current study demonstrate that both S-1 and capecitabine are effective and well-tolerated treatments in patients with MBC, while their adverse events were different. They are both convenient, orally administered drugs, making them attractive agents for use in outpatient treatment.
KW - Capecitabine
KW - Clinical trial
KW - Metastatic breast cancer
KW - Recurrent breast cancer
KW - S-1
UR - http://www.scopus.com/inward/record.url?scp=84929710790&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84929710790&partnerID=8YFLogxK
U2 - 10.1007/s00280-015-2738-3
DO - 10.1007/s00280-015-2738-3
M3 - Article
C2 - 25862350
AN - SCOPUS:84929710790
VL - 75
SP - 1183
EP - 1189
JO - Cancer Chemotherapy and Pharmacology
JF - Cancer Chemotherapy and Pharmacology
SN - 0344-5704
IS - 6
ER -