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一项前瞻性研究评估接受培非格司亭注射液与其他选择的患者发热性中性粒细胞减少症的发生率。

A prospective study to evaluate febrile neutropenia incidence in patients receiving pegfilgrastim on-body injector vs other choices.

机构信息

US Oncology Hematology Research, Rocky Mountain Cancer Centers - Midtown, 1800 Williams Street, Suite 200, Denver, CO, 80218, USA.

Duke University School of Medicine, Durham, NC, USA.

出版信息

Support Care Cancer. 2022 Oct;30(10):7913-7922. doi: 10.1007/s00520-022-07226-9. Epub 2022 Jun 22.

Abstract

PURPOSE

We evaluated the incidence of febrile neutropenia (FN) and related clinical outcomes among patients treated with myelosuppressive chemotherapy for nonmyeloid malignancies who received pegfilgrastim on-body injector (OBI) or other options (Other) for FN prophylaxis.

METHODS

In this prospective observational study, adult patients with breast, prostate, or lung cancer, or non-Hodgkin lymphoma at risk for FN were stratified into subgroups based on FN prophylaxis used in the first chemotherapy cycle: pegfilgrastim OBI vs Other (pegfilgrastim or biosimilar pegfilgrastim prefilled syringe, daily filgrastim, or no granulocyte colony-stimulating factor [G-CSF]) for up to 4 planned chemotherapy cycles.

RESULTS

This US study enrolled 2575 eligible patients (OBI, 1624; Other, 951). FN incidence was lower in the OBI group (6.4% [95% CI, 5.2-7.6%]) than in the Other group (9.4% [7.5-11.2%]), with a relative risk (RR) of 0.66 (0.47-0.91; p = .006). A decreased risk of dose delays among patients receiving pegfilgrastim OBI vs Other was observed (RR for ≥ 5 days: 0.64 [0.42-0.96], p = .023; RR for ≥ 7 days: 0.62 [0.40-0.91], p = .016). Adherence, defined as G-CSF support for all chemotherapy cycles, was 94.0% (92.9-95.2%) in the OBI group compared with 58.4% (55.2-61.5%) in the Other group. Compliance with pegfilgrastim, defined as administration the day after chemotherapy, was 88.3% in the OBI group and 48.8% in the prefilled syringe group.

CONCLUSION

Patients receiving pegfilgrastim OBI had a lower incidence of FN compared with those receiving alternatives. The OBI was associated with improved adherence to and compliance with clinically recommended G-CSF prophylaxis.

摘要

目的

我们评估了接受骨髓抑制性化疗治疗非髓性恶性肿瘤的患者中,接受培非格司亭皮下注射剂(OBI)或其他方案(其他)进行发热性中性粒细胞减少症(FN)预防的患者中 FN 的发生率及相关临床结局。

方法

在这项前瞻性观察性研究中,根据首次化疗周期中 FN 预防方案,将有发生 FN 风险的乳腺癌、前列腺癌或肺癌或非霍奇金淋巴瘤成年患者分为亚组:培非格司亭 OBI 与其他方案(培非格司亭或生物类似物培非格司亭预填充注射器、每日粒细胞集落刺激因子(G-CSF)或不使用 G-CSF)用于最多 4 个计划化疗周期。

结果

这项美国研究纳入了 2575 名符合条件的患者(OBI 组 1624 例,其他组 951 例)。OBI 组 FN 发生率(6.4%[95%CI,5.2%-7.6%])低于其他组(9.4%[7.5%-11.2%]),相对风险(RR)为 0.66(0.47-0.91;p=0.006)。与接受其他方案相比,接受培非格司亭 OBI 的患者发生剂量延迟的风险降低(≥5 天的 RR:0.64[0.42-0.96],p=0.023;≥7 天的 RR:0.62[0.40-0.91],p=0.016)。OBI 组的依从性定义为所有化疗周期均接受 G-CSF 支持,为 94.0%(92.9%-95.2%),而其他组为 58.4%(55.2%-61.5%)。OBI 组培非格司亭的遵医嘱性(化疗后次日给药)为 88.3%,预填充注射器组为 48.8%。

结论

与接受替代方案的患者相比,接受培非格司亭 OBI 的患者 FN 发生率更低。OBI 与提高临床推荐的 G-CSF 预防方案的依从性和遵医嘱性相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1ac8/9512863/62ed664a0385/520_2022_7226_Fig1_HTML.jpg

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