隔日非格司亭支持乳腺癌剂量密集型新辅助化疗的可行性分析

doi:10.3877/cma.j.issn.1674-0785.2022.06.002

目的

检验隔日非格司亭（Filgrastim）即短疗程短效粒细胞集落刺激因子（rhG-CSF）支持乳腺癌剂量密集型新辅助化疗的有效性与安全性。

方法

收集2015年7月至2018年6月于北京大学肿瘤医院乳腺癌预防治疗中心接受剂量密集型新辅助化疗同时使用隔日非格司亭预防性支持的原发性乳腺癌患者的病例信息。所有患者均计划接受4周期剂量密集型表阿霉素100 mg/m²+环磷酰胺600 mg/m²术前新辅助化疗，同时于化疗周期第4、6、8、10天皮下注射非格司亭200~300 μg。收集化疗延迟、药物减量情况计算相对剂量强度（RDI），同时记录FN发生情况。

结果

共301例乳腺癌患者信息纳入后续分析，其中15例发生化疗导致的中性粒细胞减少症（CIN）造成化疗延迟（5.0%，95%CI：2.5%~7.5%），289例RDI≥85%（96%，95%CI：93.8%~98.2%），14例（4.7%，95%CI：2.3%~7.1%）化疗期间出现FN。

结论

隔日非格司亭用于支持原发性乳腺癌剂量密集型新辅助化疗（ddEC）可行。

Objective

To retrospectively assess the efficacy and safety of short-term filgrastim in supporting dose-dense neoadjuvant chemotherapy (ddEC) for primary breast cancer based on a single database, in order to examine the feasibility of this method.

Methods

Data of patients who received dose-dense neoadjuvant chemotherapy with support of short-term filgrastim at Peking University Cancer Hospital Breast Cancer Prevention and Treatment Center from July 2015 to June 2018 were retrospectively collected. All of these patients were planned to receive four cycles of ddEC (Epirubicin 100 mg/m² and cyclophosphamide 600 mg/m²) with the usage of rhG-CSF as follows: Filgrastim 200-300 μg/d on days 4, 6, 8, and 10. The relative dose intensity (RDI) was calculated based on chemotherapy delay and the number of dosage reductions, as well as febrile neutropenia (FN).

Results

A total of 301 patients were enrolled in this study. Chemotherapy induced neutropenia related chemotherapy delay occurred in 15 patients (5.0%; 95% confidence interval [CI]: 2.5%~7.5%), 289 patients achieved an RDI≥85% (96%; 95CI: 93.8%~98.2%), and FN occurred in 14 patients (4.7%; 95%CI: 2.3%~7.1%).

Conclusion

According to this study, short-term filgrastim is feasible in supporting four cycles of neoadjuvant chemotherapy for primary breast cancer.

表1 非格司亭组化疗终止情况

终止化疗原因	人数［例（%）］ n=9	比例（%） n=301
临床评价肿瘤进展	3（33.3）	1.0
可疑与表阿霉素相关的心脏毒性	3（33.3）	1.0
CIN	1（11.1）	0.3
三系减低	1（11.1）	0.3
严重的化疗相关消化道毒性	1（11.1）	0.3

表1 非格司亭组化疗终止情况

终止化疗原因	人数［例（%）］ n=9	比例（%） n=301
临床评价肿瘤进展	3（33.3）	1.0
可疑与表阿霉素相关的心脏毒性	3（33.3）	1.0
CIN	1（11.1）	0.3
三系减低	1（11.1）	0.3
严重的化疗相关消化道毒性	1（11.1）	0.3

表2 应用非格司亭的患者化疗延迟情况

延迟化疗原因	人数［例（%）］ n=32	比例（%） n=301
CIN	15（46.9）	5.0
转氨酶异常	10（31.3）	3.3
上呼吸道感染（ANC正常）	2（6.3）	0.7
4度贫血	1（3.1）	0.3
严重的化疗相关消化道毒性	1（3.1）	0.3
其他^*	3（9.4）	1.0

表2 应用非格司亭的患者化疗延迟情况

延迟化疗原因	人数［例（%）］ n=32	比例（%） n=301
CIN	15（46.9）	5.0
转氨酶异常	10（31.3）	3.3
上呼吸道感染（ANC正常）	2（6.3）	0.7
4度贫血	1（3.1）	0.3
严重的化疗相关消化道毒性	1（3.1）	0.3
其他^*	3（9.4）	1.0

表3 应用非格司亭患者发生CIN及FN情况

CIN类型

人数［例（%）］

n=33

占该组比例（%）

n=301

发热性中性粒细胞减少（FN）

14（42.4）

4.7

非发热性中性粒细胞减少

19（57.6）

6.3

表3 应用非格司亭患者发生CIN及FN情况

CIN类型

人数［例（%）］

n=33

占该组比例（%）

n=301

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