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Original Research| Volume 184, P62-72, May 2023

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Multicentre real-world data of ramucirumab plus docetaxel after combined platinum-based chemotherapy with programmed death-1 blockade in advanced non-small cell lung cancer: NEJ051 (REACTIVE study)

Published:February 10, 2023DOI:https://doi.org/10.1016/j.ejca.2023.01.025

      Highlights

      • The response rate for docetaxel plus ramucirumab (RD) after chemo-immunotherapy was 28.8%.
      • Progression free survivaland overall survival for RD after chemo-immunotherapy were 4.1 months and 11.6 months, respectively.
      • The frequency of pneumonitis due to RD after chemo-immunotherapy was 10.8%.
      • Bone metastasis, poor performance status and non-adenocarcinoma were prognostic factors for poor overall survival .

      Abstract

      Background

      Ramucirumab plus docetaxel (RD) is a promising treatment for previously treated advanced non-small cell lung cancer (NSCLC). However, its clinical significance after platinum-based chemotherapy plus programmed death-1 (PD-1) blockade remains unclear.

      Research question

      What is the clinical significance of RD as a second-line treatment after the failure of chemo-immunotherapy in NSCLC?

      Study design and methods

      In this multicentre retrospective study, 288 patients with advanced NSCLC who received RDas second-line therapy after platinum-based chemotherapy plus PD-1 blockade, at 62 Japanese institutions from January 2017 to August 2020, were included. Prognostic analyses were performed using the log-rank test. Prognostic factor analyses were performed using a Cox regression analysis.

      Results

      A total of 288 patients were enrolled: 222 were men (77.1%), 262 were aged <75 years (91.0%), 237 (82.3%) had smoking history and 269 (93.4%) had a performance status (PS) of 0–1. One hundred ninety-nine patients (69.1%) were classified as adenocarcinoma (AC) and 89 (30.9%) as non-AC. The types of PD-1 blockade used in the first-line treatment were anti-PD-1 antibody and anti-programmed death-ligand 1 antibody in 236 (81.9%) and 52 (18.1%) patients, respectively. The objective response rate for RD was 28.8% (95% confidence interval [CI], 23.7–34.4). The disease control rate was 69.8% (95% CI, 64.1–75.0).The median progression free survival and overall survival were 4.1 months (95% CI, 3.5–4.6) and 11.6 months (95% CI, 9.9–13.9), respectively. In a multivariate analysis, non-AC and PS 2–3 were independent prognostic factors for worse progression free survival , while bone metastasis on diagnosis, PS 2–3 and non-AC were identified as independent prognostic factors for poor overall survival.

      Interpretation

      RD is a feasible second-line treatment in patients with advanced NSCLC who had received combined chemo-immunotherapy with PD-1 blockade.

      Clinical trial registration number

      UMIN000042333.

      Keywords

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