From Policy Analysis Inc. (PAI), Brookline, Massachusetts; Amgen Inc., Thousand Oaks, California; Department of Pharmaceutical Health Outcomes and Policy, College of Pharmacy, Texas Medical Center, University of Houston, Houston, Texas; and Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, Washington.
J Natl Compr Canc Netw. 2015 Aug;13(8):979-86. doi: 10.6004/jnccn.2015.0118.
Clinical practice guidelines recommend prophylaxis in patients with cancer receiving a colony-stimulating factor (CSF) when the risk of febrile neutropenia (FN) is high (>20%). For patients receiving chemotherapy regimens not documented as high-risk, the decision regarding CSF prophylaxis use can be challenging, because some patients may be at high risk based on a combination of the regimen and individual risk factors.
A retrospective cohort design and US private health care claims data were used. Study subjects received chemotherapy regimens classified as "low" or "intermediate," or unclassified, in terms of FN risk, and were stratified by cancer and regimen. For each subject, the first chemotherapy course, and each cycle and FN episode within the course, were identified. FN incidence proportions were estimated by the presence and number of risk factors and chronic comorbidities.
Across the 17 tumor/regimen combinations considered (n=160,304 in total), 74% to 98% of patients had 1 or more risk factor for FN and 41% to 89% had 2 or more. Among patients with 1 or more risk factor, FN incidence ranged from 7.2% to 29.0% across regimens, and the relative risk of FN (vs those without risk factors) ranged from 1.1 (95% CI, 0.8-1.3) to 2.2 (95% CI, 1.5-3.0). FN incidence increased in a graded and monotonic fashion with the number of risk factors and comorbidities.
In this retrospective evaluation of patients with cancer receiving chemotherapy regimens not classified as high-risk for FN in US clinical practice, most patients had 1 or more FN risk factor and many had 2 or more. FN incidence was found to be elevated in these patients, especially those with multiple risk factors.
临床实践指南建议,在接受集落刺激因子(CSF)治疗的癌症患者中,如果发生发热性中性粒细胞减少症(FN)的风险较高(>20%),则进行预防。对于接受未被记录为高风险的化疗方案的患者,使用 CSF 预防的决策可能具有挑战性,因为一些患者可能基于方案和个体危险因素的组合而处于高风险。
采用回顾性队列设计和美国私人医疗保健索赔数据。研究对象接受了 FN 风险分类为“低”或“中”或未分类的化疗方案,并按癌症和方案分层。对于每个患者,确定了第一个化疗疗程,以及疗程内的每个周期和 FN 发作。FN 发生率比例通过存在和数量的危险因素和慢性合并症来估计。
在所考虑的 17 个肿瘤/方案组合中(总共 160304 例患者),74%至 98%的患者有 1 个或多个 FN 危险因素,41%至 89%的患者有 2 个或多个危险因素。在有 1 个或多个危险因素的患者中,不同方案的 FN 发生率范围为 7.2%至 29.0%,FN 的相对风险(与无危险因素的患者相比)范围为 1.1(95%CI,0.8-1.3)至 2.2(95%CI,1.5-3.0)。FN 发生率呈分级和单调递增趋势,与危险因素和合并症的数量成正比。
在这项对美国临床实践中未被归类为 FN 高风险的化疗方案的癌症患者的回顾性评估中,大多数患者有 1 个或多个 FN 危险因素,许多患者有 2 个或多个危险因素。在这些患者中发现 FN 发生率较高,尤其是那些有多个危险因素的患者。