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安罗替尼作为铂耐药卵巢癌的探索性治疗:一项关于疗效和安全性的回顾性研究

Anlotinib as Exploratory Therapy for Platinum-Resistant Ovarian Cancer: A Retrospective Study on Efficacy and Safety.

作者信息

Ni Jing, Cheng Xianzhong, Chen Jin, Guo Wenwen, Dai Zhiqin

机构信息

Department of Gynecologic Oncology, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, Jiangsu 210009, People's Republic of China.

Department of Pathology, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210009, People's Republic of China.

出版信息

Onco Targets Ther. 2020 Oct 5;13:9857-9863. doi: 10.2147/OTT.S268613. eCollection 2020.

DOI:10.2147/OTT.S268613
PMID:33116571
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7547134/
Abstract

PURPOSE

Survival of platinum-resistant ovarian cancer (PROC) patients is significantly shortened to around 12 months. Anlotinib is a new multi-target tyrosine kinase inhibitor. The goal of this study is to evaluate the efficacy and safety of anlotinib in PROC patients.

PATIENTS AND METHODS

PROC patients treated with anlotinib in Jiangsu Cancer Hospital between June 2018 to September 2019 were recruited. Most patients received an initial bolus of 12mg orally once daily on days 1-14 of a 21-day cycle (except one received a dose of 10mg and another one received a dose of 8mg orally once a day). The adverse events (AEs) and efficacy were analyzed by CTCAE 4.0 and RECIST 1.1.

RESULTS

Of all 15 enrolled patients, 12 patients received anlotinib as multi-line therapy and 3 patients received it as maintenance therapy. In the multi-line therapy group, eight patients received anlotinib monotherapy and four patients received anlotinib combined with chemotherapy. Ultimately, evaluation showed that one patient achieved partial response (PR), five patients achieved stable disease (SD) and one patient had progressive disease (PD) with monotherapy, yielding objective response rate (ORR) of 14.3% (95% CI=0.01-0.58) and disease control rate (DCR) of 85.7% (95% CI=0.42-0.99). One patient achieved PR, two patients achieved SD with combination therapy, yielding ORR of 33.3% (95% CI=0.02-0.87) and DCR of 100% (95% CI=0.31-1.00). Three patients with maintenance therapy were followed up for 5, 8, and 11 months, respectively. The most grade 1-2 AEs were hand-foot syndrome, nausea, and hypertension. Serious AEs (SAEs) (Grade 3-4) were observed in one patient with oral ulcer and another patient with hand-foot syndrome that were managed by dose reduction.

CONCLUSION

Anlotinib was of promising efficacy and well tolerated in PROC patients. This is the first retrospective study about exploratory therapy for ovarian cancer patients with anlotinib.

摘要

目的

铂耐药卵巢癌(PROC)患者的生存期显著缩短至约12个月。安罗替尼是一种新型多靶点酪氨酸激酶抑制剂。本研究的目的是评估安罗替尼在PROC患者中的疗效和安全性。

患者与方法

招募2018年6月至2019年9月在江苏省肿瘤医院接受安罗替尼治疗的PROC患者。大多数患者在21天周期的第1 - 14天接受初始口服剂量12mg,每日一次(除1例接受10mg剂量,另1例接受8mg口服每日一次)。采用CTCAE 4.0和RECIST 1.1分析不良事件(AE)和疗效。

结果

在所有15例入组患者中,12例患者接受安罗替尼作为多线治疗,3例患者接受其作为维持治疗。在多线治疗组中,8例患者接受安罗替尼单药治疗,4例患者接受安罗替尼联合化疗。最终评估显示,单药治疗中有1例患者达到部分缓解(PR),5例患者疾病稳定(SD),1例患者疾病进展(PD),客观缓解率(ORR)为14.3%(95%CI = 0.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c461/7547134/4fe1e40e956a/OTT-13-9857-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c461/7547134/9e7406e59266/OTT-13-9857-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c461/7547134/4fe1e40e956a/OTT-13-9857-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c461/7547134/9e7406e59266/OTT-13-9857-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c461/7547134/4fe1e40e956a/OTT-13-9857-g0002.jpg

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本文引用的文献

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N Engl J Med. 2019 Dec 19;381(25):2416-2428. doi: 10.1056/NEJMoa1911361.
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Chemotherapy versus surgery for initial treatment in advanced ovarian epithelial cancer.晚期卵巢上皮癌初始治疗中化疗与手术的比较
Cochrane Database Syst Rev. 2019 Oct 31;2019(10):CD005343. doi: 10.1002/14651858.CD005343.pub4.
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Niraparib monotherapy for late-line treatment of ovarian cancer (QUADRA): a multicentre, open-label, single-arm, phase 2 trial.
单药安罗替尼或联合化疗治疗铂耐药复发性卵巢癌的有效性和安全性:一项单中心回顾性研究
Am J Transl Res. 2023 Mar 15;15(3):1973-1981. eCollection 2023.
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Targeted therapy and immunotherapy: Diamonds in the rough in the treatment of epithelial ovarian cancer.靶向治疗与免疫治疗:上皮性卵巢癌治疗中的璞玉
Front Pharmacol. 2023 Mar 24;14:1131342. doi: 10.3389/fphar.2023.1131342. eCollection 2023.
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Anlotinib Suppressed Ovarian Cancer Progression via Inducing G2/M Phase Arrest and Apoptosis.安罗替尼通过诱导G2/M期阻滞和凋亡抑制卵巢癌进展。
J Clin Med. 2022 Dec 25;12(1):162. doi: 10.3390/jcm12010162.
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Antitumoral Effect of Plocabulin in High Grade Serous Ovarian Carcinoma Cell Line Models.普罗卡布林在高级别浆液性卵巢癌细胞系模型中的抗肿瘤作用
Front Oncol. 2022 Mar 17;12:862321. doi: 10.3389/fonc.2022.862321. eCollection 2022.
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Lancet Oncol. 2017 Jan;18(1):75-87. doi: 10.1016/S1470-2045(16)30559-9. Epub 2016 Nov 29.