Ikebe Taichi, Ogata Masao, Miyazaki Miki, Miyazaki Yasuhiko, Ohtsuka Eiichi, Saburi Yoshio, Goto Kanako, Ikewaki Junji, Kohno Kazuhiro, Uno Noritaka, Imamura Tomoyuki, Akagi Teruhisa, Kadota Junichi
Department of Internal Medicine 2, Oita University Faculty of Medicine.
Rinsho Ketsueki. 2010 Feb;51(2):114-21.
Thalidomide is now recognized as an important agent for multiple myeloma. In this study, we retrospectively analyzed the effect of thalidomide therapy in 52 patients with relapsed/refractory multiple myeloma. Median age was 70 years. Eight patients were treated with thalidomide alone, 36 with dexamethasone, and 8 with chemotherapy. The maintenance dose of thalidomide was 100 mg/day in 42 cases. The probability of overall survival and progression-free survival one year after the start of thalidomide were 76.2% and 70.9%, respectively. Complete or partial response was obtained in 16 patients (31%). The probability of survival was better in patients who obtained a partial or complete response than in non-responders (P=0.04). Adverse effects (CTCAE criteria Grade 3-4) were somnolence (n=3), constipation (n=5), peripheral neuropathy (n=1), deep vein thrombosis (n=1), anemia (n=10), leukocytopenia (n=10), and thrombocytopenia (n=3). The high incidence of cytopenia in this study suggests that the Japanese population tends to display bone marrow suppression after thalidomide therapy. Some patients developed peripheral neuropathy at the early stage of administration and attention was necessary. In conclusion, thalidomide therapy is safe and effective in patients with refractory multiple myeloma.
沙利度胺现在被认为是治疗多发性骨髓瘤的一种重要药物。在本研究中,我们回顾性分析了沙利度胺治疗52例复发/难治性多发性骨髓瘤患者的疗效。中位年龄为70岁。8例患者仅接受沙利度胺治疗,36例接受地塞米松治疗,8例接受化疗。42例患者沙利度胺的维持剂量为100mg/天。开始使用沙利度胺一年后的总生存率和无进展生存率分别为76.2%和70.9%。16例患者(31%)获得完全或部分缓解。获得部分或完全缓解的患者的生存率高于未缓解患者(P=0.04)。不良反应(CTCAE标准3-4级)包括嗜睡(n=3)、便秘(n=5)、周围神经病变(n=1)、深静脉血栓形成(n=1)、贫血(n=10)、白细胞减少(n=10)和血小板减少(n=3)。本研究中血细胞减少的高发生率表明,日本人群在沙利度胺治疗后倾向于出现骨髓抑制。一些患者在给药早期出现周围神经病变,需要引起注意。总之,沙利度胺治疗难治性多发性骨髓瘤患者安全有效。