Introduction: In 2020, colorectal cancer will be the fourth most frequently diagnosed malignant neoplasm and the second leading cause of site-specific, cancer-related deaths in the USA. Notably, 80% of the new cases are, by staging criteria, potentially curable even those with completely resected stage 4 disease. If slightly more than half the losses can be attributed to metastatic disease at presentation, then the remaining portion of deaths may be linked to disease relapse after surgery and, if applicable, adjuvant chemotherapy. The inference that these therapies are not curative for a significant number of subjects poses a role for maintenance therapy. Objective: To assess event-free survival (EFS) of patients who received capecitabine as maintenance therapy following treatment according to current guidelines. Methods: Clinical outcomes data were collected for 35 subjects treated with capecitabine as maintenance therapy. Descriptive statistical analyses were conducted on collective data related to duration of maintenance therapy and disease or clinical status from surgery to initial event. Kaplan-Meier method and log-rank test were used to analyze EFS and overall survival. Results: Of the entire cohort, 26 subjects have no evidence of disease (NED), a median of 5.5 years from surgery. Kaplan-Meier analyses indicated a 5-year EFS rate of 74% (95% CI: 60–90%). Eighteen of these 26 patients received capecitabine ≥30 months. Eight of the 17 subjects treated with capecitabine therapy for #x3c;30 months developed progressive disease; the majority of the relapses occurred within 20 months of surgery. The difference between the two groups was statistically significant. Six subjects died, only two of who had metastatic disease at the time of death; the other four had NED at least 4 years from surgery. Five patients with resected stage 4 disease who received capecitabine as maintenance therapy were alive #x3e;5 years from surgery. Conclusion: The findings and analyses of this cohort of patients suggest that maintenance capecitabine therapy reduces the risk of disease progression and cancer-related death.
Gastrointest Tumors

中文翻译：

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卡培他滨作为高危、已切除结直肠癌的维持治疗

简介：到 2020 年，结直肠癌将成为美国第四大最常诊断出的恶性肿瘤，也是导致特定部位癌症相关死亡的第二大原因。值得注意的是，根据分期标准，80% 的新病例即使是完全切除的 4 期疾病也有可能治愈。如果略多于一半的损失可归因于就诊时的转移性疾病，那么其余部分的死亡可能与手术后疾病复发和辅助化疗（如果适用）有关。这些疗法不能治愈大量受试者的推论构成了维持疗法的作用。客观的：根据当前指南评估接受卡培他滨作为维持治疗的患者的无事件生存期 (EFS)。方法：收集了 35 名接受卡培他滨维持治疗的受试者的临床结果数据。对与维持治疗持续时间和疾病或从手术到初始事件的临床状态相关的集体数据进行了描述性统计分析。Kaplan-Meier 方法和对数秩检验用于分析 EFS 和总生存期。结果：在整个队列中，有 26 名受试者没有疾病证据 (NED)，手术后中位时间为 5.5 年。Kaplan-Meier 分析表明 5 年 EFS 率为 74%（95% CI：60-90%）。这 26 名患者中有 18 名接受卡培他滨治疗≥30 个月。接受卡培他滨治疗 #x3c 的 17 名受试者中有 8 名；30 个月出现进行性疾病；大多数复发发生在手术后 20 个月内。两组之间的差异具有统计学意义。六名受试者死亡，其中只有两人在死亡时患有转移性疾病；其他四人在手术后至少 4 年患有 NED。接受卡培他滨作为维持治疗的 5 名切除的 4 期疾病患者存活 #x3e；手术后 5 年。结论：对这组患者的研究结果和分析表明，卡培他滨维持治疗可降低疾病进展和癌症相关死亡的风险。
胃肠道肿瘤