Albumin-bound paclitaxel plus anlotinib in patients with recurrent, platinum-resistant primary epithelial ovarian cancer (A-Plus): a phase II, single-arm, prospective study.
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引用次数: 0
Abstract
This study aimed to evaluate the efficacy and safety of combining albumin-bound paclitaxel (abpaclitaxel) and anlotinib for ovarian cancer. In this study, 44 patients diagnosed with platinum-resistant ovarian cancer were enrolled. Patients received ab-paclitaxel along with anlotinib until disease progression or intolerable toxicity. Efficacy was assessed according to RECIST 1.1 criteria or Rustin's criteria. The primary endpoint was the investigator-evaluated objective response rate (ORR). 44 patients were enrolled between January 2021 and March 2023 with a median age of 49 years. Twenty-nine had measurable lesions and 15 had non-measurable lesions. Overall, the investigator-evaluated ORR was 56.8% (25/44; 95% CI 0.411-0.713) in intention-to-treat population and 58.1% (25/43; 95% CI 0.422-0.726) in per-protocol population. The median progression-free survival was 9.8 months, and the median duration of response was 7.4 months. For safety, grade 3/4 adverse events (AEs) included leukopenia, gum pain, hypertension, and hand-foot syndrome. The response rates were 55.0% (11/20) in patients with previous use of antiangiogenic reagents and who had previous use of PARP inhibitors. The combination of ab-paclitaxel and anlotinib showed promising anti-tumor activity and a manageable safety profile in platinum-resistant ovarian cancer. Patients with previous use of antiangiogenic drugs or PARP inhibitors still benefited from this protocol.
本研究旨在评价白蛋白结合紫杉醇(abpaclitaxel)联合安洛替尼治疗卵巢癌的疗效和安全性。在这项研究中,44名诊断为铂耐药卵巢癌的患者入组。患者接受ab-紫杉醇和安洛替尼联合治疗,直到疾病进展或出现无法忍受的毒性。根据RECIST 1.1标准或Rustin标准评估疗效。主要终点是研究者评估的客观缓解率(ORR)。在2021年1月至2023年3月期间招募了44名患者,中位年龄为49岁。29例病变可测量,15例病变不可测量。总体而言,研究者评估的意向治疗人群的ORR为56.8% (25/44;95% CI 0.411-0.713),按方案人群的ORR为58.1% (25/43;95% CI 0.422-0.726)。中位无进展生存期为9.8个月,中位缓解持续时间为7.4个月。安全性方面,3/4级不良事件(ae)包括白细胞减少、牙龈痛、高血压和手足综合征。在既往使用过抗血管生成试剂和既往使用过PARP抑制剂的患者中,有效率为55.0%(11/20)。ab-紫杉醇和anlotinib联合治疗铂耐药卵巢癌显示出良好的抗肿瘤活性和可管理的安全性。先前使用过抗血管生成药物或PARP抑制剂的患者仍然受益于该方案。
Frontiers of MedicineONCOLOGYMEDICINE, RESEARCH & EXPERIMENTAL&-MEDICINE, RESEARCH & EXPERIMENTAL
CiteScore
18.30
自引率
0.00%
发文量
800
期刊介绍:
Frontiers of Medicine is an international general medical journal sponsored by the Ministry of Education of China. The journal is jointly published by the Higher Education Press and Springer. Since the first issue of 2010, this journal has been indexed in PubMed/MEDLINE.
Frontiers of Medicine is dedicated to publishing original research and review articles on the latest advances in clinical and basic medicine with a focus on epidemiology, traditional Chinese medicine, translational research, healthcare, public health and health policies.