Extended survival in advanced and refractory multiple myeloma after single-agent thalidomide: identification of prognostic factors in a phase 2 study of 169 patients
Extended survival in advanced and refractory multiple myeloma after single-agent thalidomide: identification of prognostic factors in a phase 2 study of 169 patients
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DOI：
10.1182/blood.v98.2.492
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发表时间：
2001-07-15
期刊：
影响因子：
20.3
通讯作者：
Tricot, G
中科院分区：
文献类型：
--
作者：
Barlogie, B;Desikan, R;Tricot, G
沙利度胺（thalidomide， THAL） （200 mg/d，每2周增加200 mg至800 mg）的2期临床试验报告，涉及169例晚期骨髓瘤（MM）患者(异常细胞遗传学（CG）， 67%；既往自体移植（76%）扩展了84例患者的早期结果。37%的患者骨髓瘤蛋白减少25%（30%的患者减少50%，14%的患者接近完全或完全缓解），浆细胞标记指数（PCLI）低（低于0.5%）和CG正常的患者更常见。2年无事件生存率和总生存率分别为20% +/- 6%和48% +/- 6%，当CG正常、PCLI小于0.5%、β(2)-微球蛋白为3mg /L时，这些生存率更高。反应率更高，生存期更长，特别是在3个月（中位累积剂量）给予超过42 g THAL的高危患者（里程碑分析）；这支持了THAL在晚期MM中的剂量-反应效应。(C) 2001年由美国血液学学会发表。
This report of a phase 2 trial of thalidomide (THAL) (200 mg/d; 200 mg increment every 2 weeks to 800 mg) far 169 patients with advanced myeloma (MM) (abnormal cytogenetics (CG), 67%; prior autotransplant, 76%) extends earlier results in 84 patients. A 25% myeloma protein reduction was obtained in 37% of patients (50% reduction in 30% of patients; near-complete or complete remission in 14%) and was more frequent with low plasma cell labeling index (PCLI) (below 0.5%) and normal CG. Two-year event-free and overall survival rates were 20% +/- 6% and 48% +/- 6%, respectively, and these were superior with normal CG, PCLI of less than 0.5%, and beta (2)-microglobulin of 3 mg/L. Response rates were higher and survival was longer especially in high-risk patients given more than 42 g THAL in 3 months (median cumulative dose) (landmark analysis); this supports a THAL dose-response effect in advanced MM. (C) 2001 by The American Society of Hematology.