Oster W, Herrmann F, Gamm H, Zeile G, Lindemann A, Müller G, Brune T, Kraemer H P, Mertelsmann R
Department of Hematology, Johannes Gutenberg-University, Mainz, Federal Republic of Germany.
J Clin Oncol. 1990 Jun;8(6):956-62. doi: 10.1200/JCO.1990.8.6.956.
This clinical trial was performed to study the effects of intravenously (IV) administered recombinant human (rh) erythropoietin (EPO) at escalating doses (150, 300, and 450 U/kg, administered as an IV bolus injection, twice weekly, for 6, 4, and 4 weeks, respectively) in five patients with low-grade non-Hodgkin's lymphoma (Ig NHL) and bone marrow involvement and one patient with multiple myeloma (MM). All patients were anemic due to underlying disease. None of the patients had a history of bleeding, hemolysis, renal insufficiency, or other disorders causing anemia in addition to bone marrow infiltrating malignancy. Endogenous EPO serum levels were significantly increased in all patients (74 to 202 mU/mL). Five patients (one MM, four small-cell lymphocytic [SCLC] NHL) showed a dramatic increase of hemoglobin (Hb), hematocrit (Hk) and RBC count becoming obvious on the second EPO dose level. Initial ferritin serum values, which were high mostly due to polytransfusion, were significantly reduced in responding patients. Erythropoiesis of one patient with extensive follicular mixed (fm) NHL did not respond to EPO treatment. Platelet (PLT) count increase (greater than 75% above starting levels) during and following EPO therapy was observed in one patient with MM. Adverse events due to EPO therapy have not been recorded. These findings point out a previously unrecognized capacity of EPO given at pharmacologic doses to stimulate erythropoiesis in patients with anemia due to bone marrow infiltration by neoplastic lymphocytes in spite of enhanced endogenous EPO expression.
本临床试验旨在研究静脉注射重组人促红细胞生成素（rhEPO）递增剂量（分别为150、300和450 U/kg，静脉推注给药，每周两次，分别持续6周、4周和4周）对5例低度非霍奇金淋巴瘤（Ig NHL）伴骨髓受累患者及1例多发性骨髓瘤（MM）患者的影响。所有患者均因基础疾病而贫血。所有患者均无出血、溶血、肾功能不全或除骨髓浸润性恶性肿瘤外导致贫血的其他疾病史。所有患者的内源性促红细胞生成素血清水平均显著升高（74至202 mU/mL）。5例患者（1例MM，4例小细胞淋巴细胞性[SCLC] NHL）在第二个促红细胞生成素剂量水平时血红蛋白（Hb）、血细胞比容（Hk）和红细胞计数显著增加。反应性患者中，主要因多次输血导致的初始血清铁蛋白值显著降低。1例广泛滤泡混合性（fm）NHL患者的红细胞生成对促红细胞生成素治疗无反应。1例MM患者在促红细胞生成素治疗期间及治疗后血小板（PLT）计数增加（高于起始水平75%以上）。未记录到促红细胞生成素治疗引起的不良事件。这些发现指出，尽管内源性促红细胞生成素表达增强，但给予药理剂量的促红细胞生成素对因肿瘤淋巴细胞骨髓浸润导致贫血的患者具有此前未被认识到的刺激红细胞生成的能力。
