title: A multicenter phase III prospective randomized trial of high-dose epirubicin in combination with cyclophosphamide (EC) versus docetaxel followed by EC in node-positive breast cancer. GOIM (Gruppo Oncologico Italia Meridionale) 9902 study.
abstract: BACKGROUND
  The Gruppo Oncologico Italia Meridionale 9902 trial compared four cycles of high-dose epirubicin plus cyclophosphamide (EC) with four cycles of docetaxel (Taxotere, D) followed by four cycles of EC as adjuvant treatment of node-positive breast cancer.
  
  
  METHODS
  Patients were randomly assigned to EC (E 120 mg/m(2), C 600 mg/m(2), arm A) for four cycles or four cycles of D (100 mg/m(2)) followed by four cycles of EC (arm B), both regimens every 21 days. Hormone receptor-positive patients were given hormonal therapy for 5 years. Primary end point was 5-year disease-free survival (DFS). Secondary objectives were overall survival (OS) and safety.
  
  
  RESULTS
  There were 750 patients enrolled. With a median follow-up of 64 months, 5-year DFS was 73.4% in both arms, and 5-year OS was 89.5% versus 90.7% in arm A and B [hazard ratio was 0.99 (95% confidence interval for DFS 0.75-1.31; P = 0.95)], respectively. Grade 3-4 toxicity was more common in arm B.
  
  
  CONCLUSIONS
  This study did not show advantages from the addition of docetaxel to high-dose EC as adjuvant chemotherapy in node-positive breast cancer. The small sample size and low number of DFS events may have limited the ability to observe statistically significant difference between the two arms.
authors.affiliation: Division of Medical Oncology B, Regina Elena National Cancer Institute, Rome. Electronic address: pvici@ifo.it.
authors.forename: P
authors.initials: P
authors.lastname: Vici
authors.affiliation: Division of Medical Oncology, Oncologic Institute, Bari; Breast Surgery Unit, Oncologic Institute, Bari; Oncologic Unit, Dimiccoli Hospital, Barletta.
authors.forename: M
authors.initials: M
authors.lastname: Brandi
authors.affiliation: Division of Medical Oncology, Oncologic Institute, Bari.
authors.forename: F
authors.initials: F
authors.lastname: Giotta
authors.affiliation: Division of Medical Oncology B, Regina Elena National Cancer Institute, Rome.
authors.forename: P
authors.initials: P
authors.lastname: Foggi
authors.affiliation: Breast Surgery Unit, Oncologic Institute, Bari.
authors.forename: F
authors.initials: F
authors.lastname: Schittulli
authors.affiliation: Division of Medical Oncology B, Regina Elena National Cancer Institute, Rome.
authors.forename: L
authors.initials: L
authors.lastname: Di Lauro
authors.affiliation: Division of Medical Oncology, Department of Surgery and Oncology, University of Palermo, Palermo.
authors.forename: N
authors.initials: N
authors.lastname: Gebbia
authors.affiliation: Division of Medical Oncology, Medicine and Surgery, University of Cagliari, Cagliari.
authors.forename: B
authors.initials: B
authors.lastname: Massidda
authors.affiliation: Division of Medical Oncology, S. Francesco Hospital, Paola.
authors.forename: G
authors.initials: G
authors.lastname: Filippelli
authors.affiliation: Department of Statistics.
authors.forename: D
authors.initials: D
authors.lastname: Giannarelli
authors.affiliation: Department of Pathology, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Di Benedetto
authors.affiliation: Department of Pathology, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Mottolese
authors.affiliation: Division of Medical Oncology, Oncologic Institute, Bari.
authors.forename: G
authors.initials: G
authors.lastname: Colucci
authors.affiliation: Division of Medical Oncology B, Regina Elena National Cancer Institute, Rome.
authors.forename: M
authors.initials: M
authors.lastname: Lopez
mesh_terms: D000328:Adult; D000465:Algorithms; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002277:Carcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D003520:Cyclophosphamide / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D015251:Epirubicin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D007558:Italy; D008198:Lymph Nodes / Q000473:pathology; D008207:Lymphatic Metastasis; D008875:Middle Aged; D011446:Prospective Studies; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D015251:Epirubicin; D003520:Cyclophosphamide