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Pembrolizumab in advanced NSCLC patients with poor performance status and high PD-L1 expression: OLCSG 1801

Authors :
Shinobu, Hosokawa
Eiki, Ichihara
Daijiro, Harada
Shoichi, Kuyama
Koji, Inoue
Kenichi, Gemba
Hirohisa, Ichikawa
Yuka, Kato
Naohiro, Oda
Isao, Oze
Tomoki, Tamura
Toshiyuki, Kozuki
Takahiro, Umeno
Toshio, Kubo
Katsuyuki, Hotta
Akihiro, Bessho
Yoshinobu, Maeda
Katsuyuki, Kiura
Source :
International journal of clinical oncology. 27(7)
Publication Year :
2022

Abstract

The role of pembrolizumab in the treatment of poor performance status (PS) patients remains unclear.We conducted a phase II trial to investigate the efficacy and safety of pembrolizumab as first-line therapy for non-small-cell lung cancer (NSCLC) patients with PSs of 2-3 and programmed cell death ligand 1 (PD-L1) expression ≥ 50%. The primary endpoint of this study was the objective response rate (ORR).Fourteen patients treated at eight institutions were enrolled. Most patients had PS 2 (12/14; 86%) and others had PS 3 (2/14; 14%). The ORR was 57.1% (95% confidence interval 28.9-82.3%), which met the primary endpoint. The median progression-free survival (PFS) and 1-year PFS rates were 5.8 months and 20.0%, respectively. At the time of data cut-off, one patient had received treatment for more than 1 year; another patient had received treatment for more than 2 years. Nine patients had improved PS with treatment (Wilcoxon signed-rank test, p = 0.003). Two patients had immune-related adverse events ≥ grade 3: grades 5 and 3 elevation in alanine and aspartate aminotransferases. Two PS 3-stage patients were diagnosed with clinically progressive disease prior to initial computed tomography; both died within 2 months.Pembrolizumab was effective for the treatment of NSCLC patients with a poor PS and PD-L1 level ≥ 50%. However, given the poor outcomes of the PS 3 patients, the drug is not indicated for such patients. Adverse events, including liver dysfunction, should be carefully monitored.UMIN000030955.

Details

ISSN :
14377772
Volume :
27
Issue :
7
Database :
OpenAIRE
Journal :
International journal of clinical oncology
Accession number :
edsair.pmid..........1ace4757d6fd91b9f8eb0e75fecbad0d