Center for Hematologic Malignancies, National Cancer Center, Goyang, Korea.
Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Cancer Res Treat. 2023 Apr;55(2):693-703. doi: 10.4143/crt.2022.952.
A three-drug combination of cyclophosphamide, bortezomib, and dexamethasone (CVD) shows significant efficacy and manageable toxicity as induction therapy in patients with multiple myeloma.
In this phase II study, we enrolled 45 patients who achieved a very good partial response (VGPR) or partial response (PR) after autologous stem cell transplantation (ASCT) and evaluated the efficacy and toxicity of CVD consolidation. CVD consolidation comprised three cycles of cyclophosphamide 300 mg/m2 orally on days 1, 8, and 15, and bortezomib 1.3 mg/m2 subcutaneously on days 1, 8, 15, and 22, along with dexamethasone 20 mg orally or intravenously on days 1 and 2, 8 and 9, 15 and 16, and 22 and 23.
At enrollment, 39 patients (86.7%) showed VGPR, and nine (13.3%) presented with PR. Nineteen patients (45.2%) achieved a complete response or better as their best response after the end of consolidation. Overall, 22 of 42 patients (52.4%) experienced an improved response status with CVD consolidation. Three-year overall survival and progression-free survival rates were 89.0% and 42.7%, respectively. The most common non-hematologic toxicities were peripheral neuropathy and infection (20.5%), with no grade ≥ 3 neuropathy observed.
These results showed that CVD consolidation therapy improved the response with reasonable toxicity in patients with residual disease after ASCT. This trial was registered with the Clinical Research Information Service, Republic of Korea (KCT0001327).
环磷酰胺、硼替佐米和地塞米松（CVD）三药联合方案作为多发性骨髓瘤患者自体造血干细胞移植（ASCT）后的诱导治疗具有显著疗效和可管理的毒性。
在这项 II 期研究中，我们纳入了 45 例在 ASCT 后获得非常好的部分缓解（VGPR）或部分缓解（PR）的患者，并评估了 CVD 巩固治疗的疗效和毒性。CVD 巩固治疗包括环磷酰胺 300mg/m2 口服，第 1、8 和 15 天；硼替佐米 1.3mg/m2 皮下注射，第 1、8、15 和 22 天；同时，地塞米松 20mg 口服或静脉注射，第 1 和 2 天、第 8 和 9 天、第 15 和 16 天、第 22 和 23 天。
在入组时，39 例（86.7%）患者达到 VGPR，9 例（13.3%）患者达到 PR。19 例（45.2%）患者在巩固治疗结束后获得完全缓解或更好的最佳缓解。总体而言，42 例患者中有 22 例（52.4%）通过 CVD 巩固治疗改善了缓解状态。3 年总生存率和无进展生存率分别为 89.0%和 42.7%。最常见的非血液学毒性是周围神经病和感染（20.5%），未观察到≥3 级神经病。
这些结果表明，CVD 巩固治疗可改善 ASCT 后残留疾病患者的缓解情况，且毒性可耐受。本试验在韩国临床试验注册中心（KCT0001327）注册。
