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对于体能状态较差的晚期胃癌患者,作为三线或更后线治疗时,需谨慎调整阿帕替尼的剂量。

Careful dose modification of apatinib as third or further-line treatment in advanced gastric cancer patients with poor performance status.

作者信息

Chen Jianxin, Wang Junhui, Miao Qian

机构信息

Department of Medical Oncology.

Department of Radiation Oncology, Quzhou People's Hospital, Quzhou, Zhejiang, China.

出版信息

Medicine (Baltimore). 2019 Nov;98(45):e17890. doi: 10.1097/MD.0000000000017890.

Abstract

The retrospective study was conducted to evaluate the efficacy and safety of careful dose modification of apatinib as third or further-line treatment in advanced gastric cancer (aGC) patients with poor performance status (PS = 2 or 3).Patients with aGC of poor PS who had received at least 2 lines of chemotherapy were treated with apatinib at a dose of 250 mg initially and best supportive care (BSC). During the whole treatment, the dose of apatinib was adjusted according to the status of PS (group treatment). Meanwhile, patients of poor PS (PS = 2 or 3) with aGC who received BSC alone after second or further-line treatment in the recent 5 years in our institution have been investigated for their median overall survival (mOS) as control. Kaplan-Meier curve was adopted for the description of OS in the 2 groups. Univariate analysis was conducted with log-rank test between OS and the potential characteristics including gender, age, PS status, primary tumor lesion, Her-2 status, and previous lines of treatment. Toxicities were assessed with the criteria of National Cancer Institute Common Toxicity Criteria (NCI CTC) version 4.0.A total of 23 patients who received apatinib plus BSC treatment and 41 patients treated with BSC alone were reviewed in the present study. Median exposure time of apatinib was 2.4 months ranging from 0.2 to 5.1 months. The median OS in the group treatment was 4.3 months (95% CI, 2.735-5.865) comparing to the control as 2.1 months (95% CI, 1.473-2.727, P = .0004). In addition, PS status was shown as the only independently significant factor to influence the OS (P = .049). Fatigue (82.6%), appetite decrease (73.9%), and anemia (69.6%) appeared to be the most common adverse events at any grade during the therapy of apatinib.The outcomes of the present study revealed that therapeutic model of careful dose modification of apatinib therapy initiated with low dose plus BSC as third or further-line treatment might be more beneficial on survival time comparing to BSC alone in patients with aGC of poor PS, however, as well as apparent adverse events.

摘要

本回顾性研究旨在评估对体能状态较差(PS=2或3)的晚期胃癌(aGC)患者,将阿帕替尼作为三线或更后线治疗进行谨慎剂量调整的疗效和安全性。PS较差且接受过至少2线化疗的aGC患者,初始接受250mg阿帕替尼及最佳支持治疗(BSC)。在整个治疗过程中,根据PS状态调整阿帕替尼剂量(分组治疗)。同时,对我院近5年中二线或更后线治疗后仅接受BSC的PS较差(PS=2或3)的aGC患者的中位总生存期(mOS)进行调查作为对照。采用Kaplan-Meier曲线描述两组的总生存期。对总生存期与包括性别、年龄、PS状态、原发肿瘤病灶、Her-2状态及既往治疗线数等潜在特征进行单因素分析,采用对数秩检验。毒性反应按照美国国立癌症研究所通用毒性标准(NCI CTC)4.0版标准进行评估。本研究共纳入23例接受阿帕替尼联合BSC治疗的患者和41例仅接受BSC治疗的患者。阿帕替尼的中位暴露时间为2.4个月,范围为0.2至5.1个月。分组治疗组的中位总生存期为4.3个月(95%CI,2.735-5.865),而对照组为2.1个月(95%CI,1.473-2.727,P=0.0004)。此外,PS状态是唯一影响总生存期的独立显著因素(P=0.049)。疲劳(82.6%)、食欲减退(73.9%)和贫血(69.6%)似乎是阿帕替尼治疗期间任何级别最常见的不良事件。本研究结果显示,对于PS较差的aGC患者,以低剂量起始联合BSC进行阿帕替尼谨慎剂量调整的治疗模式与单纯BSC相比,可能在生存时间方面更有益,但也有明显的不良事件。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab6a/6855580/0e0b6f57a3dd/medi-98-e17890-g002.jpg

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