2016年9月12日，美国临床肿瘤学会官方期刊《临床肿瘤学杂志》在线发表华盛顿大学、哈钦森癌症结局研究所、美国临床肿瘤学会、圣歌（美国第二大医疗保险集团）、美国肿瘤学网络、德克萨斯肿瘤学网络、普罗维登斯癌症中心、和仕康（圣歌旗下独立运营的医疗数据分析公司）的研究报告，描述了粒细胞集落刺激因子（G-CSF）预防乳腺癌患者接受中性粒细胞减少相关住院风险低到中等化疗方案后的结局。
该研究从14项美国商业健康保险计划的医疗和药品索赔数据库，回顾性分析了8745例年龄≥18岁乳腺癌患者，2008～2013年开始第一周期化疗，采用多西他赛＋环磷酰胺（TC）、多西他赛＋卡铂＋曲妥珠单抗（TCH）、多柔比星＋环磷酰胺（常规剂量AC）方案。一级预防（PP）定义为化疗开始5天内注射G-CSF。结局定义为化疗开始后21天内的中性粒细胞减少、发热、感染相关住院。采用多变量回归和需要治疗例数分析。
结果发现，接受TC、TCH、AC方案的患者例数（PP、无PP）分别为4815（2849、1966）、2292（1444、848）、1638（857、781）。PP使中性粒细胞减少相关住院风险在TC和TCH方案分别降低71%（P＜0.001）和81%（P＜0.001），但在AC方案升高21%（P=0.43）。对于TC和TCH方案，需要治疗21天以避免中性粒细胞减少相关住院的患者例数（95%置信区间）分别为20（16～26）和18（13～25）。
中性粒细胞减少相关住院风险
注：PP（一级预防），AOR（校正比值比）
因此，对于接受TC和TCH方案化疗的乳腺癌患者，一级G-CSF预防与降低中性粒细胞减少相关住院风险的低到中度获益有相关性。需要进一步评估，以更好地了解，在该情况下，哪些患者最受益于G-CSF预防。
J Clin Oncol. 2016 Sep 19. [Epub ahead of print]
Risk of Neutropenia-Related Hospitalization in Patients Who Received Colony-Stimulating Factors With Chemotherapy for Breast Cancer.
Abiy Agiro, Qinli Ma, Anupama Kurup Acheson, Sze-jung Wu, Debra A. Patt, John J. Barron, Jennifer L. Malin, Alan Rosenberg, Richard L. Schilsky, Gary H. Lyman.
HealthCore, Wilmington, DE; Providence Cancer Center, Portland, OR; Texas Oncology, Austin; The US Oncology Network, Houston, TX; Anthem, Woodland, CA; Anthem, Chicago, IL; American Society of Clinical Oncology, Alexandria, VA; Hutchinson Institute for Cancer Outcomes Research and University of Washington, Seattle, WA.
PURPOSE: To describe outcomes after granulocyte colony-stimulating factor (G-CSF) prophylaxis in patients with breast cancer who received chemotherapy regimens with low-to-intermediate risk of induction of neutropenia-related hospitalization.
PATIENTS AND METHODS: We identified 8,745 patients age ≥ 18 years from a medical and pharmacy claims database for 14 commercial US health plans. This retrospective analysis included patients with breast cancer who began first-cycle chemotherapy from 2008 to 2013 using docetaxel and cyclophosphamide (TC); docetaxel, carboplatin, and trastuzumab (TCH); or doxorubicin and cyclophosphamide (conventional-dose AC) regimens. Primary prophylaxis (PP) was defined as G-CSF administration within 5 days of beginning chemotherapy. Outcome was neutropenia, fever, or infection-related hospitalization within 21 days of initiating chemotherapy. Multivariable regressions and number-needed-to-treat analyses were used.
RESULTS: A total of 4,815 patients received TC (2,849 PP; 1,966 no PP); 2,292 patients received TCH (1,444 PP; 848 no PP); and 1,638 patients received AC (857 PP; 781 no PP) regimen. PP was associated with reduced risk of neutropenia-related hospitalization for TC (2.0% PP; 7.1% no PP; adjusted odds ratio [AOR], 0.29; 95% CI, 0.22 to 0.39) and TCH (1.3% PP; 7.1% no PP; AOR, 0.19; 95% CI, 0.12 to 0.30), but not AC (4.7% PP; 3.8% no PP; AOR, 1.21; 95% CI, 0.75 to 1.93) regimens. For the TC regimen, 20 patients (95% CI, 16 to 26) would have to be treated for 21 days to avoid one neutropenia-related hospitalization; with the TCH regimen, 18 patients (95% CI, 13 to 25) would have to be treated.
CONCLUSION: Primary G-CSF prophylaxis was associated with low-to-modest benefit in lowering neutropenia-related hospitalization in patients with breast cancer who received TC and TCH regimens. Further evaluation is needed to better understand which patients benefit most from G-CSF prophylaxis in this setting.
Funded by Anthem.
DOI: 10.1200/JCO.2016.67.2899
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