Hiddemann W, Unterhalt M, Pott C, Wörmann B, Sandford D, Freund M, Engert A, Gassmann W, Holtkamp W, Seufert J
Department of Hematology and Oncology, University of Göttingen, Germany.
Semin Oncol. 1993 Oct;20(5 Suppl 7):28-31.
In a phase II study, 45 patients with advanced low-grade non-Hodgkin's lymphomas (NHLs) who had failed on or had relapsed after first-line chemotherapy were treated with a 5-day regimen of fludarabine, 25 mg/m2/d, by a 30-minute infusion. All patients were pretreated and had received one to 11 preceding regimens (median, three regimens). Histologic subtypes included 17 centrocytic/centroblastic NHLs, three centrocytic NHLs, 23 lymphoplasmocytoid immunocytomas, and one case each of peripheral T-cell and lymphocytic lymphoma. From 38 presently evaluable patients, 12 (31%) cases responded (five [13%] complete and seven [18%] partial remissions). Treatment-associated toxicity was mild to moderate, with myelosuppression comprising the major side effect. From the 12 complete and partial response patients, seven are currently in unmaintained remission for more than 12 months. These data indicate a high activity of fludarabine in heavily pretreated patients with low-grade NHL. Further investigations are warranted to assess the most appropriate usage for this highly promising agent at earlier stages of low-grade NHL therapy.
在一项II期研究中，45例一线化疗失败或复发的晚期低度非霍奇金淋巴瘤（NHL）患者接受了为期5天的氟达拉滨治疗方案，剂量为25mg/m²/天，静脉输注30分钟。所有患者均接受过预处理，之前接受过1至11种治疗方案（中位数为3种方案）。组织学亚型包括17例中心细胞/中心母细胞性NHL、3例中心细胞性NHL、23例淋巴浆细胞样免疫细胞瘤，以及各1例外周T细胞淋巴瘤和淋巴细胞淋巴瘤。在38例目前可评估的患者中，12例（31%）有反应（5例[13%]完全缓解，7例[18%]部分缓解）。治疗相关毒性为轻至中度，主要副作用为骨髓抑制。在12例完全缓解和部分缓解的患者中，7例目前处于未维持缓解状态超过12个月。这些数据表明氟达拉滨在高度预处理的低度NHL患者中具有高活性。有必要进一步研究以评估这种极有前景的药物在低度NHL治疗早期阶段的最恰当用法。
