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

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.

journal_name

Breast Cancer Res Treat

journal_title

Breast cancer research and treatment

authors

Ackland SP,Gebski V,Zdenkowski N,Wilson A,Green M,Tees S,Dhillon H,Van Hazel G,Levi J,Simes RJ,Forbes JF,Coates AS,for Breast Cancer Trials Ltd (formerly known as the Australia and New Zealand Breast Cancer Trials Group).

doi

10.1007/s10549-019-05187-y

subject

Has Abstract

pub_date

2019-07-01 00:00:00

pages

357-365

issue

2

eissn

0167-6806

issn

1573-7217

pii

10.1007/s10549-019-05187-y

journal_volume

176

pub_type

杂志文章,随机对照试验

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