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Epirubicin and cyclophosphamide versus epirubicin and docetaxel as first-line therapy for women with metastatic breast cancer: final results of a randomised phase III trial

journal contribution
posted on 2023-06-07, 16:05 authored by J.U. Blohmer, Peter Schmid, J. Hilfrich, K. Friese, A. Kleine-Tebbe, H. Koelbl, H. Sommer, G. Morack, M.B. Wischnewsky, W. Lichtenegger, S. Kuemmel
Patients and methods: Patients (n = 240) were randomly assigned to receive either ED (epirubicin 75 mg/m(2) and docetaxel 75 mg/m(2)) or EC (epirubicin 90 mg/m(2) and cyclophosphamide 600 mg/m(2)). The primary end point was objective response rate (ORR). Secondary end points were progression-free survival (PFS), overall survival (OS), and safety. Results: ORR for patients randomly assigned to receive EC and ED were 42% and 47%, respectively (P = 0.63). Median PFS [10.1 versus 10.3 months; hazard ratio (HR) 0.98; log-rank P = 0.38] and OS (19.9 versus 30.0 months; HR 0.663; log-rank P = 0.21) were comparable in both arms. Although grade 3/4 leucopenia occurred more frequently with ED (81% versus 73%; P = 0.01), there were no significant differences in the incidence of febrile neutropenia and grade 3/4 infections. Grade 3/4 non-haematologic toxicity was infrequent in both arms. Congestive heart failure was observed in one patient in each arm. Conclusion: In this randomised trial, no differences in the efficacy study end points were observed between the two treatment arms.

History

Publication status

  • Published

Journal

Annals of Oncology

ISSN

0923-7534

Publisher

Oxford University Press

Issue

7

Volume

21

Page range

1430-1435

Department affiliated with

  • Clinical and Experimental Medicine Publications

Full text available

  • No

Peer reviewed?

  • Yes

Legacy Posted Date

2011-08-16

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