Phase II evaluation of gemcitabine monotherapy for cutaneous T-cell lymphoma
Phase II evaluation of gemcitabine monotherapy for cutaneous T-cell lymphoma
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DOI：
10.3816/clm.2006.n.039
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发表时间：
2006-07-01
期刊：
影响因子：
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通讯作者：
Apisarnthanarax, Narin
中科院分区：
文献类型：
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作者：
Duvic, Madeleine;Talpur, Rakhshandra;Apisarnthanarax, Narin
目的：探讨吉西他滨单药治疗皮肤T细胞淋巴瘤(CTCL)的安全性和有效性。患者和方法：25名11期开放试验中的CTCL患者和8名非研究中的患者分别在第1、8和15天静脉注射吉西他滨(1000 mg/m(2))，共6个周期。医生的全球评估是基于皮肤的体表面积、淋巴结和血液的流式细胞仪测量。结果：2例CD30(+)间变性大T细胞淋巴瘤和31例真菌样肉芽肿患者(IB期[T2，n=2]、IIA期[T2，n=1]、1113期[T3，n=13]、IVA期[T3N3，n=3；T4b2，n=2；T4b2N3，n=2]和IVB期[T4b2N1，n=6；T4N3b2M1，n=1；T3N3M1，n=1])接受过平均5次治疗(范围1-13次)。25例研究患者中有17例(68%)有反应(2例完全缓解[8%])，8例患者中有4例(1例完全缓解)。13例真菌样肉芽肿(T3)患者中有7例有效，10例肿瘤负担减轻，11例Sezary综合征患者中有8例有效。吉西他滨耐受性良好。发生骨髓抑制14例，3级8例，溶血性尿毒症综合征2例，肺栓塞2例，充血性心力衰竭、急性心肌梗死、稳定型心绞痛各1例。肝转氨酶升高(4例)、粘膜炎(3例)、嗜睡(7例)、发热(8例)、皮肤色素沉着(6例)、输液相关性黄斑丘疹(1例)和放射反应(1例)。结论：吉西他滨是一种有效的单一疗法，对严重预治疗的晚期CTCL患者有68%的总有效率。
Purpose: The purpose of this study was to investigate safety and efficacy of gemcitabine monotherapy for cutaneous T-cell lymphoma (CTCL). Patients and Methods: Twenty-five patients with CTCL on a phase 11 open-label trial and 8 patients off study received intravenous gemcitabine (1000 Mg/m(2)) on day 1, 8, and 15 for >= 6 cycles. Physicians' global assessment was based on body surface area involvement in skin, measurement of lymph nodes, and blood by flow cytometry. Results: Two patients with CD30(+) anaplastic large T-cell lymphoma and 31 with mycosis fungoides (stage IB [T2, n = 2], stage IIA [T2, n = 1], stage 1113 [T3, n = 13], stage IVA [T3 N3, n = 3; T4b2, n = 2; T4b2 N3, n = 2], and stage IVB [T4b2 N1, n = 6; T4 N3b2 M1, n = 1; T3 N3 M1, n = 1]) had received a median of 5 previous therapies (range, 1-13 therapies). Responses were seen in 17 of 25 (68%) study patients (2 complete responses [8%]) and 4 of 8 patients (1 complete response) off protocol. Seven of 13 patients with mycosis fungoides (T3) responded, 10 had tumor burden reductions, and 8 of 11 patients with Sezary syndrome responded. Gemcitabine was well tolerated. Myelosuppression (n = 14; grade 3, n = 8), hemolytic uremic syndrome (in 2 elderly patients with Sezary syndrome), pulmonary embolism (n = 2), and 1 episode each of congestive heart failure, acute myocardial infarction, and stable angina were observed. Increased hepatic transaminases (n = 4), mucositis (n = 3), lethargy (n = 7), fever (n = 8), cutaneous hyperpigmentation (n = 6), infusion-related maculopapular rash (n = 1), and radiation recall (n = 1) were also seen. Conclusion: Gemcitabine is an effective monotherapy with a 68% overall response rate in patients with advanced, heavily pretreated CTCL.