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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
- Source :
- Breast Cancer Research and Treatment
- Publication Year :
- 2017
- Publisher :
- Springer Science and Business Media LLC, 2017.
-
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.
- Subjects :
- Oncology
Cancer Research
Adjuvant chemotherapy
medicine.medical_treatment
Breast cancer
0302 clinical medicine
Antineoplastic Combined Chemotherapy Protocols
Breast
Prospective Studies
030212 general & internal medicine
Mastectomy
Early breast cancer
food and beverages
Middle Aged
Clinical Trial
Chemotherapy, Adjuvant
Hematologic Neoplasms
Lymphatic Metastasis
030220 oncology & carcinogenesis
Female
Long term safety
Adjuvant
Adult
medicine.medical_specialty
Randomized
Breast Neoplasms
Disease-Free Survival
Young Adult
Tailored dose
03 medical and health sciences
Pharmacokinetics
Internal medicine
medicine
Humans
Cancer och onkologi
Dose-Response Relationship, Drug
business.industry
medicine.disease
Long-Term Care
Cardiotoxicity
Cancer and Oncology
Feasibility Studies
Dose-dense
Neoplasm Recurrence, Local
business
human activities
Follow-Up Studies
Subjects
Details
- ISSN :
- 15737217 and 01676806
- Volume :
- 168
- Database :
- OpenAIRE
- Journal :
- Breast Cancer Research and Treatment
- Accession number :
- edsair.doi.dedup.....ea87ce8ee1bcd2712a6f969713df72ac