Trask Peter C, Bushmakin Andrew G, Cappelleri Joseph C, Bycott Paul, Liau Katherine, Kim Sinil
Global Outcomes Research, Pfizer Inc., New London, CT 06320, USA.
Acta Oncol. 2008;47(5):843-51. doi: 10.1080/02841860802047395.
Patients with metastatic renal cell carcinoma (RCC) are often treated with cytokine therapy, although the effect is modest and second-line therapy is often warranted. Relatively little is known regarding the impact on health-related quality of life (HRQOL) in cytokine-refractory patients. This study examined the HRQOL of patients with metastatic RCC treated with axitinib, a new targeted therapy that affects the vessels supplying blood to the tumor.
Patients with metastatic RCC and progression following first-line cytokine therapy were enrolled into a single-arm, open-label multicenter phase II trial. Axitinib was administered orally twice daily until disease progression or intolerance. The primary endpoint was objective response rate, with secondary endpoints being time to progression, overall survival, safety and HRQOL. The longitudinal analyses of the HRQOL data through 144 weeks of treatment, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, are presented here.
Fifty-two patients completed baseline HRQOL assessments. Statistically significant baseline-post-treatment changes were observed on the role, cognitive and social functioning scales as well as on the nausea and vomiting, pain and diarrhea symptoms. All of the changes were less than one-quarter of the category, with diarrhea being the exception at less than half a category, suggesting that the changes as reported by patients were not meaningful.
Treatment of metastatic RCC with axitinib demonstrated acceptable disruption in HRQOL functioning and symptoms when compared to baseline levels. From a patient-reported perspective, treatment with axitinib appears to be well tolerated.
转移性肾细胞癌（RCC）患者常接受细胞因子治疗，尽管效果一般，且往往需要二线治疗。对于细胞因子难治性患者对健康相关生活质量（HRQOL）的影响，人们了解相对较少。本研究调查了接受阿昔替尼治疗的转移性RCC患者的HRQOL，阿昔替尼是一种影响肿瘤供血血管的新型靶向治疗药物。
一线细胞因子治疗后病情进展的转移性RCC患者被纳入一项单臂、开放标签的多中心II期试验。阿昔替尼每日口服两次，直至疾病进展或出现不耐受。主要终点为客观缓解率，次要终点为无进展生存期、总生存期、安全性和HRQOL。本文展示了通过欧洲癌症研究与治疗组织生活质量问卷核心30量表对治疗144周期间HRQOL数据的纵向分析结果。
52例患者完成了基线HRQOL评估。在角色、认知和社会功能量表以及恶心呕吐、疼痛和腹泻症状方面观察到治疗后与基线相比有统计学意义的变化。所有变化均小于一个类别分值的四分之一，腹泻除外，其变化小于半个类别分值，这表明患者报告的这些变化并无实际意义。
与基线水平相比，用阿昔替尼治疗转移性RCC在HRQOL功能和症状方面显示出可接受的干扰。从患者报告的角度来看，阿昔替尼治疗似乎耐受性良好。
