A phase II trial of thalidomide in patients with refractory uterine carcinosarcoma and correlation with biomarkers of angiogenesis: a Gynecologic Oncology Group study.
A phase II trial of thalidomide in patients with refractory uterine carcinosarcoma and correlation with biomarkers of angiogenesis: a Gynecologic Oncology Group study.
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沙利度胺治疗难治性子宫癌肉瘤患者的 II 期试验及其与血管生成生物标志物的相关性：一项妇科肿瘤小组研究。
DOI：
10.1016/j.ygyno.2012.07.095
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发表时间：
2012
影响因子：
4.7
通讯作者：
Benbrook,DorisMangiaracina
中科院分区：
文献类型：
--
作者：
McMeekin,DScott;Sill,MichaelW;Darcy,KathleenM;Abulafia,Ovadia;Hanjani,Parviz;Pearl,MichaelL;Rubin,StephenC;Rose,PeterG;Small,Laurie;Benbrook,DorisMangiaracina
OBJECTIVESTo evaluate the efficacy and adverse events of thalidomide in previously-treated, measurable, persistent or recurrent carcinosarcoma of the uterus, and to explore associations between angiogenic markers with patient demographics and clinical outcome.METHODSEligible, consenting patients were treated until disease progression or toxicity intervened with daily starting dose of 200mg thalidomide/day that was increased by 200mg every 2weeks to a target dose of 1000mg/day. Endpoints included progression-free survival (PFS)≥6months (primary), toxicity, response, overall PFS and survival. Pre- and post-treatment plasma were evaluated for a panel of angiogenic biomarkers and assessed against clinical outcomes.RESULTSOf 55 enrolled patients, 45 were evaluable for toxicity and survival. Two patients (4%; 90% CI 1–13%) experienced a partial response, and 8 (18%; 90% CI 9–30%) had PFS≥6months. Median PFS was 1.9months and median survival was 5.9months. Grade 2–3 sensory neuropathy was noted in 6 patients, and 4, 3, and 3 patients experienced grade 3 sedation, fatigue, and constipation, respectively. Three patients had grade 4 adverse events (2 thromboembolic, 1 anemia). High pre-treatment VEGFA levels were associated with poorer PFS and survival.CONCLUSIONSTreatment with thalidomide met the protocol specified goal of prolonging PFS at 6months. However, based on results with newer agents, the activity was insufficient to support further investigation. Association between pre-treatment VEGFA and prognosis in this population supports further evaluation of anti-angiogenic therapies in uterine carcinosarcoma.
