Nakazato Tomonori, Hagihara Masao, Sahara Naohi, Tamai Yotaro, Ishii Ryuji, Tamaki Shigehisa, Wake Atsushi, Tajika Kenji, Sakai Rika, Kobayashi Takeshi, Hua Jian, Inoue Morihiro, Aisa Yoshinobu, Fujisawa Shin, Miyazaki Koji, Irie Seiji, Tanaka Eri, Higashihara Masaaki
Department of Hematology, Yokohama Municipal Citizen's Hospital, 1-1 Mitsuzawanishicho, Kanagawa-ku, Yokohama, 221-0855, Japan.
Department of Hematology, Eiju General Hospital, Tokyo, Japan.
Ann Hematol. 2021 Nov;100(11):2745-2754. doi: 10.1007/s00277-021-04592-y. Epub 2021 Jul 31.
The Vulnerable Elders Survey-13 (VES-13) is a well-studied simplified frailty screening tool for elderly patients in the oncology setting. We conducted a prospective clinical trial to evaluate the efficacy and safety of dose-adjusted treatment based on the VES-13 in transplant-ineligible patients with newly diagnosed multiple myeloma (MM). In the Fit group (VES-13 <3), patients were treated with 4 cycles of standard-dose VCD (bortezomib, cyclophosphamide, and dexamethasone) followed by 4 cycles of standard-dose VTD (bortezomib, thalidomide, and dexamethasone). In the Frail group (VES-13 ≥3), patients were treated with 4 cycles of reduced-dose VCD followed by 4 cycles of reduced-dose VTD. The median age was 75 years (66-86 years), and 34% of the cases were classified as PS 3. Among the Fit group (n=16), the overall response rate (ORR) was 87.5%. Among the Frail group (n=31), the ORR was 87.1%. There were no significant differences in progression-free survival (PFS) and overall survival (OS) between the Fit and Frail groups (3-year PFS: 68.8% vs 53.3%, P = 0.658; 3-year OS: 70.0% vs 77.6%, P = 0.919). Personalized VCD-VTD sequential therapy based on the VES-13 was associated with high response rates and showed acceptable safety in elderly frail patients with MM. The study is registered as UMIN000011235.
脆弱老年人调查-13（VES-13）是一种经过充分研究的、用于肿瘤环境中老年患者的简化衰弱筛查工具。我们进行了一项前瞻性临床试验，以评估基于VES-13的剂量调整治疗在新诊断的多发性骨髓瘤（MM）且不符合移植条件的患者中的疗效和安全性。在健康组（VES-13＜3）中，患者接受4个周期的标准剂量VCD（硼替佐米、环磷酰胺和地塞米松）治疗，随后接受4个周期的标准剂量VTD（硼替佐米、沙利度胺和地塞米松）治疗。在虚弱组（VES-13≥3）中，患者接受4个周期的减量VCD治疗，随后接受4个周期的减量VTD治疗。中位年龄为75岁（66 - 86岁），34%的病例被分类为PS 3。在健康组（n = 16）中，总缓解率（ORR）为87.5%。在虚弱组（n = 31）中，ORR为87.1%。健康组和虚弱组之间的无进展生存期（PFS）和总生存期（OS）无显著差异（3年PFS：68.8%对53.3%，P = 0.658；3年OS：70.0%对77.6%，P = 0.919）。基于VES-13的个性化VCD-VTD序贯治疗与高缓解率相关，并且在老年虚弱MM患者中显示出可接受的安全性。该研究已注册为UMIN000011235。
