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Clinical Trial
. 2006 May 8;94(9):1237-44.
doi: 10.1038/sj.bjc.6603085.

Randomised Trial: Survival Benefit and Safety of Adjuvant Dose-Dense Chemotherapy for Node-Positive Breast Cancer

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Free PMC article
Clinical Trial

Randomised Trial: Survival Benefit and Safety of Adjuvant Dose-Dense Chemotherapy for Node-Positive Breast Cancer

S Kümmel et al. Br J Cancer. .
Free PMC article

Abstract

We evaluated the survival benefit, safety, feasibility, and tolerability of dose-dense (DD) adjuvant chemotherapy with epirubicin and paclitaxel for women with node-positive primary breast cancer. Randomised patients (n=216) received DD or conventional-schedule (CS) chemotherapy. Dose-dense regimen patients (n=108) received epirubicin 90 mg m-2 plus paclitaxel 175 mg m-2 in four 14-day cycles, then cyclophosphamide 600 mg m-2, methotrexate 40 mg m-2, and fluorouracil 600 mg m-2 (CMF 600/40/600) in three 14-day cycles, plus filgrastim 5 microg kg day-1 as growth support in every cycle. Conventional-schedule regimen patients (n=108) received epirubicin 90 mg m-2 plus cyclophosphamide 600 mg m-2 in four 21-day cycles, then CMF 600/40/600 in three 21-day cycles, plus filgrastim if required. After a median follow-up of 38.4 months, 71 patients (33%) relapsed or died: DD, 33 patients (15 deaths); CS, 38 patients (22 deaths). Dose dense showed a trend for improved disease-free survival (DFS) and overall survival (OS). Four-year rates of DFS and OS were 64 and 85% for DD, and 58 and 75% for CS. All seven cycles were administered to 208 patients (96%). Rates of cycle delay, discontinuation, dose reduction, and adverse events were similar in both groups. Dose-dense sequential chemotherapy with epirubicin/paclitaxel then CMF, supported by filgrastim, is safe and improves survival for patients with node-positive breast cancer.

Figures

Figure 1
Figure 1
Study design and patient disposition.
Figure 2
Figure 2
Disease-free survival.
Figure 3
Figure 3
Overall survival.
Figure 4
Figure 4
Disease-free survival by treatment group and oestrogen hormone receptor status.
Figure 5
Figure 5
Disease-free survival by treatment group and nodal status.
Figure 6
Figure 6
Disease-free survival by malignancy grade.

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