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聚乙二醇化重组人粒细胞刺激因子对接受化疗的胃肠道恶性肿瘤患者当日给药的安全性和有效性

Safety and Efficacy of Same-Day Administration of Pegfilgrastim in Patients Receiving Chemotherapy for Gastrointestinal Malignancies.

作者信息

Matera Robert M, Relias Valerie, Saif Muhammad Wasif

机构信息

Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA.

Department of Medical Oncology, Northwell Health Cancer Institute, Donald and Barbara Zucker School of Medicine at Hofstra and Feinstein Institute for Medical Research, USA.

出版信息

Cancer Med J. 2021 Apr 1;4(1):6-11. Epub 2020 May 18.

Abstract

BACKGROUND

Pegfilgrastim is typically administered 24 hours after chemotherapy per package insert; however some patients are unable or unwilling to return for this additional visit due to work or transportation especially with regimens consisting of infusional 5-FU. Same-day dosing eliminates need for this additional visit. Results from prior studies in other tumor types are inconclusive as few support same-day dosing whereas others show inferiority. Purpose of our study was to determine safety and efficacy of administering pegfilgrastim on same day as chemotherapy in patients with gastrointestinal (GI) malignancies.

METHOD

A single-institution retrospective review was conducted of 69 patients with GI malignancies who received chemotherapy and same-day pegfilgrastim (6 mg) within 1 hour of completion of chemotherapy from Jan 2014 through Jan 2017. As per institutional guidelines, patients were counseled on risks of same-day pegfilgrastim prior to its administration. These patients were compared with a set of 70 patients who received pegfilgrastim 24-hours after completing the chemotherapy for GI cancers.

RESULT

A total of 536 chemotherapy cycles in 69 patients were analyzed. Median absolute neutrophil count nadir for all cycles was 4538/uL (Range: 1160 - 25168). Grade 1 and 2 neutropenia developed in 6 of 536 (1%) cycles. Bone pain reported in 3 patients (4%). There were no episodes of grade 3 or 4 neutropenia or febrile neutropenia. None had dose reductions, chemotherapy delays, hospitalizations, or antibiotic use due to neutropenia.

CONCLUSION

We believe our study is the first in GI malignancies to report that same-day pegfilgrastim administration may be as effective and safe as next-day administration, benefiting patients and might reduce costs.

摘要

背景

根据药品说明书,培非格司亭通常在化疗后24小时给药;然而,一些患者由于工作或交通原因无法或不愿返回进行这次额外就诊,尤其是对于包含氟尿嘧啶持续静脉输注的化疗方案。当日给药可避免这次额外就诊。先前在其他肿瘤类型中的研究结果尚无定论,少数研究支持当日给药,而其他研究则显示当日给药效果较差。我们研究的目的是确定在胃肠道(GI)恶性肿瘤患者中,在化疗当日给予培非格司亭的安全性和有效性。

方法

对2014年1月至2017年1月期间在单机构接受化疗且在化疗完成后1小时内接受当日培非格司亭(6毫克)治疗的69例GI恶性肿瘤患者进行回顾性研究。根据机构指南,在给予当日培非格司亭之前,向患者告知其风险。将这些患者与一组70例完成GI癌症化疗后24小时接受培非格司亭治疗的患者进行比较。

结果

共分析了69例患者的536个化疗周期。所有周期的中性粒细胞绝对计数最低点中位数为4538/微升(范围:1160 - 25168)。536个周期中有6个(1%)出现1级和2级中性粒细胞减少。3例患者(4%)报告有骨痛。没有3级或4级中性粒细胞减少或发热性中性粒细胞减少的情况发生。无人因中性粒细胞减少而出现剂量减少、化疗延迟、住院或使用抗生素。

结论

我们认为我们的研究是首次在GI恶性肿瘤中报告当日给予培非格司亭可能与次日给药一样有效和安全,这对患者有益且可能降低成本。

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