title: The efficacy and safety of gemcitabine plus paclitaxel combination first-line therapy for Japanese patients with metastatic breast cancer including triple-negative phenotype.
abstract: OBJECTIVE
  Gemcitabine (GEM)-paclitaxel combination therapy has been confirmed as a standard therapy for metastatic/recurrent breast cancer (MBC) in Western countries. This study was conducted to assess the efficacy and safety of GEM-paclitaxel combination therapy in Japanese MBC patients.
  
  
  METHODS
  Patients were administered paclitaxel 175 mg/m(2) on day 1, and GEM 1,000 or 1,250 mg/m(2) on days 1 and 8 of 21-day cycle. The primary endpoint of this study was overall response rate; secondary endpoints were duration of response, time to progression, survival time and rate.
  
  
  RESULTS
  Paclitaxel 175 mg/m(2) plus GEM 1,250 mg/m(2) was determined as the recommended dose. A total of 56 patients received 506 cycles of treatment (median: 7.5 cycles) with a relative dose intensity of 79.6% for GEM and 85.8% for paclitaxel. The response rate was 44.6% (25/56 patients), median time to progression 8.6 months and median survival time 27.1 months. In triple-negative patients, the response rate was 35.7% (5/14 patients), and the median time to progression was 6.0 months. The most frequent grade ≥ 3 toxicities were neutropenia (82.1%), leukopenia (62.5%) and ALT increase (14.3%).
  
  
  CONCLUSIONS
  This study confirmed the efficacy and safety of GEM-paclitaxel combination therapy in Japanese MBC patients.
authors.affiliation: Department of Breast Oncology, Shikoku Cancer Center, 160 Kou, Minami-umemotocho, Matsuyama 791-0280, Japan. kaogi@shikoku-cc.go.jp
authors.forename: Kenjiro
authors.initials: K
authors.lastname: Aogi
authors.forename: Masayuki
authors.initials: M
authors.lastname: Yoshida
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Sagara
authors.forename: Shunji
authors.initials: S
authors.lastname: Kamigaki
authors.forename: Minoru
authors.initials: M
authors.lastname: Okazaki
authors.forename: Jumpei
authors.initials: J
authors.lastname: Funai
authors.forename: Toshio
authors.initials: T
authors.lastname: Fujimoto
authors.forename: Masakazu
authors.initials: M
authors.lastname: Toi
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Saeki
authors.forename: Shigemitsu
authors.initials: S
authors.lastname: Takashima
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009376:Neoplasms, Hormone-Dependent / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D017239:Paclitaxel / Q000008:administration & dosage; D010641:Phenotype; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000096:biosynthesis* / Q000235:genetics; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D017239:Paclitaxel; D018719:Erb-b2 Receptor Tyrosine Kinases; D000093542:Gemcitabine; C508053:ERBB2 protein, human