This study evaluated efficacy and safety of darbepoetin alfa administered every 3 weeks (Q3W) at fixed doses of 300 or 500 μg with or without intravenous (IV) iron in treating anemia in patients receiving multicycle chemotherapy. This Phase 2, double‐blind, 2 × 2 factorial study randomized patients to one of four treatment arms; darbepoetin alfa 300 μg (n = 62), darbepoetin alfa 300 μg plus IV iron (n = 60), darbepoetin alfa 500 μg (n = 60), or darbepoetin alfa 500 μg plus IV iron (n = 60). Patients had nonmyeloid malignancies, hemoglobin levels ≤10 g dL−1, and no iron deficiency. Primary endpoint was achievement of target hemoglobin (≥11 g dL−1). Secondary endpoints included incidence of transfusions and change in Functional Assessment of Cancer Therapy Fatigue (FACT‐F) score from baseline to end of study. Safety was evaluated by incidence of adverse events. No evidence of a statistically significant interaction between darbepoetin alfa dose received and IV iron usage was observed, therefore, results are provided separately comparing darbepoetin alfa doses and comparing IV iron usage groups. Similar proportions of patients receiving darbepoetin alfa 300 or 500 μg achieved target hemoglobin (75 and 78%, respectively); Kaplan–Meier median time to target hemoglobin was 10 and 8 weeks, respectively. More patients receiving IV iron (82%) than not receiving IV iron (72%) achieved hemoglobin target. Adverse events profiles were similar for darbepoetin alfa treatment groups. Transient anaphylactoid reactions were reported in two patients receiving IV iron. Darbepoetin alfa at 300 μg Q3W and 500 μg Q3W showed similar benefit, while added IV iron improved treatment response in these patients. Am. J. Hematol., 2010. © 2010 Wiley‐Liss, Inc.

Ключевые слова: сопроводительная терапия, рак молочной железы, полихимиотерапия, Ремаксол.Objective: to evaluate the clinical efficiency of incorporating Remaxol into a therapy regimen for patients with Stages IIB and IIIA breast cancer (BC). Subjects and methods. A total of 300 patients with Stages IIB and IIIA BC were examined. The first stage in all the patients was polychemotherapy using the FAC regimen, by repeating the cycle every 3 weeks (a total of 6 cycles). After each polychemotherapy cycle, a study group (Group 1) of 150 patients received Remaxol 400 ml slowly injected once daily as 4 administrations. A comparison group (Group 2) of 150 patients used standard therapy. The patients were examined in accordance with the accepted standards over time: before treatment, after every second cycle of chemotherapy, and 1 month after treatment. Results. Accompanying therapy with Remaxol was found to reduce polychemotherapy-induced hepatotoxicity, as manifested by a faster and more pronounced reduction in the indicators of hepatic activity and by improved quality of life in the patients, by increasing the indicators of social emotional and physical activity. Conclusion. The findings suggest that Remaxol should be incorporated as an agent of accompanying therapy during chemotherapy in patients with BC.

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