A phase II study of sunitinib in patients with recurrent epithelial ovarian and primary peritoneal carcinoma: an NCIC Clinical Trials Group Study
A phase II study of sunitinib in patients with recurrent epithelial ovarian and primary peritoneal carcinoma: an NCIC Clinical Trials Group Study
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DOI：
10.1093/annonc/mdq357
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发表时间：
2011-02-01
影响因子：
50.5
通讯作者：
Eisenhauer, E. A.
中科院分区：
文献类型：
--
作者：
Biagi, J. J.;Oza, A. M.;Eisenhauer, E. A.
目的：舒尼替尼是一种多靶点受体酪氨酸激酶抑制剂。我们进行了两个阶段的第二阶段的研究，以评估复发性上皮性卵巢cancer.Patients和方法的客观响应率口服舒尼替尼：资格需要可测量的疾病和一个或两个先前的化疗，至少一个铂为基础。允许铂敏感或耐药疾病。初始给药方案为舒尼替尼50 mg/d，共4/6周。在停药期间观察液体积累导致通过连续37.5毫克，每天给药的第二阶段accument.Results：30名合格的患者，大多数有浆液性组织学（67%），铂敏感（73%），并有两个先前的化疗（60%）。观察到1例部分缓解（3.3%）和3例CA 125缓解（10%），均发生在使用间歇给药的铂敏感患者中。16人（53%）病情稳定。5例可测量疾病减少>30%。总体中位无进展生存期为4.1个月。常见的不良反应包括疲劳、胃肠道症状、手足综合征和高血压。结论：单药舒尼替尼在复发性铂敏感性卵巢癌中具有适度的活性，但仅在50 mg间歇剂量方案下，这表明剂量和方案可能是进一步评估舒尼替尼在这种癌症环境中的重要考虑因素。
Purpose: Sunitinib is a multitargeted receptor tyrosine kinase inhibitor. We conducted a two-stage phase II study to evaluate the objective response rate of oral sunitinib in recurrent epithelial ovarian cancer.Patients and methods: Eligibility required measurable disease and one or two prior chemotherapies, at least one platinum based. Platinum-sensitive or -resistant disease was allowed. Initial dose schedule was sunitinib 50 mg daily, 4 of 6 weeks. Observation of fluid accumulations during off-treatment periods resulted in adoption of continuous 37.5 mg daily dosing in the second stage of accrual.Results: Of 30 eligible patients, most had serous histology (67%), were platinum sensitive (73%) and had two prior chemotherapies (60%). One partial response (3.3%) and three CA125 responses (10%) were observed, all in platinum-sensitive patients using intermittent dosing. Sixteen (53%) had stable disease. Five had >30% decrease in measurable disease. Overall median progression-free survival was 4.1 months. Common adverse events included fatigue, gastrointestinal symptoms, hand-foot syndrome and hypertension. No gastrointestinal perforation occurred.Conclusions: Single-agent sunitinib has modest activity in recurrent platinum-sensitive ovarian cancer, but only at the 50 mg intermittent dose schedule, suggesting that dose and schedule may be vital considerations in further evaluation of sunitinib in this cancer setting.