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喷司他丁治疗晚期T细胞淋巴恶性肿瘤的II期研究:MD安德森癌症中心系列研究的更新

Phase II study of pentostatin in advanced T-cell lymphoid malignancies: update of an M.D. Anderson Cancer Center series.

作者信息

Tsimberidou Apostolia-Maria, Giles Francis, Duvic Madeleine, Fayad Luis, Kurzrock Razelle

机构信息

Department of Leukemia, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX 77030, USA.

出版信息

Cancer. 2004 Jan 15;100(2):342-9. doi: 10.1002/cncr.11899.

DOI:10.1002/cncr.11899
PMID:14716770
Abstract

BACKGROUND

The goal of the current study was to assess the toxicity, safety, and efficacy of pentostatin in patients with T-cell lymphoid malignancies.

METHODS

Patients were eligible if they had biopsy-proven T-cell lymphoma or leukemia and failure to respond to previous therapy or an expected complete response rate to conventional therapy of < 20%. Pentostatin was administered at an initial dose of 3.75 or 5.0 mg/m(2) by intravenous bolus daily over a consecutive 3-day period every 3 weeks.

RESULTS

Forty-two of 44 patients enrolled in the study were evaluable. The median age of the patients was 62 years (range, 38-86 years). Patients received a median of 3 previous therapies (range, 0-10 previous therapies). Of these patients, 32 (76%) had mycosis fungoides/Sézary syndrome and 10 patients (24%) had other T-cell leukemias or lymphomas. The overall response rate was 54.8% (complete remission, 6 patients [14.3%]; partial remission, 17 patients [40.5%]). Durable responses were observed mainly in patients with Sézary syndrome or peripheral T-cell lymphoma. The median follow-up period for surviving patients was 20 months (range, 1-83+ months). The median duration of response was 4.3 months (range, 1-61 months). The most common toxicities were neutropenia, nausea, and CD4 suppression. A transient early "flare" of disease was observed in some responders.

CONCLUSIONS

At these doses, pentostatin was reasonably well tolerated and is an effective drug for the treatment of T-cell lymphomas.

摘要

背景

本研究的目的是评估喷司他丁对T细胞淋巴瘤患者的毒性、安全性和疗效。

方法

若患者经活检证实患有T细胞淋巴瘤或白血病,且对既往治疗无反应或对传统治疗的预期完全缓解率低于20%,则符合入选标准。喷司他丁的初始剂量为3.75或5.0mg/m²,通过静脉推注,每3周连续3天每日给药。

结果

纳入研究的44例患者中有42例可进行评估。患者的中位年龄为62岁(范围38 - 86岁)。患者接受的既往治疗中位数为3次(范围0 - 10次)。其中,32例(76%)患有蕈样肉芽肿/赛塞里综合征,10例(24%)患有其他T细胞白血病或淋巴瘤。总缓解率为54.8%(完全缓解6例[14.3%];部分缓解17例[40.5%])。主要在赛塞里综合征或外周T细胞淋巴瘤患者中观察到持久缓解。存活患者的中位随访期为20个月(范围1 - 83 +个月)。中位缓解持续时间为4.3个月(范围1 - 61个月)。最常见的毒性反应为中性粒细胞减少、恶心和CD4抑制。在一些缓解者中观察到疾病的短暂早期“爆发”。

结论

在这些剂量下,喷司他丁耐受性良好,是治疗T细胞淋巴瘤的有效药物。

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