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A randomised study of tailored toxicity-based dosage of fluorouracil-epirubicin-cyclophosphamide chemotherapy for early breast cancer (SBG 2000-1)
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Experimental and Clinical Oncology.
Rigshosp, Dept Oncol, Copenhagen, Denmark.
Gavle Cent Hosp, Dept Oncol, Gavle, Sweden;Orebro Univ Hosp, Dept Oncol, Orebro, Sweden.
Herlev Hosp, Dept Oncol, Herlev, Denmark.
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2018 (English)In: European Journal of Cancer, ISSN 0959-8049, E-ISSN 1879-0852, Vol. 94, p. 79-86Article in journal (Refereed) Published
Abstract [en]

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/m(2), epirubicin 60 mg/m(2), 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/m(2), C 900-1200 mg/m(2)) 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 0.57e1.16, 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.

Place, publisher, year, edition, pages
ELSEVIER SCI LTD , 2018. Vol. 94, p. 79-86
Keywords [en]
Adjuvant, Breast cancer, Chemotherapy, Dosage, Dose tailoring, Leukopenia
National Category
Cancer and Oncology
Identifiers
URN: urn:nbn:se:uu:diva-352580DOI: 10.1016/j.ejca.2018.02.016ISI: 000429403700009PubMedID: 29547834OAI: oai:DiVA.org:uu-352580DiVA, id: diva2:1237100
Available from: 2018-08-07 Created: 2018-08-07 Last updated: 2018-08-07Bibliographically approved

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