Department of Internal Medicine, Matsuyama Red-Cross Hospital, Ehime, Japan.
Department of Hematology, Kobe City Medical Center General Hospital, Kobe, Japan.
Ann Hematol. 2019 Dec;98(12):2805-2814. doi: 10.1007/s00277-019-03794-9. Epub 2019 Oct 16.
In the ALCYONE trial, daratumumab plus bortezomib, melphalan, and prednisone (D-VMP) reduced the risk of disease progression or death by 50% versus bortezomib, melphalan, and prednisone (VMP) in patients with transplant-ineligible newly diagnosed multiple myeloma. Here, we report a subanalysis of East Asian patients from ALCYONE. After a median follow-up of 17.1 and 15.9 months for Japanese (n = 50) and Korean (n = 41) patients, respectively, median progression-free survival for D-VMP versus VMP was not reached (NR) versus 20.7 months in Japanese patients and NR versus 14.0 months in Korean patients. The overall response rate for D-VMP versus VMP was 96% versus 92% in Japanese patients and 91% versus 61% in Korean patients. Using next-generation sequencing, minimal residual disease negativity at 10 sensitivity for D-VMP versus VMP was 33% versus 8% among Japanese patients and 17% versus 0% among Korean patients. Rates of any grade and grade 3/4 pneumonia were consistent with the rates observed for the global safety population. Similar efficacy and safety findings were observed in the combined Japanese and Korean subgroup and ≥ 75 years of age subgroup. In conclusion, D-VMP was safe and efficacious in East Asian patients, consistent with the global ALCYONE population.
在 ALCYONE 试验中,与硼替佐米、马法兰和泼尼松(VMP)相比,达雷妥尤单抗联合硼替佐米、马法兰和泼尼松(D-VMP)降低了不适合移植的新诊断多发性骨髓瘤患者疾病进展或死亡的风险 50%。在此,我们报告了来自 ALCYONE 的东亚患者的亚组分析。在日本患者(n=50)和韩国患者(n=41)的中位随访分别为 17.1 和 15.9 个月后,D-VMP 与 VMP 相比,日本患者的中位无进展生存期未达到(NR)与 20.7 个月,韩国患者的中位无进展生存期 NR 与 14.0 个月。D-VMP 与 VMP 的总体缓解率在日本患者中分别为 96%和 92%,在韩国患者中分别为 91%和 61%。使用下一代测序,D-VMP 与 VMP 的微小残留病阴性率在日本患者中为 10 灵敏度 33%与 8%,在韩国患者中为 17%与 0%。任何级别和 3/4 级肺炎的发生率与全球安全性人群观察到的发生率一致。在日本和韩国联合亚组和≥75 岁年龄亚组中观察到了相似的疗效和安全性结果。总之,D-VMP 在东亚患者中是安全有效的,与全球 ALCYONE 人群一致。
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