Department of Medical Oncology, Centre Léon Bérard, University of Lyon, Lyon, France.
Anticancer Drugs. 2012 Nov;23(10):1107-11. doi: 10.1097/CAD.0b013e328358d226.
The objective of this study was to evaluate the efficacy and tolerability of capecitabine as a single agent in the treatment of recurrent/metastatic head and neck squamous cell carcinoma. Patients were treated with oral capecitabine according to good clinical practice. Efficacy and safety outcomes were analyzed retrospectively. The response and adverse events rates and their exact confidence intervals (CIs) were calculated. Survival distributions were estimated using the Kaplan-Meier method. Twenty-nine patients were included in the study. Twenty-five patients (86%) had received at least three previous lines of chemotherapy. The disease control rate was 48% (95% CI: 29-67%). The median progression-free survival was 2.0 months (95% CI: 0.1-3.9 months) and the median overall survival was 7.0 months (95% CI: 4.1-9.9 months). Hand-foot syndrome, fatigue, and mucositis were the most frequent severe side effects. No patient died, and only three patients discontinued treatment because of side effects. Capecitabine seems to be an active and well-tolerated regimen, even in heavily pretreated, frail patients.
2C 'Outcomes Research'.
本研究旨在评估卡培他滨单药治疗复发性/转移性头颈部鳞状细胞癌的疗效和耐受性。患者根据良好临床实践接受口服卡培他滨治疗。回顾性分析了疗效和安全性结局。计算了反应率和不良事件率及其确切置信区间（CI）。使用 Kaplan-Meier 方法估计生存分布。共纳入 29 例患者。25 例（86%）患者至少接受过三线化疗。疾病控制率为 48%（95%CI：29-67%）。中位无进展生存期为 2.0 个月（95%CI：0.1-3.9 个月），中位总生存期为 7.0 个月（95%CI：4.1-9.9 个月）。手足综合征、乏力和黏膜炎是最常见的严重副作用。无患者死亡，仅 3 例患者因副作用停止治疗。卡培他滨似乎是一种有效且耐受良好的方案，即使是在预处理过的虚弱患者中也是如此。
2C“结局研究”。
