PEG 修饰的粒细胞集落刺激因子（PEG-G-CSF）在 FOLFOXIRI 联合贝伐珠单抗治疗转移性结直肠癌患者中预防重度中性粒细胞减少症的临床实用性：一项单中心回顾性研究。
Clinical utility of polyethylene glycol conjugated granulocyte colony-stimulating factor (PEG-G-CSF) for preventing severe neutropenia in metastatic colorectal cancer patients treated with FOLFOXIRI plus bevacizumab: a single-center retrospective study.
机构信息
Department of Gastroenterology, The Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan.
出版信息
BMC Cancer. 2020 Apr 28;20(1):358. doi: 10.1186/s12885-020-06864-8.
BACKGROUND
This study aimed to evaluate the efficacy and the safety of polyethylene glycol conjugated granulocyte colony-stimulating factor (PEG-G-CSF) for preventing neutropenia in metastatic colorectal cancer (mCRC) patients that received fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) plus bevacizumab (Bev) in clinical practice.
METHODS
We retrospectively analyzed mCRC patients who received FOLFOXIRI plus Bev between December 2015 and December 2017. We evaluated the efficacy of PEG-G-CSF as preventing or treating grade 3 or 4 neutropenia, the overall response rate (ORR) according to the Response Evaluation Criteria in Solid Tumors version 1.1, progression-free survival (PFS), overall survival (OS), and adverse events of FOLFOXIRI plus Bev based on the Common Terminology Criteria for Adverse Events version 4.0.
RESULTS
A total of 26 patients (median age 53.5 years) were included. The ORR rate was 65.3%, the median PFS was 9.6 months (7.2-16.9), and the median OS was 24.2 months (13.6-NA). Grade 3 or 4 neutropenia occurred in 53.8% of the patients, and febrile neutropenia occurred in 7.7%. PEG-G-CSF was given to 77.0% of the patients, including prophylactically (n = 9) and after the development of grade 3 or 4 neutropenia (n = 11). No patients experienced grade 3 or 4 neutropenia after the administration of PEG-G-CSF. In seven of the nine patients who received PEG-G-CSF prophylactically (77.8%), no dose adjustment was required.
CONCLUSIONS
PEG-G-CSF is useful in preventing severe neutropenia in mCRC patients treated with FOLFOXIRI plus Bev.
背景
本研究旨在评估聚乙二醇化粒细胞集落刺激因子（PEG-G-CSF）在转移性结直肠癌（mCRC）患者中的疗效和安全性，这些患者在临床实践中接受氟尿嘧啶、亚叶酸、奥沙利铂和伊立替康（FOLFOXIRI）加贝伐珠单抗（Bev）治疗。
方法
我们回顾性分析了 2015 年 12 月至 2017 年 12 月期间接受 FOLFOXIRI 加 Bev 治疗的 mCRC 患者。我们评估了 PEG-G-CSF 预防或治疗 3 级或 4 级中性粒细胞减少症的疗效、根据实体瘤反应评价标准 1.1 评估的总缓解率（ORR）、无进展生存期（PFS）、总生存期（OS）以及根据不良事件通用术语标准 4.0 评估的 FOLFOXIRI 加 Bev 的不良反应。
结果
共纳入 26 例患者（中位年龄 53.5 岁）。ORR 率为 65.3%，中位 PFS 为 9.6 个月（7.2-16.9），中位 OS 为 24.2 个月（13.6-NA）。53.8%的患者发生 3 级或 4 级中性粒细胞减少症，7.7%的患者发生发热性中性粒细胞减少症。77.0%的患者使用了 PEG-G-CSF，包括预防性（n=9）和发生 3 级或 4 级中性粒细胞减少症后（n=11）。使用 PEG-G-CSF 后，没有患者发生 3 级或 4 级中性粒细胞减少症。9 例预防性使用 PEG-G-CSF 的患者中，有 7 例（77.8%）无需调整剂量。
结论
PEG-G-CSF 可有效预防接受 FOLFOXIRI 加 Bev 治疗的 mCRC 患者发生严重中性粒细胞减少症。
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