TY - JOUR
T1 - Low dose capecitabine plus weekly paclitaxel in patients with metastatic breast cancer
T2 - A multicenter phase II study KBCSG-0609
AU - Taguchi, Tetsuya
AU - Yamamoto, Daigo
AU - Masuda, Norikazu
AU - Oba, Koji
AU - Nakayama, Takahiro
AU - Nagata, Takuya
AU - Nomura, Masaya
AU - Yoshidome, Katsuhide
AU - Yoshino, Hiroshi
AU - Matsunami, Nobuki
AU - Miyashita, Masaru
AU - Furuya, Yoshihiko
AU - Ishida, Takanori
AU - Wakita, Kazuyuki
AU - Sakamoto, Junichi
AU - Noguchi, Shinzaburo
N1 - Copyright:
Copyright 2013 Elsevier B.V., All rights reserved.
PY - 2013/3
Y1 - 2013/3
N2 - Purpose: The combination of capecitabine and paclitaxel (XP) has demonstrated synergistic antitumor activity in preclinical models. The purpose of this phase II study was to evaluate the efficacy and safety of a monthly XP regimen in patients with metastatic breast cancer (MBC). Methods: Eligible patients had received one or fewer prior chemotherapy regimens for MBC. Patients received oral capecitabine of low dose (828 mg/m2 twice daily, days 1-21) plus paclitaxel (80 mg/m2, i.v., over 60 min, days 1, 8 and 15) every 28 days until disease progression or unacceptable toxicity. The primary endpoint was overall response rate (ORR). Progression-free survival (PFS), overall survival (OS) and safety were secondary endpoints. An exploratory analysis of efficacy according to hormone receptor (HR) status was performed. Results: Forty-four patients were enrolled, and 43 patients were evaluable. ORR was 46.5 %. PFS and OS were 8.3 and 22.9 months, respectively. ORR was 45.5 % in patients with HR-positive tumors and 50 % in HR-negative cases. The most frequently observed grade 3/4 adverse events were neutropenia (27.9 %), leukopenia (11.6 %), hand-foot syndrome (HFS, 9.3 %) and fatigue (7.0 %). There were no discontinuations due to HFS. Conclusions: Monthly XP was an effective and well-tolerated regimen for the first- or second-line treatment for MBC.
AB - Purpose: The combination of capecitabine and paclitaxel (XP) has demonstrated synergistic antitumor activity in preclinical models. The purpose of this phase II study was to evaluate the efficacy and safety of a monthly XP regimen in patients with metastatic breast cancer (MBC). Methods: Eligible patients had received one or fewer prior chemotherapy regimens for MBC. Patients received oral capecitabine of low dose (828 mg/m2 twice daily, days 1-21) plus paclitaxel (80 mg/m2, i.v., over 60 min, days 1, 8 and 15) every 28 days until disease progression or unacceptable toxicity. The primary endpoint was overall response rate (ORR). Progression-free survival (PFS), overall survival (OS) and safety were secondary endpoints. An exploratory analysis of efficacy according to hormone receptor (HR) status was performed. Results: Forty-four patients were enrolled, and 43 patients were evaluable. ORR was 46.5 %. PFS and OS were 8.3 and 22.9 months, respectively. ORR was 45.5 % in patients with HR-positive tumors and 50 % in HR-negative cases. The most frequently observed grade 3/4 adverse events were neutropenia (27.9 %), leukopenia (11.6 %), hand-foot syndrome (HFS, 9.3 %) and fatigue (7.0 %). There were no discontinuations due to HFS. Conclusions: Monthly XP was an effective and well-tolerated regimen for the first- or second-line treatment for MBC.
KW - Capecitabine
KW - Metastatic breast cancer
KW - Paclitaxel
KW - Phase II
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U2 - 10.1007/s00280-012-2068-7
DO - 10.1007/s00280-012-2068-7
M3 - Article
C2 - 23334260
AN - SCOPUS:84875832885
VL - 71
SP - 741
EP - 747
JO - Cancer Chemotherapy and Pharmacology
JF - Cancer Chemotherapy and Pharmacology
SN - 0344-5704
IS - 3
ER -