title: A phase-III trial of doxorubicin and docetaxel versus doxorubicin and paclitaxel in metastatic breast cancer: results of the ERASME 3 study.
abstract: OBJECTIVE
  In first-line metastatic breast cancer, both paclitaxel (P)-doxorubicin (A) and docetaxel (D)-doxorubicin (A) combinations have shown superiority over treatments without taxane. The aim of this study was to compare the two combinations.
  
  
  METHODS
  Chemotherapy-naive (except for adjuvant therapy) metastatic breast cancer patients were randomly assigned to intravenous AD (arm D) or AP (arm P) every 3 weeks for a maximum of four cycles, then four cycles of single agent docetaxel (arm D) or paclitaxel (arm P). Primary endpoint was overall quality of life (QoL) measured by EORTC QLQ-C30 after four courses of doxorubicin-taxane combination. Secondary endpoints were toxicity, overall survival (OS), progression-free survival (PFS), and QoL sub-scores.
  
  
  RESULTS
  Between March 2000 and April 2004, 210 patients were randomized: 103 to arm P and 107 to arm D. Patient characteristics were well balanced between arms. After four courses, QoL score differences between groups or compared to baseline scores were not significant. Response rate was 39.6% for AD and 41.8% for AP. After a median follow-up of 50.2 months, median PFS and median OS were 8.7 and 21.4 months in arm D and 8.0 and 27.3 months in arm P (p = 0.977 and 0.081, respectively). Hematological toxicity was significantly more frequent in arm D than in arm P (p < 10(-6)), as well as grades 3-4 asthenia (p = 0.03). Neuropathy occurred more frequently in arm P (p = 0.03).
  
  
  CONCLUSIONS
  In this study, paclitaxel or docetaxel combined with doxorubicin were not significantly different in terms of QoL scores and efficacy, but had different toxicity profiles.
authors.affiliation: Medical Oncology, Hopital Edouard Herriot, Université de Lyon et Hospices Civils de Lyon, Lyon, France.
authors.forename: Philippe A
authors.initials: PA
authors.lastname: Cassier
authors.forename: Sylvie
authors.initials: S
authors.lastname: Chabaud
authors.forename: Véronique
authors.initials: V
authors.lastname: Trillet-Lenoir
authors.forename: Pierre-Yves
authors.initials: PY
authors.lastname: Peaud
authors.forename: Jean-Dominique
authors.initials: JD
authors.lastname: Tigaud
authors.forename: Hervé
authors.initials: H
authors.lastname: Cure
authors.forename: Hubert
authors.initials: H
authors.lastname: Orfeuvre
authors.forename: Bruno
authors.initials: B
authors.lastname: Salles
authors.forename: Claude
authors.initials: C
authors.lastname: Martin
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Jacquin
authors.forename: Cecile
authors.initials: C
authors.lastname: Agostini
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Guastalla
authors.forename: David
authors.initials: D
authors.lastname: Pérol
authors.forename: Thomas
authors.initials: T
authors.lastname: Bachelot
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D018572:Disease-Free Survival; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D011788:Quality of Life; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D004317:Doxorubicin; D017239:Paclitaxel