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Real-world programmed death-ligand 1 prevalence rates in non-small cell lung cancer: correlation with clinicopathological features and tumour mutation status
  1. Mikaela Holmes1,
  2. Annabelle Mahar1,
  3. Trina Lum1,
  4. Steven Kao2,3,
  5. Wendy Anne Cooper1,3,4
  1. 1 Department of Tissue Pathology and Diagnostic Oncology, NSW Health Pathology, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
  2. 2 Department of Medical Oncology, Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
  3. 3 Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia
  4. 4 School of Medicine, Western Sydney University, Sydney, New South Wales, Australia
  1. Correspondence to Dr Wendy Anne Cooper, Tissue Pathology and Diagnostic Oncology, NSW Health Pathology, Royal Prince Alfred Hospital, Camperdown NSW 2050, New South Wales, Australia; wendy.cooper{at}


Aims The detection of programmed death-ligand 1 (PD-L1) protein expression on tumour cells by immunohistochemistry (IHC) is a predictor of response to immune checkpoint inhibitors. New immunotherapeutic options are changing the treatment paradigm for patients with advanced non-small cell lung cancer (NSCLC). The aim of this retrospective study was to investigate real-world prevalence of PD-L1 expression in NSCLC and any correlations with clinicopathological features.

Methods We reviewed 425 NSCLC cases at a Sydney metropolitan hospital that had PD-L1 IHC (SP263 clone) expression estimated as part of routine diagnostic assessment during a 30-month period.

Results Overall, 32.2% of cases were negative for PD-L1 expression (<1%), 40.3% demonstrated low expression (1%–49%) and 27.5% exhibited high protein expression (≥50%). High PD-L1 expression rates were more likely in non-lung resection cases and in KRAS mutant NSCLC as opposed to KRAS wildtype, while lower expression rates were more commonly found in EGFR mutant NSCLC compared with EGFR wildtype tumours.

Conclusions Ongoing observation and comparison of PD-L1 expression rates is an important practice for ensuring its validity as a predictive biomarker. The results from our study align with and contribute to the growing field of published real-world PD-L1 prevalence rates in NSCLC.

  • immunohistochemistry
  • lung neoplasms
  • biomarkers, tumor

Statistics from


  • Handling editor Runjan Chetty.

  • Contributors MH and WAC identified retrospective cases, obtained clinicopathological data and wrote the initial draft of the manuscript. TL optimised and performed immunohistochemical staining. AM and WAC interpreted immunohistochemistry slides. All authors contributed to manuscript revision.

  • Funding This study was partly supported by a grant from AstraZeneca.

  • Competing interests MH, AM, TL and WAC declare no conflict of interests. SK declares compensated advisory board (institutional) from AstraZeneca, Boerhinger, Roche, Merck Sharp & Dohme and Pfizer; honoraria from AstraZeneca, Bristol-Myers-Squibb, Merck Sharp & Dohme, Pfizer and Roche; and travel from AstraZeneca, Boerhinger, Bristol-Myers-Squibb and Roche.

  • Patient consent for publication Not required.

  • Ethics approval The study was approved by the Sydney Local Health District Royal Prince Alfred Hospital (SLHD RPAH) human research ethics committee (HREC/15/RPAH/577).

  • Provenance and peer review Not commissioned; internally peer reviewed.

  • Data availability statement Data are available on reasonable request.

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