Jefferson School of Population Health, Health Economics and Outcomes Research, Thomas Jefferson University, Philadelphia, PA.
Global Health Economics, Amgen, Inc., Thousand Oaks, CA.
Ann Oncol. 2010 Jul;21(7):1455-1461. doi: 10.1093/annonc/mdp535. Epub 2010 Jan 25.
Systemic agents in cancer treatment were often associated with possible infusion reactions (IRs). This study estimated the incidence of IRs requiring medical intervention and assessed the clinical and economic impacts of IRs in patients with colorectal cancer (CRC) treated with cetuximab.
Details on patients with CRC receiving cetuximab in 2004-2006 were extracted from a large USA administrative claims database. IRs were identified based on the occurrence of outpatient treatment, emergency room (ER) visit, and/or hospitalization for hypersensitivity and allergic reactions. Multivariate regressions were used to examine potential risk factors and quantify the economic impact of IRs.
A total of 1122 CRC patients receiving cetuximab were identified. The incidence of IRs requiring medical intervention was 8.4%. Sixty-eight percent of the patients had treatment disruptions and 34% discontinued cetuximab treatment. Mean adjusted costs were $13,863 for cetuximab administrations with an IR requiring ER visit or hospitalization and $6280 for those with an IR requiring outpatient treatment, compared with $4555 for those without an IR.
The incidence rate of cetuximab-related IRs requiring medical intervention in clinical practice was found to be higher than rates reported in the product label and clinical trials. The clinical and economic impacts of these IRs are substantial.
癌症治疗中的全身性药物常与可能的输注反应(IR)相关。本研究评估了接受西妥昔单抗治疗的结直肠癌(CRC)患者中需要医疗干预的 IR 发生率,并评估了 IR 对患者的临床和经济影响。
从美国一个大型行政索赔数据库中提取了 2004-2006 年接受西妥昔单抗治疗的 CRC 患者的详细信息。根据过敏和过敏反应的门诊治疗、急诊室(ER)就诊和/或住院情况确定 IR。采用多变量回归分析来检查潜在的风险因素,并量化 IR 的经济影响。
共确定了 1122 例接受西妥昔单抗治疗的 CRC 患者。需要医疗干预的 IR 发生率为 8.4%。68%的患者治疗中断,34%的患者停止西妥昔单抗治疗。发生需要 ER 就诊或住院的 IR 的西妥昔单抗给药的平均调整费用为 13863 美元,而发生需要门诊治疗的 IR 的费用为 6280 美元,而无 IR 的患者费用为 4555 美元。
在临床实践中,西妥昔单抗相关 IR 发生率高于产品标签和临床试验报告的发生率。这些 IR 的临床和经济影响是巨大的。