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重组人粒细胞集落刺激因子可加速霍奇金病患者大剂量化疗及自体骨髓移植后的粒细胞恢复。

Recombinant human granulocyte colony-stimulating factor hastens granulocyte recovery after high-dose chemotherapy and autologous bone marrow transplantation in Hodgkin's disease.

作者信息

Taylor K M, Jagannath S, Spitzer G, Spinolo J A, Tucker S L, Fogel B, Cabanillas F F, Hagemeister F B, Souza L M

机构信息

Department of Hematology, M.D. Anderson Cancer Center, University of Texas, Houston 77030.

出版信息

J Clin Oncol. 1989 Dec;7(12):1791-9. doi: 10.1200/JCO.1989.7.12.1791.

Abstract

To determine whether recombinant human granulocyte colony-stimulating factor (rhG-CSF) can accelerate granulocyte recovery after high-dose combination chemotherapy with autologous bone marrow transplantation (ABMT) in patients with Hodgkin's disease, we performed a nonrandomized phase II study using historical controls as a comparison. Eighteen relapsed/refractory Hodgkin's disease patients who received cyclophosphamide at 1.5 g/m2/day (days -6 to -3), carmustine (BCNU) at 300 mg/m2 (day -6), and etoposide (VP-16) at 125 mg/m2 every 12 hours (days -6 to -4), followed by ABMT (day 0) were treated with rhG-CSF at 60 micrograms/kg/day for a maximum of 28 days beginning on day 1. rhG-CSF dosage was gradually diminished and stopped once an adequate granulocyte count was maintained. rhG-CSF significantly accelerated absolute granulocyte count (AGC) compared with historical controls recovery to the 100/microL level (median, 9 days v 13 days; P = .103 x 10(-4), 500/microL level (median, 13 days v 22 days; P = 0.189 x 10(-2), and 1000/microL level (median, 16 days v 30 days levels; P = .125 x 10(-5). Platelet recovery to 50,000/microL was not significantly altered (P = .370). rhG-CSF was well tolerated, bone pain and myalgia being the only side effects noted. rhG-CSF hastens granulocyte recovery after high-dose chemotherapy with ABMT in patients with relapsed/refractory Hodgkin's disease without significant toxicity.

摘要

为了确定重组人粒细胞集落刺激因子(rhG-CSF)能否加速霍奇金病患者在大剂量联合化疗及自体骨髓移植(ABMT)后粒细胞的恢复,我们进行了一项非随机的II期研究,以历史对照作为比较。18例复发/难治性霍奇金病患者接受了如下治疗:环磷酰胺1.5 g/m²/天(第-6天至-3天)、卡莫司汀(BCNU)300 mg/m²(第-6天)、依托泊苷(VP-16)125 mg/m²每12小时一次(第-6天至-4天),随后进行ABMT(第0天),并从第1天开始接受rhG-CSF治疗,剂量为60微克/千克/天,最长持续28天。rhG-CSF剂量逐渐减少,一旦维持足够的粒细胞计数即停用。与历史对照相比,rhG-CSF显著加速了绝对粒细胞计数(AGC)恢复至100/微升水平(中位数,分别为9天和13天;P = 0.103×10⁻⁴)、500/微升水平(中位数,分别为13天和22天;P = 0.189×10⁻²)以及1000/微升水平(中位数,分别为16天和30天;P = 0.125×10⁻⁵)。血小板恢复至50,000/微升无显著改变(P = 0.370)。rhG-CSF耐受性良好,仅观察到骨痛和肌痛这两种副作用。rhG-CSF可加速复发/难治性霍奇金病患者在大剂量化疗及ABMT后的粒细胞恢复,且无明显毒性。

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