比较氟尿嘧啶与氟尿嘧啶/奥沙利铂辅助化疗治疗 III 期结肠癌的不良反应：基于人群的分析。
Comparison of adverse events during 5-fluorouracil versus 5-fluorouracil/oxaliplatin adjuvant chemotherapy for stage III colon cancer: a population-based analysis.
机构信息
Department of Medicine, Division of Hematology and Oncology, University of Virginia, Charlottesville, Virginia, USA.
出版信息
Cancer. 2012 Sep 1;118(17):4309-20. doi: 10.1002/cncr.27422. Epub 2012 Jan 31.
BACKGROUND
In clinical trials, combined 5-fluorouracil (5FU) plus oxaliplatin improves the survival of patients who have resected, stage III colon cancer with manageable toxicity. However, the tolerability of this in the general population of patients with colon cancer is uncertain.
METHODS
Adverse outcomes were compared in patients with stage III colon cancer who received either 5FU or 5FU/oxaliplatin within 120 days of undergoing resection versus a control group of patients with stage II colon cancer who did not receive chemotherapy in the Surveillance, Epidemiology, and End Results (SEER)-Medicare database and in data from the New York State Cancer Registry linked to Medicare and Medicaid. Hospitalizations, emergency room (ER) visits, and outpatient adverse events (AEs) were measured in claims from 30 days to 9 months after patients underwent resection. Multiple logistic regression was used to calculate adjusted odds ratios of events by treatment. Propensity score matching was used to minimize selection bias.
RESULTS
Adverse outcomes were more frequent for chemotherapy recipients. AE rates were higher in patients who received 5FU/oxaliplatin (81%) compared with patients who received 5FU alone (72%), in the SEER-Medicare data. The effect of oxaliplatin on AEs was greater in older patients: The odds ratio was 2.10 (95% confidence interval, 1.53-2.87) for patients aged ≥ 75 years versus 1.75 (95% confidence interval, 1.39-2.21) for patients aged <75 years. ER use was high in Medicaid patients (83% of those who received chemotherapy), but neither ER use nor hospitalization was increased by oxaliplatin. The 60-day mortality rate was 1% to 3% for patients who received 5FU alone and 1% to 2% for patients who received combined 5FU/oxaliplatin.
CONCLUSIONS
The incremental harms of adjuvant chemotherapy with 5FU/oxaliplatin versus 5FU alone were modest in patients with stage III colon cancer who were insured by Medicare and Medicaid. The additional harms in patients aged ≥ 75 years largely were restricted to outpatient events and did not extend to an increased rate of hospitalization or early death.
背景
在临床试验中，联合氟尿嘧啶（5FU）加奥沙利铂可提高可耐受毒性的 III 期结直肠癌患者的生存率。然而，在一般结直肠癌患者人群中，这种方法的耐受性尚不确定。
方法
比较接受 5FU 或 5FU/奥沙利铂治疗的 III 期结直肠癌患者与未接受化疗的 II 期结直肠癌患者的不良结局，后者来自监测、流行病学和最终结果（SEER）-医疗保险数据库以及与医疗保险和医疗补助相关联的纽约州癌症登记处的数据。从患者接受手术后 30 天至 9 个月，从索赔中测量住院、急诊（ER）就诊和门诊不良事件（AE）。使用多变量逻辑回归计算按治疗调整的事件的比值比。采用倾向评分匹配以最小化选择偏倚。
结果
接受化疗的患者不良结局更常见。在 SEER-医疗保险数据中，接受 5FU/奥沙利铂治疗的患者（81%）比接受单独 5FU 治疗的患者（72%）的 AE 发生率更高。奥沙利铂对 AE 的影响在老年患者中更大：年龄≥75 岁的患者比值比为 2.10（95%置信区间，1.53-2.87），年龄<75 岁的患者比值比为 1.75（95%置信区间，1.39-2.21）。 Medicaid 患者 ER 使用频率较高（接受化疗的患者中有 83%），但奥沙利铂既没有增加 ER 使用，也没有增加住院治疗。接受单独 5FU 治疗的患者 60 天死亡率为 1%至 3%，接受联合 5FU/奥沙利铂治疗的患者为 1%至 2%。
结论
在 Medicare 和 Medicaid 保险的 III 期结直肠癌患者中，5FU/奥沙利铂辅助化疗与单独使用 5FU 相比，其增量危害较小。年龄≥75 岁患者的额外危害主要限于门诊事件，不会导致住院或早期死亡的发生率增加。
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