Westin J, Rödjer S, Turesson I, Cortelezzi A, Hjorth M, Zador G
Department of Medicine/Haematology, University of Lund, Sweden.
Br J Haematol. 1995 Mar;89(3):561-8. doi: 10.1111/j.1365-2141.1995.tb08364.x.
This clinical trial was designed to investigate if maintenance therapy with alfa-interferon could prolong the plateau phase in patients with multiple myeloma. In addition, the tolerability of interferon treatment and its effect on survival were evaluated. From September 1987 to September 1989 a total of 314 patients were accrued to a multi-institutional randomized clinical trial. All patients entered into the protocol received standard melphalan-prednisone (MP) induction therapy. Response was noted in 184 (59%) and a plateau phase achieved in 155 (49%). From the latter group, 125 eligible patients were randomized to either interferon alfa-2b or no maintenance. The patients were followed for an average of 51 months (minimum 36 months) from the time of randomization. The plateau phase was significantly prolonged in the group of patients treated with interferon (median 13.9 v 5.7 months from the time of randomization; P < 0.0001). The interferon therapy was tolerated fairly well, moderate granulocytopenia and a chronic fatigue syndrome being the most frequent side-effects (22% v 18% W.H.O. grade 3 toxicity). The median survival from randomization was almost identical in both groups (36 v 35 months). The study shows that interferon maintenance therapy given to multiple myeloma patients who have achieved a response to initial treatment with MP prolongs the plateau phase duration with tolerable toxicity. The clinical value of this finding should be interpreted with caution, because survival was not prolonged. Further studies are required to clarify the role of interferon in the treatment of multiple myeloma.
本临床试验旨在研究α干扰素维持治疗能否延长多发性骨髓瘤患者的平台期。此外，还评估了干扰素治疗的耐受性及其对生存的影响。1987年9月至1989年9月，共有314例患者纳入一项多机构随机临床试验。所有进入该方案的患者均接受标准的美法仑-泼尼松（MP）诱导治疗。184例（59%）有反应，155例（49%）达到平台期。从后一组中，125例符合条件的患者被随机分为α-2b干扰素维持治疗组或不进行维持治疗组。从随机分组时起，患者平均随访51个月（最短36个月）。接受干扰素治疗的患者组平台期显著延长（从随机分组时起中位数为13.9个月对5.7个月；P<0.0001）。干扰素治疗耐受性相当好，中度粒细胞减少和慢性疲劳综合征是最常见的副作用（WHO 3级毒性分别为22%对18%）。两组从随机分组时起的中位生存期几乎相同（36个月对35个月）。该研究表明，对初始MP治疗有反应的多发性骨髓瘤患者给予干扰素维持治疗可延长平台期持续时间，且毒性可耐受。这一发现的临床价值应谨慎解读，因为生存期并未延长。需要进一步研究以阐明干扰素在多发性骨髓瘤治疗中的作用。
