Department of Hematology, Mayo Clinic Rochester, Rochester, MN, USA.
School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Leukemia. 2017 Nov;31(11):2443-2448. doi: 10.1038/leu.2017.138. Epub 2017 May 12.
Introduction of new myeloma therapies offers new options for patients refractory to immunomodulatory drugs (IMiDs) and proteasome inhibitors (PIs). In this multicenter study, patients with relapsed multiple myeloma, who have received at least three prior lines of therapy, are refractory to both an IMiD (lenalidomide or pomalidomide) and a PI (bortezomib or carfilzomib), and have been exposed to an alkylating agent were identified. The time patients met the above criteria was defined as time zero (T). Five hundred and forty-three patients diagnosed between 2006 and 2014 were enrolled in this study. Median age at T was 62 years (range 31-87); 61% were males. The median duration between diagnosis and T was 3.1 years. The median number of lines of therapy before T was 4 (range 3-13). The median overall survival (OS) from T for the entire cohort was 13 (95% confidence interval (CI) 11, 15) months. At least one regimen recorded after T in 462 (85%) patients, with a median (95% CI) progression-free survival and OS from T of 5 (4, 6), and 15.2 (13, 17) months, respectively. The study provides the expected outcome of relapsed multiple myeloma that is refractory to a PI and an IMiD, a benchmark for comparison of new therapies being evaluated.
新的骨髓瘤疗法的引入为那些对免疫调节药物(IMiDs)和蛋白酶体抑制剂(PIs)耐药的患者提供了新的选择。在这项多中心研究中,确定了至少接受过三线治疗且对 IMiD(来那度胺或泊马度胺)和 PI(硼替佐米或卡非佐米)均耐药,且曾接触过烷化剂的复发性多发性骨髓瘤患者。将患者符合上述标准的时间定义为时间零(T)。本研究纳入了 2006 年至 2014 年间诊断的 543 例患者。T 时的中位年龄为 62 岁(范围 31-87);61%为男性。T 时诊断与 T 之间的中位时间为 3.1 年。T 前的中位治疗线数为 4 条(范围 3-13)。整个队列从 T 开始的中位总生存期(OS)为 13 个月(95%置信区间(CI)为 11,15)。在 462 例(85%)患者中至少记录了一种治疗方案,T 后中位(95%CI)无进展生存期和 OS 分别为 5(4,6)和 15.2(13,17)个月。该研究提供了对 PI 和 IMiD 耐药的复发性多发性骨髓瘤的预期结果,可作为正在评估的新疗法的比较基准。