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

Research output: Contribution to journalArticle


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.


  • Swedish Breast Cancer Group (SweBCG)
  • Danish Breast Cancer Group (DBCG)
  • Scandinavian Breast Cancer Group (SBG)
External organisations
  • Copenhagen University Hospital
  • Gävle Hospital
  • Herlev Hospital
  • Södersjukhuset
  • Umeå University
  • Aarhus University Hospital
  • Karlstad Hospital
  • Karolinska University Hospital
  • Sahlgrenska University Hospital
  • Vejle Hospital
  • Västmanland Hospital
  • Karolinska Institutet
  • Uppsala University Hospital
  • Örebro University Hospital
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Cancer and Oncology


  • Adjuvant, Breast cancer, Chemotherapy, Dosage, Dose tailoring, Leukopenia
Original languageEnglish
Pages (from-to)79-86
Number of pages8
JournalEuropean Journal of Cancer
Publication statusPublished - 2018 May
Publication categoryResearch