title: Feasibility of 4 cycles of docetaxel and cyclophosphamide every 14 days as an adjuvant regimen for breast cancer: a Wisconsin Oncology Network study.
abstract: BACKGROUND
  Dose-dense therapies have had a major effect on reducing toxicity and improving outcomes in breast cancer. A combination of TC every 3 weeks has emerged as a common chemotherapy regimen used for treatment of node-negative or lower-risk node-positive breast cancer. We tested whether it is feasible to deliver TC on a dose-dense schedule, with therapy completed within 10 weeks.
  
  
  METHODS
  We enrolled women with early stage breast cancer on a single-arm phase II study of adjuvant dose-dense TC through a regional oncology network. All women completed primary surgery before accrual, and subsequent therapy with TC was deemed appropriate by the treating physician. Planned treatment was docetaxel 75 mg/m(2) plus cyclophosphamide 600 mg/m(2) every 2 weeks for 4 cycles with subcutaneous pegfilgrastim 6 mg administered 24 to 48 hours after the administration of each chemotherapy cycle.
  
  
  RESULTS
  Of 42 women enrolled, 41 were evaluable using prespecified criteria. Of these, 37 (90.2%) completed therapy within 10 weeks and 34 (83%) completed therapy at 8 weeks without dose modification. Rates of neuropathy were similar to that reported previously. The rate of neutropenic fever was low (2.5%). Rash and plantar-palmar erythrodythesia were common and reached grade 3 in 4 subjects (9.8%).
  
  
  CONCLUSIONS
  Dose-dense TC is feasible with tolerability profiles similar to standard TC and a low likelihood of neutropenic fever. This study supports further clinical development of this 8-week adjuvant chemotherapy regimen.
authors.affiliation: University of Wisconsin Carbone Cancer Center, Madison, WI; Hematology/Oncology Division, Department of Medicine, University of Wisconsin, Madison, WI. Electronic address: mburkard@wisc.edu.
authors.forename: Mark E
authors.initials: ME
authors.lastname: Burkard
authors.affiliation: University of Wisconsin Carbone Cancer Center, Madison, WI; Hematology/Oncology Division, Department of Medicine, University of Wisconsin, Madison, WI.
authors.forename: Kari B
authors.initials: KB
authors.lastname: Wisinski
authors.affiliation: University of Wisconsin Carbone Cancer Center, Madison, WI; Hematology/Oncology Division, Department of Medicine, University of Wisconsin, Madison, WI.
authors.forename: Uchenna O
authors.initials: UO
authors.lastname: Njiaju
authors.affiliation: University of Wisconsin Carbone Cancer Center, Madison, WI.
authors.forename: Sarahmaria
authors.initials: S
authors.lastname: Donohue
authors.affiliation: University of Wisconsin Carbone Cancer Center, Madison, WI; Hematology/Oncology Division, Department of Medicine, University of Wisconsin, Madison, WI.
authors.forename: Robert
authors.initials: R
authors.lastname: Hegeman
authors.affiliation: University of Wisconsin Carbone Cancer Center, Madison, WI; Hematology/Oncology Division, Department of Medicine, University of Wisconsin, Madison, WI.
authors.forename: Amy
authors.initials: A
authors.lastname: Stella
authors.affiliation: Bellin Memorial Hospital, Green Bay, WI.
authors.forename: Patrick
authors.initials: P
authors.lastname: Mansky
authors.affiliation: Columbia St Mary's, Milwaukee, WI.
authors.forename: Varsha
authors.initials: V
authors.lastname: Shah
authors.affiliation: Fox Valley Hematology and Oncology, Appleton, WI.
authors.forename: Timothy
authors.initials: T
authors.lastname: Goggins
authors.affiliation: Aurora Cancer Care, Wauwatosa, WI.
authors.forename: Rubina
authors.initials: R
authors.lastname: Qamar
authors.affiliation: Gundersen Lutheran Health System, Lacrosse, WI.
authors.forename: Leah
authors.initials: L
authors.lastname: Dietrich
authors.affiliation: University of Wisconsin Carbone Cancer Center, Madison, WI; Departments of Biostatistics and Medical Informatics and Statistics, University of Wisconsin, Madison, WI.
authors.forename: Kyungmann
authors.initials: K
authors.lastname: Kim
authors.affiliation: University of Wisconsin Carbone Cancer Center, Madison, WI; Hematology/Oncology Division, Department of Medicine, University of Wisconsin, Madison, WI.
authors.forename: Anne M
authors.initials: AM
authors.lastname: Traynor
authors.affiliation: University of Wisconsin Carbone Cancer Center, Madison, WI; Hematology/Oncology Division, Department of Medicine, University of Wisconsin, Madison, WI.
authors.forename: Amye J
authors.initials: AJ
authors.lastname: Tevaarwerk
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant / Q000379:methods*; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D000077143:Docetaxel; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008875:Middle Aged; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D003520:Cyclophosphamide
keywords: Chemotherapy; Febrile neutropenia; Granulocyte-colony stimulating factor; Palmar-plantar erythrodysthesia; Pegfilgrastim