Police Rachel L, Trask Peter C, Wang Jianmin, Olivares Robert, Khan Shahnaz, Abbe Adeline, Colosia Ann, Njue Annete, Sherril Beth, Ruiz-Soto Rodrigo, Kaye James A, Hamadani Mehdi
Medical College of Wisconsin, Milawukee, USA.
Medical College of Wisconsin, Milawukee, USA
J Oncol Pharm Pract. 2016 Oct;22(5):666-78. doi: 10.1177/1078155215603230. Epub 2015 Aug 28.
This systematic literature review evaluated the clinical efficacy and safety of interventions used in relapsed/refractory follicular lymphoma. Primary efficacy outcomes were objective response rate, progression-free survival and overall survival. Safety endpoints were grade 3/4 toxicities, serious adverse events and withdrawals or deaths due to toxicity. Studies were selected if they were randomized controlled trials reporting on the efficacy or safety of treatments for relapsed or refractory follicular lymphoma, and if outcomes were reported separately from trials that included other lymphoid neoplasms. We used the Bucher method for conducting adjusted indirect comparisons within a meta-analysis. We identified 10 randomized controlled trials of treatments for relapsed/refractory follicular lymphoma. The most prominent drug investigated (alone or in combination) was rituximab. Most trials did not report median overall survival. Two trials reported median event-free survival (range, 1.2-23.2 months). Six of ten trials reported objective response rate (range, 9-93%). Meta-analysis showed only one statistically significant result: rituximab + bortezomib yielded a significantly higher objective response rate than rituximab monotherapy (relative risk, 1.28; 95% confidence interval, 1.11-1.47). Otherwise, there were no discernable differences in overall survival or progression-free survival, partly due to insufficient reporting of results in the clinical trials. The relatively small number of randomized controlled trials, few overlapping treatment arms, and variability in the randomized controlled trial features and in the endpoints studied complicate the formal comparison of therapies for relapsed/refractory follicular lymphoma. Additional well-designed randomized controlled trials are needed to fully understand the relative outcomes of older and more recently developed therapies.
本系统文献综述评估了用于复发/难治性滤泡性淋巴瘤的干预措施的临床疗效和安全性。主要疗效指标为客观缓解率、无进展生存期和总生存期。安全终点为3/4级毒性、严重不良事件以及因毒性导致的撤药或死亡。若研究为报告复发或难治性滤泡性淋巴瘤治疗疗效或安全性的随机对照试验，且结果与纳入其他淋巴样肿瘤的试验分开报告，则纳入该研究。我们采用布彻方法在荟萃分析中进行调整后的间接比较。我们确定了10项复发/难治性滤泡性淋巴瘤治疗的随机对照试验。研究最多的药物（单独或联合使用）是利妥昔单抗。大多数试验未报告总生存期的中位数。两项试验报告了无事件生存期的中位数（范围为1.2 - 23.2个月）。十项试验中的六项报告了客观缓解率（范围为9% - 93%）。荟萃分析仅显示一项具有统计学意义的结果：利妥昔单抗 + 硼替佐米的客观缓解率显著高于利妥昔单抗单药治疗（相对风险，1.28；95%置信区间，1.11 - 1.47）。否则，在总生存期或无进展生存期方面没有明显差异，部分原因是临床试验中结果报告不足。随机对照试验数量相对较少、重叠的治疗组较少，以及随机对照试验特征和研究终点的变异性，使得复发/难治性滤泡性淋巴瘤治疗方法的正式比较变得复杂。需要更多设计良好的随机对照试验来全面了解较老和最新开发疗法的相对疗效。
