Anemia Criteria in the Elderly:Is It Time to Re-Evaluate?

MANHASSET, New York- Current criteria for correcting anemia in older cancer patients are not stringent enough, recent findings suggest. However, clinical trials will be needed to show that using erythropoietic agents to correct anemia beyond the generally accepted hemoglobin (Hb) threshold of 12 g/dL will provide an added patient benefit, according to Stuart Lichtman, MD. "We have the means to correct these measures," said Dr. Lichtman, associate professor of clinical medicine, NYU School of Medicine, Division of Oncology, North Shore University Hospital, Manhasset, New York. "The question is, can we prove the benefit in a prospective manner?" Dr. Lichtman spoke at a satellite symposium sponsored by Amgen and held in conjunction with the first annual Geriatric Oncology Consortium multidisciplinary conference. NCCN Guidelines National Comprehensive Cancer Network (NCCN) guidelines describe how to minimize anemia toxicity in elderly patients undergoing chemotherapy. The guidelines recommend using hematopoietic growth factors prophylactically in patients aged 70 years or older undergoing chemother-apy that has a dose intensity comparable with CHOP (cyclophosphamide [Cytoxan/Neosar]/doxorubicin HCl/ vincristine [Oncovin]/prednisone). The guidelines also state that erythropoietic agents should be used to maintain Hb levels at greater than 12 g/dL. Adhering to those guidelines will ensure that chemotherapy effectiveness and quality of life are maintained, according to Dr. Lichtman. However, emerging data suggest that the cutoffof ≤ 12 g/dL as criteria for defining anemia in older people should be reevaluated. In a recent study that raised this question, investigators showed that incremental rises in Hb above 12 g/dL may decrease the incidence of functional disability in older women (J AmGeriatr Soc 50:1257-1264, 2002). The study was a cross-sectional analysis of two population-based studies (Women's Health and Aging Studies I and II, Baltimore, Maryland) including 633 community dwellingwomen aged 70 to 80 years. Investigators measured Hb levels and assessed difficulty with mobility, as shown by either walking one-quarter mile or climbing 10 steps. Investigators found that mobility varied within the "normal" Hb range of 12 to 16 g/dL. For example, an Hb level of 12 g/dL was associated with more mobility difficulty vs an Hb level of 13.5 g/dL. Performance-based scores improved with increasing Hb categories, from less than 12, to 12- 13, to 13-14 g/dL. Based on these findings, investigators said Hb ≤ 12 g/dL "might be a suboptimal criterion for defining anemia in older women," because even Hb levels considered "low normal" by today's standards were associated with an adverse effect on mobility. "The maximum optimal hemoglobin in this study was approximately 13 to 14 [g/dL]," Dr. Lichtman said. "A hemoglobin of 11 is not good enough, and a hemoglobin of 12 g/dL might even be a suboptimal criterion for defining anemia. These researchers have shown that older patients with a hemoglobin level of 14 had an improved degree of function." These hypotheses must be formally tested, however, in clinical trials uti-lizing erythropoietic agents, ideally in studies that specifically include elderly individuals with cancer. Erythropoietic growth factors that are available to treat anemia include epoetin alfa(Drug information on epoetin alfa) (Procrit) and darbepoetin (Aranesp). Dr. Lichtman noted that data on file with Amgen, the manufacturer of Aranesp, show that this particularagent yields similar efficacy in younger and older cancer patients. Correcting anemia with erythropoietic agents can alleviate fatigue, tiredness, and other symptoms in older cancer patients. More importantly, however, correcting anemia may ensure elderly patients receive the appropriate chemotherapy dose and schedule. "It's easy to minimize toxicity by giving less-effective therapy, but if you do have a responsive disease (such as non-Hodgkin's lymphoma), you really do have to stick to the dosing schedule that we know can be effective," Dr. Lichtman said.