title: Darbepoetin alfa as primary prophylaxis of anemia in patients with breast cancer treated preoperatively with docetaxel/doxorubicin/cyclophosphamide.
abstract: BACKGROUND
  At present, the combination of docetaxel/doxorubicin/cyclophosphamide (TAC) is considered a treatment option for patients with node-positive primary breast cancer; however, treatment is associated with grade 1-4 anemia in up to 95% of patients (grade 2-4 in 36%).
  
  
  METHODS
  We prospectively investigated the use of a primary prophylaxis with darbepoetin alfa once every 3 weeks in 35 patients receiving 6-8 cycles of TAC as neoadjuvant treatment for breast cancer. Darbepoetin alfa treatment was started on day 1 of a TAC cycle if hemoglobin (Hb) level was </= 14 g/dL. The dose was adapted to 9 mug/kg if Hb level was </= 13 g/dL on day 21 of the previous cycle, to 4.5 mug/kg if Hb level was between 13 g/dL and 14 g/dL, and was discontinued if Hb level increased to >/= 14 g/dL. The primary aim was to prevent Hb levels </= 12 g/dL before surgery.
  
  
  RESULTS
  During 112 (50.2%) and 93 (41.7%) of 223 cycles, 4.5 mug/kg and 9 mug/kg of darbepoetin alfa were given, respectively. The dose was decreased from 9 mug/kg to 4.5 mug/kg in 21 patients (60%) and in 28 cycles (12.4%). Treatment was discontinued because of Hb levels > 14 g/dL in 12 patients (34.3%) and in 13 cycles (5.4%). Hemoglobin level on day 21 of the last cycle was </= 12 g/dL in 4 patients (11.4%). Eighteen patients (51.4%) during 36 cycles (16.1%) showed Hb levels </= 12 g/dL throughout treatment. No National Cancer Institute Common Toxicity Criteria grade 2-4 anemia was observed. Symptoms of fatigue (Functional Assessment of Cancer Therapy-Anemia) decreased slightly throughout treatment.
  
  
  CONCLUSIONS
  Anemia during TAC chemotherapy can be avoided by a single injection of darbepoetin alfa every 3 weeks.
authors.affiliation: Department of Obstetrics and Gynecology, Johann Wolfgang Goethe Universtät, Theodor-Stern-Kai 7; 60590 Frankfurt am Main, Germany German Breast Group, Schleussner Str 42, 63236 Neu-Isenburg, Germany.
authors.forename: Sibylle
authors.initials: S
authors.lastname: Loibl
authors.forename: Manfred
authors.initials: M
authors.lastname: Kaufmann
authors.forename: Vidya
authors.initials: V
authors.lastname: Maataoui
authors.forename: Keyur M
authors.initials: KM
authors.lastname: Mehta
authors.forename: Katharina
authors.initials: K
authors.lastname: Hofmann
authors.forename: Simone
authors.initials: S
authors.lastname: Petrich
authors.forename: Gunter
authors.initials: G
authors.lastname: von Minckwitz