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阿帕替尼联合多西他赛治疗晚期食管癌的临床疗效及生存分析

Clinical efficacy and survival analysis of apatinib combined with docetaxel in advanced esophageal cancer.

作者信息

Li Jing, Jia Yongxu, Gao Yaping, Chang Zhiwei, Han Huiqiong, Yan Jie, Qin Yanru

机构信息

Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, Henan Province, People's Republic of China,

出版信息

Onco Targets Ther. 2019 Apr 8;12:2577-2583. doi: 10.2147/OTT.S191736. eCollection 2019.

Abstract

BACKGROUND AND AIM

Standard chemotherapy has limited clinical efficacy in patients with esophageal cancer and there is a significant and unmet clinical need for effective treatment options for these patients. The aim of this study was to compare the clinical efficacy of the novel, targeted drug apatinib combined with docetaxel, and docetaxel combined with S-1 as second- or further-line treatment for patients with advanced esophageal cancer.

METHODS

We enrolled 33 patients with advanced esophageal cancer in chemotherapy group or apatinib combined with chemotherapy group in this retrospective study. Apatinib (500 mg) was taken orally once daily; docetaxel was administered at a dose of 75 mg/m; and S-1 was optional at a dose of 40-60 mg, based on body surface area. The primary endpoint of this study was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), and the incidence and severity of adverse events (AEs).

RESULTS

No complete response was observed in the two groups. However, two and five patients achieved partial response in the chemotherapy group and the apatinib combined with chemotherapy group, respectively. The ORR and DCR for the chemotherapy group was 11.1% and 33.3%, respectively. In the apatinib combination group, ORR and DCR was 88.9% and 93.3%, respectively. Anemia (11.1%) and neutropenia (5.6%) were the most frequent grade III/IV AEs observed in the chemotherapy group. In the apatinib combination group, the most frequent grade III/IV AEs were anemia (13.3%), hypertension (6.7%), and proteinuria (6.7%). Median PFS was significantly longer in the apatinib combination group than in the chemotherapy group (175 days vs 85 days, =0.01).

CONCLUSION

The combination of apatinib and docetaxel has a manageable toxicity profile and may prolong survival. Therefore, this combination may be used as as second- or further-line treatment for patients with advanced esophageal cancer.

摘要

背景与目的

标准化疗对食管癌患者的临床疗效有限,这些患者对有效治疗方案存在显著且未满足的临床需求。本研究的目的是比较新型靶向药物阿帕替尼联合多西他赛与多西他赛联合S-1作为晚期食管癌患者二线或后续治疗的临床疗效。

方法

在这项回顾性研究中,我们将33例晚期食管癌患者纳入化疗组或阿帕替尼联合化疗组。阿帕替尼(500毫克)每日口服一次;多西他赛的给药剂量为75毫克/平方米;S-1根据体表面积,剂量为40 - 60毫克,可选用。本研究的主要终点是无进展生存期(PFS)。次要终点包括客观缓解率(ORR)、疾病控制率(DCR)以及不良事件(AE)的发生率和严重程度。

结果

两组均未观察到完全缓解。然而,化疗组和阿帕替尼联合化疗组分别有2例和5例患者达到部分缓解。化疗组的ORR和DCR分别为11.1%和33.3%。在阿帕替尼联合组中,ORR和DCR分别为88.9%和93.3%。贫血(11.1%)和中性粒细胞减少(5.6%)是化疗组中观察到的最常见的III/IV级AE。在阿帕替尼联合组中,最常见的III/IV级AE是贫血(13.3%)、高血压(6.7%)和蛋白尿(6.7%)。阿帕替尼联合组的中位PFS显著长于化疗组(175天对85天,P = 0.01)。

结论

阿帕替尼与多西他赛联合具有可管理的毒性特征,可能延长生存期。因此,这种联合方案可作为晚期食管癌患者的二线或后续治疗。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1454/6459155/ad43f9a017df/ott-12-2577Fig1.jpg

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