title: Low dose capecitabine plus weekly paclitaxel in patients with metastatic breast cancer: a multicenter phase II study KBCSG-0609.
abstract: OBJECTIVE
  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/m(2) twice daily, days 1-21) plus paclitaxel (80 mg/m(2), 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.
authors: Department of Endocrine and Breast Surgery, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan. ttaguchi@koto.kpu-m.ac.jp
authors: Tetsuya
authors: T
authors: Taguchi
authors: Daigo
authors: D
authors: Yamamoto
authors: Norikazu
authors: N
authors: Masuda
authors: Koji
authors: K
authors: Oba
authors: Takahiro
authors: T
authors: Nakayama
authors: Takuya
authors: T
authors: Nagata
authors: Masaya
authors: M
authors: Nomura
authors: Katsuhide
authors: K
authors: Yoshidome
authors: Hiroshi
authors: H
authors: Yoshino
authors: Nobuki
authors: N
authors: Matsunami
authors: Masaru
authors: M
authors: Miyashita
authors: Yoshihiko
authors: Y
authors: Furuya
authors: Takanori
authors: T
authors: Ishida
authors: Kazuyuki
authors: K
authors: Wakita
authors: Junichi
authors: J
authors: Sakamoto
authors: Shinzaburo
authors: S
authors: Noguchi
mesh_terms: D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D023381:Endpoint Determination; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D060831:Hand-Foot Syndrome; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000188:drug therapy; D017239:Paclitaxel / Q000008:administration & dosage; D018401:Sample Size; D016019:Survival Analysis
chemical_list: D000903:Antibiotics, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D003841:Deoxycytidine; D000069287:Capecitabine; D017239:Paclitaxel; D005472:Fluorouracil