Shimazu Yutaka, Kanda Junya, Kaneko Hitomi, Imada Kazunori, Yamamura Ryosuke, Kosugi Satoru, Shimura Yuji, Ito Tomoki, Fuchida Shin-Ichi, Uchiyama Hitoji, Fukushima Kentaro, Yoshihara Satoshi, Hanamoto Hitoshi, Tanaka Hirokazu, Uoshima Nobuhiko, Ohta Kensuke, Yagi Hideo, Shibayama Hirohiko, Onda Yoshiyuki, Tanaka Yasuhiro, Adachi Yoko, Matsuda Mitsuhiro, Iida Masato, Miyoshi Takashi, Matsui Toshimitsu, Takahashi Ryoichi, Takakuwa Teruhito, Hino Masayuki, Hosen Naoki, Nomura Shosaku, Shimazaki Chihiro, Matsumura Itaru, Takaori-Kondo Akifumi, Kuroda Junya
Department of Hematology and Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Department of Hematology and Oncology, Graduate School of Medicine, Kyoto University, 54 Kawaramachi, Shogoin, Sakyoku, Kyoto 606-8507, Japan.
Ther Adv Hematol. 2022 Dec 13;13:20406207221142487. doi: 10.1177/20406207221142487. eCollection 2022.
Daratumumab is one of the most widely used treatments for relapsed/refractory multiple myeloma (MM) patients. However, not all patients achieve a lasting therapeutic response with daratumumab.
We hypothesized that a durable response to daratumumab could be predicted by the balance between the MM tumor burden and host immune status.
We conducted a retrospective study using the real-world data in the Kansai Myeloma Forum (KMF) database.
We retrospectively analyzed 324 relapsed/refractory MM patients who were treated with daratumumab in the KMF database.
In this study, 196 patients were treated with daratumumab, lenalidomide, and dexamethasone (DLd) regimen and 128 patients were treated with daratumumab, bortezomib, and dexamethasone (DBd) regimen. The median age at treatment, number of prior treatment regimens and time-to-next-treatment (TTNT) were 68, 4 and 8.02 months, respectively. A multivariate analysis showed that the TTNT under the DLd regimen was longer with either higher monocyte counts (analysis 1), higher white blood cell (WBC) counts (analysis 2), lower β microglobulin (B2MG < 5.5 mg/L) or fewer prior regimens (<4). No parameters were correlated with TTNT under the DBd regimen.
We propose a simple scoring model to predict a durable effect of the DLd regimen by classifying patients into three categories based on either monocyte counts (0 points for ⩾200/μl; 1 point for <200/μl) or WBC counts (0 points for ⩾3500/μl; 1 point for <3500/μl) plus B2MG (0 points for <5.5 mg/L; 1 point for ⩾5.5 mg/L). Patients with a score of 0 showed significantly longer TTNT and significantly better survival compared to those with a score of 1 or 2 (both < 0.001). To confirm this concept, our results will need to be validated in other cohorts.
达雷妥尤单抗是复发/难治性多发性骨髓瘤（MM）患者中使用最广泛的治疗方法之一。然而，并非所有患者使用达雷妥尤单抗都能获得持久的治疗反应。
我们假设MM肿瘤负荷与宿主免疫状态之间的平衡可以预测对达雷妥尤单抗的持久反应。
我们使用关西骨髓瘤论坛（KMF）数据库中的真实世界数据进行了一项回顾性研究。
我们回顾性分析了KMF数据库中324例接受达雷妥尤单抗治疗的复发/难治性MM患者。
在本研究中，196例患者接受了达雷妥尤单抗、来那度胺和地塞米松（DLd）方案治疗，128例患者接受了达雷妥尤单抗、硼替佐米和地塞米松（DBd）方案治疗。治疗时的中位年龄、既往治疗方案数量和下次治疗时间（TTNT）分别为68岁、4种和8.02个月。多变量分析显示，DLd方案下，单核细胞计数较高（分析1）、白细胞（WBC）计数较高（分析2）、β微球蛋白较低（B2MG < 5.5 mg/L）或既往治疗方案较少（<4种）时，TTNT较长。DBd方案下，没有参数与TTNT相关。
我们提出了一个简单的评分模型，通过根据单核细胞计数（≥200/μl为0分；<200/μl为1分）或WBC计数（≥3500/μl为0分；<3500/μl为1分）加上B2MG（<5.5 mg/L为0分；≥5.5 mg/L为1分）将患者分为三类，来预测DLd方案的持久疗效。与得分为1或2的患者相比（均<0.001），得分为0的患者TTNT明显更长，生存情况明显更好。为了证实这一概念，我们的结果需要在其他队列中进行验证。
