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The Capital Region of Denmark - a part of Copenhagen University Hospital

A randomised study of tailored toxicity-based dosage of fluorouracil-epirubicin-cyclophosphamide chemotherapy for early breast cancer (SBG 2000-1)

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  • H Lindman
  • M Andersson
  • J Ahlgren
  • E Balslev
  • A Sverrisdottir
  • S B Holmberg
  • N O Bengtsson
  • E H Jacobsen
  • A B Jensen
  • J Hansen
  • M K Tuxen
  • L Malmberg
  • K Villman
  • H Anderson
  • B Ejlertsen
  • J Bergh
  • C Blomqvist
  • Swedish Breast Cancer Group (SweBCG), the Danish Breast Cancer Group (DBCG) and the Scandinavian Breast Cancer Group (SBG)
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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.

Original languageEnglish
JournalEuropean journal of cancer (Oxford, England : 1990)
Pages (from-to)79-86
Number of pages8
Publication statusPublished - May 2018

ID: 54833562