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阿昔替尼治疗转移性肾细胞癌:单中心经验

Axitinib in metastatic renal cell carcinoma: single center experience.

作者信息

Buraczewska Agnieszka, Kardas Joanna

机构信息

Department of Oncology, Military Institute of Medicine, Warsaw, Poland.

出版信息

Contemp Oncol (Pozn). 2016;20(6):481-485. doi: 10.5114/wo.2016.65609. Epub 2017 Jan 12.

Abstract

AIM OF THE STUDY

Due to the emergence of new therapeutic opportunities in the second-line treatment of metastatic renal cell carcinoma, the choice of the appropriate medication requires consideration. Making the selection one should take into account the likelihood of response, the probability of toxicity, properties of the drug and the clinical characteristics of the patient. Aim of the work was to confirm antitumor efficacy of axitinib in patients with metastatic clear-cell renal-cell carcinoma in the second line treatment remaining under the care of our institution. The primary objective was to determine antitumor activity, secondary - to evaluate progression free survival, safety of the treatment and to analyse clinical characteristics of treated population.

RESULTS

Treatment records of 27 patients (9 females, 18 males) treated from October 2014 to the present (July 2016) were reviewed. The median duration of treatment which corresponds to the time to disease progression in observed population was 6 months (range: under 1 month - 16 months). 1 patient (3.7%) had got objective response (PR, partial remission). Clinical benefit rate (PR + SD (stable disease) was 66%. 9 patients (33.33%) experienced treatment toxicity only in the first degree of CTCAE (common toxicity criteria for adverse events), 11 patients (40.74%) presented the second degree toxicity and 5 patients (18.5%) - third degree. The most commonly reported treatment related adverse events were diarrhea (47%), fatigue (26%), hand-foot syndrome (26%), deterioration of blood pressure control (22.2%), abnormal liver function tests (18.5%), mucositis (11.1%). We observed 3 cases of unacceptable toxicity.

CONCLUSIONS

Axitinib confirms its effectiveness also in situation outside clinical trials, however, it is characterized by significant toxicity. Therefore, qualification for treatment should take into account the clinical patient characteristics. Effective diagnosis and treatment of side effects and dose optimization are the key skills of the attending physician.

摘要

研究目的

由于转移性肾细胞癌二线治疗中出现了新的治疗机会,因此在选择合适的药物时需要慎重考虑。在做出选择时,应考虑反应的可能性、毒性的概率、药物特性以及患者的临床特征。本研究的目的是证实阿昔替尼在我院接受二线治疗的转移性透明细胞肾细胞癌患者中的抗肿瘤疗效。主要目标是确定抗肿瘤活性,次要目标是评估无进展生存期、治疗安全性并分析治疗人群的临床特征。

结果

回顾了2014年10月至目前(2016年7月)接受治疗的27例患者(9例女性,18例男性)的治疗记录。观察人群中与疾病进展时间相对应的中位治疗持续时间为6个月(范围:不足1个月至16个月)。1例患者(3.7%)获得客观缓解(PR,部分缓解)。临床获益率(PR + SD[疾病稳定])为66%。9例患者(33.33%)仅经历了CTCAE(不良事件通用毒性标准)一级的治疗毒性,11例患者(40.74%)出现二级毒性,5例患者(18.5%)出现三级毒性。最常报告的与治疗相关的不良事件为腹泻(47%)、疲劳(26%)、手足综合征(26%)、血压控制恶化(22.2%)、肝功能检查异常(18.5%)、黏膜炎(11.1%)。我们观察到3例不可接受的毒性反应。

结论

阿昔替尼在临床试验之外的情况下也证实了其有效性,然而,它具有明显的毒性。因此,治疗资格的确定应考虑患者的临床特征。有效诊断和治疗副作用以及剂量优化是主治医师的关键技能。

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