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

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

Research output: Contribution to journalArticlepeer-review

4 Citations (Scopus)


Background: The role of pembrolizumab in the treatment of poor performance status (PS) patients remains unclear. Patients and methods: 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). Results: 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. Conclusion: 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. Registration ID: UMIN000030955.

Original languageEnglish
JournalInternational Journal of Clinical Oncology
Publication statusAccepted/In press - 2022


  • Immune checkpoint inhibitor
  • PD-L1
  • Pembrolizumab
  • Performance status

ASJC Scopus subject areas

  • Surgery
  • Hematology
  • Oncology


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