Rifkin Robert M, Medhekar Rohan, Amirian E Susan, Aguilar Kathleen M, Wilson Thomas, Boyd Marley, Mezzi Khalid, Panjabi Sumeet
Rocky Mountain Cancer Centers, Denver, CO, USA McKesson Specialty Health, The US Oncology Network, The Woodlands, TX, USA.
Amgen, Inc., Thousand Oaks, CA, USA.
Ther Adv Hematol. 2019 Jan 11;10:2040620718816699. doi: 10.1177/2040620718816699. eCollection 2019.
Most multiple myeloma (MM) patients ultimately progress, with remission duration decreasing after first relapse. Recently, novel agents have been approved for the treatment of relapsed MM. There is a paucity of real-world data on these treatments. We sought to compare time to next treatment (TTNT) in MM patients in their second line of therapy (LOT2), treated with common proteasome inhibitor (PI)-based triplets.
Adult MM patients who received carfilzomib (K) between 1 November 2013 and 29 February 2016 at US Oncology Network (USON) clinics utilizing iKnowMed™ electronic health records (EHRs) were identified. Patients were included if they were ⩾18 years of age, not enrolled in clinical trials, had ⩾2 visits at a USON clinic and received LOT2 regimens consisting of: K+lenalidomide with steroid (KRd), bortezomib+lenalidomide with steroid (VRd), or bortezomib+cyclophosphamide with steroid (VCyd). TTNT was estimated from LOT2 initiation to LOT3 initiation using the Kaplan-Meier method, and hazard ratios (HRs) were estimated using Cox modeling.
A total of 718 patients received a K-containing regimen sometime during their MM treatment (LOT1 to LOT5). Of these, 156 patients received: KRd ( = 112; 71.8%), VRd ( =27; 17.3%), or VCyd ( = 17; 10.9%). Baseline characteristics were similar between groups (mean age: 64.8 years; 58% male). Median TTNT was longest for KRd [25.3 months; 95% confidence interval (CI): 19.71-NR], VRd or VCyd (VRd median TTNT: 10.2 months, 95% CI: 4.24-12.71; VCyd: 6.5 months, 95% CI: 3.02-12.78; log-rank < 0.0001). The adjusted HR for KRd was 0.19 (95% CI: 0.11-0.37), compared with VRd.
Considering the real-world nature of these data, the median TTNT observed with KRd was relatively consistent, with progression-free survival (PFS) for KRd observed in the phase III ASPIRE trial (median PFS: ITT population = 26.3 months; LOT2 = 29.6 months). Patients who received KRd at first relapse had significantly longer TTNT, compared with those on VRd or VCyd, confirming the value of KRd as an important treatment option for relapsed MM.
大多数多发性骨髓瘤（MM）患者最终会病情进展，首次复发后缓解期会缩短。最近，新型药物已被批准用于复发MM的治疗。关于这些治疗方法的真实世界数据较少。我们试图比较接受常用蛋白酶体抑制剂（PI）为基础的三联疗法的MM患者在二线治疗（LOT2）中的下次治疗时间（TTNT）。
利用iKnowMed™电子健康记录（EHRs）识别2013年11月1日至2016年2月29日期间在美国肿瘤网络（USON）诊所接受卡非佐米（K）治疗的成年MM患者。纳入标准为年龄≥18岁、未参加临床试验、在美国肿瘤网络诊所就诊≥2次且接受以下LOT2方案治疗的患者：K+来那度胺联合类固醇（KRd）、硼替佐米+来那度胺联合类固醇（VRd）或硼替佐米+环磷酰胺联合类固醇（VCyd）。采用Kaplan-Meier方法从LOT2开始至LOT3开始估计TTNT，并使用Cox模型估计风险比（HRs）。
共有718例患者在MM治疗期间（LOT1至LOT）的某个时间接受了含K的方案治疗。其中，156例患者接受了：KRd（n = 112；71.8%）、VRd（n = 27；17.3%）或VCyd（n = 17；10.9%）。各组间基线特征相似（平均年龄：64.8岁；58%为男性）。KRd的中位TTNT最长[25.3个月；95%置信区间（CI）：19.71-未达到（NR）]，VRd或VCyd（VRd中位TTNT：10.2个月，95%CI：4.24-12.71；VCyd：6.5个月，95%CI：3.02-12.78；对数秩检验P < 0.0001）。与VRd相比，KRd的校正HR为0.19（95%CI：0.11-0.37）。
考虑到这些数据的真实世界性质，KRd观察到的中位TTNT相对一致，在III期ASPIRE试验中观察到KRd的无进展生存期（PFS）（ITT人群中位PFS = 26.3个月；LOT2 = 29.6个月）。与接受VRd或VCyd治疗的患者相比，首次复发时接受KRd治疗的患者TTNT显著更长，证实了KRd作为复发MM重要治疗选择的价值。
