High rate of extra-haematological toxicity compromises dose-dense sequential adjuvant chemotherapy for breast cancer.

Abstract:

BACKGROUND:A dose-dense strategy has been considered to improve results of adjuvant chemotherapy for breast cancer. This randomised phase II trial investigated the feasibility of this approach with sequential anthracyclines and taxanes-based chemotherapy. METHODS:Patients with high-risk node-positive breast cancer were treated with three cycles of fluorouracil 500 mg m(-2), epirubicin 100 mg m(-2), cyclophosphamide 500 mg m(-2) (FEC 100) followed by three cycles of docetaxel 100 mg m(-2) delivered at 2-weekly intervals supported by primary prophylaxis with filgrastim. All patients were randomised to either uninterrupted treatment (arm A) or to have a 2-week additional period of rest between the FEC and docetaxel (arm B). The primary endpoint was the rate of success of chemotherapy delivery. Using a two-stage Fleming design, 120 patients were required with one interim analysis. RESULTS:In March 2005, enrolment was stopped into arm A after the observation of severe skin toxicities. Following the planned interim analysis, the study was closed because of the high rate of grade 3/4 skin toxicities in both arms (arm A: 32.4% and arm B: 18.9%). CONCLUSION:Sequential dose-dense FEC 100 followed by docetaxel 100 mg m(-2) is not feasible. Feasibility still depends largely on several factors including the choice of drugs, dosage and sequence of administration.

journal_name

Br J Cancer

authors

Brain E,Levy C,Serin D,Roché H,Spielmann M,Delva R,Veyret C,Mauriac L,Rios M,Martin AL,Jimenez M,Asselain B,Gauthier M,Bonnetain F,Fumoleau P

doi

10.1038/bjc.2011.414

subject

Has Abstract

pub_date

2011-11-08 00:00:00

pages

1480-6

issue

10

eissn

0007-0920

issn

1532-1827

pii

bjc2011414

journal_volume

105

pub_type

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