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Open Access 01-04-2018 | Clinical trial

Long-term safety and survival outcomes from the Scandinavian Breast Group 2004-1 randomized phase II trial of tailored dose-dense adjuvant chemotherapy for early breast cancer

Authors: Alexios Matikas, Sara Margolin, Mats Hellström, Hemming Johansson, Nils-Olof Bengtsson, Lena Karlsson, Per Edlund, Per Karlsson, Elisabet Lidbrink, Barbro Linderholm, Henrik Lindman, Per Malmstrom, Kenneth Villman, Theodoros Foukakis, Jonas Bergh

Published in: Breast Cancer Research and Treatment | Issue 2/2018

Abstract

Purpose

Although adjuvant polychemotherapy improves outcomes for early breast cancer, the significant variability in terms of pharmacokinetics results in differences in efficacy and both short and long-term toxicities. Retrospective studies support the use of dose tailoring according to the hematologic nadirs.

Methods

The SBG 2004-1 trial was a randomized feasibility phase II study which assessed tailored dose-dense epirubicin and cyclophosphamide (EC) followed by docetaxel (T) (group A), the same regimen with fixed doses (group B) and the TAC regimen (group C). Women aged 18–65 years, ECOG PS 0-1 with at least one positive axillary lymph node were randomized 1:1:1. The primary endpoint of the study was the safety and feasibility of the treatment. Toxicity was graded according to CTC-AE version 3.0. The design and short-term toxicity have been previously published. Here, we report safety and efficacy data after 10 years of follow-up.

Results

A total of 124 patients were included in the study. After a median follow-up of 10.3 years, the probability for 10-year survival was 78.5, 75.1, and 63.4% and for relapse free survival 64.1, 71.0, and 59.5% for groups A, B, and C, respectively. There were no cases of clinically diagnosed cardiotoxicity or hematologic malignancies. No patient was lost to follow-up.

Conclusions

In this randomized phase II trial, tailored dose adjuvant chemotherapy was feasible, without an increased risk for long-term adverse events after a median follow-up of 10 years.

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Title: Long-term safety and survival outcomes from the Scandinavian Breast Group 2004-1 randomized phase II trial of tailored dose-dense adjuvant chemotherapy for early breast cancer
Authors: Alexios Matikas
Sara Margolin
Mats Hellström
Hemming Johansson
Nils-Olof Bengtsson
Lena Karlsson
Per Edlund
Per Karlsson
Elisabet Lidbrink
Barbro Linderholm
Henrik Lindman
Per Malmstrom
Kenneth Villman
Theodoros Foukakis
Jonas Bergh
Publication date: 01-04-2018
Publisher: Springer US
Published in: Breast Cancer Research and Treatment / Issue 2/2018
Print ISSN: 0167-6806
Electronic ISSN: 1573-7217
DOI: https://doi.org/10.1007/s10549-017-4599-4

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