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采用联合VBMCP化疗和干扰素(重组干扰素α 2b)诱导多发性骨髓瘤患者达到完全缓解

Complete remission induction with combined VBMCP chemotherapy and interferon (rIFN alpha 2b) in patients with multiple myeloma.

作者信息

Oken M M, Kyle R A, Greipp P R, Kay N E, Tsiatis A, Gregory S A, Spiegel R J, O'Connell M J

机构信息

The Virginia Piper Cancer Institute, Minneapolis, MN, USA.

出版信息

Leuk Lymphoma. 1996 Feb;20(5-6):447-52. doi: 10.3109/10428199609052427.

Abstract

The purpose of this study was to evaluate a new regimen for the treatment of multiple myeloma based on alternating 3-week cycles of chemotherapy and interferon (rIFN alpha 2). In this prospective phase II clinical trial the Eastern Cooperative Oncology Group evaluated a regimen consisting of 2 cycles of VBMCP (Vincristine 1.2 mg/M(2) IV d1, BCNU 20 mg/M(2) IV d1, Melphalan 8 mg/M(2) PO dl-4, Cyclophosphamide 400 mg/M2 IV d1, Prednisone 40 mg/M(2) PO d1-7) followed by alternating 3-week cycles of VBMCP and rIFN alpha2 5 Mu/M(2) SC 3x/week. Treatment was administered for 2 years. Fifty-eight patients with previously untreated multiple myeloma were entered. Objective response (OR) required 50% decrease in M-protein with correction of severe anemia and no progression of skeletal disease. Complete remission (CR) was defined by disappearance of M-protein and normalization of the bone marrow morphology. Life table analysis was utilized to express survival and response duration. Fifty-four patients were evaluable. Objective response was seen in 80% of patients including CR in 30% (16 patients). The median response duration is 35 months, 46 months for patients with CR. The median survival is 42 months for all patients. Five year survival is 42%. Although 78% of patients had neutrophil nadirs <1000 x 10(9)/L, the incidence of severe infection was only 9%. These data demonstrate that VBMCP + interferon is an effective new regimen combining chemotherapy with a biological response modifier for the treatment of multiple myeloma. The incidence of CR is high, and the response and survival durations appear to be 1 year longer than usually seen with standard chemotherapy. A current ECOG randomized trial compares VBMCP + interferon with VBMCP alone.

摘要

本研究的目的是评估一种基于化疗与干扰素(重组干扰素α2)交替进行的3周周期治疗多发性骨髓瘤的新方案。在这项前瞻性II期临床试验中,东部肿瘤协作组评估了一种方案,该方案包括2个周期的VBMCP(长春新碱1.2mg/M²静脉注射第1天,卡氮芥20mg/M²静脉注射第1天,美法仑8mg/M²口服第1 - 4天,环磷酰胺400mg/M²静脉注射第1天,泼尼松40mg/M²口服第1 - 7天),随后是VBMCP与重组干扰素α2 5Mu/M²皮下注射每周3次交替进行的3周周期。治疗持续2年。58例既往未治疗的多发性骨髓瘤患者入组。客观缓解(OR)要求M蛋白降低50%,同时重度贫血得到纠正且骨骼疾病无进展。完全缓解(CR)定义为M蛋白消失且骨髓形态正常化。采用生命表分析来表示生存和缓解持续时间。54例患者可评估。80%的患者出现客观缓解,其中30%(16例患者)达到CR。中位缓解持续时间为35个月,CR患者为46个月。所有患者的中位生存期为42个月。5年生存率为42%。尽管78%的患者中性粒细胞最低点<1000×10⁹/L,但严重感染的发生率仅为9%。这些数据表明,VBMCP +干扰素是一种将化疗与生物反应调节剂相结合治疗多发性骨髓瘤的有效新方案。CR发生率高,缓解和生存持续时间似乎比标准化疗通常所见长1年。东部肿瘤协作组目前的一项随机试验正在比较VBMCP +干扰素与单纯VBMCP的疗效。

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