Risk stratification in multiple myeloma is important for prognostication, patient selection for clinical trials, and comparison of treatment approaches. We developed and validated a staging system that incorporates additional FISH abnormalities not included in the R-ISS and reflects the additive effects of co-occurring high-risk disease features. We first evaluated the prognostic value of predefined cytogenetic and laboratory abnormalities in 2556 Mayo Clinic patients diagnosed between February 2004 and June 2019. We then used data from 1327 patients to develop a risk stratification model and validated this in 502 patients enrolled in the MMRF CoMMpass study. On multivariate analysis, high-risk IgH translocations [risk ratio (RR): 1.7], 1q gain/amplification (RR: 1.4), chromosome17 abnormalities (RR: 1.6), ISS III (RR: 1.7), and elevated LDH (RR: 1.3) were independently associated with decreased overall survival (OS). Among 1327 evaluable patients, OS was 11.0 (95% CI: 9.2–12.6), 7.0 (95% CI: 6.3–9.2), and 4.5 (95% CI: 3.7–5.2) years in patients with 0 (stage I), 1 (stage II), and ≥2 (stage III) high-risk factors, respectively. In the MMRF cohort, median OS was 7.8 (95% CI: NR-NR), 6.0 (95% CI: 5.7-NR), and 4.3 (95% CI: 2.7-NR) years in the 3 groups, respectively (P < 0.001). This 5-factor, 3-tier system is easy to implement in practice and improves upon the current R-ISS.
多发性骨髓瘤的风险分层对预后判断、临床试验患者选择及治疗方案的比较至关重要。我们开发并验证了一种分期系统，该系统纳入了R-ISS未涵盖的额外FISH异常，并反映了共存高危疾病特征的累加效应。我们首先评估了2004年2月至2019年6月期间梅奥诊所2556例确诊患者中预设细胞遗传学及实验室异常的预后价值，随后使用1327例患者的数据建立风险分层模型，并在MMRF CoMMpass研究的502例入组患者中进行了验证。多变量分析显示，高危IgH易位[风险比(RR):1.7]、1q增益/扩增(RR:1.4)、17号染色体异常(RR:1.6)、ISS III期(RR:1.7)以及LDH升高(RR:1.3)均与总生存期(OS)降低独立相关。在1327例可评估患者中，具有0个（I期）、1个（II期）和≥2个（III期）高危因素患者的OS分别为11.0年（95%CI:9.2-12.6）、7.0年（95%CI:6.3-9.2）和4.5年（95%CI:3.7-5.2）。在MMRF队列中，三组患者的中位OS分别为7.8年（95%CI:NR-NR）、6.0年（95%CI:5.7-NR）和4.3年（95%CI:2.7-NR）（P<0.001）。这一包含5个因素、3个层级的分期系统易于临床实施，并对现有R-ISS体系作出了改进。
A simple additive staging system for newly diagnosed multiple myeloma
肿瘤(癌症)患者之家