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Efficacy and safety of chiauranib in a combination therapy in platinum-resistant or refractory ovarian cancer: a multicenter, open-label, phase Ib and II study.
Li, Jin; Liu, Jihong; Yin, Rutie; Zou, Dongling; Zheng, Hong; Cao, Junning; Chen, Zhendong; Sun, Wei; Gao, Yunong; Zhang, Songling; Zeng, Linjuan; An, Ruifang; Lu, Xianping; Ye, Shuang; Wu, Xiaohua.
Afiliação
  • Li J; Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, Shanghai, 200032, China.
  • Liu J; Department of Oncology, Shanghai Medical College of Fudan University, Shanghai, 200032, China.
  • Yin R; Gynaecology Department, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, China.
  • Zou D; Gynecological Tumor Radiochemotherapy Department, West China Second University Hospital, Sichuan University, Chengdu, 610041, China.
  • Zheng H; Gynecological Oncology Center, Chongqing University Cancer Hospital, Chongqing, 400000, China.
  • Cao J; Gynaecological Oncology Department, Beijing Cancer Hospital, Beijing, 100142, China.
  • Chen Z; Department of Oncology, Shanghai Medical College of Fudan University, Shanghai, 200032, China.
  • Sun W; Department of Chemotherapy, Fudan University Shanghai Cancer Center, Shanghai, 200032, China.
  • Gao Y; Gynaecological Oncology Department, The Second Hospital of Anhui Medical University, Hefei, 230601, China.
  • Zhang S; Gynaecological Oncology Department, Anhui Province Cancer Hospital, Hefei, 230000, China.
  • Zeng L; Gynaecological Oncology Department, Beijing Cancer Hospital, Beijing, 100142, China.
  • An R; Gynaecological Oncology Department, Cancer Center of The First Hospital of Jilin University, Changchun, 130021, China.
  • Lu X; Abdominal and Pelvic Oncology Department, The Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, 519099, China.
  • Ye S; Gynaecology and Obstetrics Department, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, China.
  • Wu X; Shenzhen Chipscreen Biosciences Co., Ltd., Nanshan District, 3157 Shahe West Road, Zhigu Industrial ParkShenzhen City, Guangdong Province, No. 518055, China.
Mol Cancer ; 23(1): 162, 2024 Aug 09.
Article em En | MEDLINE | ID: mdl-39123210
ABSTRACT

BACKGROUND:

Platinum-resistant or refractory ovarian cancer is a highly lethal gynecologic disease with limited treatment options. Chiauranib is a novel small-molecule selective inhibitor, which could effectively target multiple pathways including Aurora B and CSF-1R to inhibit cell cycle process and improve anti-tumor immune function, as long as VEGF pathway for tumor extinction.

METHODS:

A phase II study was sequentially conducted after a phase Ib monotherapy study to evaluate the efficacy of chiauranib combined with chemotherapy. Chinese patients with recurrent ovarian cancer were enrolled. Eligible patients received chiauranib combined with a maximum of six cycles of chemotherapy etoposide (CE group) or weekly-paclitaxel (CP group). Patients, who exhibited a complete or partial response, or stable disease following combo treatment, progressed to maintenance phase to receive chiauranib monotherapy. Primary endpoint was progression-free survival (PFS) according to RECIST v1.1.

RESULTS:

From November 2017 to March 2019, 25 patients were enrolled in a phase 1b study and a median PFS of 3.7 months (95% CI 1.8-NE) was achieved by chiauranib monotherapy. From July 2019 to December 2020, a total of 47 patients were enrolled in the phase II study. One CP patient did not receive the study drugs, and three patients withdrew before the first tumor assessment. Thus, 43 patients (CE group 22 patients; CP group 21 patients) were included in the evaluation. The median PFS was 5·4 months (95% CI 2·8-5·6) and 5·6 months (95% CI 3·4-7·0), respectively.

CONCLUSIONS:

This was the first study to evaluate chiauranib, a novel multi-targeted kinase inhibitor in patients with ovarian cancer. The administration of chiauranib along with etoposide or weekly-paclitaxel significantly enhanced the efficacy with manageable adverse events. This warrants further clinical studies on this novel treatment. A phase III study is promising and ongoing. TRIAL REGISTRATION ClinicaTrials.gov identifier NCT03901118 (phase II) and NCT03166891 (phase Ib).
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Neoplasias Ovarianas / Protocolos de Quimioterapia Combinada Antineoplásica / Resistencia a Medicamentos Antineoplásicos Limite: Adult / Aged / Female / Humans / Middle aged Idioma: En Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Neoplasias Ovarianas / Protocolos de Quimioterapia Combinada Antineoplásica / Resistencia a Medicamentos Antineoplásicos Limite: Adult / Aged / Female / Humans / Middle aged Idioma: En Ano de publicação: 2024 Tipo de documento: Article