UNASSIGNED: The study was designed to compare an @entity5948 -containing regimen to a regimen combining both @entity5948 and @entity1311 as adjuvant therapy for high-risk @entity0 @entity1 . In this multicenter, randomized phase-III trial, node-positive early @entity0 @entity1 were randomly assigned to receive either 6 cycles of FEC ( @entity1487 600  mg/m(2), @entity1259 60  mg/m(2) and @entity786 600  mg/m(2), day 1, every 3  weeks) or 4 cycles of EP ( @entity1259 90  mg/m(2) and @entity1311 175  mg/m(2), day 1, every 3  weeks). The primary endpoint was overall survival (OS). Secondary endpoints included @entity137 and event-free survival (EFS). From 1996 to 2001, 1055 @entity1 were enrolled. At a median follow-up of 12.8  years, 335 @entity204 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). @entity1 treated with FEC experienced more frequently @entity390 and @entity391 , @entity3136 , and @entity1431 as compared to @entity1 treated with EP. @entity137 which occurred more frequently with EP were @entity417 , @entity221 , @entity925 , and @entity2359 . Our study failed to demonstrate a superiority of an adjuvant treatment with four EP as compared to six FEC in @entity0 @entity1 .

@entity1487 , XXXX and @entity786 versus @entity1259 and @entity1311 in node-positive early @entity0 : a phase-III randomized GONO-MIG5 trial.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'Toxicities'] @entity390 :: ('MESH:D009325', 'Disease') :: ['nausea'] @entity0 :: ('MESH:D001943', 'Disease') :: ['breast cancer', 'node-positive breast cancer'] @entity3136 :: ('MESH:D013280', 'Disease') :: ['stomatitis'] @entity417 :: ('MESH:D000740', 'Disease') :: ['anemia'] @entity5948 :: ('D018943', 'Chemical') :: ['anthracycline'] @entity1259 :: ('MESH:D015251', 'Chemical') :: ['epirubicin'] @entity1311 :: ('MESH:D017239', 'Chemical') :: ['paclitaxel'] @entity786 :: ('MESH:D003520', 'Chemical') :: ['cyclophosphamide'] @entity391 :: ('MESH:D014839', 'Disease') :: ['vomiting'] @entity2359 :: ('MESH:D020258', 'Disease') :: ['neurotoxicity'] @entity925 :: ('MESH:D063806', 'Disease') :: ['myalgias'] @entity1431 :: ('MESH:D007970', 'Disease') :: ['leukopenia'] @entity204 :: ('MESH:D003643', 'Disease') :: ['deaths'] @entity221 :: ('MESH:D005334', 'Disease') :: ['fever'] @entity1487 :: ('MESH:D005472', 'Chemical') :: ['5-fluorouracil']
@entity1259 :: (MESH:D015251,Chemical) :: ['epirubicin']
