Li Juan, Cai Jia-hui, Huang Bei-hui, Liu Jun-ru, Zheng Dong
Department of Hematology, Sun Yat-sen University, Guangzhou, China.
Zhonghua Yi Xue Za Zhi. 2011 Dec 27;91(48):3417-20.
To explore the efficacies and toxicities in multiple myeloma (MM) patients on the maintenance therapies of thalidomide and interferon-α so as to seek the optimal chemotherapeutic regimen.
A retrospective analysis was conducted for 57 MM patients on the maintenance therapies of thalidomide and interferon-α after introduction and consolidation. And 56 MM patients without maintenance therapy were enrolled as the control group.
The values of progression-free survival (PFS) and overall survival (OS) were significantly longer in the maintenance group and this translated into an improved estimated 3-year PFS of 75.4% (71.8%, 83.3%) versus 23.2% in the control group (P < 0.01). The estimated 4-year OS was higher in the maintenance group [89.5% (89.7%, 88.9%) vs 33.9%, P < 0.01]. No statistically significant differences existed among different maintenance groups in terms of PFS and OS. The administration of maintenance therapy extended both PFS and OS for MM patients of various M-proteins (P < 0.05). However, in the thalidomide group, PFS and OS were extended only in MM of immunoglobulin G (IgG) and immunoglobulin A (IgA) but not in light-chain patients. Furthermore, the MM patients of Durie-Salmon (DS) stages II and III and international staging system (ISS) stages II and III extended PFS and OS through maintenance (P < 0.05). While in those of ISS stage I, the differences were insignificant in terms of PFS and OS between two groups. The results were similar between the thalidomide and control groups. The patients achieving a partial remission (PR) or higher response level benefited from the maintenance therapy in terms of PFS and OS (P < 0.05). In the thalidomide group, the patients with below PR prolonged OS (P = 0.031) but did not achieve a longer PFS (P = 0.091). Both PFS and OS were extended through maintenance therapy after either stem cell transplantation or consolidation chemotherapies (P < 0.05). There was no significant difference in terms of PFS and OS between MM patients without maintenance therapy after transplantation and those without transplantation. The adverse effects of thalidomide, milder than those of interferon-α, could be tolerated in most patients. The incidence and severity of adverse effects showed no significant difference between the combination maintenance and single agent therapies.
The maintenance therapies of thalidomide and interferon-α could improve the profiles of PFS and OS in MM patients. And there was no significant difference between them in terms of PFS and OS. However, the maintenance therapy of thalidomide is a better option due to its convenient application, milder adverse effects, reasonable cost and better efficacies in MM patients not achieving PR or receiving induction therapy without bortezomib or without transplantation.
探讨沙利度胺和α干扰素维持治疗对多发性骨髓瘤（MM）患者的疗效及毒性，以寻求最佳化疗方案。
对57例接受沙利度胺和α干扰素维持治疗的MM患者进行导入期和巩固期治疗后进行回顾性分析。并将56例未接受维持治疗的MM患者作为对照组。
维持治疗组的无进展生存期（PFS）和总生存期（OS）值显著延长，这使得估计的3年PFS提高至75.4%（71.8%，83.3%），而对照组为23.2%（P<0.01）。维持治疗组的估计4年OS更高[89.5%（89.7%，88.9%）对33.9%，P<0.01]。不同维持治疗组在PFS和OS方面无统计学显著差异。维持治疗延长了各种M蛋白的MM患者的PFS和OS（P<0.05）。然而，在沙利度胺组中，PFS和OS仅在免疫球蛋白G（IgG）和免疫球蛋白A（IgA）的MM患者中延长，而在轻链患者中未延长。此外，Durie-Salmon（DS）分期II和III期以及国际分期系统（ISS）分期II和III期的MM患者通过维持治疗延长了PFS和OS（P<0.05）。而在ISS I期患者中，两组在PFS和OS方面差异不显著。沙利度胺组和对照组的结果相似。达到部分缓解（PR）或更高缓解水平的患者在PFS和OS方面从维持治疗中获益（P<0.05）。在沙利度胺组中，PR以下的患者延长了OS（P=0.031），但未获得更长的PFS（P=0.091）。干细胞移植或巩固化疗后通过维持治疗均延长了PFS和OS（P<0.05）。移植后未接受维持治疗的MM患者与未移植患者在PFS和OS方面无显著差异。沙利度胺的不良反应比α干扰素轻，大多数患者可以耐受。联合维持治疗和单药治疗在不良反应的发生率和严重程度方面无显著差异。
沙利度胺和α干扰素维持治疗可改善MM患者的PFS和OS情况。它们在PFS和OS方面无显著差异。然而，沙利度胺维持治疗是更好的选择，因为其应用方便、不良反应较轻、成本合理，且对未达到PR或接受不含硼替佐米或未进行移植的诱导治疗的MM患者疗效更好。
