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在连续CT扫描上评估溶骨性病变大小是新诊断多发性骨髓瘤骨再矿化的可靠研究终点。

Assessing Osteolytic Lesion Size on Sequential CT Scans Is a Reliable Study Endpoint for Bone Remineralization in Newly Diagnosed Multiple Myeloma.

作者信息

Grunz Jan-Peter, Kunz Andreas Steven, Baumann Freerk T, Hasenclever Dirk, Sieren Malte Maria, Heldmann Stefan, Bley Thorsten Alexander, Einsele Hermann, Knop Stefan, Jundt Franziska

机构信息

Department of Diagnostic and Interventional Radiology, University Hospital Würzburg, Oberdürrbacher Straße 6, 97080 Würzburg, Germany.

Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Dusseldorf, University Hospital of Cologne, Kerpener Straße 62, 50937 Cologne, Germany.

出版信息

Cancers (Basel). 2023 Aug 7;15(15):4008. doi: 10.3390/cancers15154008.

DOI:10.3390/cancers15154008
PMID:37568823
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10417114/
Abstract

Multiple myeloma (MM) frequently induces persisting osteolytic manifestations despite hematologic treatment response. This study aimed to establish a biometrically valid study endpoint for bone remineralization through quantitative and qualitative analyses in sequential CT scans. Twenty patients (seven women, 58 ± 8 years) with newly diagnosed MM received standardized induction therapy comprising the anti-SLAMF7 antibody elotuzumab, carfilzomib, lenalidomide, and dexamethasone (E-KRd). All patients underwent whole-body low-dose CT scans before and after six cycles of E-KRd. Two radiologists independently recorded osteolytic lesion sizes, as well as the presence of cortical destruction, pathologic fractures, rim and trabecular sclerosis. Bland-Altman analyses and Krippendorff's α were employed to assess inter-reader reliability, which was high for lesion size measurement (standard error 1.2 mm) and all qualitative criteria assessed (α ≥ 0.74). After six cycles of E-KRd induction, osteolytic lesion size decreased by 22% ( < 0.001). While lesion size response did not correlate with the initial lesion size at baseline imaging (Pearson's r = 0.144), logistic regression analysis revealed that the majority of responding osteolyses exhibited trabecular sclerosis ( < 0.001). The sum of osteolytic lesion sizes on sequential CT scans defines a reliable study endpoint to characterize bone remineralization. Patient level response is strongly associated with the presence of trabecular sclerosis.

摘要

多发性骨髓瘤(MM)尽管在血液学治疗上有反应,但仍常引发持续的溶骨性表现。本研究旨在通过对连续CT扫描进行定量和定性分析,建立一个关于骨再矿化的生物统计学有效研究终点。20例新诊断的MM患者(7名女性,58±8岁)接受了标准化诱导治疗,包括抗信号淋巴细胞激活分子家族成员7(SLAMF7)抗体埃罗妥珠单抗、卡非佐米、来那度胺和地塞米松(E-KRd)。所有患者在接受六个周期的E-KRd治疗前后均进行了全身低剂量CT扫描。两名放射科医生独立记录溶骨性病变大小,以及皮质破坏、病理性骨折、边缘和小梁硬化的情况。采用Bland-Altman分析和Krippendorff'sα评估阅片者间的可靠性,病变大小测量(标准误差1.2mm)和所有评估的定性标准(α≥0.74)的可靠性都很高。在六个周期的E-KRd诱导治疗后,溶骨性病变大小减少了22%(<0.001)。虽然病变大小反应与基线影像学检查时的初始病变大小无关(Pearson相关系数r = 0.144),但逻辑回归分析显示,大多数有反应的溶骨性病变表现为小梁硬化(<0.001)。连续CT扫描上溶骨性病变大小的总和定义了一个可靠的研究终点,用于表征骨再矿化。患者水平的反应与小梁硬化的存在密切相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0bc3/10417114/a943025ccf68/cancers-15-04008-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0bc3/10417114/25ddfc14ee14/cancers-15-04008-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0bc3/10417114/e5e675e2fdd2/cancers-15-04008-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0bc3/10417114/ac7090be1091/cancers-15-04008-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0bc3/10417114/93b7dfabae78/cancers-15-04008-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0bc3/10417114/8f60981c9fea/cancers-15-04008-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0bc3/10417114/a943025ccf68/cancers-15-04008-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0bc3/10417114/25ddfc14ee14/cancers-15-04008-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0bc3/10417114/e5e675e2fdd2/cancers-15-04008-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0bc3/10417114/ac7090be1091/cancers-15-04008-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0bc3/10417114/93b7dfabae78/cancers-15-04008-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0bc3/10417114/8f60981c9fea/cancers-15-04008-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0bc3/10417114/a943025ccf68/cancers-15-04008-g006.jpg

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