Santoro A, Bredenfeld H, Devizzi L, Tesch H, Bonfante V, Viviani S, Fiedler F, Parra H S, Benoehr C, Pacini M, Bonadonna G, Diehl V
Istituto Clinico Humanitas, Rozzano-Milano, Italy.
J Clin Oncol. 2000 Jul;18(13):2615-9. doi: 10.1200/JCO.2000.18.13.2615.
To explore the use of gemcitabine for the treatment of patients with relapsing or refractory Hodgkin's disease.
Eligible patients had measurable disease and more than one previous chemotherapy regimen. Patients previously treated with high-dose chemotherapy with autologous bone marrow or peripheral stem-cell support were not included. Gemcitabine, 1,250 mg/m(2), was administered as a 30-minute intravenous infusion on days 1, 8, and 15 of each 28-day cycle of therapy. The dosing schedule remained fixed, and any dose of gemcitabine that could not be given on time was omitted. Patients who had not experienced any hematologic or nonhematologic toxicity after one complete cycle of therapy were permitted to have subsequent doses increased by 20%: that is, from 1, 250 mg/m(2) to 1,500 mg/m(2).
Of the 23 enrolled patients, 22 were assessable for response; all 23 patients were included in the efficacy analysis. Disease status for two patients (9%) reached a state of complete remission, and seven patients (30%) achieved a partial response, for an overall response rate of 39% (95% confidence interval, 19.7% to 61.5%). The likelihood of achieving a response was not influenced by a patients' main pretreatment characteristics or by their response to their last prior chemotherapy. The median duration of response was 6.7 months (range, 2 to 33+ months), and the median overall survival time was 10.7 months (range, 4 to 34.7+ months). In general, toxicities were mild; no treatment-related deaths occurred, and only one life-threatening adverse event was reported for this study.
Gemcitabine was shown to be active in heavily pretreated patients with Hodgkin's disease, producing a response rate of 39%. Additionally, drug-related toxicities were mild, which thus suggests the possible inclusion of gemcitabine in an earlier phase of treatment.
探讨吉西他滨用于治疗复发或难治性霍奇金淋巴瘤患者的疗效。
符合条件的患者患有可测量的疾病且接受过不止一种先前的化疗方案。先前接受过高剂量化疗并伴有自体骨髓或外周干细胞支持治疗的患者未纳入研究。在每28天一个疗程的治疗中，第1、8和15天静脉输注吉西他滨1250mg/m²，输注时间为30分钟。给药方案保持固定，任何未能按时给予的吉西他滨剂量均被省略。在一个完整疗程治疗后未出现任何血液学或非血液学毒性的患者，后续剂量允许增加20%，即从1250mg/m²增至1500mg/m²。
23例入组患者中，22例可评估疗效；所有23例患者均纳入疗效分析。2例患者（9%）疾病状态达到完全缓解，7例患者（30%）获得部分缓解，总缓解率为39%（95%置信区间，19.7%至61.5%）。获得缓解的可能性不受患者主要预处理特征或对其最后一次先前化疗反应的影响。缓解的中位持续时间为6.7个月（范围，2至33 +个月），中位总生存时间为10.7个月（范围，4至34.7 +个月）。总体而言，毒性较轻；未发生与治疗相关的死亡，本研究仅报告了1例危及生命的不良事件。
吉西他滨在预处理严重的霍奇金淋巴瘤患者中显示出活性，缓解率为39%。此外，药物相关毒性较轻，这表明吉西他滨可能可纳入更早阶段的治疗。
