Pfizer Oncology, Global Outcomes Research, Pfizer Inc, MS 6025-A3221, 50 Pequot Ave, New London, CT 06320, USA.
J Cancer Surviv. 2011 Sep;5(3):255-62. doi: 10.1007/s11764-011-0178-6. Epub 2011 Apr 7.
The goal of the study was to determine the relationship of baseline Functional Assessment of Cancer Therapy-Kidney Cancer Symptom Index (FKSI) scores with median progression-free survival (mPFS) and median overall survival (mOS) after treatment with axitinib in patients with sorafenib-refractory metastatic renal cell carcinoma.
As part of a multicenter, open-label, phase II study, patients (N = 62) reported symptoms at baseline using the FKSI, with higher scores indicating less severe symptoms. A Weibull (fully parametric) model was fit to time-to-event data to establish the relationship of baseline FKSI score with mPFS and mOS. Kaplan-Meier curves were obtained as sensitivity analyses.
Longer progression-free and overall survivals were associated with higher (more favorable) baseline FKSI-15 and FKSI disease-related symptoms (FKSI-DRS) subscale specific to kidney cancer scores. For example, for FKSI-15 scores of 0 (most symptoms), 30, and 60 (no symptoms), the mPFS were 0.72, 3.83, and 20.43 months, respectively, and the mOS were 1.05, 6.27, and 37.53 months. Similar patterns and interpretations were observed for the FKSI-DRS scores. The results from the Kaplan-Meier analyses supported the parametric model.
DISCUSSIONS/CONCLUSIONS: Baseline patient-reported kidney cancer symptoms are linked to mPFS and mOS in a clear and interpretable way. These results support the evaluation of patient-reported symptoms at baseline in clinical trials and in clinical practice to measure symptom severity and potentially predict progression-free and overall survival outcomes.
The results provide a heightened opportunity to use patient data not only to assist in medical treatment planning but also to prepare patients, who have advanced disease and an already reduced expected lifespan, with an opportunity to deal with the psychosocial aspects of the dying process.
本研究旨在确定索拉非尼耐药转移性肾细胞癌患者接受阿昔替尼治疗后，基线功能评估癌症治疗-肾细胞癌症状指数（FKSI）评分与中位无进展生存期（mPFS）和中位总生存期（mOS）的关系。
作为一项多中心、开放标签、II 期研究的一部分，患者（N=62）在基线时使用 FKSI 报告症状，得分越高表示症状越不严重。使用威布尔（完全参数）模型拟合生存时间数据，以建立基线 FKSI 评分与 mPFS 和 mOS 的关系。Kaplan-Meier 曲线作为敏感性分析获得。
更长的无进展生存期和总生存期与更高（更有利）的基线 FKSI-15 和 FKSI 疾病相关症状（FKSI-DRS）评分相关，该评分是针对肾细胞癌的特异性量表。例如，对于 FKSI-15 评分为 0（症状最多）、30 和 60（无症状），mPFS 分别为 0.72、3.83 和 20.43 个月，mOS 分别为 1.05、6.27 和 37.53 个月。FKSI-DRS 评分也观察到类似的模式和解释。Kaplan-Meier 分析的结果支持参数模型。
讨论/结论：基线患者报告的肾细胞癌症状与 mPFS 和 mOS 之间存在明确且可解释的关系。这些结果支持在临床试验和临床实践中评估基线时的患者报告症状，以衡量症状严重程度，并可能预测无进展生存期和总生存期的结果。
这些结果不仅为利用患者数据协助医疗治疗计划提供了更多机会，也为那些患有晚期疾病且预期寿命已经缩短的患者提供了机会，使他们有机会应对死亡过程中的心理社会方面。
