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A randomised feasibility/phase II study (SBG 2004-1) with dose-dense/tailored epirubicin, cyclophoshamide (EC) followed by docetaxel (T) or fixed dosed dose-dense EC/T versus T, doxorubicin and C (TAC) in node-positive breast cancer

Margolin, Sara; Bengtsson, Nils-Olof; Carlsson, Lena; Edlund, Per; Hellstrom, Mats; Karlsson, Per; Lidbrink, Elisabet; Linderholm, Barbro; Lindman, Henrik and Malmström, Per LU , et al. (2011) In Acta Oncologica 50(1). p.35-41
Abstract
The aim of the study was to evaluate the feasibility of tailored and dose-dense epirubicin and cyclophosphamide followed by docetaxel as adjuvant breast cancer therapy. Material and methods. Patients with node-positive breast cancer received either four cycles of biweekly and tailored EC (epirubicin 38-60-75-90-105-120 mg/m(2), cyclophosphamide 450-600-900-1200 mg/m(2)) followed by four cycles of docetaxel (60-75-85-100 mg/m(2)) (arm A) or the same regimen with fixed doses (E90C600 x 4 -> T-75 x 4) (arm B) or docetaxel, doxorubicin and cyclophosphamide (T(75)A(50)C(500)) every three weeks for six cycles (arm C). All patients received G-CSF support and prophylactic ciprofloxacin. Results. One-hundred and twenty-four patients were... (More)
The aim of the study was to evaluate the feasibility of tailored and dose-dense epirubicin and cyclophosphamide followed by docetaxel as adjuvant breast cancer therapy. Material and methods. Patients with node-positive breast cancer received either four cycles of biweekly and tailored EC (epirubicin 38-60-75-90-105-120 mg/m(2), cyclophosphamide 450-600-900-1200 mg/m(2)) followed by four cycles of docetaxel (60-75-85-100 mg/m(2)) (arm A) or the same regimen with fixed doses (E90C600 x 4 -> T-75 x 4) (arm B) or docetaxel, doxorubicin and cyclophosphamide (T(75)A(50)C(500)) every three weeks for six cycles (arm C). All patients received G-CSF support and prophylactic ciprofloxacin. Results. One-hundred and twenty-four patients were randomised in the study. In the A, B and C arm, 17% 19% and 3% of the patients had one or more cycles delayed due to side-effects whereas 24%, 5% and 15% experienced a grade 3 infection or febrile neutropenia. After the introduction of an extra week between the EC and T parts in the A and B arms, grade 3 hand-foot-skin reactions were reduced from 5 to 0.2%. Twenty-nine percent (A and B) and 20% (C) of the patients were hospitalised due to side-effects. Discussion. Dose-dense and tailored EC/T can be given with manageable toxicity and is after adjustment presently studied in the phase III Panther trial. (Less)
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Contribution to journal
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published
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Acta Oncologica
volume
50
issue
1
pages
35 - 41
publisher
Taylor & Francis
external identifiers
  • wos:000285554200005
  • scopus:78650551401
ISSN
1651-226X
DOI
10.3109/0284186X.2010.535847
language
English
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yes
id
a3efe821-041e-4381-a40c-bf92e5933150 (old id 1791187)
date added to LUP
2011-03-02 14:12:13
date last changed
2017-05-21 04:07:01
@article{a3efe821-041e-4381-a40c-bf92e5933150,
  abstract     = {The aim of the study was to evaluate the feasibility of tailored and dose-dense epirubicin and cyclophosphamide followed by docetaxel as adjuvant breast cancer therapy. Material and methods. Patients with node-positive breast cancer received either four cycles of biweekly and tailored EC (epirubicin 38-60-75-90-105-120 mg/m(2), cyclophosphamide 450-600-900-1200 mg/m(2)) followed by four cycles of docetaxel (60-75-85-100 mg/m(2)) (arm A) or the same regimen with fixed doses (E90C600 x 4 -> T-75 x 4) (arm B) or docetaxel, doxorubicin and cyclophosphamide (T(75)A(50)C(500)) every three weeks for six cycles (arm C). All patients received G-CSF support and prophylactic ciprofloxacin. Results. One-hundred and twenty-four patients were randomised in the study. In the A, B and C arm, 17% 19% and 3% of the patients had one or more cycles delayed due to side-effects whereas 24%, 5% and 15% experienced a grade 3 infection or febrile neutropenia. After the introduction of an extra week between the EC and T parts in the A and B arms, grade 3 hand-foot-skin reactions were reduced from 5 to 0.2%. Twenty-nine percent (A and B) and 20% (C) of the patients were hospitalised due to side-effects. Discussion. Dose-dense and tailored EC/T can be given with manageable toxicity and is after adjustment presently studied in the phase III Panther trial.},
  author       = {Margolin, Sara and Bengtsson, Nils-Olof and Carlsson, Lena and Edlund, Per and Hellstrom, Mats and Karlsson, Per and Lidbrink, Elisabet and Linderholm, Barbro and Lindman, Henrik and Malmström, Per and Skold, Dagny Pettersson and Soderberg, Martin and Villman, Kenneth and Bergh, Jonas},
  issn         = {1651-226X},
  language     = {eng},
  number       = {1},
  pages        = {35--41},
  publisher    = {Taylor & Francis},
  series       = {Acta Oncologica},
  title        = {A randomised feasibility/phase II study (SBG 2004-1) with dose-dense/tailored epirubicin, cyclophoshamide (EC) followed by docetaxel (T) or fixed dosed dose-dense EC/T versus T, doxorubicin and C (TAC) in node-positive breast cancer},
  url          = {http://dx.doi.org/10.3109/0284186X.2010.535847},
  volume       = {50},
  year         = {2011},
}