Iida Shinsuke, Yasutomi Yusuke, Samyshkin Yevgeniy, Chen Yi-Chen, Chen Chi-Chang, Lee Wen Shi, Kim Seok-Won, McGuiness Catherine, Zhou Zifan, McNamara Simon
Department of Hematology & Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
GSK Tokyo, Tokyo, Japan.
PLoS One. 2025 Jan 23;20(1):e0315932. doi: 10.1371/journal.pone.0315932. eCollection 2025.
Approval of proteasome inhibitors, immunomodulatory drugs, and anti-CD38 monoclonal antibodies (mAbs), such as daratumumab, has reshaped treatment patterns in patients with multiple myeloma (MM) in Japan. This retrospective study evaluated patient characteristics, treatment patterns, and trends in MM patients using Medical Data Vision, the largest electronic health records database in Japan with anonymous inpatient and outpatient health information.
Patients aged ≥18 years, with ≥2 records of an MM diagnostic and disease code and ≥1 record of MM treatment between 01 April 2008 and 30 June 2023 were included. Patients starting first-line (1L) treatment on or after 01 January 2020 were categorized into the 1+L cohort; those starting second-line (2L) treatment on or after 01 January 2018 were allocated to the 2+L cohort.
Within the study period, 21,066 patients had an MM diagnosis, including 6,337 and 5,964 patients in the 1+L and 2+L cohorts, respectively. Median age was 74 years in both cohorts and gender distribution was similar (52.4% and 51.3% males, respectively). In the 1+L cohort, most patients (5,754/6,337; 90.8%) did not receive transplant, among whom 51.0% received 1L lenalidomide-based therapy, primarily daratumumab/lenalidomide/dexamethasone (DRd; 15.0%) or lenalidomide/dexamethasone (Rd;14.0%). In non-transplant patients, 1L DRd use increased from 6.0% in January-June 2020 to 28.0% in January-June 2023. In the 2+L cohort, 2L lenalidomide-based therapy use decreased from 65.0% in January-June 2018 to 37.0% in January-June 2023; daratumumab-based therapy increased from 14.0% to 39.0%. Retreatment with lenalidomide-, daratumumab-, and isatuximab-based therapy occurred in 44.1%, 35.2%, and 5.6% of patients, respectively.
The high use of lenalidomide and DRd in 1L, and high rates of retreatment with lenalidomide and anti-CD38 mAbs in 2L+ indicate a substantial need for new treatment modalities that can be used in 2L+ patients who previously received lenalidomide with/without an anti-CD38 mAb therapy.
蛋白酶体抑制剂、免疫调节药物以及抗CD38单克隆抗体(mAb)如达雷妥尤单抗的获批,重塑了日本多发性骨髓瘤(MM)患者的治疗模式。本回顾性研究利用日本最大的包含匿名住院和门诊健康信息的电子健康记录数据库——医学数据视野,评估了MM患者的特征、治疗模式及趋势。
纳入年龄≥18岁,在2008年4月1日至2023年6月30日期间有≥2条MM诊断和疾病编码记录以及≥1条MM治疗记录的患者。2020年1月1日及以后开始一线(1L)治疗的患者被归入1+L队列;2018年1月1日及以后开始二线(2L)治疗的患者被分配到2+L队列。
在研究期间,21,066例患者被诊断为MM,其中1+L队列和2+L队列分别有6,337例和5,964例患者。两个队列的中位年龄均为74岁,性别分布相似(男性分别为52.4%和51.3%)。在1+L队列中,大多数患者(5,754/6,337;90.8%)未接受移植,其中51.0%接受了基于来那度胺的1L治疗,主要是达雷妥尤单抗/来那度胺/地塞米松(DRd;15.0%)或来那度胺/地塞米松(Rd;14.0%)。在未接受移植的患者中,1L DRd的使用从2020年1月至6月的6.0%增加到2023年1月至6月的28.0%。在2+L队列中,基于来那度胺的2L治疗使用率从2018年1月至6月的65.0%降至2023年1月至6月的37.0%;基于达雷妥尤单抗的治疗从14.0%增加到39.0%。分别有44.1%、35.2%和5.6%的患者接受了基于来那度胺、达雷妥尤单抗和isatuximab的再治疗。
1L治疗中,来那度胺和DRd的高使用率,以及2L+患者中来那度胺和抗CD38 mAb的高再治疗率,表明对于先前接受过来那度胺联合/不联合抗CD38 mAb治疗的2L+患者,迫切需要新的治疗方式。