Long-term safety and survival outcomes from the Scandinavian Breast Group 2004-1 randomized phase II trial of tailored dose-dense adjuvant chemotherapy for early breast cancer

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Although adjuvant polychemotherapy improves outcomes for early breast cancer, the significant variability in terms of pharmacokinetics results in differences in efficacy and both short and long-term toxicities. Retrospective studies support the use of dose tailoring according to the hematologic nadirs. The SBG 2004-1 trial was a randomized feasibility phase II study which assessed tailored dose-dense epirubicin and cyclophosphamide (EC) followed by docetaxel (T) (group A), the same regimen with fixed doses (group B) and the TAC regimen (group C). Women aged 18-65 years, ECOG PS 0-1 with at least one positive axillary lymph node were randomized 1:1:1. The primary endpoint of the study was the safety and feasibility of the treatment. Toxicity was graded according to CTC-AE version 3.0. The design and short-term toxicity have been previously published. Here, we report safety and efficacy data after 10 years of follow-up. A total of 124 patients were included in the study. After a median follow-up of 10.3 years, the probability for 10-year survival was 78.5, 75.1, and 63.4% and for relapse free survival 64.1, 71.0, and 59.5% for groups A, B, and C, respectively. There were no cases of clinically diagnosed cardiotoxicity or hematologic malignancies. No patient was lost to follow-up. In this randomized phase II trial, tailored dose adjuvant chemotherapy was feasible, without an increased risk for long-term adverse events after a median follow-up of 10 years.

Margolin, SaraKarolinska Institutet (författare)
Hellström, MatsKarolinska Univ Hosp, Radiumhemmet, Dept Oncol, Stockholm, Sweden. (författare)
Johansson, HemmingKarolinska Institutet (författare)
Bengtsson, Nils-OlofNorrland Univ Hosp, Umea, Sweden. (författare)
Karlsson, LenaCty Hosp, Sundsvall, Sweden. (författare)
Edlund, PerGavle Cent Hosp, Gavle, Sweden. (författare)
Karlsson, Per,1963Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology(Swepub:gu)xkperd (författare)
Lidbrink, ElisabetKarolinska Univ Hosp, Radiumhemmet, Dept Oncol, Stockholm, Sweden. (författare)
Linderholm, Barbro,1959Gothenburg University,Göteborgs universitet,Karolinska Institutet,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology(Swepub:gu)xlibar (författare)
Lindman, HenrikUppsala universitet,Experimentell och klinisk onkologi(Swepub:uu)henrlind (författare)
Malmstrom, PerSkane Univ Hosp, Dept Oncol & Radiat Phys, Lund, Sweden. (författare)
Villman, KennethOrebro Univ Hosp, Orebro, Sweden. (författare)
Foukakis, TheodorosKarolinska Institutet (författare)
Bergh, JonasKarolinska Institutet (författare)
Karolinska InstitutetKarolinska Univ Hosp, Radiumhemmet, Dept Oncol, Stockholm, Sweden. (creator_code:org_t)

Ingår i:Breast Cancer Research and Treatment: SPRINGER168:2, s. 349-3550167-68061573-7217

Av författaren/redakt...: Matikas, Alexios; Margolin, Sara; Hellström, Mats; Johansson, Hemmi ...; Bengtsson, Nils- ...; Karlsson, Lena; visa fler...; Edlund, Per; Karlsson, Per, 1 ...; Lidbrink, Elisab ...; Linderholm, Barb ...; Lindman, Henrik; Malmstrom, Per; Villman, Kenneth; Foukakis, Theodo ...; Bergh, Jonas; visa färre...

Om ämnet

MEDICIN OCH HÄLSOVETENSKAP: MEDICIN OCH HÄLS ...; och Klinisk medicin; och Cancer och onkol ...

Av lärosätet: Uppsala universitet; Karolinska Institutet; Göteborgs universitet

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