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喷司他丁(2'-脱氧助间型霉素,dCF)用于低级别(B-T细胞)以及中高级别(T细胞)恶性淋巴瘤患者:欧洲癌症研究与治疗组织早期临床试验组的II期研究

Pentostatin (2'-deoxycoformycin, dCF) in patients with low-grade (B-T-cell) and intermediate- and high-grade (T-cell) malignant lymphomas: phase II study of the EORTC Early Clinical Trials Group.

作者信息

Monfardini S, Sorio R, Cavalli F, Cerny T H, Van Glabbeke M, Kaye S, Smyth J F

机构信息

Division of Medical Oncology, Centro di Riferimento Oncologico, Aviano, Italy.

出版信息

Oncology. 1996 Mar-Apr;53(2):163-8. doi: 10.1159/000227554.

Abstract

Thirty-seven eligible patients with advanced non-Hodgkin's lymphoma of low-grade, T-cell intermediate- and high-grade histology were treated with pentostatin (2'-deoxycoformycin, dCF) 4mg/m2 i.v. weekly for 3 weeks and then every 14 days to be followed after 3 doses by the same dosage every 4 weeks until maximum response or progression. Only patients with no more than two chemotherapy regimens were entered in this trial. All patients had measurable disease, performance status of 1,0 and 2 and adequate bone marrow, renal and liver function. Five of 37 eligible patients experienced a partial response of 8 months' median duration (range 7-12). The response rate was 17% in low-grade, 8% in T-cell intermediate- and high-grade and 14% in cutaneous T cell lymphoma. The only eligible patient with Hodgkin's disease underwent progression while on treatment. One case presented with grade 3 leukopenia and another one died of septicaemia, possibly treatment-related. Elevated but reversible creatinine levels were observed in 13% of patients and conjunctivitis in 7%. The toxicity of dCF at this low-dose schedule was acceptable, but the therapeutic activity in pretreated patients with low-grade, T-cell intermediate- and high-grade and cutaneous T-cell lymphomas was limited.

摘要

37例符合条件的低级别、T细胞中级和高级组织学类型的晚期非霍奇金淋巴瘤患者接受喷司他丁(2'-脱氧助间型霉素,dCF)治疗,剂量为4mg/m²,静脉注射,每周1次,共3周,之后每14天1次,3剂后每4周给予相同剂量,直至出现最大反应或病情进展。本试验仅纳入接受不超过两种化疗方案的患者。所有患者均有可测量的病灶,体能状态评分为1、0和2,骨髓、肾脏和肝功能良好。37例符合条件的患者中有5例出现部分缓解,中位缓解持续时间为8个月(范围7 - 12个月)。低级别淋巴瘤的缓解率为17%,T细胞中级和高级淋巴瘤为8%,皮肤T细胞淋巴瘤为14%。唯一符合条件的霍奇金病患者在治疗期间病情进展。1例出现3级白细胞减少,另1例死于败血症,可能与治疗有关。13%的患者肌酐水平升高但可逆转,7%的患者出现结膜炎。在这种低剂量方案下,dCF的毒性是可接受的,但对经预处理的低级别、T细胞中级和高级以及皮肤T细胞淋巴瘤患者的治疗活性有限。

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