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低剂量全身电子束治疗作为减轻蕈样肉芽肿患者疾病负担的有效方式:来自 3 项 II 期临床试验的汇总分析结果。

Low-dose total skin electron beam therapy as an effective modality to reduce disease burden in patients with mycosis fungoides: results of a pooled analysis from 3 phase-II clinical trials.

机构信息

Department of Radiation Oncology, Stanford Cancer Institute, Stanford, California.

Department of Dermatology, Stanford Cancer Institute, Stanford, California.

出版信息

J Am Acad Dermatol. 2015 Feb;72(2):286-92. doi: 10.1016/j.jaad.2014.10.014. Epub 2014 Dec 2.

DOI:10.1016/j.jaad.2014.10.014
PMID:25476993
Abstract

BACKGROUND

Standard-dose (36-Gy) total skin electron beam therapy (TSEBT) is a highly effective treatment in mycosis fungoides. However, the regimen is time-intensive and may be associated with significant toxicity.

OBJECTIVE

We sought to evaluate the efficacy and tolerability associated with low-dose (12-Gy) TSEBT.

METHODS

Data from 3 clinical trials using low-dose (12-Gy) TSEBT were pooled. In all trials, TSEBT-naïve patients with stage IB to IIIA mycosis fungoides were treated with TSEBT (12 Gy, 1 Gy per fraction over 3 weeks). The primary end point was clinical response rate. Secondary end points included time to response and duration of clinical benefit.

RESULTS

In all, 33 patients enrolled. Eighteen were male; stages were 22 IB, 2 IIA, 7 IIB, and 2 IIIA. Overall response rate was 88% (29/33), including 9 patients with complete response. Median time to response was 7.6 weeks (3-12.4 weeks). Median duration of clinical benefit was 70.7 weeks (95% confidence interval 41.8-133.8 weeks). Toxicities from TSEBT were mild and reversible.

LIMITATIONS

Conclusions are limited because of the small number of patients.

CONCLUSIONS

Low-dose TSEBT provides reliable and rapid reduction of disease burden in patients with mycosis fungoides, which could be administered safely multiple times during the course of a patient's disease with acceptable toxicity profile.

摘要

背景

标准剂量(36 戈瑞)全身电子束治疗(TSEBT)是蕈样肉芽肿的一种非常有效的治疗方法。然而,该方案时间密集,可能与显著的毒性有关。

目的

我们旨在评估低剂量(12 戈瑞)TSEBT 相关的疗效和耐受性。

方法

汇总了 3 项使用低剂量(12 戈瑞)TSEBT 的临床试验数据。在所有试验中,TSEBT 初治的 I 期至 IIIA 期蕈样肉芽肿患者接受 TSEBT(12 Gy,3 周内 1 Gy/次)治疗。主要终点是临床缓解率。次要终点包括缓解时间和临床获益持续时间。

结果

共纳入 33 例患者。其中 18 例为男性,分期为 22 例 IB、2 例 IIA、7 例 IIB 和 2 例 IIIA。总缓解率为 88%(29/33),其中 9 例患者达到完全缓解。缓解时间的中位数为 7.6 周(3-12.4 周)。临床获益持续时间的中位数为 70.7 周(95%置信区间 41.8-133.8 周)。TSEBT 的毒性为轻度和可逆的。

局限性

由于患者数量较少,结论受到限制。

结论

低剂量 TSEBT 可可靠且快速地减轻蕈样肉芽肿患者的疾病负担,并且可以在患者疾病过程中多次安全地给予,具有可接受的毒性特征。

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