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. 2024 Feb 15;14(1):3816.
doi: 10.1038/s41598-024-54166-x.

Prophylactic pegfilgrastim reduces febrile neutropenia in ramucirumab plus docetaxel after chemoimmunotherapy in advanced NSCLC: post hoc analysis from NEJ051

Keita Miura  1 , Ou Yamaguchi  2 , Keita Mori  3 , Atsushi Nakamura  4 , Motohiro Tamiya  5 , Tomohiro Oba  6 , Noriko Yanagitani  7 , Hideaki Mizutani  8 , Takashi Ninomiya  9 , Tomosue Kajiwara  10 , Kentaro Ito  11 , Akihiko Miyanaga  12 , Daisuke Arai  13 , Hiroaki Kodama  14 , Kunihiko Kobayashi  15 , Kyoichi Kaira  16
Affiliations

Prophylactic pegfilgrastim reduces febrile neutropenia in ramucirumab plus docetaxel after chemoimmunotherapy in advanced NSCLC: post hoc analysis from NEJ051

Keita Miura et al. Sci Rep. .

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.

Keywords: Febrile neutropenia; Neutropenia; Non-small cell lung cancer; Pegfilgrastim; Ramucirumab plus docetaxel.

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Conflict of interest statement

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Keita Miura reports a relationship with Chugai Pharmaceutical Co Ltd that includes speaking and lecture fees. Keita Miura reports a relationship with Taiho Pharmaceutical Co Ltd that includes speaking and lecture fees. Kentaro Ito reports a relationship with Eli Lilly that includes speaking and lecture fees. Kentaro Ito reports a relationship with Boehringer Ingelheim that includes speaking and lecture fees. Kentaro Ito reports a relationship with Takeda Pharmaceutical Co Ltd that includes speaking and lecture fees. Kentaro Ito reports a relationship with Chugai Pharmaceutical Co Ltd that includes speaking and lecture fees. Kentaro Ito reports a relationship with Pfizer that includes speaking and lecture fees. Kentaro Ito reports a relationship with Merck & Co Inc. that includes speaking and lecture fees. Kentaro Ito reports a relationship with AstraZeneca that includes speaking and lecture fees. Kentaro Ito reports a relationship with Ono Pharmaceutical Co Ltd that includes speaking and lecture fees. Kentaro Ito reports a relationship with Taiho Pharmaceutical Co Ltd that includes speaking and lecture fees. Daisuke Arai reports a relationship with Chugai Pharmaceutical Co Ltd that includes speaking and lecture fees. Daisuke Arai reports a relationship with AstraZeneka KK Tokyo Branch that includes speaking and lecture fees. Daisuke Arai reports a relationship with Ono Pharmaceutical Co Ltd that includes speaking and lecture fees. Daisuke Arai reports a relationship with Taiho Pharmaceutical Co Ltd that includes speaking and lecture fees. Daisuke Arai reports a relationship with Takeda Pharmaceutical Co Ltd that includes speaking and lecture fees. Daisuke Arai reports a relationship with Nippon Kayaku Co Ltd that includes speaking and lecture fees. Daisuke Arai reports a relationship with Merck & Co Inc that includes speaking and lecture fees. Kyoichi Kaira reports financial support was provided by Eli Lilly Japan KK. Kyoichi Kaira reports a relationship with AstraZeneca Pharmaceuticals LP that includes speaking and lecture fees. Hiroaki Kodama reports a relationship with Chugai Pharmaceutical Co Ltd that includes speaking and lecture fees. Hiroaki Kodama reports a relationship with Boehringer Ingelheim Pharmaceuticals Inc that includes speaking and lecture fees. Hiroaki Kodama reports a relationship with Novartis Pharmaceuticals Corporation that includes speaking and lecture fees. Kunihiko Kobayashi reports a relationship with AstraZeneca that includes speaking and lecture fees. Kunihiko Kobayashi reports a relationship with Takeda Pharmaceutical Co Ltd that includes speaking and lecture fees. Atsushi Nakamura reports a relationship with MSD that includes speaking and lecture fees. Atsushi Nakamura reports a relationship with Thermo Fisher Scientific that includes speaking and lecture fees. Atsushi Nakamura reports a relationship with AstraZeneca that includes speaking and lecture fees. Atsushi Nakamura reports a relationship with Eli Lilly Japan KK that includes speaking and lecture fees. Atsushi Nakamura reports a relationship with Chugai Pharmaceutical Co Ltd that includes speaking and lecture fees. Atsushi Nakamura reports a relationship with Taiho Pharmaceutical Co Ltd that includes speaking and lecture fees. Atsushi Nakamura reports a relationship with Nippon Kayaku Co Ltd that includes speaking and lecture fees. Atsushi Nakamura reports a relationship with Novartis Pharma that includes speaking and lecture fees. Takashi Ninomiya reports a relationship with Boehringer Ingelheim that includes speaking and lecture fees. Takashi Ninomiya reports a relationship with AstraZeneca that includes speaking and lecture fees. Takashi Ninomiya reports a relationship with Chugai Pharmaceutical Co Ltd that includes speaking and lecture fees. Ou Yamaguchi reports a relationship with Eli Lilly Japan K.K. that includes speaking and lecture fees. Ou Yamaguchi reports a relationship with Ono Pharmaceutical Co Ltd that includes speaking and lecture fees. Ou Yamaguchi reports a relationship with Bristol Myers Squibb Co that includes speaking and lecture fees. Ou Yamaguchi reports a relationship with Chugai Pharmaceutical Co Ltd that includes speaking and lecture fees. Ou Yamaguchi reports a relationship with Merck Sharp & Dohme Corp that includes speaking and lecture fees. Ou Yamaguchi reports a relationship with AstraZeneca that includes speaking and lecture fees. Noriko Yanagitani reports a relationship with Chugai Pharmaceutical Co Ltd that includes speaking and lecture fees. Noriko Yanagitani reports a relationshipwith Ono Pharmaceutical Co Ltd that includes speaking and lecture fees. Noriko Yanagitani reports a relationship with Bristol Myers Squibb that includes speaking and lecture fees. Noriko Yanagitani reports a relationship with Pfizer Inc that includes speaking and lecture fees. Noriko Yanagitani reports a relationship with Takeda Pharmaceutical Company Limited that includes speaking and lecture fees. Noriko Yanagitani reports a relationship with Eli Lilly and Company that includes speaking and lecture fees. Noriko Yanagitani reports a relationship with AstraZeneca PLC that includes speaking and lecture fees. Noriko Yanagitani reports a relationship with Bayer Holding Co Ltd that includes speaking and lecture fees. Noriko Yanagitani reports a relationship with Chugai Pharmaceutical Co Ltd that includes paid expert testimony. All other Authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Figure 1
Figure 1
Kaplan–Meier curves showing progression-free survival (A) and overall survival (B) classified according to the presence or absence of prophylactic pegfilgrastim (PEG) in ramucirumab plus docetaxel treatment. Median progression free survival was 4.3 months (95% CI 3.9–4.8) in the PEG prophylaxis group and 2.5 months (95% CI 1.1–3.9) in the control group (p = 0.002). Median overall survival was 12.8 months (95% CI 10.7–14.9) in the PEG prophylaxis group and 8.1 months (95% CI 5.0–11.2) in the control group (p = 0.004).
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