Connect MM Registry: The Importance of Establishing Baseline Disease Characteristics
Connect MM Registry: The Importance of Establishing Baseline Disease Characteristics
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DOI：
10.1016/j.clml.2014.12.002
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发表时间：
2015-06-01
影响因子：
2.7
通讯作者：
Durie, Brian G. M.
中科院分区：
文献类型：
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作者：
Rifkin, Robert M.;Abonour, Rafat;Durie, Brian G. M.
在本分析中，我们重点关注Connect MM登记研究中确定多发性骨髓瘤患者基线特征的重要性。在报告的基线数据的百分比方面观察到了变化。使用建议的国家综合癌症网络诊断检查和国际骨髓瘤工作组标准创建基线患者疾病特征的可靠记录，为监测疾病进展和对治疗的反应提供了基础。背景：Connect MM是美国首个也是最大的观察性、非干预性、前瞻性登记研究，用于新诊断为多发性骨髓瘤（NDMM）的患者。它收集临床实践中患者的纵向数据，包括临床试验中的患者。患者和方法：在入组的1513例患者中，1493例符合方案要求。结果：中位年龄为67岁，81.9%（1223/1493）为白人，57.2%（854/1493）为男性。在这些患者中，26.5%（232/877）为国际分期系统I期，34.9%（306/877）为II期，38.7%（339/877）为III期。96.6%（1017/1053）的美国东部肿瘤协作组体能状态为0/1/2。91.6%（1282/1399）的患者存在克隆性浆细胞> 10%，98.8%（1343/1359）存在M成分。7.3%（108/1481）的患者存在高钙血症，18.3%（271/1484）的患者存在血清肌酐> 2 mg/dL，45.1%（673/1493）的患者存在贫血，76.7%（1143/1490）的患者存在骨受累。在15个国家综合癌症网络（NCCN）推荐的诊断测试中，平均进行了12次。分别有38.4%（574/1493）、62.1%（927/1493）和66%（985/1493）的患者报告了乳酸脱氢酶评估、血清游离轻链比率和免疫固定。72.3%（1080/1493）、74.1%（1107/1493）和78.0%（1164/1493）的患者分别报告了定量免疫球蛋白、β 2微球蛋白和蛋白电泳（血清或尿液）。92.2%（1376/1493）的患者报告了骨髓活检，但仅63.2%（944/1493）和59.8%（893/1493）的患者分别报告了常规细胞遗传学和荧光原位杂交分析。在16.9%（253/1493）中发现了高危细胞遗传学特征（根据国际骨髓瘤工作组[IMWG]标准）。结论：该分析提供了深入了解NDMM患者在一系列临床实践中的人口统计学和疾病特征。使用建议的NCCN诊断检查和IMWG标准创建基线患者疾病特征的可靠记录，为监测疾病进展和治疗反应提供了基础。
In this analysis, we focused on the importance of establishing baseline characteristics in multiple myeloma patients in the Connect MM registry. Variations were observed in the percentage of reported baseline data. Creating solid records of baseline patient disease characteristics using suggested National Comprehensive Cancer Network diagnostic work-up and International Myeloma Working Group criteria provides a foundation for monitoring disease progression and response to treatment.Background: Connect MM is the first and largest observational, noninterventional, prospective registry of patients newly diagnosed with multiple myeloma (NDMM) in the United States. It collects longitudinal data on patients within clinical practice including patients in clinical trials. Patients and Methods: Of the 1513 patients enrolled, 1493 were protocol-eligible. Results: Median age was 67 years, 81.9% (1223/1493) were Caucasian, and 57.2% (854/1493) were male. Of these patients, 26.5% (232/877) were International Staging System stage I, 34.9% (306/877) stage II, and 38.7% (339/877) stage III. Eastern Cooperative Oncology Group performance status of 0/1/2 were reported in 96.6% (1017/1053). Clonal plasma cells > 10% were found in 91.6% (1282/1399) of patients and M-component in 98.8% (1343/1359). Hypercalcemia was present in 7.3% (108/1481) of patients, serum creatinine > 2 mg/dL in 18.3% (271/1484), anemia in 45.1% (673/1493), and bone involvement in 76.7% (1143/1490). Of the 15 National Comprehensive Cancer Network (NCCN) recommended diagnostic tests, a median of 12 were performed. Lactate dehydrogenase assessment, serum free light chain ratio, and immunofixation were,reported in 38.4% (574/1493), 62.1% (927/1493), and 66% (985/1493) of patients, respectively. Quantitative immunoglobulin, beta-2 microglobulin, and protein electrophoresis (serum or urine) were reported in 72.3% (1080/1493), 74.1% (1107/1493), and 78.0% (1164/1493) of patients, respectively. Bone marrow biopsy was reported in 92.2% (1376/1493), but conventional cytogenetic and fluorescence in situ hybridization analysis were reported in only 63.2% (944/1493) and 59.8% (893/1493) of patients, respectively. A high-risk cytogenetic profile (according to International Myeloma Working Group [IMWG] criteria) was found in 16.9% (253/1493). Conclusion: This analysis provides insight into the demographic and disease characteristics of NDMM patients in a range of clinical practices. Creating solid records of baseline patient disease characteristics using suggested NCCN diagnostic workup and IMWG criteria provides a foundation for monitoring disease progression and response to treatment.