卡培他滨奥沙利铂用于老年晚期胃癌患者的初步安全性分析：一项 II 期试验。
Initial Safety Analysis of CapeOx for Elderly Patients With Advanced Gastric Cancer Patients: A Phase II Trial.
机构信息
Department of Gastroenterological Chemotherapy, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan;
Department of Gastroenterological Chemotherapy, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
出版信息
Anticancer Res. 2022 May;42(5):2683-2687. doi: 10.21873/anticanres.15746.
BACKGROUND
Safety of combination chemotherapy using platinum and fluorouracil has not been evaluated adequately for advanced gastric cancer (AGC) in elderly patients.
PATIENTS AND METHODS
We initiated a phase II study to evaluate the efficacy and safety of capecitabine plus oxaliplatin (CapeOX) as first-line therapy for patients with AGC aged ≥70 years. Planned assessment of toxicity was made upon recruitment of the first 20 patients.
RESULTS
In five out of 20 patients, unacceptable toxicity was observed, including three patients who were unable to complete the initial two courses due to adverse events. Among the other 15 patients, dose reduction due to toxicity were needed in 10 and treatment delay for adverse events also occurred in 12 patients during the first two courses.
CONCLUSION
Early analyses of safety suggest that the CapeOX regimen was not tolerated without dose reduction for elderly patients with AGC in this study.
背景
对于老年晚期胃癌（AGC）患者，尚未充分评估含铂和氟尿嘧啶的联合化疗的安全性。
患者和方法
我们启动了一项 II 期研究，以评估卡培他滨联合奥沙利铂（CapeOX）作为 AGC 老年患者（≥70 岁）一线治疗的疗效和安全性。在招募的前 20 例患者中，对毒性进行了计划评估。
结果
在 20 例患者中有 5 例出现不可接受的毒性，包括 3 例因不良事件而无法完成最初的两个疗程。在其余 15 例患者中，有 10 例因毒性需要减少剂量，并且在最初的两个疗程中，有 12 例因不良事件而导致治疗延迟。
结论
早期安全性分析表明，在这项研究中，对于老年 AGC 患者，CapeOX 方案不能耐受而无需减少剂量。
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