Weekly epoetin alfa during adjuvant chemotherapy for breast cancer: effect on hemoglobin levels and quality of life.
OBJECTIVE
Anemia, fatigue, and diminished quality of life (QOL) often are associated with chemotherapy. In a previous study of patients with early-stage breast cancer and a mean baseline hemoglobin (Hb) level of 12.1 g/dL, Hb decreased by 2.0 g/dL after 4 cycles of adjuvant chemotherapy. The current open-label, nonrandomized, multicenter, prospective, community-based study evaluated the effects of 12-24 weeks of epoetin alfa (40,000 U subcutaneously once weekly initiated at the start of standard adjuvant chemotherapy) in patients with stage I-III breast cancer and baseline Hb levels > or =10 g/dL to < or =14 g/dL on Hb level, transfusions, and QOL.


METHODS
Of 1792 patients enrolled, 1785 were evaluable for safety and 1632 for efficacy. Mean age was 53 years +/- 10.7 and mean baseline Hb level was 12.3 g/dL +/- 1.0. From baseline levels, epoetin alfa significantly increased Hb (1.3 g/dL +/- 1.5; P < 0.05) and improved QOL according to the Linear Analog Scale Assessment (LASA) of energy (5.1 mm +/- 27.7), LASA activity (5.1 mm +/- 28.2), LASA overall QOL (4.3 mm +/- 26.7), and Functional Assessment of Cancer Therapy-Anemia (1.7 points +/- 14.0; P < 0.05 in each case). Patients with baseline mild anemia (Hb level >10 g/dL to < or =12 g/dL) also had significant improvements from baseline levels in all 3 LASA parameters (P < 0.05). Epoetin alfa was well tolerated; clinically relevant thrombovascular events were reported in 4.3% of patients.


RESULTS
In this study, epoetin alfa significantly improved Hb and QOL in mildly anemic patients with early-stage breast cancer receiving adjuvant chemotherapy. However, based on recent studies showing an increased risk of thrombovascular events in patients with cancer treated with erythropoietic agents beyond correction of anemia, treatment with epoetin alfa is not indicated or recommended in patients with cancer and Hb levels > 12 g/dL.


CONCLUSIONS
Controlled studies are warranted to confirm the safety and efficacy of epoetin alfa therapy in patients with mild anemia receiving chemotherapy.
Hudis
Clifford A
CA
Breast Cancer Medicine Service, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA. hudisc@mskcc.org
Vogel
Charles L
CL
Gralow
Julie R
JR
Williams
Denise
D
D000328:Adult; D000740:Anemia / Q000139:chemically induced* / Q000188:drug therapy*; D001943:Breast Neoplasms / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005221:Fatigue; D005260:Female; D006397:Hematinics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006454:Hemoglobins / Q000032:analysis*; D006801:Humans; D007279:Injections, Subcutaneous; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D011994:Recombinant Proteins; D012720:Severity of Illness Index; D016896:Treatment Outcome
D006397:Hematinics; D006454:Hemoglobins; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa