PURPOSE: In 1996, we initiated the French multicenter phase III randomized trial to compare the effect on disease-free survival (DFS) of concurrent versus sequential chemotherapy (CT) and radiotherapy (RT) after breast-conserving surgery for stages I and II @entity0 . This report presents the clinical results with a median follow-up of 60 months. @entity1 AND METHODS: Between February 1996 and April 2000, 716 @entity1 were entered onto this trial. Adjuvant treatment began within 6 weeks after surgery. Sequential treatment of CT administered first followed by RT was compared with concurrent treatment of CT administered with RT. The CT regimen consisted of @entity2664 (12 mg/m2), @entity1487 (500 mg/m2), and @entity786 (500 mg/m2) on day 1, and it was repeated every 21 days for six courses. RT was delivered to the breast and, when indicated, to the regional lymphatics. RESULTS: There was no statistically significant difference in treatment in the 5-year DFS (80% in both groups; P = .83), locoregional recurrence-free survival (LRFS; 92% in sequential v 95% in concurrent; P = .76), @entity3 -free survival (87% in sequential v 84% in concurrent; P = .55), or overall survival (90% in sequential v 91% in concurrent; P = .76). Nevertheless, in the node-positive subgroup, the 5-year LRFS was statistically better in the concurrent arm (97% in concurrent v 91% in sequential; P = .02), corresponding to a risk of locoregional recurrence decreased by 39% (hazard ratio, 0.61; 95% CI, 0.38 to 0.93). CONCLUSION: This treatment protocol remains an appealing clinical option for many @entity1 with operable @entity0 at a high risk of recurrence. Combination treatments with new drugs for @entity0 are warranted.

Phase III trial of concurrent or sequential adjuvant chemoradiotherapy after conservative surgery for XXXX : final results of the ARCOSEIN trial.

@entity1 :: ('9606', 'Species') :: ['women', 'patients', 'PATIENTS'] @entity0 :: ('MESH:D001943', 'Disease') :: ['breast cancer'] @entity2664 :: ('MESH:D008942', 'Chemical') :: ['mitoxantrone'] @entity786 :: ('MESH:D003520', 'Chemical') :: ['cyclophosphamide'] @entity3 :: ('MESH:D009362', 'Disease') :: ['metastasis'] @entity1487 :: ('MESH:D005472', 'Chemical') :: ['fluorouracil']
@entity0 :: (MESH:D001943,Disease) :: ['early-stage breast cancer']
