A Phase II Study of Thalidomide in Advanced Metastatic Renal Cell Carcinoma
A Phase II Study of Thalidomide in Advanced Metastatic Renal Cell Carcinoma
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沙利度胺治疗晚期转移性肾细胞癌的 II 期研究
DOI：
10.1023/a:1020669705369
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发表时间：
2002
影响因子：
3.4
通讯作者：
L. Elias
中科院分区：
文献类型：
--
作者：
D. Minor;D. Monroe;L. Damico;G. Meng;Uma Suryadevara;L. Elias
目的：评价沙利度胺对晚期转移性肾癌患者的毒性和活性，并检测血管生成因子血管内皮生长因子(VEGF165)在治疗过程中的变化。
患者和方法：29名患者参加了沙利度胺的研究，采用患者内剂量递增计划。5例患者服用沙利度胺400 mg/d，54天后升至1200 mg/d。59%的患者曾接受过IL-2治疗，52%的患者表现为2或3级。8例患者采用双抗夹心ELISA法测定其血浆VEGF165水平。
结果：24例患者可评价疗效，1例部分缓解11个月，1例肝肺转移(4%)，1例轻度缓解，2例稳定6个月以上。嗜睡和便秘是主要的毒性反应，大多数患者不能耐受1200 mg/d的剂量。治疗前后全身血浆VEGF165水平无明显变化。
结论：这些结果与沙利度胺在肾细胞癌中的低活性水平一致。在这些患者群体中，每天超过800毫克的剂量很难实现，但较低的剂量是可行的。如果有的话，沙利度胺治疗肾癌的剂量-反应关系尚不清楚。
AbstractObjectives: To evaluate the toxicityand activity of thalidomide in patientswith advanced metastatic renal cell cancerand to measure changes of one angiogenicfactor, vascular endothelial growth factor(VEGF)165, with therapy.
Patients and methods: 29 patients were enrolled on astudy of thalidomide using an intra-patientdose escalation schedule. Patients beganthalidomide at 400 mg/d and escalated astolerated to 1200 mg/d by day 54.Fifty-nine per cent of patients had hadprevious therapy with IL-2 and 52% wereperformance status 2 or 3. Systemic plasmaVEGF165 levels were measured by dualmonoclonal ELISA in 8 patients.
Results: 24 patients were evaluable forresponse with one partial response of 11months duration of a patient with hepaticand pulmonary metastases (4%), one minorresponse, and 2 patients stable for over 6months. Somnolence and constipation wereprominent toxicities and most patientscould not tolerate the 1200 mg/day doselevel. Systemic plasma VEGF165 levels didnot change with therapy.
Conclusion: These results are consistent with a lowlevel of activity of thalidomide in renalcell carcinoma. Administration of dosesover 800 mg/day was difficult to achieve inthis patient population, however lowerdoses were practical. The dose-responserelationship, if any, of thalidomide forrenal cell carcinoma is unclear.
影响因子：
158.5
作者：
Singhal, S;Mehta, J;Crowley, J
通讯作者：
Crowley, J
影响因子：
45.3
作者：
Little, RF;Wyvill, KM;Yarchoan, R
通讯作者：
Yarchoan, R