Weekly epoetin alfa during adjuvant chemotherapy for breast cancer: Effect on hemoglobin levels and quality of life Journal Article
| Authors: | Hudis, C. A.; Vogel, C. L.; Gralow, J. R.; Williams, D.; Procrit Study Group |
| Article Title: | Weekly epoetin alfa during adjuvant chemotherapy for breast cancer: Effect on hemoglobin levels and quality of life |
| Abstract: | Purpose: 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 mean baseline hemoglobin (Hb) level of 12.1 g/dL, Hb decreased by 2.0 g/dL after 4 cyles 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 start of standard adjuvant chemotherapy) in patients with stage I-III breast cancer and baseline Hb levels ≥ 10 g/dL to ≤ 14 g/dL on Hb level, transfusions, and QOL. Patients and 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 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 ≤ 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. Conclusion: Controlled studies are warranted to confirm the safety and efficacy of epoetin alfa therapy in patients with mild anemia receiving chemotherapy. |
| Keywords: | adult; cancer chemotherapy; controlled study; treatment outcome; middle aged; functional assessment; major clinical study; clinical trial; constipation; drug tolerability; fatigue; diarrhea; drug efficacy; drug safety; hypertension; cancer adjuvant therapy; chemotherapy, adjuvant; cancer staging; antineoplastic agent; prospective studies; anorexia; edema; quality of life; controlled clinical trial; drug eruption; pain; breast cancer; anemia; gastrointestinal symptom; nausea; stomatitis; vomiting; myalgia; bone pain; breast neoplasms; arthralgia; coughing; drug fever; drug hypersensitivity; injection site reaction; lung embolism; drug induced headache; insomnia; severity of illness index; cardiovascular disease; cerebrovascular disease; heart infarction; multicenter study; thromboembolism; thrombosis; iron; blood transfusion; rating scale; daily life activity; hot flush; drug dose regimen; dyspepsia; energy; alopecia; injections, subcutaneous; recombinant erythropoietin; hemoglobins; leg pain; granulocytopenia; heart arrest; upper respiratory tract infection; community care; drug indication; phase 4 clinical trial; pharyngitis; hematinics; epoetin alfa; hemoglobin determination; thrombophlebitis; artery embolism; functional assessment of cancer therapy-anemia scale; linear analog scale assessment; transfusion reductions; erythrocyte disorder |
| Journal Title: | Clinical Breast Cancer |
| Volume: | 6 |
| Issue: | 2 |
| ISSN: | 1526-8209 |
| Publisher: | Elsevier Inc. |
| Date Published: | 2005-06-01 |
| Start Page: | 132 |
| End Page: | 142 |
| Language: | English |
| PUBMED: | 16001991 |
| PROVIDER: | scopus |
| DOI: | 10.3816/cbc.2005.n.015 |
| DOI/URL: | |
| Notes: | - "Export Date: 24 October 2012" - "CODEN: CBCLB" - "Source: Scopus" |
