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Programmed Death-ligand 1 Expression With Clone 22C3 in Non-small Cell Lung Cancer: A Single Institution Experience
Maiko Takeda1, Takahiko Kasai1, Maiko Naito2
1Department of Laboratory Medicine and Pathology, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Japan.
Background:
In recent years, the anti-programmed cell death 1 (PD-1) drug pembrolizumab (Keytruda) was approved for treatment of unresectable advanced non-small cell lung cancer (NSCLC) as first- or second-line therapy depending on the clone 22C3-programmed death-ligand 1 (PD-L1) immunohistochemical expression score by the companion diagnostic assay. We herein evaluated 22C3-PD-L1 expression of NSCLC in a single institution experience and compared it with clinicopathologic features.
Materials And Methods:
We assessed 22C3-PD-L1 expressions of 411 patients with NSCLC from our institution, including in past specimens. Programmed death-ligand 1 immunohistochemistry (IHC) testing was performed using the PD-L1 clone 22C3 pharmDx kit (Agilent Technologies/Dako, Carpinteria, CA, USA). Patients were separated into 3 groups with <1% (no expression), 1% to 49% (low expression), or ⩾50% (high expression) positive tumor cells.
Results:
In all, 137 patients (33%) did not express PD-L1, 155 (38%) showed low expression, and 119 (29%) demonstrated high expression. Archival samples showed lower PD-L1 expression than that of recent samples, and the ratios of no expression case significantly increased by using paraffin blocks embedded particularly in more than 4 years ago. Programmed death-ligand 1 positivity was significantly associated with male sex, smoking, higher tumor grade, squamous cell carcinoma in histologic type, wild-type EGFR, and ALK rearrangement positive.
Conclusions:
The rate of 22C3-PD-L1 expression of NSCLC detected in this study was similar to the frequencies of the previous reports, although the ratio of expression case decreased when using old paraffin blocks.
Insights
Pembrolizumab (Keytruda) is approved for non-small cell lung cancer (NSCLC) based on PD-L1 expression. This study found PD-L1 expression rates consistent with prior reports, though older samples showed decreased expression.
Area of Science:
- Oncology
- Immunotherapy
- Cancer Diagnostics
Background:
- Pembrolizumab (Keytruda), an anti-programmed cell death 1 (PD-1) therapy, is approved for advanced non-small cell lung cancer (NSCLC).
- Treatment efficacy is determined by programmed death-ligand 1 (PD-L1) expression levels, assessed via immunohistochemical assays.
- This study evaluates 22C3-PD-L1 expression in NSCLC within a single institution.
Purpose of the Study:
- To assess 22C3-PD-L1 expression in a cohort of NSCLC patients.
- To compare PD-L1 expression with various clinicopathologic features.
- To investigate the impact of sample age on PD-L1 expression detection.
Main Methods:
- Analyzed 22C3-PD-L1 expression in 411 NSCLC patients using immunohistochemistry (IHC) with the 22C3 pharmDx kit.
- Classified patients into three groups: <1% (no expression), 1%-49% (low expression), and ⩾50% (high expression) positive tumor cells.
- Compared PD-L1 expression with clinicopathologic data and analyzed differences based on specimen age.
Main Results:
- PD-L1 expression was observed in 67% of patients: 33% no expression, 38% low expression, and 29% high expression.
- Archival samples, particularly those over 4 years old, exhibited significantly lower PD-L1 expression compared to recent samples.
- PD-L1 positivity was associated with male sex, smoking history, higher tumor grade, squamous cell carcinoma, wild-type EGFR, and ALK rearrangement.
Conclusions:
- The overall rate of 22C3-PD-L1 expression in NSCLC aligns with previous research findings.
- The use of older paraffin-embedded blocks can lead to an underestimation of PD-L1 expression.
- Accurate PD-L1 assessment is crucial for guiding immunotherapy decisions in NSCLC.
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