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Sequential therapy of four cycles of bortezomib, melphalan, and prednisolone followed by continuous lenalidomide and dexamethasone for transplant-ineligible newly diagnosed multiple myeloma.
Annals of Hematology ( IF 3.5 ) Pub Date : 2019-11-25 , DOI: 10.1007/s00277-019-03859-9
Reiko Isa 1, 2 , Nobuhiko Uoshima 2, 3 , Ryoichi Takahashi 4 , Sonoko Nakano-Akamatsu 4 , Eri Kawata 2 , Hiroto Kaneko 5, 6 , Kazuho Shimura 5 , Yuri Kamitsuji 2, 3, 7 , Tomoko Takimoto-Shimomura 1 , Shinsuke Mizutani 1 , Yoshiaki Chinen 1, 7 , Muneo Ohshiro 6 , Takahiro Fujino 1, 6 , Yuka Kawaji 1, 6 , Hitoji Uchiyama 6 , Nana Sasaki 2 , Taku Tsukamoto 1 , Yuji Shimura 1 , Tsutomu Kobayashi 1 , Masafumi Taniwaki 1, 5, 8 , Junya Kuroda 1 ,
Affiliation  

The combinations of melphalan, bortezomib, and prednisolone (VMP) and of lenalidomide and dexamethasone (Rd) are standard treatment strategies for transplant-ineligible newly diagnosed multiple myeloma (NDMM). To make the most of these two strategies, we investigated the efficacy and feasibility of first-line treatment with 4 cycles of VMP followed by continuous Rd therapy in a multi-institutional phase 2 study in Japanese patients with transplant-ineligible NDMM. Thirty-six patients of median age 74 years old with NDMM initially received 35-day cycles of VMP: oral melphalan (6 mg/m2) and prednisolone (60 mg/m2) on days 1 to 4 and bortezomib (1.3 mg/m2) on days 1, 8, 15, and 22. After 4 cycles of VMP, treatment was switched to 28-day cycles of Rd, which was continued until disease progression or emergence of an unacceptable adverse event (AE) in 33 patients, while one patient who achieved CR after VMP continued VMP at the physician's discretion. The overall response rates after VMP and after Rd were 66.7% and 86.1%, including CR rates of 5.6% and 36.1%, respectively. In a median follow-up period of 34.3 months, the progression-free survival and overall survival rates at 3 years were 43.2% and 81.3%, respectively. Grade 3-4 hematological AEs included neutropenia (39% with VMP and 24% with Rd) and thrombocytopenia (11% with VMP and 3% with Rd). There was no death due to an AE. In conclusion, sequential therapy with VMP followed by Rd is effective and mostly feasible for transplant-ineligible NDMM. The study is registered as UMIN000034815.

中文翻译:

硼替佐米,美法仑和泼尼松龙四个周期的顺序治疗,然后连续来那度胺和地塞米松治疗不适合移植的新诊断多发性骨髓瘤。

美法仑,硼替佐米和泼尼松龙(VMP)以及来那度胺和地塞米松(Rd)的组合是不适合移植的新诊断多发性骨髓瘤(NDMM)的标准治疗策略。为了充分利用这两种策略,我们在日本的不适合移植的NDMM患者的多机构2期研究中,研究了4周期VMP一线治疗然后连续Rd治疗的有效性和可行性。36名中位年龄74岁的NDMM患者最初接受了35天的VMP周期:在第1至4天口服美法仑(6 mg / m2)和泼尼松龙(60 mg / m2),以及硼替佐米(1.3 mg / m2)在第1天,第8天,第15天和第22天,在VMP的4个周期后,将治疗切换为Rd的28天周期,这种情况一直持续到33名患者疾病进展或出现不良不良事件(AE)为止,而一名在VMP后获得CR的患者则根据医生的判断继续使用VMP。VMP后和Rd后的总缓解率分别为66.7%和86.1%,其中CR分别为5.6%和36.1%。在34.3个月的中位随访期内,无进展生存期和3年总生存率分别为43.2%和81.3%。3-4级血液学不良事件包括中性粒细胞减少症(VMP为39%,Rd为24%)和血小板减少症(VMP为11%,Rd为3%)。没有因AE死亡。总之,对于不适合移植的NDMM,先后行VMP继之以Rd的序贯治疗是有效且最可行的。该研究注册为UMIN000034815。而一名在VMP后获得CR的患者则根据医生的判断继续使用VMP。VMP后和Rd后的总缓解率为66.7%和86.1%,其中CR分别为5.6%和36.1%。在34.3个月的中位随访期内,无进展生存期和3年总生存率分别为43.2%和81.3%。3-4级血液学不良事件包括中性粒细胞减少症(VMP为39%,Rd为24%)和血小板减少症(VMP为11%,Rd为3%)。没有因AE死亡。总之,对于不适合移植的NDMM,先后行VMP继之以Rd的序贯治疗是有效且最可行的。该研究注册为UMIN000034815。而一名在VMP后获得CR的患者则根据医师的判断继续使用VMP。VMP后和Rd后的总缓解率分别为66.7%和86.1%,其中CR分别为5.6%和36.1%。在34.3个月的中位随访期内,无进展生存期和3年总生存率分别为43.2%和81.3%。3-4级血液学不良事件包括中性粒细胞减少症(VMP为39%,Rd为24%)和血小板减少症(VMP为11%,Rd为3%)。没有因AE死亡。总之,对于不适合移植的NDMM,先后行VMP继之以Rd的序贯治疗是有效且最可行的。该研究注册为UMIN000034815。分别。在34.3个月的中位随访期内,无进展生存期和3年总生存率分别为43.2%和81.3%。3-4级血液学不良事件包括中性粒细胞减少症(VMP为39%,Rd为24%)和血小板减少症(VMP为11%,Rd为3%)。没有因AE死亡。总之,对于不适合移植的NDMM,先后行VMP继之以Rd的序贯治疗是有效且最可行的。该研究注册为UMIN000034815。分别。在34.3个月的中位随访期内,无进展生存期和3年总生存率分别为43.2%和81.3%。3-4级血液学不良事件包括中性粒细胞减少症(VMP为39%,Rd为24%)和血小板减少症(VMP为11%,Rd为3%)。没有因AE死亡。总之,对于不适合移植的NDMM,先后行VMP继之以Rd的序贯治疗是有效且最可行的。该研究注册为UMIN000034815。在不适合移植的NDMM中,VMP序贯治疗后再进行Rd治疗是有效的,并且在大多数情况下是可行的。该研究注册为UMIN000034815。在不适合移植的NDMM中,VMP序贯治疗后再进行Rd治疗是有效的,并且在大多数情况下是可行的。该研究注册为UMIN000034815。
更新日期:2019-11-01
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