Division of Medical Oncology, The Moncton Hospital, 135 MacBeath Ave., Moncton, New Brunswick, E1C 6Z8, Canada,
Support Care Cancer. 2014 Dec;22(12):3227-34. doi: 10.1007/s00520-014-2318-9. Epub 2014 Jul 5.
The purpose of this study is to determine the incidence of febrile neutropenia (FN) among women receiving FEC-D (flurouracil 500 mg/m(2), epirubicin 100 mg/m(2), and cyclophosphamide 500 mg/m(2) every 3 weeks for three cycles followed by docetaxel 100 mg/m(2) every 3 weeks for three cycles) chemotherapy for early stage breast cancer (ESBC) and the impact of primary granulocyte colony-stimulating factor (G-CSF) prophylaxis in a non-clinical trial setting.
A retrospective chart review of women referred for ESBC to The Moncton Hospital between 2005 and 2010 evaluated patient and disease characteristics, adjuvant chemotherapy receipt, G-CSF usage, FN incidence, hospital admission rates, and length of stay. Association of variables with FN was examined, and exploratory multivariable logistic regression modeling examined the impact of baseline variables on risk of FN.
Of 520 patients enrolled in the database, 251 (48.3 %) received adjuvant chemotherapy for ESBC. Most (66.9 %) received FEC-D. Overall, 55 (21.9 %) patients developed FN. Forty-four (26.2 %) patients on FEC-D developed FN. Forty of 129 (31.0 %) FEC-D patients who did not receive primary G-CSF prophylaxis developed FN, versus 4 of 39 (10.3 %) receiving G-CSF. Receipt of FEC-D or TC (docetaxel 75 mg/m(2) and cyclophosphamide 600 mg/m(2) every 3 weeks for four or six cycles) was associated with odds ratios of 6.5 or 6.77, respectively, for the development of FN. Receipt of trastuzumab with chemotherapy was associated with an odds ratio of 3.48 for developing FN versus no trastuzumab. Primary G-CSF prophylaxis led to a 63 % reduction in the odds ratio of developing FN.
Incidence of FN with FEC-D treatment is considerably higher in clinical practice than reported in phase III trials. Consistent with ASCO guidelines, prophylactic G-CSF should be considered for all ESBC patients receiving adjuvant FEC-D.
本研究旨在确定接受 FEC-D(氟尿嘧啶 500mg/m²,表柔比星 100mg/m²,环磷酰胺 500mg/m²,每 3 周一次,共 3 个周期,然后多西他赛 100mg/m²,每 3 周一次,共 3 个周期)化疗的早期乳腺癌(ESBC)女性中发热性中性粒细胞减少症(FN)的发生率,以及在非临床试验环境下初级粒细胞集落刺激因子(G-CSF)预防的影响。
对 2005 年至 2010 年间转诊至 Moncton 医院的 ESBC 女性患者进行回顾性图表审查,评估患者和疾病特征、辅助化疗的接受情况、G-CSF 的使用、FN 的发生率、住院率和住院时间。对变量与 FN 的关系进行了检验,并进行了探索性多变量逻辑回归建模,以检验基线变量对 FN 风险的影响。
在数据库中登记的 520 名患者中,251 名(48.3%)接受了 ESBC 的辅助化疗。大多数(66.9%)接受了 FEC-D。总体而言,55 名(21.9%)患者发生 FN。44 名(26.2%)接受 FEC-D 的患者发生 FN。40 名未接受初级 G-CSF 预防的 129 名 FEC-D 患者发生 FN,而 39 名接受 G-CSF 的患者中仅有 4 名发生 FN。接受 FEC-D 或 TC(多西他赛 75mg/m²和环磷酰胺 600mg/m²,每 3 周一次,共 4 或 6 个周期)治疗的患者发生 FN 的比值比分别为 6.5 或 6.77。接受曲妥珠单抗联合化疗的患者发生 FN 的比值比为 3.48,而未接受曲妥珠单抗的患者为 3.48。初级 G-CSF 预防可使发生 FN 的比值比降低 63%。
在临床实践中,FEC-D 治疗后 FN 的发生率明显高于 III 期试验报告的发生率。根据 ASCO 指南,所有接受辅助 FEC-D 治疗的 ESBC 患者均应考虑使用预防性 G-CSF。