Emory Winship Cancer Institute, Emory University, Atlanta, GA, USA.
Georgia Cancer Center for Excellence at Grady Healthcare, Atlanta, GA, USA.
J Oncol Pharm Pract. 2021 Jul;27(5):1159-1164. doi: 10.1177/1078155220945771. Epub 2020 Aug 6.
Pegfilgrastim, a long-acting granulocyte-colony-stimulating factor used to prevent neutropenia, is not indicated for administration within 24 h of completion of chemotherapy. The safety of administering pegfilgrastim in gastrointestinal cancer chemotherapy regimens containing continuous intravenous infusion of 5-fluorouracil (5-FUCI) on the day of completion of 5-fluorouracil has not been adequately studied.
An institutional review board-approved retrospective analysis of patients with a gastrointestinal malignancy receiving pegfilgrastim on the final day of 5-FUCI was conducted. The primary end point was to determine the incidence of grade 3 and grade 4 neutropenia and febrile neutropenia when pegfilgrastim was administered on the final day of 5-FUCI. The secondary endpoint was to determine rate of dose reductions and treatment delays.
A total of 300 patients were reviewed from January 2010 to May 2017. The most common cancers were colorectal (25%) and pancreatic (60%), with 77% of patients having late stage disease. The risk of a patient developing grade 3 neutropenia was 0.010 (95% CI 0.002-0.029) and grade 4 neutropenia was 0.007 (95% CI 0.001-0.024). The risk of febrile neutropenia was 0.007 (95% CI 0.001-0.024). The risks of treatment delay and treatment reduction were 0.013 (95% CI 0.004-0.034) and 0.010 (95% CI 0.002-0.029), respectively.
The low risk of grade 3 and grade 4 neutropenia, febrile neutropenia, as well as dose delays and/or reduction suggests that pegfilgrastim can be administered on the final day of 5-FUCI. Limitations of this study were that it was retrospective in nature and was conducted at a single institution.
培非格司亭是一种长效粒细胞集落刺激因子，用于预防中性粒细胞减少症，但不建议在化疗完成后 24 小时内使用。在含有氟尿嘧啶持续静脉输注（5-FUCI）的胃肠道癌化疗方案中，培非格司亭在氟尿嘧啶完成当日给药的安全性尚未得到充分研究。
对接受培非格司亭治疗的胃肠道恶性肿瘤患者进行了机构审查委员会批准的回顾性分析，这些患者在 5-FUCI 的最后一天接受了培非格司亭治疗。主要终点是确定在氟尿嘧啶完成当日给予培非格司亭时，3 级和 4 级中性粒细胞减少症和发热性中性粒细胞减少症的发生率。次要终点是确定剂量减少和治疗延迟的发生率。
共回顾了 2010 年 1 月至 2017 年 5 月期间的 300 例患者。最常见的癌症是结直肠癌（25%）和胰腺癌（60%），77%的患者患有晚期疾病。患者发生 3 级中性粒细胞减少症的风险为 0.010（95%CI 0.002-0.029），4 级中性粒细胞减少症的风险为 0.007（95%CI 0.001-0.024）。发热性中性粒细胞减少症的风险为 0.007（95%CI 0.001-0.024）。治疗延迟和治疗减少的风险分别为 0.013（95%CI 0.004-0.034）和 0.010（95%CI 0.002-0.029）。
3 级和 4 级中性粒细胞减少症、发热性中性粒细胞减少症以及剂量延迟和/或减少的风险较低，提示培非格司亭可以在氟尿嘧啶完成当日给予。本研究的局限性在于它是回顾性的，并且是在一个机构进行的。
