title: First-line therapy with moderate dose capecitabine in metastatic breast cancer is safe and active: results of the MONICA trial.
abstract: BACKGROUND
  To determine activity and safety of capecitabine at a moderate dose of 2000 mg/m(2) as first-line therapy for metastatic breast cancer.
  
  
  METHODS
  In this prospective phase II trial, patients with HER2-negative metastatic breast cancer received first-line capecitabine 2000 mg/m(2) on days 1-14 every 3 weeks. The primary aim was to exclude a time to progression (TTP) <6 months. Secondary end-points were overall response rate, overall survival (OS), toxicity and quality of life.
  
  
  RESULTS
  Median age of the 161 included patients was 65 years. Median TTP and OS were 7.3 months [95% (confidence interval) CI: 6.2-8.4] and 17.1 months (95% CI: 14.0-20.3), respectively. An overall response rate of 26.1%, including 13 complete remissions was observed. Patients developing grade I-III hand-foot syndrome had a significantly longer TTP and OS and patients >65 years also achieved a significantly longer TTP. Haematological grade I-IV toxicities were leucopenia (64.0%), anaemia (50.9%) and thrombocytopenia (28.0%). Relevant non-haematological toxicities were hand-food-syndrome (37.3%), fatigue (34.2%), nausea (29.8%) and diarrhoea (20.5%). Quality of life assessment revealed an improved emotional function, but worsening of nausea and vomiting from cycle 1-10.
  
  
  CONCLUSIONS
  Capecitabine at a dose of 2000 mg/m(2) is active and safe as first-line treatment of patients with metastatic breast cancer.
authors.affiliation: Universitäts-Frauenklinik, Frankfurt, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Kaufmann
authors.forename: N
authors.initials: N
authors.lastname: Maass
authors.forename: S D
authors.initials: SD
authors.lastname: Costa
authors.forename: A
authors.initials: A
authors.lastname: Schneeweiss
authors.forename: S
authors.initials: S
authors.lastname: Loibl
authors.forename: M W
authors.initials: MW
authors.lastname: Sütterlin
authors.forename: I
authors.initials: I
authors.lastname: Schrader
authors.forename: B
authors.initials: B
authors.lastname: Gerber
authors.forename: W
authors.initials: W
authors.lastname: Bauer
authors.forename: W
authors.initials: W
authors.lastname: Wiest
authors.forename: O
authors.initials: O
authors.lastname: Tomé
authors.forename: A
authors.initials: A
authors.lastname: Distelrath
authors.forename: V
authors.initials: V
authors.lastname: Hagen
authors.forename: A
authors.initials: A
authors.lastname: Kleine-Tebbe
authors.forename: E
authors.initials: E
authors.lastname: Ruckhaeberle
authors.forename: K
authors.initials: K
authors.lastname: Mehta
authors.forename: G
authors.initials: G
authors.lastname: von Minckwitz
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy*; D018567:Breast Neoplasms, Male / Q000188:drug therapy; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011446:Prospective Studies; D011788:Quality of Life
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil