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

Breast Canc Trials Ltd

Research output: Contribution to journalArticle

Abstract

PurposeThe 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.MethodsThis open label trial randomised 235 women with metastatic breast cancer to receive either high-dose epirubicin 150mg/m(2) and cyclophosphamide 1500mg/m(2) with filgrastim support every 3 weeks for 3 cycles (HDEC) or standard dose epirubicin 75mg/m(2) and cyclophosphamide 750mg/m(2) every 3 weeks for 6 cycles (SDEC). Primary outcomes were time to progression, overall survival and quality of life.ResultsIn 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.ConclusionFor 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.

Original languageEnglish
Pages (from-to)357-365
Number of pages9
JournalBreast Cancer Research and Treatment
Volume176
Issue number2
DOIs
Publication statusPublished - Jul 2019

Cite this

@article{43fb5e51438a4238928fcdd29c3fbed5,
title = "Dose intensity in anthracycline-based chemotherapy for metastatic breast cancer: mature results of the randomised clinical trial ANZ 9311",
abstract = "PurposeThe 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.MethodsThis open label trial randomised 235 women with metastatic breast cancer to receive either high-dose epirubicin 150mg/m(2) and cyclophosphamide 1500mg/m(2) with filgrastim support every 3 weeks for 3 cycles (HDEC) or standard dose epirubicin 75mg/m(2) and cyclophosphamide 750mg/m(2) every 3 weeks for 6 cycles (SDEC). Primary outcomes were time to progression, overall survival and quality of life.ResultsIn 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.ConclusionFor 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.",
keywords = "Breast cancer, Chemotherapy, Anthracycline, Dose intensity, Survival, Quality of life, QUALITY-OF-LIFE, PHASE-II, ADJUVANT CHEMOTHERAPY, CELL MOBILIZATION, CYCLOPHOSPHAMIDE, EPIRUBICIN, PACLITAXEL, DENSE, COMBINATION, SUPPORT",
author = "{Breast Canc Trials Ltd} and Ackland, {Stephen. P.} and V. Gebski and N. Zdenkowski and A. Wilson and M. Green and S. Tees and H. Dhillon and {Van Hazel}, G. and J. Levi and Simes, {R. J.} and Forbes, {J. F.} and Coates, {A. S.}",
year = "2019",
month = "7",
doi = "10.1007/s10549-019-05187-y",
language = "English",
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pages = "357--365",
journal = "Breast Cancer Research and Treatment",
issn = "0167-6806",
publisher = "Springer",
number = "2",

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Dose intensity in anthracycline-based chemotherapy for metastatic breast cancer : mature results of the randomised clinical trial ANZ 9311. / Breast Canc Trials Ltd.

In: Breast Cancer Research and Treatment, Vol. 176, No. 2, 07.2019, p. 357-365.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Dose intensity in anthracycline-based chemotherapy for metastatic breast cancer

T2 - mature results of the randomised clinical trial ANZ 9311

AU - Breast Canc Trials Ltd

AU - Ackland, Stephen. P.

AU - Gebski, V.

AU - Zdenkowski, N.

AU - Wilson, A.

AU - Green, M.

AU - Tees, S.

AU - Dhillon, H.

AU - Van Hazel, G.

AU - Levi, J.

AU - Simes, R. J.

AU - Forbes, J. F.

AU - Coates, A. S.

PY - 2019/7

Y1 - 2019/7

N2 - PurposeThe 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.MethodsThis open label trial randomised 235 women with metastatic breast cancer to receive either high-dose epirubicin 150mg/m(2) and cyclophosphamide 1500mg/m(2) with filgrastim support every 3 weeks for 3 cycles (HDEC) or standard dose epirubicin 75mg/m(2) and cyclophosphamide 750mg/m(2) every 3 weeks for 6 cycles (SDEC). Primary outcomes were time to progression, overall survival and quality of life.ResultsIn 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.ConclusionFor 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.

AB - PurposeThe 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.MethodsThis open label trial randomised 235 women with metastatic breast cancer to receive either high-dose epirubicin 150mg/m(2) and cyclophosphamide 1500mg/m(2) with filgrastim support every 3 weeks for 3 cycles (HDEC) or standard dose epirubicin 75mg/m(2) and cyclophosphamide 750mg/m(2) every 3 weeks for 6 cycles (SDEC). Primary outcomes were time to progression, overall survival and quality of life.ResultsIn 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.ConclusionFor 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.

KW - Breast cancer

KW - Chemotherapy

KW - Anthracycline

KW - Dose intensity

KW - Survival

KW - Quality of life

KW - QUALITY-OF-LIFE

KW - PHASE-II

KW - ADJUVANT CHEMOTHERAPY

KW - CELL MOBILIZATION

KW - CYCLOPHOSPHAMIDE

KW - EPIRUBICIN

KW - PACLITAXEL

KW - DENSE

KW - COMBINATION

KW - SUPPORT

U2 - 10.1007/s10549-019-05187-y

DO - 10.1007/s10549-019-05187-y

M3 - Article

VL - 176

SP - 357

EP - 365

JO - Breast Cancer Research and Treatment

JF - Breast Cancer Research and Treatment

SN - 0167-6806

IS - 2

ER -