Glaspy J
Department of Medicine, UCLA School of Medcine, USA.
Semin Hematol. 1997 Jul;34(3 Suppl 2):20-6.
Untreated anemia is common in cancer patients. Previous studies have demonstrated that both the existence of cancer and treatment with chemotherapy can suppress the normal endogenous erythropoietic response to anemia, making some cancer patients transfusion cadidates. In placebo-controlled phase III studies, administration of recombinant human erythropoietin (epoetin alfa) increased hemoglobin (Hb) levels and decreased transfusion requirements in patients undergoing cancer chemotherapy. In these studies, an increase in self-perceived energy level, functional status, and overall quality of life (QOL) was noted in the subset of patients in whom hematocrit levels increased by > or = 6%. To examine more closely the relationship between epoetin alfa therapy and QOL issues in patients undergoing chemotherapy, we conducted an open-label phase IV study involving 2,030 patients treated at 570 community cancer centers in the United States. Patients initially received epoetin alfa 150 U/kg subcutaneously (s.c.) three times per week for 4 months; if response was judged inadequate, the dosage was increased after 8 weeks to 300 U/kg s.c. three times per week. Hb levels and transfusion requirements were monitored monthly. Before and after the study, each patient completed a linear analog self-assessment scale designed to measure energy level, daily activity, and overall QOL. During epoetin alfa therapy, there was a progressive and significant increase (P < .001) in Hb concentrations. Significantly fewer (P < .001) patients were transfused and fewer transfusions were administered per patient per month after the first month of epoetin alfa therapy. Fifty-eight percent of the patients who required a transfusion during the first month of epoetin alfa therapy did not require a transfusion during the subsequent 3 months of the study. The entire patient population demonstrated a significant increase in mean scores for energy level, daily activity, and overall QOL. The magnitude of the increase in these scores correlated with the magnitude of the increase in Hb concentration. Statistically significant improvement in energy scores, daily activity, and overall QOL (P < .05) were observed, regardless of tumor response. These observations require confirmation on placebo-controlled trials, but the implications for oncology practice are important. They suggest that in cancer patients undergoing chemotherapy, the tradition of leaving anemia untreated may compromise patients' ability to function and their QOL.
未经治疗的贫血在癌症患者中很常见。先前的研究表明，癌症的存在以及化疗都能抑制机体对贫血正常的内源性促红细胞生成反应，这使得一些癌症患者成为输血候选对象。在安慰剂对照的III期研究中，给予重组人促红细胞生成素（阿法依泊汀）可提高接受癌症化疗患者的血红蛋白（Hb）水平，并减少输血需求。在这些研究中，血细胞比容水平升高≥6%的患者亚组中，自我感觉的能量水平、功能状态和总体生活质量（QOL）均有所提高。为了更深入地研究阿法依泊汀治疗与化疗患者QOL问题之间的关系，我们在美国570个社区癌症中心进行了一项开放标签的IV期研究，涉及2030例患者。患者最初皮下注射（s.c.）阿法依泊汀150 U/kg，每周3次，共4个月；如果判断反应不足，则在8周后将剂量增加至300 U/kg s.c.，每周3次。每月监测Hb水平和输血需求。研究前后，每位患者完成一份线性模拟自我评估量表，旨在测量能量水平、日常活动和总体QOL。在阿法依泊汀治疗期间，Hb浓度呈渐进性显著升高（P<0.001）。阿法依泊汀治疗第一个月后，接受输血的患者显著减少（P<0.001），且每位患者每月的输血量减少。在阿法依泊汀治疗第一个月需要输血的患者中，58%在研究随后的3个月中不再需要输血。全体患者的能量水平、日常活动和总体QOL的平均得分均显著提高。这些得分的提高幅度与Hb浓度的升高幅度相关。无论肿瘤反应如何，能量得分、日常活动和总体QOL均有统计学意义的改善（P<0.05）。这些观察结果需要在安慰剂对照试验中得到证实，但对肿瘤学实践的意义重大。它们表明，在接受化疗的癌症患者中，任由贫血不治疗的传统做法可能会损害患者的功能能力及其QOL。
