University of Texas MD Anderson Cancer Center, Houston, TX, USA.
St Joseph Heritage Healthcare, Santa Rosa, CA, USA.
Cancer Med. 2021 Sep;10(17):5748-5756. doi: 10.1002/cam4.4089. Epub 2021 Aug 18.
Supportive care interventions used to manage chemotherapy-induced myelosuppression (CIM), including granulocyte colony-stimulating factors (G-CSFs), erythropoiesis-stimulating agents (ESAs), and red blood cell (RBC) transfusions, are burdensome to patients and associated with greater costs to health care systems. We evaluated the utilization of supportive care interventions and their relationship with the myeloprotective agent, trilaciclib.
Data were pooled from three independent randomized phase 2 clinical trials of trilaciclib or placebo administered prior to chemotherapy in patients with extensive-stage small cell lung cancer (ES-SCLC). The impact of supportive care on the duration of severe neutropenia (DSN), occurrence of severe neutropenia (SN), and occurrence of RBC transfusions on/after week 5 was analyzed across cycles 1-4. Concordance and association between grade 3/4 anemia, RBC transfusions on/after week 5, and ESA administration was also evaluated.
The use of G-CSFs, ESAs, or RBC transfusions on/after week 5 was significantly lower among patients receiving trilaciclib versus placebo (28.5% vs. 56.3%, p < 0.0001; 3.3% vs. 11.8%, p = 0.0254; and 14.6% vs. 26.1%, p = 0.0252, respectively). Compared with placebo, trilaciclib significantly reduced DSN and SN, irrespective of G-CSF administration. RBC transfusions and ESAs were most often administered in patients with grade 3/4 anemia; however, patients typically received RBC transfusions over ESA administration.
By improving CIM and reducing the need for associated supportive care, trilaciclib has the potential to reduce the burden of myelosuppression on patients receiving myelosuppressive chemotherapy for the treatment of ES-SCLC.
ClinicalTrials.gov (NCT02499770; NCT03041311; NCT02514447).
用于管理化疗引起的骨髓抑制（CIM）的支持性护理干预措施，包括粒细胞集落刺激因子（G-CSFs）、促红细胞生成素刺激剂（ESAs）和红细胞（RBC）输注，会给患者带来负担，并增加医疗保健系统的成本。我们评估了支持性护理干预措施的利用情况及其与骨髓保护剂替拉西利的关系。
数据来自替拉西利或安慰剂在广泛期小细胞肺癌（ES-SCLC）患者化疗前进行的三项独立的随机 2 期临床试验的汇总。分析了在第 1-4 周期内，支持性护理对严重中性粒细胞减少症（DSN）持续时间、严重中性粒细胞减少症（SN）发生和第 5 周后 RBC 输注的影响。还评估了 3/4 级贫血、第 5 周后 RBC 输注和 ESA 给药之间的一致性和关联。
与安慰剂相比，接受替拉西利治疗的患者在第 5 周后使用 G-CSF、ESA 或 RBC 输注的比例显著降低（28.5% vs. 56.3%，p<0.0001；3.3% vs. 11.8%，p=0.0254；14.6% vs. 26.1%，p=0.0252）。与安慰剂相比，无论是否使用 G-CSF，替拉西利均显著降低了 DSN 和 SN。RBC 输注和 ESA 最常用于 3/4 级贫血患者；然而，患者通常先接受 RBC 输注，然后再接受 ESA 治疗。
通过改善 CIM 并减少相关支持性护理的需求，替拉西利有可能减轻接受骨髓抑制化疗治疗 ES-SCLC 患者的骨髓抑制负担。
ClinicalTrials.gov（NCT02499770；NCT03041311；NCT02514447）。
