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- Lindman, Henrik, et al.
(författare)
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A randomised study of tailored toxicity-based dosage of fluorouracil-epirubicin-cyclophosphamide chemotherapy for early breast cancer (SBG 2000-1)
- 2018
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Ingår i: European Journal of Cancer. - : Elsevier BV. - 0959-8049 .- 1879-0852. ; 94, s. 79-86
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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| 2. |
- Loman, N., et al.
(författare)
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Nordic trip, a randomized phase 3 study in early triple negative breast cancer
- 2016
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Ingår i: Cancer Research. - Lund Univ, Skane Univ Hosp, Lund, Sweden. Sahlgrens Acad, Gothenburg, Sweden. Univ Hosp, Gothenburg, Sweden. Univ Helsinki, Cent Hosp, Helsinki, Finland. Univ Helsinki, Helsinki, Finland. Rigshosp, DBCG Secretariat, DK-2100 Copenhagen, Denmark. Univ Hosp, Landspitali, Reykjavik, Iceland. Akershus Univ Hosp, Lorenskog, Norway. Orebro Univ Hosp, Orebro, Sweden. Uppsala Univ, Akad Hosp, Uppsala, Sweden.. - 0008-5472 .- 1538-7445. ; 76
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)
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