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26.04.2019 | Clinical trial

Dose intensity in anthracycline-based chemotherapy for metastatic breast cancer: mature results of the randomised clinical trial ANZ 9311

verfasst von: Stephen. P. Ackland, V. Gebski, N. Zdenkowski, A. Wilson, M. Green, S. Tees, H. Dhillon, G. Van Hazel, J. Levi, R. J. Simes, J. F. Forbes, A. S. Coates, for Breast Cancer Trials Ltd (formerly known as the Australia and New Zealand Breast Cancer Trials Group)

Erschienen in: Breast Cancer Research and Treatment | Ausgabe 2/2019

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Abstract

Purpose

The separate impacts of dose and dose intensity of chemotherapy for metastatic breast cancer remain uncertain. The primary objective of this trial was to compare a short, high-dose, intensive course of epirubicin and cyclophosphamide (EC) with a longer conventional dose regimen delivering the same total dose of chemotherapy.

Methods

This open label trial randomised 235 women with metastatic breast cancer to receive either high-dose epirubicin 150 mg/m² and cyclophosphamide 1500 mg/m² with filgrastim support every 3 weeks for 3 cycles (HDEC) or standard dose epirubicin 75 mg/m² and cyclophosphamide 750 mg/m² every 3 weeks for 6 cycles (SDEC). Primary outcomes were time to progression, overall survival and quality of life.

Results

In 118 patients allocated HDEC 90% of the planned dose was delivered, compared to 96% in the 117 participants allocated SDEC. There were no significant differences in the time to disease progression (5.7 vs. 5.8 months, P = 0.19) or overall survival (14.5 vs. 16.5 months, P = 0.29) between HDEC and SDEC, respectively. Patients on HDEC reported worse quality of life during therapy, but scores improved after completion to approximate those reported by patients allocated SDEC. Objective tumour response was recorded in 33 (28%) on HDEC and 42 patients (36%) on SDEC. HDEC produced more haematologic toxicity.

Conclusion

For women with metastatic breast cancer, disease progression, survival or quality of life were no better with high-dose intensity compared to standard dose EC chemotherapy.

Australian Clinical Trials Registry registration number ACTRN12605000478617.

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Titel: Dose intensity in anthracycline-based chemotherapy for metastatic breast cancer: mature results of the randomised clinical trial ANZ 9311
verfasst von: Stephen. P. Ackland
V. Gebski
N. Zdenkowski
A. Wilson
M. Green
S. Tees
H. Dhillon
G. Van Hazel
J. Levi
R. J. Simes
J. F. Forbes
A. S. Coates
for Breast Cancer Trials Ltd (formerly known as the Australia and New Zealand Breast Cancer Trials Group)
Publikationsdatum: 26.04.2019
Verlag: Springer US
Erschienen in: Breast Cancer Research and Treatment / Ausgabe 2/2019
Print ISSN: 0167-6806
Elektronische ISSN: 1573-7217
DOI: https://doi.org/10.1007/s10549-019-05187-y

Springer Medizin

Dose intensity in anthracycline-based chemotherapy for metastatic breast cancer: mature results of the randomised clinical trial ANZ 9311