Gemcitabine as frontline treatment for cutaneous T-cell lymphoma - Phase II study of 32 patients
Gemcitabine as frontline treatment for cutaneous T-cell lymphoma - Phase II study of 32 patients
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DOI：
10.1002/cncr.21449
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发表时间：
2005-12-01
期刊：
影响因子：
6.2
通讯作者：
Zinzani, PL
中科院分区：
文献类型：
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作者：
Marchi, E;Alinari, L;Zinzani, PL
背景。基于吉西他滨在大量预处理的皮肤t细胞淋巴瘤（CTCL）患者中的活性，本研究的目的是确定吉西他滨在治疗晚期未经治疗的CTCL患者中的作用。2002年6月至2004年2月，32例未经治疗的蕈样真菌病（MF） （n = 26例）；未明确的外周t细胞淋巴瘤（PTCLU），仅累及皮肤（n = 5例）；和Sezary综合征（SS） （n = 1例患者）纳入了一项7家机构的II期试验，并接受吉西他滨治疗。该药物在28天疗程的第1、8和15天以1200mg /m(2)的剂量静脉注射，持续30分钟，共6个周期。在研究的32例患者中，7例（22%）获得完全缓解（CR）， 17例（53%）获得部分缓解（PR），而其余8例患者没有从治疗中获益。5例cr经组织学证实。发现MF和PTCLU患者的CR和PR率分别相同。CR的中位持续时间为10个月（范围4-22个月）。治疗似乎耐受性良好；血液学毒性轻微，无恶心/呕吐或器官毒性。目前的II期研究结果表明，吉西他滨作为单一药物在未治疗的CTCL患者中具有活性。需要进一步研究吉西他滨与其他药物联合治疗晚期未经治疗的CTCL。
BACKGROUND. Based on the activity of gemcitabine in heavily pretreated patients with cutaneous T-cell lymphoma (CTCL), the objective of the current study was to determine the role of gemcitabine in the treatment of patients with advanced, untreated CTCL.METHODS. Between June 2002 and February 2004, 32 untreated patients with mycosis fungoides (MF) (n = 26 patients); peripheral T-cell lymphoma, unspecified (PTCLU) with exclusive skin involvement (n = 5 patients); and Sezary syndrome (SS) (n = 1 patient) were enrolled in a 7-institution, Phase II trial and treated with gemcitabine. This drug was given on Days 1, 8, and 15 of a 28-day schedule at a dose of 1200 mg/m(2) intravenously over 30 minutes for a total of 6 cycles.RESULTS. Of the 32 patients studied, 7 (22%) achieved a complete response (CR) and 17 (53%) achieved a partial response (PR), whereas the remaining 8 patients showed no benefit from the treatment. Five of the CRs were confirmed histologically. The CR and PR rates were found to be the same for patients with MF and PTCLU, respectively. The median duration of CR was 10 months (range, 4-22 mos). Treatment appeared to be well tolerated; hematologic toxicity was mild and no nausea/emesis or organ toxicity was noted.CONCLUSIONS. The results of the current Phase II study demonstrate the activity of gemcitabine as a single agent in untreated CTCL patients. Further studies using gemcitabine in combination, either contemporary or sequentially, with other drugs in patients with advanced stage, untreated CTCL are needed.