Cohen A M, Meytes D, Many A, Brenner B, Aghai E, Shaklai M, Kaufman S, Shtalrid M, Attias D, Manor Y
Department of Hematology, Hasharon Hospital, Petah Tikva, Israel.
Isr J Med Sci. 1995 Oct;31(10):604-10.
In 1988, a prospective, randomized multicenter study was initiated to determine the efficacy of a combined induction regimen with recombinant interferon-alpha-2b (IFN-alpha) and maintenance with IFN-alpha on the response and survival rates in multiple myeloma (MM) patients. Induction therapy consisted of VMCP (vincristine, melphalan, cyclophosphamide, prednisone), randomized to combine IFN-alpha at a dose of 2 x 10(6) U, 5 days per week throughout the induction period of 12 months. Patients who achieved plateau phase were subsequently randomized again between IFN alpha maintenance (2 x 10(6) U, 3 days a week) for 12 months and no maintenance therapy. Of the previously untreated patients, 84 were initially randomized for induction therapy, and 31 for the maintenance phase with IFN-alpha. Results of the cohort median survival, based on the intention to treat, have shown that those on the VMCP/IFN-alpha arm had a median survival of 53 months, compared with patients on the VMCP induction arm who a median survival of 26 months (P = 0.052). The median survival of stage 3 evaluable patients who were on the VMCP/IFN induction arm was 43 months, and 13 months for patients treated by VMCP alone (P = 0.008). No significant difference in survival was detected among patients in partial remission (after induction) who had a second IFN-alpha randomization at the plateau phase. Hematologic toxicity, mild to moderate fever, and fatigue were more common in the VMCP/IFN induction arm. The results show that VMCP/IFN is a well-tolerated treatment regimen, and is superior to VMCP for patients with stage 3 myeloma.
1988年，一项前瞻性、随机多中心研究启动，以确定重组干扰素-α-2b（IFN-α）联合诱导方案及IFN-α维持治疗对多发性骨髓瘤（MM）患者缓解率和生存率的影响。诱导治疗采用VMCP方案（长春新碱、美法仑、环磷酰胺、泼尼松），随机联合剂量为2×10⁶U的IFN-α，在12个月的诱导期内每周5天使用。达到平台期的患者随后再次随机分为接受IFN-α维持治疗（2×10⁶U，每周3天）12个月组和不接受维持治疗组。在先前未接受治疗的患者中，84例最初被随机分配接受诱导治疗，31例进入IFN-α维持治疗阶段。基于意向性治疗的队列中位生存期结果显示，VMCP/IFN-α组的中位生存期为53个月，而VMCP诱导组患者的中位生存期为26个月（P = 0.052）。VMCP/IFN诱导组中可评估的3期患者的中位生存期为43个月，单独接受VMCP治疗的患者为13个月（P = 0.008）。在平台期接受第二次IFN-α随机分组的部分缓解（诱导后）患者中，未检测到生存率有显著差异。血液学毒性、轻至中度发热和疲劳在VMCP/IFN诱导组中更为常见。结果表明，VMCP/IFN是一种耐受性良好的治疗方案，对于3期骨髓瘤患者优于VMCP。
