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阿帕替尼治疗复发性或晚期宫颈癌患者的有效性及预后因素:一项回顾性研究。

Effectiveness and prognostic factors of apatinib treatment in patients with recurrent or advanced cervical carcinoma: A retrospective study.

机构信息

Department of Radiation and Medical Oncology, Zhongnan Hospital of Wuhan University, Wuhan, People's Republic of China.

Hubei Key Laboratory of Tumor Biological Behaviors, Zhongnan Hospital of Wuhan University, Wuhan, People's Republic of China.

出版信息

Cancer Med. 2021 Jul;10(13):4282-4290. doi: 10.1002/cam4.3966. Epub 2021 May 13.

Abstract

BACKGROUND

Apatinib is an oral anti-angiogenic drug, its efficacy and prognosis in cervical carcinoma are unclear. This study evaluates the effectiveness and prognostic factors of apatinib in the treatment of recurrent or advanced cervical carcinoma.

METHODS

Patients with recurrent or advanced cervical cancer, who agreed to take apatinib, were recruited into this single-center and retrospective study, and administrated apatinib with or without combination of chemo- or radio-therapy until progressive disease (PD) or unacceptable toxicity.

RESULTS

From March 2017 to February 2019, 53 patients were reviewed. Among them, 2 (3.77%) patients occurred complete response, 16 (30.19%) patients showed partial response, 27 (50.95%) patients had stable disease, and 8 (15.09%) patients had PD. The objective response rate and disease control rate (DCR) of these patients were 33.96% and 84.91%, respectively. The DCR of patients younger than 50, nonsquamous carcinoma, first-line apatinib therapy, combined radiotherapy, lesions within radiation field, surgical history, and Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 were significantly higher than other patients (p < 0.05). The median progression-free survival (PFS) and overall survival (OS) were 6.0 months (95% CI: 4.43-7.57) and 8.0 months (95% CI: 6.52-9.48), respectively. The univariable and multivariable analysis showed that the patients with an ECOG performance status score of 2 and further line therapy were associated with poor prognosis in both PFS and OS (PFS: HR =8.35, p = 0.000; HR =6.66, p = 0.001; OS: HR = 7.40, p = 0.000; HR = 3.24, p = 0.039), respectively. The most common adverse effects (AEs) were hand-foot syndrome (35.58%), hypertension (18.87%) and fatigue (15.09%). No grade 3 AEs and drug-related death occurred.

CONCLUSION

The efficacy and prognosis of patients who are in good general condition and first-line apatinib combination therapy may be better than other patients. But further phase III clinical trials should be taken to prove this hypothesis.

摘要

背景

阿帕替尼是一种口服抗血管生成药物,其在宫颈癌中的疗效和预后尚不清楚。本研究评估了阿帕替尼治疗复发性或晚期宫颈癌的疗效和预后因素。

方法

本单中心回顾性研究招募了同意接受阿帕替尼治疗的复发性或晚期宫颈癌患者,并在给予阿帕替尼治疗的同时联合化疗或放疗,直至疾病进展(PD)或出现不可接受的毒性。

结果

2017 年 3 月至 2019 年 2 月,共纳入 53 例患者。其中,2 例(3.77%)患者完全缓解,16 例(30.19%)患者部分缓解,27 例(50.95%)患者病情稳定,8 例(15.09%)患者疾病进展。这些患者的客观缓解率(ORR)和疾病控制率(DCR)分别为 33.96%和 84.91%。年龄小于 50 岁、非鳞癌、一线阿帕替尼治疗、联合放疗、病灶位于放疗野内、有手术史、Eastern Cooperative Oncology Group(ECOG)体能状态评分 0 或 1 的患者的 DCR 明显高于其他患者(p<0.05)。中位无进展生存期(PFS)和总生存期(OS)分别为 6.0 个月(95%CI:4.43-7.57)和 8.0 个月(95%CI:6.52-9.48)。单因素和多因素分析显示,ECOG 体能状态评分 2 分和二线治疗与 PFS 和 OS 预后不良相关(PFS:HR=8.35,p=0.000;HR=6.66,p=0.001;OS:HR=7.40,p=0.000;HR=3.24,p=0.039)。最常见的不良反应(AE)是手足综合征(35.58%)、高血压(18.87%)和疲劳(15.09%)。未发生 3 级 AE 和与药物相关的死亡。

结论

一般情况良好且一线阿帕替尼联合治疗的患者的疗效和预后可能优于其他患者。但需要进一步的 III 期临床试验来验证这一假设。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a84b/8267132/fd586ceba3d8/CAM4-10-4282-g002.jpg

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