Department of Hematology, Third Xiangya Hospital, Central South University, Changsha 410013.
Department of Hematology, Xiangxi Autonomous Prefecture People's Hospital, Jishou Hunan 416007.
Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2022 Apr 28;47(4):497-504. doi: 10.11817/j.issn.1672-7347.2022.210555.
There is less clinical data on multiple myeloma (MM) in China, and the aim of this study was to collect and analyze the clinical data of newly diagnosed multiple myeloma (NDMM) patients in Hunan Province during 1 year, to understand the real clinical features and treatment outcome for Hunan Province patients with MM, and to strengthen the understanding of the standardized diagnosis process and treatment plan of MM.
The clinical data of 529 patients with NDMM in 12 large-scale general hospitals in Hunan Province from January 1 to December 31, 2019 were collected and analyzed, including baseline data, treatment regimens, duration of treatment, and adverse reactions. The clinical characteristics, treatment, and safety of patients were analyzed by SPSS 21.0.
Among the 529 NDMM patients, the age was 33-90 (median 64) years and the male-female ratio was 1.38꞉1. The clinical features ranged from high to low were as follows: Bone pain (77.7%), anemia (66.8%), renal insufficiency (40.6%), hypercalcemia (15.1%). Typing: IgG 46.5%, IgA 24.6%, IgD 2.6%, IgM 0.8%, light chain 15.7%, double clone 3.0%, no secretion 0.6%, absence 6.2%. Staging: Durie-Salmon stage I, II, and III were 4.5%, 10.6%, 77.3%, respectively, and 40 cases (7.6%) missed this data. International Staging System (ISS) stage I, II, and III were 10.4%, 24.4%, and 47.6%, respectively, and 93 cases (17.6%) were missing. Revised International Staging System (R-ISS) stage I, II, and III were 5.5%, 27.0%, 23.1%, respectively, and 235 cases (44.4%) missed this data. Among the 98 NDMM patients in the Third Xiangya Hospital, Central South University, Durie-Salmon (DS) stage missing 2.0%, ISS stage missing 12.3%, and R-ISS stage missing 12.3%.Treatment: Among the 529 patients,475 received treatment, the rate of treatment was 89.8%; 67.4% of the patients were able to complete four courses of chemotherapy at induction phase, 90.3% of the patients received proteasome inhibitor based combination chemotherapy regimen more than once, 67.2% received immunomodulator based regimen more than once, and 59.8% of the patients received proteasome inhibitor and immunomodulator based combination chemotherapy regimen more than once. Curative: Overall response rate (ORR) and high quality response rate (HQR) of the 4-course group were better than those of the 2-course group (ORR: 85% vs 65%, =0.006; HQR: 68.3% vs 24.0%, <0.001). The HQR of the standard chemotherapy group was better than that of the non-standard chemotherapy group (65.1% vs 48.2%, =0.035). Adverse reactions during treatment included hematologic toxicity (17.5%), peripheral neuropathy (24.8%), gastrointestinal adverse events (23.8%), pulmonary infection (25.9%), herpes zoster (4.6%), and venous thrombotic events (1.7%).
In 2019, the missed diagnosis rate of MM patients was high, the medium age of diagnosis was older, and the accuracy of patient diagnosis was not high. There is a great difference among medical centers, especially in the stage and risk stratified, nearly half of NDMM patients are not diagnosed with R-ISS stage; the lack of cytogenetic data needs to be supplemented by follow-up studies. A high proportion of patients with NDMM present with bone pain and anemia.Patients received treatment have higher use of chemotherapy regimens containing proteasome inhibitors and/or immunomodulators, but there is a significant gap among different medical centers, and standardized treatment needs to be strengthened. The safety during chemotherapy is controllable.
中国多发性骨髓瘤(MM)的临床数据较少,本研究旨在收集和分析湖南省 1 年内新诊断多发性骨髓瘤(NDMM)患者的临床数据,了解湖南省 MM 患者的真实临床特征和治疗结局,加强对 MM 规范化诊断流程和治疗方案的认识。
收集湖南省 12 家大型综合医院 2019 年 1 月 1 日至 12 月 31 日 529 例 NDMM 患者的临床资料,包括基线数据、治疗方案、治疗持续时间和不良反应。采用 SPSS 21.0 对患者的临床特征、治疗和安全性进行分析。
529 例 NDMM 患者中,年龄为 33-90(中位 64)岁,男女比例为 1.38꞉1。临床特征由高到低依次为:骨痛(77.7%)、贫血(66.8%)、肾功能不全(40.6%)、高钙血症(15.1%)。分型:IgG 46.5%、IgA 24.6%、IgD 2.6%、IgM 0.8%、轻链 15.7%、双克隆 3.0%、无分泌 0.6%、缺失 6.2%。分期:Durie-Salmon 分期Ⅰ、Ⅱ、Ⅲ期分别为 4.5%、10.6%、77.3%,40 例(7.6%)患者缺失该数据;国际分期系统(ISS)分期Ⅰ、Ⅱ、Ⅲ期分别为 10.4%、24.4%、47.6%,93 例(17.6%)患者缺失该数据;修订的国际分期系统(R-ISS)分期Ⅰ、Ⅱ、Ⅲ期分别为 5.5%、27.0%、23.1%,235 例(44.4%)患者缺失该数据。在中南大学湘雅三医院的 98 例 NDMM 患者中,Durie-Salmon(DS)分期缺失 2.0%,ISS 分期缺失 12.3%,R-ISS 分期缺失 12.3%。治疗:529 例患者中,475 例接受治疗,治疗率为 89.8%;诱导期 67.4%的患者能完成 4 个疗程的化疗,90.3%的患者接受蛋白酶体抑制剂为基础的联合化疗方案治疗超过 1 次,67.2%的患者接受免疫调节剂为基础的方案治疗超过 1 次,59.8%的患者接受蛋白酶体抑制剂和免疫调节剂为基础的联合化疗方案治疗超过 1 次。疗效:4 疗程组的总缓解率(ORR)和高质量缓解率(HQR)均优于 2 疗程组(ORR:85% vs 65%,=0.006;HQR:68.3% vs 24.0%,<0.001);标准化疗组的 HQR 优于非标准化疗组(65.1% vs 48.2%,=0.035)。治疗期间的不良反应包括血液学毒性(17.5%)、周围神经病变(24.8%)、胃肠道不良事件(23.8%)、肺部感染(25.9%)、带状疱疹(4.6%)和静脉血栓栓塞事件(1.7%)。
2019 年,MM 患者的漏诊率较高,中位诊断年龄较大,患者诊断准确率不高。各医疗中心之间存在较大差异,尤其是在分期和风险分层方面,近一半的 NDMM 患者未进行 R-ISS 分期诊断;细胞遗传学数据缺失,需要通过后续研究补充。大多数 NDMM 患者表现为骨痛和贫血。接受治疗的患者使用含有蛋白酶体抑制剂和/或免疫调节剂的化疗方案比例较高,但不同医疗中心之间存在显著差异,需要加强规范化治疗。化疗期间的安全性是可控的。