title: UNICANCER-PEGASE 07 study: a randomized phase III trial evaluating postoperative docetaxel-5FU regimen after neoadjuvant dose-intense chemotherapy for treatment of inflammatory breast cancer.
abstract: BACKGROUND
  Inflammatory breast cancer (IBC) is a rare and aggressive disease requiring a multimodal treatment. We evaluated the benefit of adding docetaxel-5-fluorouracil (D-5FU) regimen after preoperative dose-intense (DI) epirubicin-cyclophosphamide (EC) and locoregional treatment in IBC patients.
  
  
  METHODS
  PEGASE 07 was a national randomized phase III open-label study involving 14 hospitals in France. Women with nonmetastatic IBC were eligible and randomly assigned to receive either four cycles of DI EC (E 150 mg/m(2) and C 4000 mg/m(2) every 3 weeks with repeated hematopoietic stem cell support), then mastectomy with axillary lymph node dissection, and radiotherapy (arm A) or the same treatment followed by four cycles of D-5FU (D 85 mg/m(2), day 1 and 5FU 750 mg/m(2)/day continuous infusion, days 1-5 every 3 weeks) administered postradiotherapy (arm B). Patients with hormone receptor-positive tumors received hormonal therapy. Disease-free survival (DFS) was the primary end point. Secondary end points included tolerance, pathological complete response (pCR) rate, and overall survival (OS).
  
  
  RESULTS
  Between January 2001 and May 2005, 174 patients were enrolled and treated (87 in each arm). Median follow-up was similar in both arms: 59.6 months [95% confidence interval (CI) 58.4-60.3] in arm A and 60.5 months (95% CI 58.3-61.4) in arm B. The estimated 5-year DFS rates were not different: 55% (95% CI 43.9-64.7) in arm A and 55.5% (95% CI 44.3-65.3) in arm B [hazard ratio (HR) = 0.94 (0.61-1.48); P = 0.81]. Identical results were observed for 5-year OS: 70.2% (95% CI 59.1-78.8) in arm A and 70% (95% CI 58.8-78.7) in arm B [HR = 0.93 (0.55-1.60); P = 0.814]. Following DI EC induction, in-breast and global (breast plus nodes) pCR were 28.9% and 20.1%, respectively. Estrogen receptor and pCR status were independently associated with survival.
  
  
  CONCLUSIONS
  The addition of D-5FU after preoperative DI EC and standard local therapy did not improve DFS in IBC.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT02324088.
authors.affiliation: Department of Medical Oncology, Institut Paoli-Calmettes, Marseille Centre de Recherche en Cancérologie de Marseille, INSERM U1068, CNRS 7258, Aix-Marseille Univ, Marseille.
authors.forename: A
authors.initials: A
authors.lastname: Gonçalves
authors.affiliation: Department of Medical Oncology, Institut Curie, Université Paris Descartes, Paris.
authors.forename: J-Y
authors.initials: JY
authors.lastname: Pierga
authors.affiliation: Department of Medical Oncology, Centre Antoine Lacassagne, Nice, France.
authors.forename: J-M
authors.initials: JM
authors.lastname: Ferrero
authors.affiliation: Department of Medical Oncology, Centre Jean Perrin, Clermont-Ferrand.
authors.forename: M-A
authors.initials: MA
authors.lastname: Mouret-Reynier
authors.affiliation: Department of Medical Oncology, Centre Léon Bérard, Lyon.
authors.forename: T
authors.initials: T
authors.lastname: Bachelot
authors.affiliation: Department of Medical Oncology, Institut de Cancérologie de l'Ouest, Angers.
authors.forename: R
authors.initials: R
authors.lastname: Delva
authors.affiliation: Department of Medical Oncology, Institut du Cancer de Montpellier, Montpellier.
authors.forename: M
authors.initials: M
authors.lastname: Fabbro
authors.affiliation: Department of Medical Oncology, Institut Curie, Hôpital René Huguenin, Saint-Cloud.
authors.forename: F
authors.initials: F
authors.lastname: Lerebours
authors.affiliation: Department of Medical Oncology, Hôpital Tenon, Paris.
authors.forename: J-P
authors.initials: JP
authors.lastname: Lotz
authors.affiliation: Department of Medical Oncology, CHU, Tours.
authors.forename: C
authors.initials: C
authors.lastname: Linassier
authors.affiliation: Department of Medical Oncology, Polyclinique Bordeaux Nord-Aquitaine, Bordeaux.
authors.forename: N
authors.initials: N
authors.lastname: Dohollou
authors.affiliation: Department of Medical Oncology, Institut Jean Godinot, Reims.
authors.forename: J-C
authors.initials: JC
authors.lastname: Eymard
authors.affiliation: Department of Medical Oncology, CHG, Brive-la-Gaillarde.
authors.forename: B
authors.initials: B
authors.lastname: Leduc
authors.affiliation: Unicancer, Paris.
authors.forename: J
authors.initials: J
authors.lastname: Lemonnier
authors.affiliation: Unicancer, Paris.
authors.forename: A-L
authors.initials: AL
authors.lastname: Martin
authors.affiliation: Department of Medical Oncology, Institut Paoli-Calmettes, Marseille Centre de Recherche en Cancérologie de Marseille, INSERM U1068, CNRS 7258, Aix-Marseille Univ, Marseille.
authors.forename: J-M
authors.initials: JM
authors.lastname: Boher
authors.affiliation: Department of Medical Oncology, Institut Paoli-Calmettes, Marseille Centre de Recherche en Cancérologie de Marseille, INSERM U1068, CNRS 7258, Aix-Marseille Univ, Marseille viensp@ipc.unicancer.fr.
authors.forename: P
authors.initials: P
authors.lastname: Viens
authors.affiliation: Department of Medical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse-Oncopole,Toulouse, France.
authors.forename: H
authors.initials: H
authors.lastname: Roché
mesh_terms: D000328:Adult; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001365:Axilla; D018270:Carcinoma, Ductal, Breast / Q000188:drug therapy*; D018275:Carcinoma, Lobular / Q000188:drug therapy*; D059186:Chemoradiotherapy, Adjuvant / Q000379:methods; D017024:Chemotherapy, Adjuvant / Q000379:methods; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D000077143:Docetaxel; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D058922:Inflammatory Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism; D008197:Lymph Node Excision; D008408:Mastectomy; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods*; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D011960:Receptors, Estrogen / Q000378:metabolism; D011980:Receptors, Progesterone / Q000378:metabolism; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D018931:Antineoplastic Agents, Hormonal; D003520:Cyclophosphamide; D000077143:Docetaxel; D015251:Epirubicin; D005472:Fluorouracil; D018719:Erb-b2 Receptor Tyrosine Kinases; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; D043823:Taxoids; C508053:ERBB2 protein, human
keywords: docetaxel; dose-intense chemotherapy; inflammatory breast cancer