Parrott Madeliene, Rule Simon, Kelleher Michael, Wilson Jayne
University of Birmingham, Birmingham, United Kingdom.
Plymouth University Medical School and Derriford Hospital, Plymouth, United Kingdom.
Clin Lymphoma Myeloma Leuk. 2018 Jan;18(1):13-25.e6. doi: 10.1016/j.clml.2017.10.004. Epub 2017 Oct 13.
A systematic review was conducted to evaluate the clinical effectiveness and safety of treatments for patients with relapsed/refractory mantle cell lymphoma (MCL) unsuitable for intensive treatment. The criteria for inclusion of the trials were established before the review. A search of Medline, Embase, and the Cochrane library databases was conducted to identify phase II or III randomized controlled trials (RCTs), reported from January 1, 1994 to May 29, 2016. Relevant conference abstracts, citation lists from the included articles, published guidelines, and on-going clinical trial databases were also searched. Studies were included if they had evaluated any single agent or combination of treatments for adult patients with relapsed/refractory MCL who had received ≥ 1 previous line of therapy. Seven RCTs were identified. Only 1 treatment appeared in > 1 trial; therefore, the results from each trial could not be quantitatively pooled for meta-analysis. The lack of common comparators, differences in baseline characteristics and inclusion and exclusion criteria, and variances in the response criteria used to measure outcomes made comparison of the results difficult. Although the direction of effect for progression-free survival (PFS) and overall survival (OS) was in favor of the experimental drug in all trials, the difference in PFS was statistically significant in 5 and OS in 2. None showed statistical significance for both. A noticeable lack of RCTs evaluating treatments for patients with relapsed/refractory MCL made meaningful comparisons of effectiveness across trials rather difficult. This trend continues, because all, bar 1, of the 85 ongoing trials in this area are single-arm studies. RCTs are required to enable better evaluation of the optimal treatment regimen for this group of patients.
开展了一项系统评价，以评估针对不适合强化治疗的复发/难治性套细胞淋巴瘤（MCL）患者的治疗的临床有效性和安全性。在评价之前确定了纳入试验的标准。检索了Medline、Embase和Cochrane图书馆数据库，以识别1994年1月1日至2016年5月29日期间报告的II期或III期随机对照试验（RCT）。还检索了相关会议摘要、纳入文章的参考文献列表、已发表的指南以及正在进行的临床试验数据库。如果研究评估了接受过≥1线先前治疗的复发/难治性MCL成年患者的任何单一药物或联合治疗，则纳入研究。共识别出7项RCT。只有1种治疗方法出现在1项以上试验中；因此，无法对每项试验的结果进行定量汇总以进行荟萃分析。缺乏共同的对照、基线特征以及纳入和排除标准的差异，以及用于衡量结果的反应标准的差异，使得结果比较困难。尽管在所有试验中，无进展生存期（PFS）和总生存期（OS）的效应方向均有利于试验药物，但5项试验中PFS的差异具有统计学意义，2项试验中OS的差异具有统计学意义。没有一项试验在PFS和OS上均显示出统计学意义。明显缺乏评估复发/难治性MCL患者治疗的RCT，使得跨试验进行有意义的有效性比较相当困难。这种趋势仍在继续，因为该领域正在进行的85项试验中，除1项外，其余均为单臂研究。需要进行RCT，以便更好地评估这组患者的最佳治疗方案。
