Yuan Zhen-Gang, Hou Jian, Wang Dong-Xing, Fu Wei-Jun, Chen Yu-Bao, Xi Hao
Department of Hematology, The Second Affiliated Hospital, Second Military Medical University, Shanghai, 200003, PR China.
Ai Zheng. 2007 Dec;26(12):1369-72.
BACKGROUND & OBJECTIVE: Thalidomide is effective in treating refractory and relapsed multiple myeloma (MM). However, the efficacy of thalidomide in induction therapy for newly diagnosed MM remains unknown. This study was to evaluate the efficacy of thalidomide combined dexamethasone (TD induction regimen) on previously untreated MM, and observe the adverse events.
Thirty-nine patients with newly diagnosed MM received oral administration of thalidomide at a dose of 100-300 mg/day continuously and dexamethasone at a dose of 20-40 mg/day on Days 1-4, 9-12, 17-20 in odd months and on Days 1-4 in even months. TD regimen was repeated every 28 days. Thirty-six MM patients who received VAD regimen (vindesine, adriamycin, and dexamethasone) was regarded as a historical matched controls. The efficacy, survival time and adverse events were compared between the two groups.
The overall response rates were 71.8% in TD group and 61.1% in VAD group (P>0.05). The median progression-free survival was 14 months in TD group and 9 months in VAD group (P>0.05). Within a median follow-up of 13 months (range, 1-30 months), median overall survival (OS) was not reached in TD group, and was 29 months in VAD group. The most common adverse events (always not higher than grade 2) were constipation, fatigue, dizziness and somnolence in TD group. More grade 3-4 adverse events, included leucopenia and thrombocytopenia, and higher infection rate were observed in VAD group as compared with those in TD group (P<0.05).
The combination of thalidomide and dexamethasone is an effective induction regimen for newly diagnosed MM. It may be considered as a replacement of VAD regimen.
沙利度胺对难治性及复发性多发性骨髓瘤（MM）有效。然而，沙利度胺用于新诊断MM诱导治疗的疗效尚不清楚。本研究旨在评估沙利度胺联合地塞米松（TD诱导方案）用于初治MM的疗效，并观察不良事件。
39例新诊断的MM患者连续口服沙利度胺，剂量为100 - 300mg/天，地塞米松在奇数月的第1 - 4天、9 - 12天、17 - 20天及偶数月的第1 - 4天，剂量为20 - 40mg/天。TD方案每28天重复一次。36例接受VAD方案（长春地辛、阿霉素和地塞米松）的MM患者作为历史对照。比较两组的疗效、生存时间及不良事件。
TD组总缓解率为71.8%，VAD组为61.1%（P>0.05）。TD组中位无进展生存期为14个月，VAD组为9个月（P>0.05）。中位随访13个月（范围1 - 30个月），TD组未达到中位总生存期（OS），VAD组为29个月。TD组最常见的不良事件（均不高于2级）为便秘、乏力、头晕和嗜睡。与TD组相比，VAD组观察到更多3 - 4级不良事件，包括白细胞减少和血小板减少，且感染率更高（P<0.05）。
沙利度胺与地塞米松联合是新诊断MM有效的诱导方案。可考虑替代VAD方案。
