García-Sanz R, González-Porras J R, Hernández J M, Polo-Zarzuela M, Sureda A, Barrenetxea C, Palomera L, López R, Grande-García C, Alegre A, Vargas-Pabón M, Gutiérrez O N, Rodríguez J A, San Miguel J F
Grupo Español de Mieloma (GEM), Red Española de Mieloma (G03/136), FIS-SS PI-02/0905.
Leukemia. 2004 Apr;18(4):856-63. doi: 10.1038/sj.leu.2403322.
We evaluate the efficacy of the oral combination of thalidomide, cyclophosphamide and dexamethasone (ThaCyDex) in 71 refractory/relapsed multiple myeloma patients, including a prognostic analysis to predict both response and survival. Patients received thalidomide at escalating doses (200-800 mg/day), daily cyclophosphamide (50 mg/day) and pulsed dexamethasone (40 mg/day, 4 days every 3 weeks). On an intention-to-treat basis and using the EBMT response criteria, 2% patients reached complete response (CR), 55% partial response (PR) and 26% minor response (MR) yielding a total response (CR+PR+MR) rate of 83% after 3 months of therapy. After 6 months of therapy, responses were maintained including a 10% CR. The 2-year progression free and overall survival were 57 and 66%, respectively. A favorable response was associated with beta2 microglobulin < or =4 mg/dl, platelets >80 x 10(9)/l and nonrefractory disease. Regarding survival, low beta2 microglobulin (< or =4 mg/dl), age (< or =65 years) and absence of extramedullary myelomatous lesion were associated with a longer survival. Major adverse effects included constipation (24%), somnolence (18%), fatigue (17%) and infection (13%). Only 7% of patients developed a thrombo-embolic event. ThaCyDex is an oral regimen that induces a high response rate and long remissions, particularly in relapsing patients with beta2 microglobulin < or =4 mg/dl and < or =65 years.
我们评估了沙利度胺、环磷酰胺和地塞米松口服联合方案（ThaCyDex）对71例难治性/复发性多发性骨髓瘤患者的疗效，包括对反应和生存进行预测的预后分析。患者接受剂量递增的沙利度胺（200 - 800毫克/天）、每日环磷酰胺（50毫克/天）和脉冲式地塞米松（40毫克/天，每3周4天）治疗。基于意向性治疗原则并采用欧洲血液与骨髓移植协会（EBMT）反应标准，治疗3个月后，2%的患者达到完全缓解（CR），55%部分缓解（PR），26%轻微缓解（MR），总缓解率（CR + PR + MR）为83%。治疗6个月后，缓解得以维持，完全缓解率为10%。2年无进展生存率和总生存率分别为57%和66%。良好的反应与β2微球蛋白≤4毫克/分升、血小板＞80×10⁹/升及非难治性疾病相关。关于生存，低β2微球蛋白（≤4毫克/分升）、年龄≤65岁及无髓外骨髓瘤病变与更长的生存期相关。主要不良反应包括便秘（24%）、嗜睡（18%）、疲劳（17%）和感染（13%）。仅7%的患者发生血栓栓塞事件。ThaCyDex是一种口服方案，可诱导高反应率和长期缓解，尤其对于β2微球蛋白≤4毫克/分升且年龄≤65岁的复发患者。
