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Long-term safety an...
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
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- Matikas, Alexios (author)
- Karolinska Institutet
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- Margolin, Sara (author)
- Karolinska Institutet
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- Hellström, Mats (author)
- Karolinska Univ Hosp, Radiumhemmet, Dept Oncol, Stockholm, Sweden.
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- Johansson, Hemming (author)
- Karolinska Institutet
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- Bengtsson, Nils-Olof (author)
- Norrland Univ Hosp, Umea, Sweden.
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- Karlsson, Lena (author)
- Cty Hosp, Sundsvall, Sweden.
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- Edlund, Per (author)
- Gavle Cent Hosp, Gavle, Sweden.
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- Karlsson, Per, 1963 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology
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- Lidbrink, Elisabet (author)
- Karolinska Univ Hosp, Radiumhemmet, Dept Oncol, Stockholm, Sweden.
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- Linderholm, Barbro, 1959 (author)
- Gothenburg University,Göteborgs universitet,Karolinska Institutet,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology
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- Lindman, Henrik (author)
- Uppsala universitet,Experimentell och klinisk onkologi
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- Malmstrom, Per (author)
- Skane Univ Hosp, Dept Oncol & Radiat Phys, Lund, Sweden.
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- Villman, Kenneth (author)
- Orebro Univ Hosp, Orebro, Sweden.
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- Foukakis, Theodoros (author)
- Karolinska Institutet
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- Bergh, Jonas (author)
- Karolinska Institutet
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Karolinska Institutet Karolinska Univ Hosp, Radiumhemmet, Dept Oncol, Stockholm, Sweden (creator_code:org_t)
- 2017-11-30
- 2018
- English.
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In: Breast Cancer Research and Treatment. - : SPRINGER. - 0167-6806 .- 1573-7217. ; 168:2, s. 349-355
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Abstract
Subject headings
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- 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. 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. 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. 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Keyword
- Adjuvant chemotherapy
- Breast cancer
- Dose-dense
- Randomized
- Tailored dose
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Matikas, Alexios
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Margolin, Sara
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Hellström, Mats
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Johansson, Hemmi ...
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Bengtsson, Nils- ...
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Karlsson, Lena
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Edlund, Per
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Karlsson, Per, 1 ...
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Lidbrink, Elisab ...
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Linderholm, Barb ...
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Lindman, Henrik
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Malmstrom, Per
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Villman, Kenneth
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Foukakis, Theodo ...
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Bergh, Jonas
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cancer and Oncol ...
- Articles in the publication
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Breast Cancer Re ...
- By the university
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Uppsala University
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Karolinska Institutet
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University of Gothenburg