Albumin-bound paclitaxel plus anlotinib in patients with recurrent, platinum-resistant primary epithelial ovarian cancer (A-Plus): a phase II, single-arm, prospective study.
10.1007/s11684-025-1155-1
- Author:
Yun ZHOU
1
;
Jian ZHOU
1
;
Yin WANG
1
;
Ji-Bin LI
1
;
Rongzhen LUO
1
;
Chanjuan ZENG
1
;
Yingxin HE
1
;
Yanfang LI
2
Author Information
1. State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, 510060, China.
2. State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, 510060, China. liyf@sysucc.org.cn.
- Publication Type:Clinical Trial, Phase II
- Keywords:
ab-paclitaxel;
anlotinib;
efficacy;
safety
- MeSH:
Humans;
Female;
Middle Aged;
Indoles/therapeutic use*;
Quinolines/therapeutic use*;
Carcinoma, Ovarian Epithelial/drug therapy*;
Adult;
Ovarian Neoplasms/drug therapy*;
Prospective Studies;
Antineoplastic Combined Chemotherapy Protocols/administration & dosage*;
Aged;
Drug Resistance, Neoplasm;
Albumin-Bound Paclitaxel/therapeutic use*;
Neoplasm Recurrence, Local/drug therapy*;
Progression-Free Survival;
Paclitaxel/administration & dosage*;
Treatment Outcome
- From:
Frontiers of Medicine
2025;19(5):820-830
- CountryChina
- Language:English
-
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.
