Durable response but prolonged cytopenia after cladribine treatment in relapsed patients with indolent non-Hodgkin's lymphomas: Results of a Japanese phase II study
Durable response but prolonged cytopenia after cladribine treatment in relapsed patients with indolent non-Hodgkin's lymphomas: Results of a Japanese phase II study
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DOI：
10.1532/ijh97.04077
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发表时间：
2004-10-01
影响因子：
2.1
通讯作者：
Tobinai, K
中科院分区：
文献类型：
--
作者：
Ogura, M;Morishima, Y;Tobinai, K
我们进行了一项II期研究，以评估克拉屈滨（2-氯脱氧腺苷[2-CdA]）对难治性或复发性惰性B细胞淋巴瘤或蕈样肉芽肿患者的疗效和安全性。入组了45例患者，43例患者（包括34例滤泡性淋巴瘤患者）合格。2-CdA以0.09 mg/kg/d的剂量连续静脉输注7天，每4周重复一次，最多6个周期。总缓解率和完全缓解率分别为58.1%（25/43; 90%置信区间，44.5%-70.9%）和14.0%（6/43）。所有43例合格患者和所有25例缓解患者的2年无疾病进展比例分别为30.3%和48.1%。分别在53.3%和37.8%的患者中观察到3级或4级中性粒细胞减少和血小板减少，在治疗周期数增加的患者中观察到长期血细胞减少。3级或以上的非血液学毒性包括腹泻、心律失常、不适和胃肠道出血各1例，2例谷氨酰胺转氨酶水平升高，5例感染。观察到2例给药相关死亡。4例患者在完成2-CdA治疗后13个月至2年发生骨髓增生异常综合征（MDS）。2-CdA是一种活性药物，对难治性或复发性惰性淋巴瘤具有可接受的毒性;然而，应仔细监测长期骨髓抑制和MDS的潜在发展。(C)2004年日本血液学会。
We conducted a phase II study to evaluate the efficacy and safety of cladribine (2-chlorodeoxyadenosine [2-CdA]) for patients with refractory or relapsed indolent B-cell lymphoma or mycosis fungoides. Forty-five patients were enrolled, and 43 patients, including 34 with follicular lymphoma, were eligible. 2-CdA was given by continuous intravenous infusion at a dose of 0.09 mg/kg daily for 7 consecutive days, and this schedule was repeated every 4 weeks up to a maximum of 6 cycles. The overall and complete response rates were 58.1% (25/43; 90% confidence interval, 44.5%-70.9%) and 14.0% (6/43), respectively. The disease progression-free proportions of all 43 eligible and all 25 responding patients at 2 years were 30.3% and 48.1%, respectively. Neutropenia and thrombocytopenia of grade 3 or 4 were observed in 53.3% and 37.8% of patients, respectively, with prolonged cytopenia observed in patients with increased numbers of treatment cycles. Nonhematologic toxicities of grade 3 or greater included diarrhea, arrhythmia, malaise, and gastrointestinal bleeding in 1 patient each, an increase in glutamic-pyruvic transaminase level in 2 patients, and infection in 5 patients. Two treatment-related deaths were observed. Four patients developed myelodysplastic syndrome (MDS) at 13 months to 2 years after completion of the 2-CdA treatments. 2-CdA is an active agent with acceptable toxicity for refractory or relapsed indolent lymphoma; however, prolonged myelosuppression and the potential development of MDS should be carefully monitored. (C) 2004 The Japanese Society of Hematology.