Myeloma Unit, Division of Hematology, University of Torino, Azienda-Ospedaliero Universitaria Città della Salute e della Scienza di Torino, via Genova 3, 10126, Torino, Italy.
UOC Ematologia, Azienda Policlinico-OVE, University of Catania, Catania, Italy.
J Cancer Res Clin Oncol. 2018 Jul;144(7):1357-1366. doi: 10.1007/s00432-018-2641-5. Epub 2018 Apr 19.
Maintenance demonstrated to improve survival in newly diagnosed multiple myeloma (NDMM) patients and the achievement of complete response (CR) is a strong predictor of survival. Nevertheless, the role of maintenance according to response after induction/consolidation has not been investigated so far. To evaluate the impact of maintenance according to response, we pooled together and retrospectively analyzed data from 955 NDMM patients enrolled in two trials (GIMEMA-MM-03-05 and RV-MM-PI-209).
Primary endpoints were progression-free survival (PFS)1, PFS2 and overall survival (OS) of CR patients randomized to maintenance and no maintenance. Secondary endpoints were PFS1, PFS2 and OS in very good partial response/partial response (VGPR/PR) patients.
Overall, 213 patients obtained CR after induction/consolidation, 118 received maintenance and 95 no maintenance. In patients achieving CR, maintenance significantly improved PFS1 (HR 0.50, P < 0.001), PFS2 (HR 0.58, P 0.02) and OS (HR 0.51, P 0.02) compared with no maintenance; the advantage was maintained across all the analyzed subgroups according to age, International Staging System (ISS) stage, cytogenetic profile and treatment. Similar features were seen in VGPR/PR patients.
Maintenance prolonged survival in CR and in VGPR/PR patients. The benefit in CR patients suggests the importance of continuing treatment in patients with chemo-sensitive disease.
The two source studies are registered at ClinicalTrials.gov: identification numbers NCT01063179 and NCT00551928.
维持治疗已被证明可改善新诊断多发性骨髓瘤（NDMM）患者的生存，完全缓解（CR）的获得是生存的有力预测因素。然而，迄今为止，尚未研究根据诱导/巩固后的反应进行维持治疗的作用。为了评估根据反应进行维持治疗的影响，我们汇集并回顾性分析了两项试验（GIMEMA-MM-03-05 和 RV-MM-PI-209）中 955 例 NDMM 患者的数据。
主要终点是随机接受维持治疗和不维持治疗的 CR 患者的无进展生存期（PFS）1、PFS2 和总生存期（OS）。次要终点是非常好的部分缓解/部分缓解（VGPR/PR）患者的 PFS1、PFS2 和 OS。
总体而言，213 例患者在诱导/巩固后获得 CR，118 例接受维持治疗，95 例未接受维持治疗。在获得 CR 的患者中，与未接受维持治疗的患者相比，维持治疗显著改善了 PFS1（HR 0.50，P<0.001）、PFS2（HR 0.58，P=0.02）和 OS（HR 0.51，P=0.02）；在根据年龄、国际分期系统（ISS）分期、细胞遗传学特征和治疗进行的所有分析亚组中，均观察到了这种优势。在 VGPR/PR 患者中也观察到了类似的特征。
维持治疗延长了 CR 和 VGPR/PR 患者的生存。在 CR 患者中观察到的获益表明，在对化疗敏感的疾病患者中继续治疗的重要性。
两项原始研究均在 ClinicalTrials.gov 上注册：注册号 NCT01063179 和 NCT00551928。
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