Offidani M, Olivieri A, Montillo M, Rupoli S, Centurioni R, Alesiani F, Marchegiani G, Pieroni S, Catarini M, Pelliccia G, Altilia F, Leoni P
Clinica di Ematologia, Ancona University, Ospedale Torrette, Torrette di Ancona, Italy.
Haematologica. 1998 Jan;83(1):40-7.
The role of interferon (IFN) in the remission phase of multiple myeloma (MM) is still an open question, particularly for its scheduling and the subset of patients who could benefit from this approach. The present randomized multicenter study was designed to compare two schedules of IFN maintenance therapy in order to assess the difference in effectiveness and tolerance.
This prospective randomized multicenter study was attempted to assess the best schedule of IFN administration in the maintenance treatment of MM in plateau phase with regard to progression free survival (PFS) and toxicity. The second aim was defining the difference between the two schedules in overall survival (OS) and identifying the critical dose of IFN therapy needed to prolong plateau phase and survival. We enrolled 52 patients affected with low-risk MM (i.e. with serum beta 2-microglobulin < 6.0 mg/L and serum albumin > 3.0 g/dL); 27 patients (group A) were randomly assigned to receive IFN alpha-2b 3 megaunits (MU) subcutaneously three times a week and 25 patients (group B) 3 MU/day until disease progression.
Median progression free survival (PFS) was 11.9 months in group A and 38.3 months in group B (p = 0.0038). Median survival was 63.2 months in group A and 61.9 months in group B (p = 0.489). However, those patients who were given an IFN dose > or = 30 MU/month experienced a significantly longer PFS and survival than the other patients. Seventeen patients (32.7%) discontinued therapy and sixteen patients (30.8%) reduced IFN alpha-2b dose because of severe side effects without having a significant difference between the two schedules.
Our results show that patients treated with IFN alpha 3 MU/day had a significantly longer remission duration than patients treated with IFN alpha 3 MU three times weekly. Moreover, an IFN dose is probably critical for obtaining a longer survival in patients affected with low-risk MM. Since the patients' discomfort during a IFN maintenance therapy was frequently experienced the quality of their lives should be carefully taken into account.
干扰素（IFN）在多发性骨髓瘤（MM）缓解期的作用仍是一个悬而未决的问题，尤其是其给药方案以及哪些患者亚组能从此治疗方法中获益。本随机多中心研究旨在比较两种干扰素维持治疗方案，以评估有效性和耐受性的差异。
这项前瞻性随机多中心研究试图评估在MM平台期维持治疗中，就无进展生存期（PFS）和毒性而言，干扰素给药的最佳方案。第二个目的是确定两种方案在总生存期（OS）方面的差异，并确定延长平台期和生存期所需的干扰素治疗关键剂量。我们纳入了52例低风险MM患者（即血清β2-微球蛋白<6.0mg/L且血清白蛋白>3.0g/dL）；27例患者（A组）被随机分配接受皮下注射干扰素α-2b 3百万单位（MU），每周3次，25例患者（B组）接受3MU/天，直至疾病进展。
A组的中位无进展生存期（PFS）为11.9个月，B组为38.3个月（p = 0.0038）。A组的中位生存期为63.2个月，B组为61.9个月（p = 0.489）。然而，接受干扰素剂量≥30MU/月的患者的PFS和生存期明显长于其他患者。17例患者（32.7%）因严重副作用而停止治疗，16例患者（30.8%）减少了干扰素α-2b剂量，两种方案之间无显著差异。
我们的结果表明，接受干扰素α 3MU/天治疗的患者的缓解期明显长于接受干扰素α 3MU每周3次治疗的患者。此外，对于低风险MM患者，干扰素剂量可能是获得更长生存期的关键。由于在干扰素维持治疗期间患者经常感到不适，因此应仔细考虑他们的生活质量。
