دورية أكاديمية
A randomised study of tailored toxicity-based dosage of fluorouracil-epirubicin-cyclophosphamide chemotherapy for early breast cancer (SBG 2000-1)
| العنوان: | A randomised study of tailored toxicity-based dosage of fluorouracil-epirubicin-cyclophosphamide chemotherapy for early breast cancer (SBG 2000-1) |
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| المؤلفون: | Lindman, H., Andersson, M., Ahlgren, J., Balslev, E., Sverrisdottir, A., Holmberg, S. B., Bengtsson, N. O., Jacobsen, E. H., Jensen, A. B., Hansen, J., Tuxen, M. K., Malmberg, L., Villman, K., Anderson, H., Ejlertsen, B., Bergh, J., Blomqvist, C., Swedish Breast Cancer Group (SweBCG), Danish Breast Cancer Group (DBCG), Scandinavian Breast Cancer Group (SBG) |
| المصدر: | European Journal of Cancer; 94, pp 79-86 (2018) ; ISSN: 0959-8049 |
| بيانات النشر: | Elsevier |
| سنة النشر: | 2018 |
| المجموعة: | Lund University Publications (LUP) |
| مصطلحات موضوعية: | Cancer and Oncology, Adjuvant, Breast cancer, Chemotherapy, Dosage, Dose tailoring, Leukopenia |
| الوصف: | 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. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | https://lup.lub.lu.se/record/8bd2a596-d3ff-40c8-a87e-372d08c86459Test; http://dx.doi.org/10.1016/j.ejca.2018.02.016Test; pmid:29547834; scopus:85043507699 |
| DOI: | 10.1016/j.ejca.2018.02.016 |
| الإتاحة: | https://doi.org/10.1016/j.ejca.2018.02.016Test https://lup.lub.lu.se/record/8bd2a596-d3ff-40c8-a87e-372d08c86459Test |
| رقم الانضمام: | edsbas.D389A297 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/j.ejca.2018.02.016 |
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