Real-world effectiveness of prophylactic granulocyte colony-stimulating factor (G-CSF) early (week 1) and late (weeks 2-3) in the cycle for the prevention of febrile neutropenia (FN) among patients (pts) with breast cancer (BC) after high FN–risk chemotherapy (chemo).
Real-world effectiveness of prophylactic granulocyte colony-stimulating factor (G-CSF) early (week 1) and late (weeks 2-3) in the cycle for the prevention of febrile neutropenia (FN) among patients (pts) with breast cancer (BC) after high FN–risk chemotherapy (chemo).
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周期早期（第 1 周）和晚期（第 2-3 周）预防性粒细胞集落刺激因子 (G-CSF) 对乳腺癌患者 (pts) 预防发热性中性粒细胞减少症 (FN) 的真实效果（ BC）高 FN 风险化疗（化疗）后。
DOI：
10.1200/jco.2022.40.16_suppl.599
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发表时间：
2022
影响因子：
45.3
通讯作者：
R. Mohanlal
中科院分区：
文献类型：
--
作者：
D. Blayney;Alice Kate Cummings Joyner;J. Jarvis;D. Nunag;Jasmine Wells;Lan Huang;R. Mohanlal
背景：G-CSF可减轻化疗引起的中性粒细胞减少症(CIN)，降低FN风险。G-CSF使化疗周期中中性粒细胞绝对计数(ANC)的最低点提前(至第1周)，并缩短了最低点的持续时间(Crawford，NEJM 1991)，这表明在化疗周期的早期(第1周)CIN的保护效果不佳。在化疗周期的第1周和第2-3周，使用G-CSF的相对FN风险是未知的，并与在高FN风险化疗的真实环境中不使用G-CSF进行了对比分析。方法：使用一个代表100%收费医疗保险的行政索赔数据库，我们分析了在2019年1月1日至2015年12月31日期间开始使用多西他赛(T)、阿霉素(A)或环磷酰胺(C)单一治疗或联合治疗的BC患者。样本样本包括65岁的成年人，在化疗开始前6个月和化疗后20天内连续参加≥A、B和D部分的保险。化疗后3天内接受G-CSF治疗与未接受G-CSF治疗的患者分为两组。计算第1周开始的FN事件与第1周期第2~3周的FN事件的比率。我们将FN定义为初诊或继发诊断为中性粒细胞减少症的住院患者，并测量化疗开始和FN入院之间的间隔。结果：在18,788名接受T、A和/或C治疗的BC患者中，72%接受了G-CSF治疗。与未接受粒细胞集落刺激因子治疗的患者相比，接受粒细胞集落刺激因子治疗的患者更多地使用T、A和/或C的≥2(71%对51%)。接受粒细胞集落刺激因子治疗的患者在第1周期的总体FN发生率(4.0%)显著低于未接受粒细胞集落刺激因子治疗的患者(8.8%；n=462)(p<；0.0001)。在使用G-CSF的患者中，81%(440/546)的第一周期FN事件开始于第1周，而在第2-3周则为19%(106/546)。在没有接受G-CSF的PTS中，第一周期FN事件的开始更为均匀：41%(190/462)开始于第1周，59%(272/462)开始于第2-3周。结果是可靠的敏感性分析局限于接受≥2的T、A和/或C的PT。化疗后使用和不使用G-CSF1周和2-3周开始第一周期FN事件的比率如下所示。结论：预防性G-CSF对预防FN在2-3周是非常有效的，但在现实世界中第一周期的第一周相对无效，使患者在第一周基本上没有保护。这表明，尽管使用了G-CSF，但在周期的第一周仍有未得到满足的医疗需求。临床试验信息：NCT03294577。[表：见正文]
599 Background: G-CSF mitigates chemotherapy-induced neutropenia (CIN) and reduces FN risk. G-CSF moves the nadir of absolute neutrophil count (ANC) earlier (to week 1) in the chemo cycle and shortens nadir duration (Crawford, NEJM 1991), suggesting the potential for suboptimal CIN protection early (week 1) in the chemo cycle. The relative FN risk in week 1 vs. weeks 2-3 of the cycle with G-CSF is unknown and was analyzed compared with no G-CSF in the real-world setting with high FN risk chemo. Methods: Using a database of administrative claims representing 100% of fee-for-service Medicare, we analyzed BC pts who initiated docetaxel (T), doxorubicin (A), or cyclophosphamide (C) monotherapy or combination therapy between 01/01/2015 – 12/31/2019. Sample pts included adults aged ≥ 65 years with continuous coverage in Medicare Parts A, B, and D for 6 months before and 20 days after chemo initiation. Pts were categorized as receiving vs. not receiving G-CSF therapy within 3 days after chemo. Rate of FN events starting in week 1 vs. weeks 2-3 in cycle 1 was calculated. We defined FN as an inpatient admission with a primary or secondary diagnosis of neutropenia and measured the interval between chemo initiation and FN admission. Results: Among 18,788 Medicare beneficiaries with BC treated with T, A, and/or C, 72% received G-CSF therapy. More pts receiving G-CSF were treated with ≥ 2 of T, A, and/or C compared to pts who did not receive G-CSF (71% vs. 51%). Overall FN incidence in cycle 1 was significantly lower among pts receiving G-CSF (4.0%; n=546) compared to pts not receiving G-CSF (8.8%; n=462) (p<0.0001). In pts with G-CSF, 81% (440/546) of all 1st-cycle FN events started in week 1 vs. 19% (106/546) in weeks 2-3. In pts not receiving G-CSF, the start of 1st-cycle FN events was more equally distributed: 41% (190/462) started in week 1 vs. 59% (272/462) in weeks 2-3. Results were robust to sensitivity analyses restricted to pts receiving ≥ 2 of T, A, and/or C. The rates of 1st-cycle FN events starting in weeks 1 and 2-3 with and without G-CSF following chemo initiation is shown below. Conclusions: Prophylactic G-CSF was highly effective for the prevention of FN in weeks 2-3, but relatively ineffective in week 1 of cycle 1 in the real-world setting, leaving pts largely unprotected during the first week. This represents an unmet medical need in week 1 of the cycle, despite use of G-CSF. Clinical trial information: NCT03294577. [Table: see text]