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一项前瞻性、开放标签、多中心观察性研究,旨在评估硼替佐米-美法仑-泼尼松作为不适于自体干细胞移植的多发性骨髓瘤患者初始治疗的疗效和安全性。

A prospective, open-label, multicenter, observational study to evaluate the efficacy and safety of bortezomib-melphalan-prednisone as initial treatment for autologous stem cell transplantation-ineligible patients with multiple myeloma.

作者信息

Kim Min Kyoung, Kim Kihyun, Min Chang-Ki, Kwak Jae-Yong, Bae Sang-Byung, Yoon Sung-Soo, Lee Je-Jung, Kim Ki Hwan, Nam Seung-Hyun, Mun Yeung-Chul, Kim Hyo Jung, Bae Sung Hwa, Shin Ho-Jin, Lee Jung-Hee, Park Joon Seong, Jeong Seong Hyun, Lee Mark Hong, Kim Yang-Soo, Lee Ho Sup, Park Keon Woo, Lee Won-Sik, Lee Sang Min, Lee Jeong-Ok, Hyun Myung Soo, Jo Deog Yeon, Lim Sung-Nam, Lee Jae Hoon, Cho Do-Yeun, Do Young Rok, Kim Jeong-A, Park Seong Kyu, Kim Jin Seok, Kim Soo-Jeong, Kim Hawk, Yi Hyeon Gyu, Moon Joon Ho, Choi Chul Won, Kim Sung-Hyun, Joo Young-Don, Kim Hoon-Gu, Kim Byung Soo, Park Moo-Rim, Song Moo-Kon, Kim Su-Youn

机构信息

Department of Medicine, Yeungnam University College of Medicine, Daegu, Korea.

Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

出版信息

Oncotarget. 2017 Jun 6;8(23):37605-37618. doi: 10.18632/oncotarget.16790.

DOI:10.18632/oncotarget.16790
PMID:28402945
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5514934/
Abstract

Bortezomib-melphalan-prednisone (VMP) showed superior efficacy versus MP as first-line treatment for transplantation-ineligible multiple myeloma (MM). This study investigated the efficacy of VMP for Korean patients with MM.Overall, 177 MM patients received 9 cycles of VMP in this prospective, multicenter, observational study. The primary endpoint was 2-year progression-free survival (PFS).Thirty-nine (22%) patients were aged ≥ 75 years and 83 (47.4%) patients had International Staging System stage III. A median of 5 cycles were delivered. Overall response rate (ORR) was 72.9%, and complete response (CR) rate was 20.3%. With a median follow-up of 11.9 months, median PFS was 17 months. The 2-year PFS and overall survival (OS) rates were 29.2% and 80.0%, respectively. Median OS was not reached. PFS was significantly different depending on performance status (Eastern Cooperative Oncology Group < 2 vs. ≥ 2; p = 0.0002), β2-microglobulin level (< 5.5 vs. ≥ 5.5 mg/L; p = 0.0481), and cumulative dose of bortezomib (< 35.1 vs. ≥ 35.1 mg/m2; p < 0001). The common adverse events (AEs) were in line with the well-known toxicity profiles associated with VMP.In conclusion, VMP is a feasible and effective front-line treatment for transplant-ineligible older patients with MM in Korea. Continuing therapy with prompt adjustment of treatment according to AEs may be important to improve outcomes of elderly patients.

摘要

硼替佐米-美法仑-泼尼松(VMP)作为一线治疗方案,在不适宜进行移植的多发性骨髓瘤(MM)患者中显示出优于美法仑-泼尼松(MP)的疗效。本研究调查了VMP方案对韩国MM患者的疗效。

总体而言,在这项前瞻性、多中心、观察性研究中,177例MM患者接受了9个周期的VMP治疗。主要终点为2年无进展生存期(PFS)。

39例(22%)患者年龄≥75岁,83例(47.4%)患者国际分期系统为III期。中位给药周期数为5个周期。总缓解率(ORR)为72.9%,完全缓解(CR)率为20.3%。中位随访11.9个月时,中位PFS为17个月。2年PFS率和总生存期(OS)率分别为29.2%和80.0%。中位OS未达到。PFS根据体能状态(东部肿瘤协作组<2 vs.≥2;p = 0.0002)、β2-微球蛋白水平(<5.5 vs.≥5.5 mg/L;p = 0.0481)以及硼替佐米累积剂量(<35.1 vs.≥35.1 mg/m2;p < 0.0001)存在显著差异。常见不良事件(AE)与VMP已知的毒性特征相符。

总之,VMP是韩国不适宜进行移植的老年MM患者可行且有效的一线治疗方案。根据AE及时调整治疗方案持续治疗,对于改善老年患者的预后可能很重要。

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