Hematology Department, National Taiwan University Hospital, Taipei, Taiwan.
Hematology Department, Taipei Veterans General Hospital, Beitou District, Taipei City, Taiwan.
J Formos Med Assoc. 2017 Sep;116(9):705-710. doi: 10.1016/j.jfma.2016.11.005. Epub 2016 Dec 21.
BACKGROUND/PURPOSE: The incidence of multiple myeloma in Asia has risen in the past 30 years. Lenalidomide, an IMiD immunomodulatory agent, has improved the overall survival in patients with relapsed/refractory multiple myeloma (RRMM) when used with dexamethasone versus dexamethasone alone. This observational registry (T-CC-MM-009; NCT01752075) assessed the safety and efficacy of lenalidomide plus dexamethasone in a large Chinese population of patients with RRMM.
This registry followed the first 100 patients treated with lenalidomide plus dexamethasone in Taiwan. Patients were ≥18 years old and had ≥1 prior treatment. The recommended starting dose for the first four 28-day cycles was 25 mg lenalidomide on days 1-21 and 40 mg dexamethasone on days 1-4, 9-12, and 17-20. Thereafter, dexamethasone was given on days 1-4 only. The primary objective was safety; secondary objectives were efficacy, lenalidomide dosage, and reasons for discontinuation.
The median duration of treatment was 34.6 weeks, and 75.5% completed ≥3 cycles. Most patients (82.7%) experienced ≥1 treatment-related adverse event; the most commonly reported were neutropenia (23.5%), thrombocytopenia (19.4%), anemia (16.3%), fatigue (16.3%), and hypoesthesia (15.3%). Bleeding events (25.5% of patients) were mostly grade 1/2 (80%). Three patients (3%) had venous thromboembolic events. Two invasive second primary malignancies were reported; however, time to onset was <1 year, suggesting they may not be related to lenalidomide. The overall response rate was 34.7%; median time to disease progression was 20.5 months.
These data confirm the safety and efficacy of lenalidomide plus dexamethasone for patients with RRMM in Taiwan.
背景/目的：在过去的 30 年中，亚洲多发性骨髓瘤的发病率有所上升。来那度胺是一种 IMiD 免疫调节药物，当与地塞米松联合使用时，可改善复发/难治性多发性骨髓瘤（RRMM）患者的总生存期，而单独使用地塞米松则不然。这项观察性注册研究（T-CC-MM-009；NCT01752075）评估了来那度胺联合地塞米松在大量中国 RRMM 患者中的安全性和疗效。
该注册研究随访了台湾前 100 例接受来那度胺联合地塞米松治疗的患者。患者年龄≥18 岁，且至少接受过 1 次治疗。在前 4 个 28 天周期中，推荐起始剂量为第 1-21 天和第 1-4、9-12、17-20 天每天 25mg 来那度胺，第 1-4 天每天 40mg 地塞米松。此后，仅在第 1-4 天给予地塞米松。主要目的是安全性；次要目的是疗效、来那度胺剂量和停药原因。
中位治疗持续时间为 34.6 周，75.5%的患者完成了≥3 个周期。大多数患者（82.7%）发生了≥1 次治疗相关不良事件；最常见的是中性粒细胞减少症（23.5%）、血小板减少症（19.4%）、贫血（16.3%）、疲劳（16.3%）和感觉迟钝（15.3%）。出血事件（25.5%的患者）大多为 1/2 级（80%）。3 例患者（3%）发生静脉血栓栓塞事件。报告了 2 例侵袭性第二原发恶性肿瘤；然而，发病时间<1 年，提示它们可能与来那度胺无关。总体缓解率为 34.7%；疾病进展中位时间为 20.5 个月。
这些数据证实了来那度胺联合地塞米松治疗台湾 RRMM 患者的安全性和疗效。
