Lu Jin, Lee Jae H, Huang Shang-Yi, Qiu Lugui, Lee Je-Jung, Liu Ting, Yoon Sung-Soo, Kim Kihyun, Shen Zhi X, Eom Hyeon S, Chen Wen M, Min Chang K, Kim Hyo J, Lee Jeong O, Kwak Jae Y, Yiu Wai, Chen Guang, Ervin-Haynes Annette, Hulin Cyrille, Facon Thierry
Peking University People's Hospital, Beijing, China.
Gachon University Gil Hospital, Incheon, Korea.
Br J Haematol. 2017 Mar;176(5):743-749. doi: 10.1111/bjh.14465. Epub 2017 Jan 20.
The phase 3 FIRST (Frontline Investigation of REVLIMID + Dexamethasone Versus Standard Thalidomide) trial demonstrated that lenalidomide plus low-dose dexamethasone (Rd) until disease progression (Rd continuous) is an effective treatment option for transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). Given genetic differences between Asian and Western populations, this subanalysis of the FIRST trial examined the safety and efficacy of Rd (given continuously or for 18 cycles [Rd18]) and MPT (melphalan, prednisone, thalidomide) in 114 Asian patients from Mainland China, South Korea and Taiwan. Efficacy and safety with Rd continuous in Asian patients were consistent with those in the overall study population. The overall response rates were 77·8% for Rd continuous, 57·5% for MPT and 65·8% for Rd18. The risk of progression or death was reduced by 39% with Rd continuous versus MPT and by 35% with Rd continuous versus Rd18. Rd continuous improved the 3-year survival rate compared with MPT (70·2% vs. 56·4%) and Rd18 (58·1%). Common grade 3/4 adverse events in the Rd continuous and MPT arms were neutropenia (25·0% vs. 43·6%), infection (19·4% vs. 28·2%) and anaemia (19·4% vs. 15·4%), respectively. Thromboembolic event rates were low, and no second primary malignancies were observed. Rd continuous is safe and effective in transplant-ineligible Asian patients with NDMM.
3期FIRST（来那度胺+地塞米松对比标准沙利度胺的一线研究）试验表明，来那度胺加低剂量地塞米松（Rd）直至疾病进展（持续使用Rd）是新诊断的多发性骨髓瘤（NDMM）中不符合移植条件患者的有效治疗选择。鉴于亚洲和西方人群之间的基因差异，FIRST试验的这项亚组分析研究了持续使用Rd（持续使用或使用18个周期[Rd18]）和MPT（美法仑、泼尼松、沙利度胺）对来自中国大陆、韩国和台湾的114例亚洲患者的安全性和疗效。亚洲患者持续使用Rd的疗效和安全性与总体研究人群一致。持续使用Rd的总缓解率为77.8%，MPT为57.5%，Rd18为65.8%。与MPT相比，持续使用Rd使疾病进展或死亡风险降低39%，与Rd18相比降低35%。与MPT（70.2%对56.4%）和Rd18（58.1%）相比，持续使用Rd提高了3年生存率。持续使用Rd组和MPT组常见的3/4级不良事件分别为中性粒细胞减少（25.0%对43.6%）、感染（19.4%对28.2%）和贫血（19.4%对15.4%）。血栓栓塞事件发生率较低，未观察到第二原发性恶性肿瘤。持续使用Rd对不符合移植条件的亚洲NDMM患者安全有效。
