Department of Medicine, Weill Cornell Medicine, New York, NY.
Helios Klinikum Erfurt, Erfurt, Germany.
Blood Adv. 2020 Apr 28;4(8):1589-1593. doi: 10.1182/bloodadvances.2019001261.
The utility of posttreatment bone marrow biopsy (BMB) histology to confirm complete response (CR) in lymphoma clinical trials is in question. We retrospectively evaluated the impact of BMB on response assessment in immunochemotherapy-treated patients with previously untreated follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) in the phase 3 Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM; NCT01332968) and A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA; NCT01287741) trials, respectively. Baseline BMB was performed in all patients, with repeat BMBs in patients with a CR by computed tomography (CT) at end of induction (EOI) and a positive BMB at baseline, to confirm response. Positron emission tomography imaging was also used in some patients to assess EOI response (Lugano 2014 criteria). Among patients with an EOI CR by CT in GALLIUM and GOYA, 2.8% and 4.1%, respectively, had a BMB-altered response. These results suggest that postinduction BMB histology has minimal impact on radiographically (CT)-defined responses in both FL and DLBCL patients. In GALLIUM and GOYA, respectively, 4.7% of FL patients and 7.1% of DLBCL patients had a repeat BMB result that altered response assessment when applying Lugano 2014 criteria, indicating that bone marrow evaluation appears to add little value to response assessment in FL; however, its evaluation may still have merit in DLBCL.
在淋巴瘤临床试验中，治疗后骨髓活检（BMB）组织学用于确认完全缓解（CR）的效用存在疑问。我们回顾性评估了 BMB 对未经治疗的滤泡性淋巴瘤（FL）和弥漫性大 B 细胞淋巴瘤（DLBCL）患者免疫化疗治疗后反应评估的影响，这些患者分别参加了 III 期奥滨尤妥珠单抗（RO5072759）联合化疗对比利妥昔单抗联合化疗序贯奥滨尤妥珠单抗或利妥昔单抗维持治疗未经治疗的晚期惰性非霍奇金淋巴瘤（GALLIUM；NCT01332968）和奥滨尤妥珠单抗联合 CHOP 化疗对比利妥昔单抗联合 CHOP 化疗治疗 CD20 阳性弥漫性大 B 细胞淋巴瘤（GOYA；NCT01287741）研究。所有患者均进行了基线 BMB，在诱导结束（EOI）时 CT 显示 CR 且基线时 BMB 阳性的患者中重复进行 BMB，以确认缓解。一些患者还使用正电子发射断层扫描（PET）成像来评估 EOI 反应（卢加诺 2014 标准）。在 GALLIUM 和 GOYA 中，EOI 时 CT 缓解的患者中，分别有 2.8%和 4.1%的患者 BMB 缓解情况发生改变。这些结果表明，在 FL 和 DLBCL 患者中，诱导后 BMB 组织学对影像学（CT）定义的反应影响较小。在 GALLIUM 和 GOYA 中，分别有 4.7%的 FL 患者和 7.1%的 DLBCL 患者重复 BMB 结果改变了反应评估，当应用卢加诺 2014 标准时，这表明骨髓评估似乎对 FL 的反应评估没有太大价值；然而，它的评估在 DLBCL 中可能仍然有价值。
