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Abstract：
Ramucirumab plus docetaxel (RD) can cause febrile neutropenia (FN), which frequently requires the prophylactic administration of pegfilgrastim. However, the effects of prophylactic pegfilgrastim on FN prevention, therapeutic efficacy, and prognosis after RD have not been fully evaluated in patients with advanced non-small-cell lung cancer (NSCLC). Two hundred and eighty-eight patients with advanced NSCLC who received RD as second-line therapy after platinum-based chemotherapy plus PD-1 blockade were included. Patients were divided into groups with and without prophylactic pegfilgrastim, and adverse events, efficacy, and prognosis were compared between both groups. Of the 288 patients, 247 received prophylactic pegfilgrastim and 41 did not. The frequency of grade 3/4 neutropenia was 62 patients (25.1%) in the pegfilgrastim group and 28 (68.3%) in the control group (p < 0.001). The frequency of FN was 25 patients (10.1%) in the pegfilgrastim group and 10 (24.4%) in the control group (p = 0.018). The objective response rate was 31.2% and 14.6% in the pegfilgrastim and control groups (p = 0.039), respectively. The disease control rate was 72.9% in the pegfilgrastim group and 51.2% in the control group (p = 0.009). Median progression free survival was 4.3 months in the pegfilgrastim group and 2.5 months in the control group (p = 0.002). The median overall survival was 12.8 and 8.1 months in the pegfilgrastim and control groups (p = 0.004), respectively. Prophylactic pegfilgrastim for RD reduced the frequency of grade 3/4 neutropenia and febrile neutropenia and did not appear to be detrimental to patient outcome RD.Clinical Trial Registration Number: UMIN000042333.
摘要：
雷莫鲁单抗联合多西他赛（RD）可引起发热性中性粒细胞减少症（FN），这通常需要预防性使用pegfilgrastim。然而,预防性pegfilgrastim对FN预防的影响，治疗效果，晚期非小细胞肺癌（NSCLC）患者RD后的预后尚未得到充分评估。纳入了288例晚期NSCLC患者，他们在铂类化疗加PD-1阻断后接受RD作为二线治疗。患者分为有和没有预防性pegfilgrastim的组，和不良事件，功效,比较两组的预后。在288名患者中，247人接受了预防性pegfilgrastim，41人没有。3/4级中性粒细胞减少症的发生率pegfilgrastim组为62例（25.1％），对照组为28例（68.3％）（p<0.001）。Pegfilgrastim组的FN频率为25例（10.1％），对照组为10例（24.4％）（p=0.018）。pegfilgrastim组和对照组的客观有效率分别为31.2％和14.6％（p=0.039），分别。pegfilgrastim组的疾病控制率为72.9％，对照组为51.2％（p=0.009）。pegfilgrastim组的中位无进展生存期为4.3个月，对照组为2.5个月（p=0.002）。pegfilgrastim组和对照组的中位总生存期分别为12.8和8.1个月（p=0.004），分别。预防性使用pegfilgrastim治疗RD可减少3/4级中性粒细胞减少和发热性中性粒细胞减少的频率，并且似乎对患者预后RD没有损害。临床试验登记号：UMIN000042333。
