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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

Matikas, Alexios; Margolin, Sara; Hellström, Mats; Johansson, Hemming; Bengtsson, Nils Olof; Karlsson, Lena; Edlund, Per; Karlsson, Per; Lidbrink, Elisabet and Linderholm, Barbro, et al. (2017) In Breast Cancer Research and Treatment
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... (More)

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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keywords
Adjuvant chemotherapy, Breast cancer, Dose-dense, Randomized, Tailored dose
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Breast Cancer Research and Treatment
pages
7 pages
publisher
Springer
external identifiers
  • scopus:85035773376
ISSN
0167-6806
DOI
10.1007/s10549-017-4599-4
language
English
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no
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91309553-5ae5-42d8-8536-f3a9317fcadf
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2017-12-14 14:47:30
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2018-03-16 03:00:23
@article{91309553-5ae5-42d8-8536-f3a9317fcadf,
  abstract     = {<p>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.</p>},
  author       = {Matikas, Alexios and Margolin, Sara and Hellström, Mats and Johansson, Hemming and Bengtsson, Nils Olof and Karlsson, Lena and Edlund, Per and Karlsson, Per and Lidbrink, Elisabet and Linderholm, Barbro and Lindman, Henrik and Malmstrom, Per and Villman, Kenneth and Foukakis, Theodoros and Bergh, Jonas},
  issn         = {0167-6806},
  keyword      = {Adjuvant chemotherapy,Breast cancer,Dose-dense,Randomized,Tailored dose},
  language     = {eng},
  month        = {11},
  pages        = {7},
  publisher    = {Springer},
  series       = {Breast Cancer Research and Treatment},
  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},
  url          = {http://dx.doi.org/10.1007/s10549-017-4599-4},
  year         = {2017},
}