The DOI matches its Crossref record; 25 of the 25 references it cites were found in a registry or an index.
Randomized, Double-Blind, Placebo-Controlled Trial of Erythropoietin in Non–Small-Cell Lung Cancer With Disease-Related Anemia
Open accessAbstract
Purpose: Previous trials have suggested a quality-of-life (QOL) improvement for anemic cancer patients treated with erythropoietin, but few used QOL as the primary outcome. We designed a trial to investigate the effects of epoetin alfa therapy on the QOL of anemic patients with advanced non–small-cell carcinoma of the lung (NSCLC). Patients and Methods: A multicenter, randomized, double-blind, placebo-controlled trial was conducted. The proposed sample size was 300 patients. Eligible patients were required to have NSCLC unsuitable for curative therapy and baseline hemoglobin (Hgb) levels less than 121 g/L. Patients were assigned to 12 weekly injections of subcutaneous epoetin alpha or placebo, targeting Hgb levels between 120 and 140 g/L. The primary outcome was the difference in the change in Functional Assessment of Cancer Therapy–Anemia scores between baseline and 12 weeks. Results: Reports of thrombotic events in other epoetin trials prompted an unplanned safety analysis after 70 patients had been randomly assigned (33 to the active arm and 37 to the placebo arm). This revealed a significant difference in the median survival in favor of the patients on the placebo arm of the trial (63 v 129 days; hazard ratio, 1.84; P = .04). The Steering Committee closed the trial. Patient numbers compromised the interpretation of the QOL analysis, but a positive Hgb response was noted with epoetin alfa treatment. Conclusion: An unplanned safety analysis suggested decreased overall survival in patients with advanced NSCLC treated with epoetin alfa. Although infrequent, other similar reports highlight the need for ongoing trials evaluating erythropoietin receptor agonists to ensure that overall survival is monitored closely.
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Cites
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Bennett, C. L. (2008) · JAMA · doi:10.1001/jama.299.8.914 · Cited by 731
Recombinant Human Erythropoietin in the Treatment of Acute Ischemic Stroke
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The non‐haematopoietic biological effects of erythropoietin
Arcasoy, M. O. (2008) · British Journal of Haematology · doi:10.1111/j.1365-2141.2008.07014.x · Cited by 347
Jädersten, M., Malcovati, L., Dybedal, I., Giovanni Della Porta, M., Invernizzi, R., Montgomery, S. M., Pascutto, C., Porwit, A., Cazzola, M., & Hellström-Lindberg, E. (2008) · Journal of Clinical Oncology · doi:10.1200/jco.2007.15.4906 · Cited by 300
Multiple roles of cyclin-dependent kinase 4/6 inhibitors in cancer therapy
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Metadata
- Authors
- Wright, J. R., Ung, Y. C., Julian, J. A., Pritchard, K. I., Whelan, T. J., Smith, C., Szechtman, B., Roa, W., Mulroy, L., Rudinskas, L., Gagnon, B., Okawara, G. S., & Levine, M. N.
- Venue
- Journal of Clinical Oncology
- Published
- 2007-03-20
- Volume
- 25
- Issue
- 9
- Pages
- 1027-1032
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2126715987
- Cited by
- 428
- References
- 25
- FWCI
- 42.56
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Wright, J. R., Ung, Y. C., Julian, J. A., Pritchard, K. I., Whelan, T. J., Smith, C., Szechtman, B., Roa, W., Mulroy, L., Rudinskas, L., Gagnon, B., Okawara, G. S., & Levine, M. N. (2007). Randomized, Double-Blind, Placebo-Controlled Trial of Erythropoietin in Non–Small-Cell Lung Cancer With Disease-Related Anemia. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2006.07.1514
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.