Schlaak Max, Pickenhain Juliane, Theurich Sebastian, Skoetz Nicole, von Bergwelt-Baildon Michael, Kurschat Peter
Department ofDermatology andVenerology,UniversityHospital ofCologne,Cologne,Germany.
Cochrane Database Syst Rev. 2012 Jan 18;1:CD008908. doi: 10.1002/14651858.CD008908.pub2.
Primary cutaneous T-cell lymphomas (CTCL) belong to the group of non-Hodgkin lymphomas and usually run an indolent course. However, some patients progress to advanced tumour or leukaemic stages. Up to now, no curative treatment has been established for those cases. In the last few years, several publications have reported durable responses in some patients following allogeneic stem cell transplantation (alloSCT).
To compare the efficacy and safety of conventional therapies with allogeneic stem cell transplantation in patients with advanced primary cutaneous T-cell lymphomas.
The search strategy included the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (1950 to May 2011), Internet-databases of ongoing trials (www.controlled-trials.com; www.clinicaltrials.gov), conference proceedings of the American Society of Clinical Oncology (ASCO, 2009 to present) and the American Society of Hematology (ASH, 2009 to present). We also contacted members of the European Organisation for Research and Treatment of Cancer (EORTC) Cutaneous Lymphoma Task Force to check for ongoing study activities. We handsearched citations from identified trials and relevant review articles. In addition, randomised controlled trials from the European Group for Blood and Marrow Transplantation (EBMT) and International Conference on Cutaneous T-cell Lymphoma, ASCO and ASH up to 2010 were handsearched.
Genetically randomised controlled trials (RCT) comparing alloSCT plus conditioning therapy regardless of agents with conventional therapy as treatment for advanced CTCL were eligible to be included.
From eligible studies data would have been extracted by two review authors and assessed for quality. Primary outcome measures were overall survival, secondary criteria were time to progression, response rate, treatment-related mortality, adverse events and quality of life.
We found 2077 citations but none were relevant genetically or non-genetically randomised controlled trials. All 41 studies that were thought to be potentially suitable were excluded after full text screening for being non-randomised, not including CTCL or being review articles.
AUTHORS' CONCLUSIONS: We planned to report evidence from genetically or non-genetically randomised controlled trials comparing conventional therapy and allogeneic stem cell transplantation. However, no randomised trials addressing this question were identified. Nevertheless, prospective genetically randomised controlled trials need to be initiated to evaluate the precise role of alloSCT in advanced CTCL.
原发性皮肤T细胞淋巴瘤(CTCL)属于非霍奇金淋巴瘤,通常病程进展缓慢。然而,一些患者会进展至晚期肿瘤或白血病阶段。到目前为止,尚未确立针对这些病例的治愈性治疗方法。在过去几年中,有几篇报道称部分患者在接受异基因干细胞移植(alloSCT)后获得了持久缓解。
比较传统疗法与异基因干细胞移植治疗晚期原发性皮肤T细胞淋巴瘤患者的疗效和安全性。
检索策略包括Cochrane对照试验中心注册库(CENTRAL)、MEDLINE(1950年至2011年5月)、正在进行试验的互联网数据库(www.controlled-trials.com;www.clinicaltrials.gov)、美国临床肿瘤学会(ASCO,2009年至今)和美国血液学会(ASH,2009年至今)的会议论文集。我们还联系了欧洲癌症研究与治疗组织(EORTC)皮肤淋巴瘤特别工作组的成员,以核实正在进行的研究活动。我们手工检索了已识别试验和相关综述文章的参考文献。此外,还手工检索了欧洲血液与骨髓移植组(EBMT)以及截至2010年的皮肤T细胞淋巴瘤国际会议、ASCO和ASH的随机对照试验。
比较alloSCT加预处理疗法(无论使用何种药物)与传统疗法治疗晚期CTCL的基因随机对照试验(RCT)均符合纳入标准。
两位综述作者将从符合条件的研究中提取数据并评估质量。主要结局指标为总生存期,次要标准为疾病进展时间、缓解率、治疗相关死亡率、不良事件和生活质量。
我们共找到2077条参考文献,但均不符合基因或非基因随机对照试验的要求。经过全文筛选,所有41项被认为可能合适的研究均因非随机、未纳入CTCL或为综述文章而被排除。
我们计划报告比较传统疗法和异基因干细胞移植的基因或非基因随机对照试验的证据。然而,未找到针对该问题的随机试验。尽管如此,仍需开展前瞻性基因随机对照试验,以评估alloSCT在晚期CTCL中的精确作用。