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A randomised study ...
A randomised study of tailored toxicity-based dosage of fluorouracil-epirubicin-cyclophosphamide chemotherapy for early breast cancer (SBG 2000-1)
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- Lindman, Henrik (author)
- Uppsala universitet,Experimentell och klinisk onkologi,Uppsala University Hospital
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- Andersson, M. (author)
- Copenhagen University Hospital,Rigshosp, Dept Oncol, Copenhagen, Denmark
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- Ahlgren, J. (author)
- Gävle Hospital,Gavle Cent Hosp, Dept Oncol, Gavle, Sweden;Orebro Univ Hosp, Dept Oncol, Orebro, Sweden,Aarhus Univ Hosp, Dept Oncol, Aarhus, Denmark,Aarhus University Hospital
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- Balslev, E. (author)
- Herlev Hospital,Herlev Hosp, Dept Oncol, Herlev, Denmark,Rigshosp, Dept Oncol, Copenhagen, Denmark,Copenhagen University Hospital
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- Sverrisdottir, A. (author)
- Stockholm South General Hospital,Soder Sjukhuset, Dept Oncol, Stockholm, Sweden;Landspitali, Dept Oncol, Reykjavik, Iceland
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- Holmberg, S. B. (author)
- Sahlgrenska University Hospital,Dept Surg, Molndal, Sweden
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- Bengtsson, N. O. (author)
- Umeå University,Umea Univ Hosp, Dept Oncol, Umea, Sweden
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- Jacobsen, E. H. (author)
- Vejle Hospital,Vejle Hosp, Dept Oncol, Vejle, Denmark,Vasteras Hosp, Dept Oncol, Vasteras, Sweden;Aalborg Univ Hosp, Dept Oncol, Aalborg, Denmark,Västmanland Hospital
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- Jensen, A. B. (author)
- Karolinska Institute,Karolinska Institutet,Karolinska University Hospital
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- Hansen, J. (author)
- Västmanland Hospital
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- Tuxen, M. K. (author)
- Herlev Hospital,Herlev Hosp, Dept Oncol, Herlev, Denmark
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- Malmberg, L. (author)
- Karlstad Hospital,Karlstad Hosp, Dept Oncol, Karlstad, Sweden;Boras Hosp, Dept Oncol, Boras, Sweden
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- Villman, K. (author)
- Örebro University Hospital,Orebro Univ Hosp, Dept Oncol, Orebro, Sweden
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- Anderson, H. (author)
- Lund University,Lunds universitet,Medicinsk onkologi,Sektion I,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Medical oncology,Section I,Department of Clinical Sciences, Lund,Faculty of Medicine,Lund Univ, Dept Clin Sci, Div Canc Epidemiol, Lund, Sweden
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- Ejlertsen, B. (author)
- Copenhagen University Hospital
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- Bergh, J. (author)
- Karolinska Institute,Karolinska University Hospital
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- Blomqvist, C. (author)
- Uppsala universitet,Institutionen för immunologi, genetik och patologi,Orebro Univ Hosp, Dept Oncol, Orebro, Sweden,Uppsala University Hospital
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- Elsevier BV, 2018
- 2018
- English 8 s.
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In: European Journal of Cancer. - : Elsevier BV. - 0959-8049 .- 1879-0852. ; 94, s. 79-86
- Related links:
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http://dx.doi.org/10...
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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https://urn.kb.se/re...
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http://kipublication...
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Abstract
Subject headings
Close
- Study aim: Retrospective studies have demonstrated a worse outcome in breast cancer patients not developing leukopenia during adjuvant chemotherapy. The SBG 2000-1 is the first randomised trial designed to compare individually dosed chemotherapy without G-CSF support based on grade of toxicity to standard-dosed chemotherapy based on body surface area (BSA). Methods: Patients with early breast cancer were included and received the first cycle of standard FEC (fluorouracil 600 mg/m2, epirubicin 60 mg/m2, cyclophosphamide 600 mg/m2). Patients with nadir leukopenia grade 0–2 after first cycle were randomised between either 6 additional courses of tailored FEC with increased doses (E 75–90 mg/m2, C 900–1200 mg/m2) or fixed treatment with 6 standard FEC. Patients with grade 3–4 leukopenia were registered and treated with 6 standard FEC. Primary end-point was distant disease-free survival (DDFS). Results: The study enrolled 1535 patients, of which 1052 patients were randomised to tailored FEC (N = 524) or standard FEC (N = 528), whereas 401 patients with leukopenia grade 3–4 continued standard FEC and formed the registered cohort. Dose escalation did not statistically significantly improve 10-year DDFS (79% and 77%, HR 0.87, CI 0.67–1.14, P = 0.32) or OS (82% and 78%, respectively, HR 0.89, CI 0.57–1.16, P = 0.38). Corresponding estimates for the registered group of patients were DDFS 79% and OS 82%, respectively. Conclusions: The SBG 2000-1 study failed to show a statistically significant improvement of escalated and tailored-dosed chemotherapy compared with standard BSA-based chemotherapy in patients with low haematological toxicity, although all efficacy parameters showed a numerical advantage for tailored treatment.
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
- Breast cancer
- Chemotherapy
- Dosage
- Dose tailoring
- Leukopenia
- Adjuvant
Publication and Content Type
- art (subject category)
- ref (subject category)
Find in a library
To the university's database
- By the author/editor
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Lindman, Henrik
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Andersson, M.
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Ahlgren, J.
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Balslev, E.
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Sverrisdottir, A ...
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Holmberg, S. B.
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Bengtsson, N. O.
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Jacobsen, E. H.
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Jensen, A. B.
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Hansen, J.
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Tuxen, M. K.
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Malmberg, L.
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Villman, K.
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Anderson, H.
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Ejlertsen, B.
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Bergh, J.
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Blomqvist, C.
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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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European Journal ...
- By the university
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Lund University
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Uppsala University
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Karolinska Institutet