Biran Noa, Dhakal Binod, Lentzsch Suzanne, Siegel David, Usmani Saad Z, Rossi Adriana, Rosenbaum Cara, Bhutani Divaya, Vesole David H, Rodriguez Cesar, Nooka Ajay K, van Rhee Frits, Stork-Sloots Lisette, de Snoo Femke, Bhattacharyya Pritish K, Dash Durga Prasad, Zümrütçü Sena, van Vliet Martin H, Hari Parameswaran, Niesvizky Ruben
Myeloma Division John Theurer Cancer Center Hackensack University Medical Center Hackensack New Jersey USA.
Division of Hematology and Oncology Department of Medicine Medical College of Wisconsin Milwaukee Wisconsin USA.
EJHaem. 2021 May 11;2(3):375-384. doi: 10.1002/jha2.209. eCollection 2021 Aug.
Multiple myeloma (MM) is a heterogeneous hematologic malignancy associated with several risk factors including genetic aberrations which impact disease response and survival. Thorough risk classification is essential to select the best clinical strategy to optimize outcomes. The SKY92 molecular signature classifies patients as standard- or high-risk for progression. The PRospective Observational Multiple Myeloma Impact Study (PROMMIS; NCT02911571) measures impact of SKY92 on risk classification and treatment plan. Newly diagnosed MM patients had bone marrow aspirates analyzed for SKY92. Physicians completed a questionnaire for each patient capturing risk classification, hypothetical treatment plan, and physician confidence in the treatment plan, before and after unblinding SKY92. One hundred forty seven MM patients were enrolled. Before unblinding SKY92, physicians regarded 74 (50%) patients as clinical standard-risk. After unblinding SKY92, 16 patients were re-assigned as high-risk by the physician, and for 15 of them treatment strategy was impacted, resulting in an escalated treatment plan. For the 73 (50%) clinical high-risk patients, SKY92 indicated 46 patients to be standard-risk; for 31 of these patients the treatment strategy was impacted consistent with a de-escalation of risk. Overall, SKY92 impacted treatment decisions in 37% of patients ( < 0.001). For clinical decision-making, physicians incorporated SKY92, and the final assigned clinical risk was in line with SKY92 for 89% of patients. Furthermore, SKY92 significantly increased the confidence of the physicians' treatment decisions ( < 0.001). This study shows potential added value of SKY92 in MM for treatment decision making.
多发性骨髓瘤（MM）是一种异质性血液系统恶性肿瘤，与多种风险因素相关，包括影响疾病反应和生存的基因畸变。全面的风险分类对于选择最佳临床策略以优化治疗结果至关重要。SKY92分子特征将患者分为进展的标准风险或高风险。前瞻性观察性多发性骨髓瘤影响研究（PROMMIS；NCT02911571）评估SKY92对风险分类和治疗计划的影响。新诊断的MM患者进行了骨髓穿刺以分析SKY92。在对SKY92进行揭盲前后，医生为每位患者填写了一份问卷，记录风险分类、假设的治疗计划以及医生对治疗计划的信心。共纳入了147例MM患者。在揭盲SKY92之前，医生将74例（占50%）患者视为临床标准风险。揭盲SKY92后，16例患者被医生重新归类为高风险，其中15例患者的治疗策略受到影响，导致治疗计划升级。对于73例（占50%）临床高风险患者，SKY92显示46例为标准风险；其中31例患者的治疗策略受到影响，风险降级。总体而言，SKY92在37%的患者中影响了治疗决策（P<0.001）。对于临床决策，医生纳入了SKY92，最终确定的临床风险与SKY92相符的患者占89%。此外，SKY92显著提高了医生治疗决策的信心（P<0.001）。这项研究表明SKY92在MM治疗决策中具有潜在的附加价值。
