title: 5-Fluorouracil, epirubicin and cyclophosphamide versus epirubicin and paclitaxel in node-positive early breast cancer: a phase-III randomized GONO-MIG5 trial.
abstract: The study was designed to compare an anthracycline-containing regimen to a regimen combining both anthracycline and paclitaxel as adjuvant therapy for high-risk breast cancer patients. In this multicenter, randomized phase-III trial, node-positive early breast cancer patients were randomly assigned to receive either 6 cycles of FEC (5-fluorouracil 600 mg/m(2), epirubicin 60 mg/m(2) and cyclophosphamide 600 mg/m(2), day 1, every 3 weeks) or 4 cycles of EP (epirubicin 90 mg/m(2) and paclitaxel 175 mg/m(2), day 1, every 3 weeks). The primary endpoint was overall survival (OS). Secondary endpoints included toxicity and event-free survival (EFS). From 1996 to 2001, 1055 patients were enrolled. At a median follow-up of 12.8 years, 335 deaths had been recorded. The 10-year OS was 73 % (95 % CI 69-77) in the FEC arm and 74 % (95 % CI 70-78) in the EP arm (p = 0.405). The 10-year EFS was 51 % (95 % CI 45-56) in the FEC arm and 49 % (95 % CI 44-55) in the EP arm (p = 0.572). No difference in the hazard of death was observed (HR for EP 0.85, 95 % CI 0.68-1.06, p = 0.15). Patients treated with FEC experienced more frequently nausea and vomiting, stomatitis, and leukopenia as compared to patients treated with EP. Toxicities which occurred more frequently with EP were anemia, fever, myalgias, and neurotoxicity. Our study failed to demonstrate a superiority of an adjuvant treatment with four EP as compared to six FEC in node-positive breast cancer patients.
authors.affiliation: Department of Medical Oncology, IRCCS AOU San Martino -IST, Istituto Nazionale per la Ricerca sul Cancro, Genova, Largo R. Benzi 10, 16132, Genoa, Italy. lucia.delmastro@hsanmartino.it.
authors.forename: Lucia
authors.initials: L
authors.lastname: Del Mastro
authors.affiliation: Department of Medical Oncology, IRCCS AOU San Martino -IST, Istituto Nazionale per la Ricerca sul Cancro, Genova, Largo R. Benzi 10, 16132, Genoa, Italy.
authors.forename: Alessia
authors.initials: A
authors.lastname: Levaggi
authors.affiliation: Department of Medical Oncology, AOU Pisana, Osp. S. Chiara, Via Roma 67, 56100, Pisa, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Michelotti
authors.affiliation: Medical Oncology, Azienda Ospedaliera "Carlo Poma", Strada Lago Paiolo 10, 46100, Mantua, Italy.
authors.forename: Giovanna
authors.initials: G
authors.lastname: Cavazzini
authors.affiliation: Medical Oncology, Azienda Ospedaliera "Carlo Poma", Strada Lago Paiolo 10, 46100, Mantua, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Adami
authors.affiliation: Medical Oncology, Ospedale Civile, Via De Nicola 14, 07100, Sassari, Italy.
authors.forename: Tiziana
authors.initials: T
authors.lastname: Scotto
authors.affiliation: Medical Oncology, Ospedale Civile, Via De Nicola 14, 07100, Sassari, Italy.
authors.forename: Margherita
authors.initials: M
authors.lastname: Piras
authors.affiliation: Department of Gynecology and Obstetrics, Ospedale S. Anna, Via Ventimiglia 3, 10126, Turin, Italy.
authors.forename: Saverio
authors.initials: S
authors.lastname: Danese
authors.affiliation: Department of Medical Oncology, Ospedale S. Croce e Carle, Via M. Coppino 26, 12100, Cuneo, Italy.
authors.forename: Ornella
authors.initials: O
authors.lastname: Garrone
authors.affiliation: Breast Unit, AOU Città della Salute e delle Scienze, Via Cherasco 23, 10126, Turin, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Durando
authors.affiliation: Breast Unit, AOU Città della Salute e delle Scienze, Via Cherasco 23, 10126, Turin, Italy.
authors.forename: Valeria
authors.initials: V
authors.lastname: Accortanzo
authors.affiliation: Department of Medical Oncology, IRCCS AOU San Martino -IST, Istituto Nazionale per la Ricerca sul Cancro, Genova, Largo R. Benzi 10, 16132, Genoa, Italy.
authors.forename: Claudia
authors.initials: C
authors.lastname: Bighin
authors.affiliation: Department of Medical Oncology, IRCCS AOU San Martino -IST, Istituto Nazionale per la Ricerca sul Cancro, Genova, Largo R. Benzi 10, 16132, Genoa, Italy.
authors.forename: Loredana
authors.initials: L
authors.lastname: Miglietta
authors.affiliation: Department of Medical Oncology, IRCCS AOU San Martino -IST, Istituto Nazionale per la Ricerca sul Cancro, Genova, Largo R. Benzi 10, 16132, Genoa, Italy.
authors.forename: Simona
authors.initials: S
authors.lastname: Pastorino
authors.affiliation: Department of Medical Oncology, IRCCS AOU San Martino -IST, Istituto Nazionale per la Ricerca sul Cancro, Genova, Largo R. Benzi 10, 16132, Genoa, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Pronzato
authors.affiliation: Medical Oncology, Ospedale San Lazzaro, Via P. Belli 26, 12051, Alba, Cuneo, Italy.
authors.forename: Federico
authors.initials: F
authors.lastname: Castiglione
authors.affiliation: Department of Medical Oncology, AOU Pisana, Osp. S. Chiara, Via Roma 67, 56100, Pisa, Italy.
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Landucci
authors.affiliation: Medical Oncology 2, Istituto Oncologico Veneto IRCCS, Via Gattamelata 64, 35128, Padua, Italy.
authors.forename: PierFranco
authors.initials: P
authors.lastname: Conte
authors.affiliation: Epidemiology Unit, IRCCS AOU San Martino -IST, Istituto Nazionale per la Ricerca sul Cancro, Largo R. Benzi 10, 16132, Genoa, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Bruzzi
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality / Q000473:pathology* / Q000601:surgery; D003520:Cyclophosphamide / Q000008:administration & dosage; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D060787:Neoplasm Grading; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage; D010349:Patient Compliance; D016016:Proportional Hazards Models; D016896:Treatment Outcome; D047368:Tumor Burden
chemical_list: D015251:Epirubicin; D003520:Cyclophosphamide; D017239:Paclitaxel; D005472:Fluorouracil
keywords: Adjuvant chemotherapy; Anthracycline; Early breast cancer; Node positive; Paclitaxel