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Susana M. Campos, Mei Sheng Duh, Patrick Lefebvre and James Rosberg

Although previous studies have recognized that timely correction of anemia is desirable, no published research quantifies the association between the timeliness of the hemoglobin rise and patients' outcomes. This study evaluates whether anemic patients with cancer who are receiving chemotherapy and who experienced an early response to epoetin alfa (≥ 1 g/dL hemoglobin increase at the end of 4 weeks of treatment) experienced better clinical and drug utilization outcomes compared with patients who did not experience an early response. Three large, open-label, community studies of epoetin alfa for the treatment of chemotherapy-related anemia were retrospectively analyzed to assess the association of early hemoglobin response to subsequent transfusion requirements, subsequent hemoglobin response, quality of life, and epoetin alfa dosage administered over the study. Two epoetin alfa dosing regimens were evaluated: 10,000 units 3 times weekly with potential escalation to 20,000 units, and 40,000 units once weekly with potential escalation to 60,000 units. In all studies, patients who experienced an early hemoglobin response had statistically lower subsequent transfusion requirements, higher rates of subsequent hemoglobin response, shorter time to hemoglobin response, better improvements in quality of life scores, and lower average weekly epoetin alfa dose than patients who did not experience an early hemoglobin response. Similar proportions of patients experienced early response in the 3-times weekly and once-weekly epoetin alfa regimens. This ad hoc analysis found that early hemoglobin response to epoetin alfa therapy was associated with improved clinical benefits and drug utilization. Early hemoglobin response may therefore be considered as a desired goal of epoetin alfa therapies.

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John A. Glaspy

Patients who have cancer, particularly those undergoing chemotherapy, frequently become anemic. Therapy with erythropoiesis-stimulating agents (ESAs) is associated with an increase in hemoglobin levels, a reduction in transfusion requirements, and, according to many clinical trialists and experienced clinicians, an improvement in functional status, productivity, and quality of life. Several randomized trials of ESAs in patients who have cancer have recently reported inferior outcomes in tumor progression or survival, raising appropriate concerns about the safety of ESAs in oncology. However, 3 important caveats to these reports exist. First, these clinical trials did not reflect the common use of ESAs in oncology practice (i.e., to treat, rather than prevent, anemia in patients undergoing chemotherapy). Second, the trials were seriously flawed and did not meet reasonable standards for cancer progression or survival trials. Third, during the same period, randomized trials were presented or published that showed no negative impact on tumor progression or survival; these trials have approximately the same shortcomings as trials that suggest a safety issue exists. The lack of definitive answers about the safety of ESAs for treating chemotherapy-related anemia has placed physicians, regulators, and most importantly patients in a difficult position that can only be addressed with additional data. This article reviews relevant preclinical and clinical available data to help improve understanding and guide decision making.

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Christopher A. Laman, Scott B. Silverstein and George M. Rodgers

dextran, iron saccharate and sodium ferric gluconate . Semin Dial 2000 ; 13 : 381 – 384 . 2 Auerbach M Ballard H Trout JR . Intravenous iron optimizes the response to recombinant human erythropoietin in cancer patients with chemotherapy-related

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Chemotherapy-Related Anemia Campos Susana M. * MD, MPH Duh Mei Sheng † MPH, ScD Lefebvre Patrick § MA Rosberg James † PhD, MBA 11 2005 3 3 6 6 807 807 816 816 10.6004/jnccn.2005.0049

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Michael Auerbach and Harold Ballard

Edited by Kerrin G. Robinson

patients with chemotherapy-related anemia: a multicenter, open-label, randomized trial . J Clin Oncol 2004 ; 22 : 1301 – 1307 . 12. Auerbach M Chaudhry M Goldman H Ballard H . Value of methyl-prednisolone in prevention of the arthralgia

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Jeffrey A. Gilreath, Daniel S. Sageser, James A. Jorgenson and George M. Rodgers

. Auerbach M Ballard H Trout JR . Intravenous iron optimizes the response to recombinant human erythropoietin in cancer patients with chemotherapy-related anemia: a multicenter, open-label, randomized trial . J Clin Oncol 2004 ; 22 : 1301 – 1307

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Jennifer M. Hinkel, Edward C. Li and Stephen L. Sherman

both the nephrology and oncology literature. For patients with cancer- and chemotherapy-related anemia, data indicated that use of ESAs lowered dependence on transfusions, improved QoL, and reduced symptoms of fatigue. 3 , 6 In 2001, darbepoetin alfa

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George M. Rodgers

the response to recombinant human erythropoietin in cancer patients with chemotherapy-related anemia . J Clin Oncol 2004 ; 22 : 1301 – 1307 . 5 Bohlius J Langensiepen S Schwarzer G . Recombinant human erythropoietin and overall survival

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George M. Rodgers III, Pamela Sue Becker, Morey Blinder, David Cella, Asher Chanan-Khan, Charles Cleeland, Peter F. Coccia, Benjamin Djulbegovic, Jeffrey A. Gilreath, Eric H. Kraut, Ursula A. Matulonis, Michael M. Millenson, Denise Reinke, Joseph Rosenthal, Rowena N. Schwartz, Gerald Soff, Richard S. Stein, Gordana Vlahovic and Alva B. Weir III

significant effect of ESAs on mortality or progression. 41 , 42 In addition, several recent pharmacovigilance trials reported no decrease in survival with ESA use in patients with chemotherapy-related anemia. 43 – 45 One of these is an update on the PREPARE

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Anat Gafter-Gvili, David P. Steensma and Michael Auerbach

. References 1. Auerbach M Ballard H Trout J . Intravenous iron optimizes the response to recombinant erythropoietin in cancer patients with chemotherapy-related anemia: a multicenter, open-label, randomized trial . J Clin Oncol 2004 ; 22 : 1301