Department of Respiratory Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Department of Respiratory Medicine, Comprehensive Cancer Center, Saitama Medical University International Medical Center, 1397-1, Yamane, Hidaka, 350-1298, Japan.
Sci Rep. 2024 Feb 15;14(1):3816. doi: 10.1038/s41598-024-54166-x.
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.
雷莫芦单抗联合多西他赛（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培非格司亭。然而，在接受铂类化疗加 PD-1 阻断的二线治疗后接受 RD 的晚期非小细胞肺癌（NSCLC）患者中，预防性使用培非格司亭对 FN 预防、治疗效果和预后的影响尚未得到充分评估。
将 288 例接受 RD 作为铂类化疗加 PD-1 阻断二线治疗的晚期 NSCLC 患者纳入本研究。将患者分为使用和未使用预防性培非格司亭的两组，比较两组之间的不良反应、疗效和预后。在 288 例患者中，247 例接受预防性培非格司亭治疗，41 例未接受。培非格司亭组中 3/4 级中性粒细胞减少症的发生率为 62 例（25.1%），对照组为 28 例（68.3%）（p<0.001）。培非格司亭组 FN 的发生率为 25 例（10.1%），对照组为 10 例（24.4%）（p=0.018）。培非格司亭组和对照组的客观缓解率分别为 31.2%和 14.6%（p=0.039）。培非格司亭组疾病控制率为 72.9%，对照组为 51.2%（p=0.009）。培非格司亭组中位无进展生存期为 4.3 个月，对照组为 2.5 个月（p=0.002）。培非格司亭组和对照组的中位总生存期分别为 12.8 个月和 8.1 个月（p=0.004）。RD 中预防性使用培非格司亭可降低 3/4 级中性粒细胞减少症和发热性中性粒细胞减少症的发生率，且对患者预后无不利影响。
UMIN000042333。
