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与单独使用VMCP方案相比,干扰素α-2b联合VMCP方案用于多发性骨髓瘤诱导治疗,以及与对照组相比,干扰素α-2b用于缓解期维持治疗:中期结果。

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.

作者信息

Ludwig H, Cohen A M, Huber H, Nachbaur D, Jungi W F, Senn H, Günczler P, Schüller J, Eckhardt S, Seewann H L

机构信息

1st Department of Medicine and Medical Oncology, Whilhelminenspital, Vienna, Austria.

出版信息

Eur J Cancer. 1991;27 Suppl 4:S40-5. doi: 10.1016/0277-5379(91)90570-4.

Abstract

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 less than 0.005) under IFN + VMCP as compared to the VMCP treatment group. Survival times were significantly longer (P less than 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.

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,89例患者接受了IFN加长春新碱/美法仑/环磷酰胺/泼尼松(VMCP)作为诱导治疗,86例接受了传统的VMCP治疗。与VMCP治疗组相比,IFN + VMCP治疗组中疾病进展患者的比例显著更低(P < 0.005)。IFN + VMCP诱导治疗后的生存时间显著长于单独使用VMCP治疗后(P < 0.02)。在本研究的第二阶段,33例无进展骨髓瘤患者被分配接受IFN作为维持治疗,41例患者作为未治疗对照。接受IFN维持治疗的患者无进展生存期有延长的趋势。接受IFN治疗的患者血液学副作用的观察频率显著更高,在联合IFN + VMCP方案的患者中血液学毒性更严重,而在接受IFN维持治疗的组中轻度血液学毒性患者数量增加。其他副作用,如发热和疲劳,仍在可耐受范围内。总之,本次临床试验的初步结果表明,联合IFN + VMCP诱导治疗在减少疾病进展和延长生存期方面具有显著优势,且IFN维持治疗对多发性骨髓瘤患者可能有益。

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