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). (May 2023)

• Record Type: Journal Article
• Authors: Nakamura, Atsushi; Yamaguchi, Ou; Mori, Keita; Miura, Keita; Tamiya, Motohiro; Oba, Tomohiro; Yanagitani, Noriko; Mizutani, Hideaki; Ninomiya, Takashi; Kajiwara, Tomosue; Ito, Kentaro; Miyanaga, Akihiko; Arai, Daisuke; Kodama, Hiroaki; Kobayashi, Kunihiko; Kaira, Kyoichi
• Is Part Of: European journal of cancer. Volume 184(2023)
• Page Start: 62
• Page End: 72
• Publication Date: 2023-05
• Subjects: Chemo-immunotherapy -- Non-small cell lung cancer -- Ramucirumab plus docetaxel -- Second-line treatment -- VEGFR2; Cancer -- Periodicals; Neoplasms -- Periodicals; Cancer -- Périodiques; Cancer; Tumors; Electronic journals; Periodicals; Electronic journals; 616.994
• DOI: 10.1016/j.ejca.2023.01.025
• Languages: English
• ISSNs: 0959-8049

Abstract

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. 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 .