title: Taxane-based mono- or combination therapy for managing metastatic breast cancer (MBC) in routine practice: a multinational prospective observational study.
abstract: OBJECTIVE
  Taxanes are standard for first-line chemotherapy of metastatic breast cancer (MBC), but indications for single-agent versus combination treatment remain controversial. This non-interventional study in 12 different countries explored treatment patterns and progression-free survival (PFS) in routine practice.
  
  
  METHODS
  The prospective study was designed to determine factors associated with the choice of taxane-based regimens for MBC. Data were collected at the start of first-line treatment planned by the physician (baseline), and at subsequent routine practice visits. Patients were followed up until death, disease progression or change of treatment regimen, for a maximum of 8 months. Upon analysis, patients were classified into taxane single-agent (TM) or taxane-based combination (TC) cohorts according to scheduled first-line therapy. Logistic regression was used to investigate the relationship between choice of TM vs. TC and baseline factors.
  
  
  RESULTS
  Among the 465 patients enrolled (22.4% HER2+), 160 were prescribed TM (69% docetaxel, 31% paclitaxel) and 305 TC, frequently combined with gemcitabine (39%) or capecitabine (24%). HER2+ status was the only factor associated with choosing TC (p < 0.001). Median PFS [95% CI] was 11.5 [8.7-13.3] months for TM and 10.3 [8.4-14.4] months for TC. Among HER2+ patients (N = 104), only 59% received trastuzumab, none had previous adjuvant trastuzumab. Median PFS was 19.7 [9.3-unestimated] months for TC including trastuzumab, 18.8 [5.0-22.0] months for TC and 6.1 [3.8-13.3] months for TM without trastuzumab.
  
  
  CONCLUSIONS
  In patients from 12 different countries treated during routine practice, TCs were prescribed more frequently than single agents. HER2+ status was significantly associated with TC use. 41% of HER2+ patients received no anti-HER2 treatment; PFS results for TC with and without trastuzumab (19.7 and 18.8 months) suggested TCs without trastuzumab might be worth further investigation in these patients. However, the study was not randomized; treatment evaluation bias can therefore not be excluded.
authors.affiliation: Dr. Lütfi Kirdar Egitim ve Arastirma Hastanesi, Istanbul, Turkey.
authors.forename: Mahmut
authors.initials: M
authors.lastname: Gümüş
authors.forename: Neville
authors.initials: N
authors.lastname: Davidson
authors.forename: Thomas
authors.initials: T
authors.lastname: Bauknecht
authors.forename: Victoria
authors.initials: V
authors.lastname: Soldatenkova
authors.forename: Karim A
authors.initials: KA
authors.lastname: Benhadji
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality / Q000473:pathology; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000627:therapeutic use; D018572:Disease-Free Survival; D000077143:Docetaxel; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000627:therapeutic use; D006801:Humans; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000627:therapeutic use; D011446:Prospective Studies; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D012044:Regression Analysis; D043823:Taxoids / Q000008:administration & dosage / Q000627:therapeutic use*; D000068878:Trastuzumab; D000093542:Gemcitabine
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000069287:Capecitabine; D003841:Deoxycytidine; D000077143:Docetaxel; D005472:Fluorouracil; D017239:Paclitaxel; D018719:Erb-b2 Receptor Tyrosine Kinases; D043823:Taxoids; D000068878:Trastuzumab; D000093542:Gemcitabine; C508053:ERBB2 protein, human