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Randomised trial: survival benefit and safety of adjuvant dose-dense chemotherapy for node-positive breast cancer.

Kümmel S, Krocker J, Kohls A, Breitbach GP, Morack G, Budner M, Blohmer JU, Elling D - Br. J. Cancer (2006)

Bottom Line: 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.Rates of cycle delay, discontinuation, dose reduction, and adverse events were similar in both groups.

View Article: PubMed Central - PubMed

Affiliation: Department of Gynecology/Obstetrics, University Medicine Berlin, Charité Campus Mitte, Schumannstr. 20/21, Berlin 10117, Germany. sherko.kuemmel@charite.de

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.

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Overall survival.
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fig3: Overall survival.

Mentions: At a median follow-up duration of 38.4 months, 37 (17%) of 216 patients have died, including 15 patients (14%) in the DD-schedule group and 22 (20%) in the CS group (Figure 3). The OS rate after 2 years was 94% (89–99%) in the DD-schedule group and 92% (87–97%) in the CS group. After 4 years, the OS rate was 85% (78–94%) in the DD-schedule group and 75% (66–85%) in the CS group (Figure 3). The hazard ratio, with the DD-schedule group as reference, was 1.76 (CL 0.91–3.38; log-rang test, two-sided P=0.092), suggesting a possible increased risk of death for patients receiving the CS regimen.


Randomised trial: survival benefit and safety of adjuvant dose-dense chemotherapy for node-positive breast cancer.

Kümmel S, Krocker J, Kohls A, Breitbach GP, Morack G, Budner M, Blohmer JU, Elling D - Br. J. Cancer (2006)

Overall survival.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2361407&req=5

fig3: Overall survival.
Mentions: At a median follow-up duration of 38.4 months, 37 (17%) of 216 patients have died, including 15 patients (14%) in the DD-schedule group and 22 (20%) in the CS group (Figure 3). The OS rate after 2 years was 94% (89–99%) in the DD-schedule group and 92% (87–97%) in the CS group. After 4 years, the OS rate was 85% (78–94%) in the DD-schedule group and 75% (66–85%) in the CS group (Figure 3). The hazard ratio, with the DD-schedule group as reference, was 1.76 (CL 0.91–3.38; log-rang test, two-sided P=0.092), suggesting a possible increased risk of death for patients receiving the CS regimen.

Bottom Line: 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.Rates of cycle delay, discontinuation, dose reduction, and adverse events were similar in both groups.

View Article: PubMed Central - PubMed

Affiliation: Department of Gynecology/Obstetrics, University Medicine Berlin, Charité Campus Mitte, Schumannstr. 20/21, Berlin 10117, Germany. sherko.kuemmel@charite.de

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.

Show MeSH
Related in: MedlinePlus