干扰素α -2b联合VMCP与单独VMCP的诱导效果比较,干扰素α -2b与对照组的缓解维持效果比较:中期结果

Heinz Ludwig , Amos M. Cohen , Heinz Huber , David Nachbaur , Walter F. Jungi , Hansjörg Senn , Peter Günczler , Johannes Schüller , Sándor Eckhardt , Heinz L. Seewann , Franco Cavalli , Elke Fritz , Michael Micksche
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引用次数: 27

摘要

本试验旨在评估干扰素(IFN)联合标准诱导化疗和/或干扰素缓解维持治疗是否能改善多发性骨髓瘤患者的治疗效果。截至目前,已有89例患者接受IFN联合长春新碱/美法兰/环磷酰胺/强的松龙(VMCP)诱导治疗,86例接受常规VMCP。进展性疾病患者比例显著降低(P <0.005), IFN + VMCP组与VMCP治疗组比较。生存时间明显延长(P <IFN + VMCP诱导治疗组比单独VMCP诱导治疗组低0.02。在这项研究的第二阶段,33名无进展骨髓瘤患者被分配接受IFN作为维持治疗,41名患者作为未治疗的对照组。维持IFN治疗的患者显示出无进展生存期增加的趋势。在接受IFN治疗的患者中观察到更多的血液学副作用,在IFN + VMCP联合治疗的患者中出现更严重的血液学毒性,而在维持IFN治疗的患者中出现轻度血液学毒性的患者数量增加。其他副作用,如发烧和疲劳,仍在可容忍的范围内。总之,目前这项临床试验的初步结果表明,IFN + VMCP联合诱导治疗在减少多发性骨髓瘤患者疾病进展和延长生存期以及IFN维持治疗可能带来的益处方面具有显著优势。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Interferon alfa-2b with VMCP compared to VMCP alone for induction and interferon alfa-2b compared to controls for remission maintenance in multiple myeloma: Interim results

The present trial was designed to evaluate whether interferon (IFN) combined with standard induction chemotherapy and/or interferon remission maintenance treatment improve treatment results in patients with multiple myeloma. Up to now 89 patients have received IFN plus vincristine/melphalan/cyclophosphamide/prednisolone (VMCP) as induction therapy, and 86 conventional VMCP. The proportion of patients with progressive disease was significantly lower (P < 0.005) under IFN + VMCP as compared to the VMCP treatment group. Survival times were significantly longer (P < 0.02) after IFN + VMCP induction therapy than after VMCP alone. In the second phase of this investigation, 33 progression-free myeloma patients were assigned to receive IFN as maintenance therapy, and 41 patients served as untreated controls. Patients maintained with IFN showed a tendency towards increased progression-free survival. Haematological side effects were observed significantly more often in patients receiving IFN, with more severe haematological toxicity in patients on the combined IFN + VMCP regimen and an increased number of patients with mild haematological toxicity in the group maintained with IFN. Other side effects, such as fever and fatigue, remained within tolerable limits. In conclusion, the preliminary results of this current clinical trial indicate significant advantages of combined IFN + VMCP induction treatment in terms of reduced disease progression and prolonged survival and possible benefits of IFN maintenance therapy in patients with multiple myeloma.

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