科研之友
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摘要
Introduction. Patients presenting with advanced, recurrent, or metastatic endometrial cancer have limited treatment options. On behalf of the Gynecologic Oncology Group, we conducted this phase II trial of nintedanib (BIBF 1120), a potent small molecule triple receptor tyrosine kinase inhibitor of PDGFR alpha and beta, FGFR 1/3, and VEGFR 1-3, in this population. %26lt;br%26gt;Objectives. The primary objectives were to estimate event-free survival (EFS) at 6 months and the proportion of patients who have an objective tumor response. In addition, we sought to determine the nature and degree of toxicity. Secondary objectives were to estimate progression-free and overall survival. %26lt;br%26gt;Methods. This was a two-stage, single-arm phase II study. Eligible patients were treated with single-agent nintedanib at a dose of 200 mg twice daily. %26lt;br%26gt;Results. Of 37 patients enrolled, 32 were eligible. There were zero complete and three partial responses for an overall response rate of 9.4% (90%2-sided CI = 2.6-22.5%). Seven patients (21.9%; 90%2-sided CI = 10.7-37.2%) were EFS at 6 months, with one patient continuing on study at the time of this writing. Serious toxicity included the following grade 3 events: gastrointestinal toxicity (5), neutropenia (1), edema (1), hypertension (1), and liver function abnormalities (5). %26lt;br%26gt;Conclusions. Nintedanib lacked sufficient activity as a single agent to warrant enrollment to second stage. However, predinical data indicate it may be synergistic with paclitaxel in a population of patients enriched for specific p53 mutations that result in loss of function. Subsequent studies may evaluate this agent in combination with paclitaxel.
- 出版日期2014-12
