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Dose-tailoring of FEC adjuvant chemotherapy based on leukopenia is feasible and well tolerated. Toxicity and dose intensity in the Scandinavian Breast Group phase 3 adjuvant Trial SBG 2000-1.
- Source :
-
Acta oncologica (Stockholm, Sweden) [Acta Oncol] 2011 Apr; Vol. 50 (3), pp. 329-37. Date of Electronic Publication: 2011 Feb 08. - Publication Year :
- 2011
-
Abstract
- Unlabelled: The SBG 2000-1 trial is a randomised study that investigates if dose-tailored adjuvant FEC therapy based on the individual's leukocyte nadir value can improve outcome. The study has included 1535 women with medium and high-risk breast cancer.<br />Patients and Methods: After a first standard dosed FEC course (5-fluorouracil 600 mg/m(2), epirubicin 60 mg/mg(2) and cyclophosphamide 600 mg/m(2)), patients who did not reach leukopenia grade III or IV were randomised to standard doses (group standard) or doses tailored to achieve grade III leukopenia (group tailored) at courses 2-7. Patients who achieved leukopenia grade III or more after the first course were not randomised but continued on standard doses (group registered).<br />Results: Both planned and actually delivered number of courses (seven) were the same in all three arms. The relative dose intensity was increased by a factor of 1.31 (E 1.22, C 1.43) for patients in the tailored arm compared to the expected on standard dose. Ninety percent of the patients in the tailored arm achieved leukopenia grade III-IV compared with 29% among patients randomised to standard dosed therapy. Dose tailoring was associated with acceptable acute non-haematological toxicity with more total alopecia, nausea, vomiting and fatigue.<br />Conclusion: Dose tailoring according to leukopenia was feasible. It led to an increased dose intensity and was associated with acceptable excess of acute non-haematological toxicity.
- Subjects :
- Adult
Breast Neoplasms surgery
Carcinoma surgery
Chemotherapy, Adjuvant methods
Cyclophosphamide administration & dosage
Cyclophosphamide adverse effects
Dose-Response Relationship, Drug
Epirubicin administration & dosage
Epirubicin adverse effects
Feasibility Studies
Female
Fluorouracil administration & dosage
Fluorouracil adverse effects
Humans
Individuality
Leukopenia epidemiology
Leukopenia prevention & control
Mastectomy
Maximum Tolerated Dose
Middle Aged
Scandinavian and Nordic Countries
Severity of Illness Index
Treatment Outcome
Antineoplastic Combined Chemotherapy Protocols administration & dosage
Antineoplastic Combined Chemotherapy Protocols adverse effects
Breast Neoplasms drug therapy
Carcinoma drug therapy
Leukopenia chemically induced
Precision Medicine methods
Subjects
Details
- Language :
- English
- ISSN :
- 1651-226X
- Volume :
- 50
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Acta oncologica (Stockholm, Sweden)
- Publication Type :
- Academic Journal
- Accession number :
- 21299448
- Full Text :
- https://doi.org/10.3109/0284186X.2011.554435