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433 Prevalence of PD-L1 expression among patients with recurrent and metastatic head and neck squamous cell carcinoma in Taiwan
  1. Chia-Jui Yen1,
  2. Ming-Yu Lien2,
  3. Rebecca Cheng3,
  4. Yu-Wen Su3,
  5. Han-Nan Lin3,
  6. Michael Thomas Wong4,
  7. Song Ling Poon4,
  8. Chih-Yen Chien5 and
  9. Ruey-Long Hong6
  1. 1National Cheng Kung University Hospital, Tainan City, Taiwan
  2. 2China Medical University Hospital, Taichung, Taiwan
  3. 3MSD (I.A.) LLC, Taipei, Taiwan
  4. 4MSD International GmbH, Singapore, Singapore
  5. 5Kaohsiung Chang Gung Memorial Hospital, taipei, Taiwan
  6. 6National Taiwan University Hospital, Taipei, Taiwan


Background Tumor programmed death-receptor/ligand-1 (PD-1/PD-L1) expression negatively correlates with cancer prognosis and overall survival, 1-6 and has been shown to predict clinical responses to immunotherapy for head and neck cancers.7 In Taiwan, head and neck cancers continue to show a high prevalence associated with betel quid chewing, a practice endemic to the island. This study aims to evaluate the prevalence of PD-L1 expression in recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) patients in Taiwan.

Methods For this multi-centered prospective study, we recruited R/M HNSCC patients who are aged 20 years or older, have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, are ineligible for re-irradiation or curative surgery, and had a biopsy obtained before treatment. PD-L1 expression measured by combined positive score (CPS) and tumor proportion score (TPS) was determined by the PD-L1 IHC 22C3 pharmDx™ kit. The primary endpoint was to estimate the prevalence of PD-L1 expression, characterized by CPS≥ 1. Exploratory analyses were conducted to evaluate PD-L1 positivity by CPS≥ 20 and TPS≥ 50%, and to explore the association of prior first- or second-line systemic treatment and PD-L1 expression.

Results Between December 2019 and February 2021, 280 patients from 4 centers were enrolled, including 264 (94.3%) males with median age of 58.0 years. Notably, 211 (75.4%) had a history of betel nut chewing. The primary sites were oral cavity in 192 cases (68.5%), followed by oropharynx 43 (15.4%), hypopharynx 26 (9.3%), and larynx 20 (7.1%). Among patients with oropharyngeal cancer, 13 (30.2%) were p16 positive. Prior to enrollment, 171 (61.1%) patients had received first-line systemic treatment and 68 (24.3%) second-line. The prevalence of PD-L1 (CPS≥ 1) was 94.3% (264/280) in the total cohort, 93.8% (198/211) in the betel nut exposed subgroup, and 96.6% (56/58) in the non-betel nut exposed subgroup. Furthermore, 46.1% (129/280) of all patients were CPS≥ 20, and 17.1% (48/280) were TPS≥ 50%. A total of 159 (93.0%) and 64 (94.1%) patients were CPS≥ 1 among those that received first-line and second-line systemic treatment, respectively.

Conclusions PD-L1 expression was observed in a vast majority (94.3%) of R/M HNSCC patients. There is no difference in PD-L1 prevalence between those with betel nut exposure history and betel nut non-exposed patients. PD-L1 prevalence also does not differ in those that had received prior first-line or second-line therapy, compared to the overall study population.

Acknowledgements This study was funded by MSD. Cerner Enviza received funding for the conduct of the study and development of the abstract.


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Ethics Approval The study received ethics approval from National Taiwan University Hospital (IRB number: 201909007RSA), China Medical University Hospital (IRB number: CMUH108-REC2-150), National Cheng Kung University Hospital (IRB number: B-ER-108-252), and Chang Gung Memorial Hospital Kaohsiung Branch (IRB number: 201901757B0C501).

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