The International Staging System for multiple myeloma recently underwent a second revision (R2-ISS) to include gain/amplification of 1q21 and account for the additive prognostic significance of multiple high-risk features. The phase 3 ICARIA-MM (isatuximab–pomalidomide–dexamethasone vs. pomalidomide–dexamethasone) and IKEMA (isatuximab–carfilzomib–dexamethasone vs. carfilzomib–dexamethasone) studies provide large datasets for retrospectively validating the prognostic value of the R2-ISS in relapsed/refractory multiple myeloma. Of 609 pooled patients, 68 (11.2%) were reclassified as R2-ISS stage I, 136 (22.3%) as R2-ISS stage II, 204 (33.5%) as R2-ISS stage III, 55 (9.0%) as stage IV, and 146 (24.0%) “Not classified”. Median progression-free survival was shorter among those reclassified as R2-ISS stage II (HR 1.52, 95% CI 0.979–2.358), stage III (HR 2.59, 95% CI 1.709–3.923), and stage IV (HR 3.51, 95% CI 2.124–5.784) versus stage I. Adding isatuximab led to longer progression-free survival versus doublet therapy (adjusted HR 0.544 [95% CI 0.436–0.680]), with a consistent treatment effect observed across all R2-ISS stages. This is the first study to validate the R2-ISS with novel agents, including anti-CD38 monoclonal antibodies, and to show that R2-ISS, as a prognostic scoring system, can be applied to patients with relapsed/refractory multiple myeloma.
多发性骨髓瘤国际分期系统近期完成了第二次修订（R2-ISS），纳入了1q21区段扩增/增益，并整合了多个高危特征的累积预后意义。三期临床试验ICARIA-MM（比较伊沙妥昔单抗-泊马度胺-地塞米松与泊马度胺-地塞米松方案）和IKEMA研究（比较伊沙妥昔单抗-卡非佐米-地塞米松与卡非佐米-地塞米松方案）为回顾性验证R2-ISS在复发/难治性多发性骨髓瘤中的预后价值提供了大规模数据集。在汇总的609例患者中，68例（11.2%）被重新划分为R2-ISS I期，136例（22.3%）为II期，204例（33.5%）为III期，55例（9.0%）为IV期，146例（24.0%）"未分类"。与I期相比，重新划分为R2-ISS II期（HR 1.52，95% CI 0.979–2.358）、III期（HR 2.59，95% CI 1.709–3.923）和IV期（HR 3.51，95% CI 2.124–5.784）的患者中位无进展生存期更短。与双药联合治疗相比，加用伊沙妥昔单抗可延长无进展生存期（校正后HR 0.544 [95% CI 0.436–0.680]），且在所有R2-ISS分期中均观察到一致的治疗效果。这是首项采用包含抗CD38单克隆抗体在内的新型药物治疗方案验证R2-ISS的研究，并证明R2-ISS作为预后评分系统可适用于复发/难治性多发性骨髓瘤患者。
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