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.
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 (E(90)C(600) + 4 → T(75) + 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.
authors.affiliation: Department of Oncology, Karolinska Institute and University Hospital, Stockholm, Sweden. sara.margolin@karolinska.se
authors.forename: Sara
authors.initials: S
authors.lastname: Margolin
authors.forename: Nils-Olof
authors.initials: NO
authors.lastname: Bengtsson
authors.forename: Lena
authors.initials: L
authors.lastname: Carlsson
authors.forename: Per
authors.initials: P
authors.lastname: Edlund
authors.forename: Mats
authors.initials: M
authors.lastname: Hellstrøm
authors.forename: Per
authors.initials: P
authors.lastname: Karlsson
authors.forename: Elisabet
authors.initials: E
authors.lastname: Lidbrink
authors.forename: Barbro
authors.initials: B
authors.lastname: Linderholm
authors.forename: Henrik
authors.initials: H
authors.lastname: Lindman
authors.forename: Per
authors.initials: P
authors.lastname: Malmström
authors.forename: Dagny
authors.initials: D
authors.lastname: Pettersson Skøld
authors.forename: Martin
authors.initials: M
authors.lastname: Søderberg
authors.forename: Kenneth
authors.initials: K
authors.lastname: Villman
authors.forename: Jonas
authors.initials: J
authors.lastname: Bergh
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D004338:Drug Combinations; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D018579:Patient Selection; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D043823:Taxoids; D000077143:Docetaxel; D015251:Epirubicin; D004317:Doxorubicin; D003520:Cyclophosphamide