骨髓活检不影响接受临床试验治疗的滤泡性淋巴瘤患者的疗效评估。

Bone marrow biopsies do not impact response assessment for follicular lymphoma patients treated on clinical trials.

作者信息

Rutherford Sarah C, Li Valery, Ghione Paola, Chen Zhengming, Martin Peter, Leonard John P

机构信息

Department of Medicine, Division of Hematology and Oncology, Meyer Cancer Center, Weill Cornell Medical College and New York-Presbyterian Hospital, New York, NY, USA.

Department of Healthcare Policy and Research, Division of Biostatistics and Epidemiology, Weill Cornell Medical College, New York, NY, USA.

出版信息

Br J Haematol. 2017 Oct;179(2):242-245. doi: 10.1111/bjh.14839. Epub 2017 Jul 5.

DOI:10.1111/bjh.14839

PMID:28677889

Abstract

Clinical trials enrolling follicular lymphoma (FL) patients typically require bone marrow biopsies (BMBs) at baseline and at a subsequent point if complete response is achieved. These procedures are painful, take time and add cost. We hypothesized that BMBs do not provide information significant for response assessment in most follicular lymphoma patients on clinical trials. We identified 99 patients treated on clinical trials for follicular lymphoma between 2000 and 2016. BMBs resulted in a possible response assessment change in 1·0% of patients (95% confidence interval: 0·0-5·5%). We conclude that mandatory BMBs at baseline and for response assessment are unnecessary in clinical trials for follicular lymphoma.

摘要

招募滤泡性淋巴瘤（FL）患者的临床试验通常要求在基线时以及后续达到完全缓解时进行骨髓活检（BMB）。这些操作会带来疼痛，耗时且增加成本。我们假设在大多数接受临床试验的滤泡性淋巴瘤患者中，骨髓活检并不能为反应评估提供重要信息。我们确定了2000年至2016年间在滤泡性淋巴瘤临床试验中接受治疗的99例患者。骨髓活检导致1.0%的患者反应评估可能发生改变（95%置信区间：0.0 - 5.5%）。我们得出结论，在滤泡性淋巴瘤的临床试验中，基线时和用于反应评估的强制性骨髓活检是不必要的。