| Tumor progression associated with erythropoiesis-stimulating agents. | |
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MedLine Citation:
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PMID: 19017828 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: To evaluate, characterize, compare, and critique trials reporting increased tumor progression in patients with cancer who are receiving erythropoiesis-stimulating agents (ESAs) that led to Food and Drug Administration (FDA) actions for black box warnings and labeling changes. DATA SOURCES: Literature was accessed through MEDLINE (1950-August 2008) and PubMed (1975-August 2008) using the search terms recombinant erythropoietin, darbepoetin, epoetin, anemia, neoplasms, and disease progression. Articles cited in MedWatch alerts, Oncologic Drugs Advisory Committee meeting briefs, and bibliographies from identified articles were also reviewed. STUDY SELECTION AND DATA EXTRACTION: All studies published in English with data suggesting increased tumor progression or death due to disease progression in patients receiving ESAs were included. DATA SYNTHESIS: ESAs are approved for treatment of anemia in several different disease states, including chemotherapy-induced anemia. Ten trials investigating off-label use of ESAs in patients with cancer have reported an increased risk of tumor progression and/or treatment-associated death. Two of these trials reported worse overall survival with ESA treatment compared with placebo (28% vs 23% and 21.9% vs 16.4%), while another trial reported shorter time to death with treatment (68 vs 131 days; p = 0.04). Many of these studies had important limitations, including imbalanced groups at baseline and poor design. Moreover, none of these trials was designed to detect a statistically worse outcome with ESAs; thus, absolute conclusions regarding tumor progression cannot be drawn. As a result, better designed trials with safety as the primary outcome are ongoing. CONCLUSIONS: Additional studies are needed and being undertaken to qualify and quantify the possible risk of tumor progression with use of ESAs. Prudent practice dictates that until results of these trials are available, ESAs should be used in accordance with FDA labeling. |
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Authors:
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Ashley M Newland; Curtis D Black |
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Publication Detail:
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Type: Journal Article; Review Date: 2008-11-18 |
Journal Detail:
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Title: The Annals of pharmacotherapy Volume: 42 ISSN: 1542-6270 ISO Abbreviation: Ann Pharmacother Publication Date: 2008 Dec |
Date Detail:
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Created Date: 2008-12-02 Completed Date: 2009-01-15 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9203131 Medline TA: Ann Pharmacother Country: United States |
Other Details:
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Languages: eng Pagination: 1865-70 Citation Subset: IM |
Affiliation:
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Lahey Clinic Medical Center, Burlington, MA 01752, USA. ashley.newland@gmail.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Anemia
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chemically induced,
prevention & control* Antineoplastic Agents / adverse effects, therapeutic use Clinical Trials as Topic Disease Progression Drug Labeling Hematinics / adverse effects* Humans Neoplasms / drug therapy, mortality, physiopathology* Research Design Survival Rate United States / epidemiology United States Food and Drug Administration |
| Chemical | |
Reg. No./Substance:
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0/Antineoplastic Agents; 0/Hematinics |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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