Hus M, Dmoszynska A, Soroka-Wojtaszko M, Jawniak D, Legiec W, Ciepnuch H, Hellmann A, Wolska-Smolen T, Skotnicki A, Manko J
Department of Hematology University Medical School, Lublin, Poland.
Haematologica. 2001 Apr;86(4):404-8.
Thalidomide is currently used as a very promising drug in patients with recurrent multiple myeloma or those refractory to chemotherapy. Literature data show prolonged survival in patients with advanced multiple myeloma treated with thalidomide but the optimal time and dose of thalidomide treatment remain to be established.
We have treated 53 refractory or relapsed myeloma patients with thalidomide (Grunenthal, Aachen). The patients received thalidomide orally as monotherapy at a starting dose of 200 mg daily, with a dose increase of 100 mg every week to a maximum well-tolerated dose of 400 mg. All the patients qualified for the therapy underwent clinical and laboratory assessments every 4 weeks. Laboratory tests included complete blood count, electrophoresis, immunoglobulin level, lactate dehydrogenase (LDH), C-reactive protein, b2 microglobulin concentration, liver and renal function tests and there was also a monthly neurological examination. Bone marrow aspiration was performed every 3 months during the 12-month treatment.
Among 53 evaluable patients, a clinical response was observed in 27 (51%): there was a major response in 7 patients, a partial response in 12 and a minor response in 8.
In responding patients the earliest response was observed after 4 weeks of treatment and the latest after 12 weeks of treatment. Our results, obtained during a long observation period, show that thalidomide is an effective drug, with an acceptable degree of toxicity, in patients with refractory multiple myeloma.
沙利度胺目前被用作治疗复发性多发性骨髓瘤患者或化疗难治性患者的一种非常有前景的药物。文献数据显示，接受沙利度胺治疗的晚期多发性骨髓瘤患者生存期延长，但沙利度胺治疗的最佳时间和剂量仍有待确定。
我们用沙利度胺（德国格伦泰因公司，亚琛）治疗了53例难治性或复发性骨髓瘤患者。患者口服沙利度胺进行单一疗法治疗，起始剂量为每日200毫克，每周剂量增加100毫克，直至最大耐受剂量400毫克。所有符合治疗条件的患者每4周进行一次临床和实验室评估。实验室检查包括全血细胞计数、电泳、免疫球蛋白水平、乳酸脱氢酶（LDH）、C反应蛋白、β2微球蛋白浓度、肝肾功能检查，并且每月进行一次神经学检查。在12个月的治疗期间，每3个月进行一次骨髓穿刺。
在53例可评估患者中，27例（51%）观察到临床反应：7例患者有主要反应，12例部分反应，8例轻微反应。
在有反应的患者中，最早在治疗4周后观察到反应，最晚在治疗12周后观察到反应。我们在长时间观察期内获得的结果表明，沙利度胺对难治性多发性骨髓瘤患者是一种有效的药物，毒性程度可接受。
