Relationship Between Short‐Term Outcomes and PD‐L1 Expression Based on Combined Positive Score and Tumor Proportion Score in Recurrent or Metastatic Head and Neck Cancers Treated With Anti‐PD‐1 Antibody Monotherapy
ABSTRACT Background PD‐L1 expression in tumors and immune cells is a biomarker for the efficacy of anti‐PD‐1 antibody (APA) therapy across diverse cancers. Based on the results from the KEYNOTE‐048 trial, pembrolizumab monotherapy is indicated for platinum‐sensitive recurrent/metastatic head and nec...
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2025-01-01
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| Online Access: | https://doi.org/10.1002/cnr2.70125 |
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| author | Akihiro Ohara Taisuke Mori Mai Itoyama Kazuki Yokoyama Shun Yamamoto Ken Kato Yoshitaka Honma |
| author_facet | Akihiro Ohara Taisuke Mori Mai Itoyama Kazuki Yokoyama Shun Yamamoto Ken Kato Yoshitaka Honma |
| author_sort | Akihiro Ohara |
| collection | DOAJ |
| description | ABSTRACT Background PD‐L1 expression in tumors and immune cells is a biomarker for the efficacy of anti‐PD‐1 antibody (APA) therapy across diverse cancers. Based on the results from the KEYNOTE‐048 trial, pembrolizumab monotherapy is indicated for platinum‐sensitive recurrent/metastatic head and neck squamous cell carcinoma (R/M‐HNSCC) with a positive combined positive score (CPS). Conversely, nivolumab is utilized for platinum‐pretreated R/M‐HNSCC regardless of the positive tumor proportion score (TPS) following the results of the CheckMate‐141; however, its subgroup analysis indicated that TPS‐positive population tended to have a relatively high overall response rate and progression‐free survival (PFS). Although, the superior PD‐L1 evaluation method for predicting APA therapy efficacy in R/M‐HNSCC and the appropriate cut‐off value remain undetermined. This study aims to elucidate the relationship between short‐term outcomes and PD‐L1 expression based on CPS and TPS in R/M‐HNSCC patients undergoing APA monotherapy. Methods R/M‐HNSCC patients receiving APA monotherapy from 2018 to 2021 with available samples were enrolled. An experienced pathologist evaluated CPS and TPS utilizing the PD‐L1 IHC 22C3 pharmDx assay. Short‐term outcomes were assessed by clinical benefit rate (CBR), objective response rate (ORR), and PFS. Results Fifty‐three R/M‐HNSCC patients received APA monotherapy. Forty‐seven had CPS ≥ 1, and 44 had TPS ≥ 1%. By receiver‐operating characteristic curve analysis, the CPS cut‐off value for predicting better CBR was determined to be 50. The ORR/CBR tended to be higher when CPS was positive. Although differences in PFS were not observed for a cut‐off value of 1 or 20, they were observed for 50 (3.2 vs. 8.4 months; hazard ratio 0.44, p = 0.02). ORR and CBR were respectively 12.5% and 12.5% in the TPS < 1% group and 33.3% and 48.9% in the ≥ 1% group. The TPS < 1% group showed significantly poorer PFS (1.9 vs. 4.5 months, hazard ratio 0.40, p = 0.01). Conclusion The short‐term efficacy of APA monotherapy in R/M‐HNSCC patients tended to be better when CPS was positive. TPS helps predict the population that does not benefit from APA monotherapy. |
| format | Article |
| id | doaj-art-31d6f3e9f71244748691181b3a557b36 |
| institution | Kabale University |
| issn | 2573-8348 |
| language | English |
| publishDate | 2025-01-01 |
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| spelling | doaj-art-31d6f3e9f71244748691181b3a557b362025-01-30T15:46:35ZengWileyCancer Reports2573-83482025-01-0181n/an/a10.1002/cnr2.70125Relationship Between Short‐Term Outcomes and PD‐L1 Expression Based on Combined Positive Score and Tumor Proportion Score in Recurrent or Metastatic Head and Neck Cancers Treated With Anti‐PD‐1 Antibody MonotherapyAkihiro Ohara0Taisuke Mori1Mai Itoyama2Kazuki Yokoyama3Shun Yamamoto4Ken Kato5Yoshitaka Honma6Department of Head and Neck, Esophageal Medical Oncology National Cancer Center Hospital Tokyo JapanDepartment of Diagnostic Pathology National Cancer Center Hospital Tokyo JapanDepartment of Head and Neck, Esophageal Medical Oncology National Cancer Center Hospital Tokyo JapanDepartment of Head and Neck, Esophageal Medical Oncology National Cancer Center Hospital Tokyo JapanDepartment of Head and Neck, Esophageal Medical Oncology National Cancer Center Hospital Tokyo JapanDepartment of Head and Neck, Esophageal Medical Oncology National Cancer Center Hospital Tokyo JapanDepartment of Head and Neck, Esophageal Medical Oncology National Cancer Center Hospital Tokyo JapanABSTRACT Background PD‐L1 expression in tumors and immune cells is a biomarker for the efficacy of anti‐PD‐1 antibody (APA) therapy across diverse cancers. Based on the results from the KEYNOTE‐048 trial, pembrolizumab monotherapy is indicated for platinum‐sensitive recurrent/metastatic head and neck squamous cell carcinoma (R/M‐HNSCC) with a positive combined positive score (CPS). Conversely, nivolumab is utilized for platinum‐pretreated R/M‐HNSCC regardless of the positive tumor proportion score (TPS) following the results of the CheckMate‐141; however, its subgroup analysis indicated that TPS‐positive population tended to have a relatively high overall response rate and progression‐free survival (PFS). Although, the superior PD‐L1 evaluation method for predicting APA therapy efficacy in R/M‐HNSCC and the appropriate cut‐off value remain undetermined. This study aims to elucidate the relationship between short‐term outcomes and PD‐L1 expression based on CPS and TPS in R/M‐HNSCC patients undergoing APA monotherapy. Methods R/M‐HNSCC patients receiving APA monotherapy from 2018 to 2021 with available samples were enrolled. An experienced pathologist evaluated CPS and TPS utilizing the PD‐L1 IHC 22C3 pharmDx assay. Short‐term outcomes were assessed by clinical benefit rate (CBR), objective response rate (ORR), and PFS. Results Fifty‐three R/M‐HNSCC patients received APA monotherapy. Forty‐seven had CPS ≥ 1, and 44 had TPS ≥ 1%. By receiver‐operating characteristic curve analysis, the CPS cut‐off value for predicting better CBR was determined to be 50. The ORR/CBR tended to be higher when CPS was positive. Although differences in PFS were not observed for a cut‐off value of 1 or 20, they were observed for 50 (3.2 vs. 8.4 months; hazard ratio 0.44, p = 0.02). ORR and CBR were respectively 12.5% and 12.5% in the TPS < 1% group and 33.3% and 48.9% in the ≥ 1% group. The TPS < 1% group showed significantly poorer PFS (1.9 vs. 4.5 months, hazard ratio 0.40, p = 0.01). Conclusion The short‐term efficacy of APA monotherapy in R/M‐HNSCC patients tended to be better when CPS was positive. TPS helps predict the population that does not benefit from APA monotherapy.https://doi.org/10.1002/cnr2.70125biomarkerschemotherapyhead and neck cancerprognostic factor |
| spellingShingle | Akihiro Ohara Taisuke Mori Mai Itoyama Kazuki Yokoyama Shun Yamamoto Ken Kato Yoshitaka Honma Relationship Between Short‐Term Outcomes and PD‐L1 Expression Based on Combined Positive Score and Tumor Proportion Score in Recurrent or Metastatic Head and Neck Cancers Treated With Anti‐PD‐1 Antibody Monotherapy Cancer Reports biomarkers chemotherapy head and neck cancer prognostic factor |
| title | Relationship Between Short‐Term Outcomes and PD‐L1 Expression Based on Combined Positive Score and Tumor Proportion Score in Recurrent or Metastatic Head and Neck Cancers Treated With Anti‐PD‐1 Antibody Monotherapy |
| title_full | Relationship Between Short‐Term Outcomes and PD‐L1 Expression Based on Combined Positive Score and Tumor Proportion Score in Recurrent or Metastatic Head and Neck Cancers Treated With Anti‐PD‐1 Antibody Monotherapy |
| title_fullStr | Relationship Between Short‐Term Outcomes and PD‐L1 Expression Based on Combined Positive Score and Tumor Proportion Score in Recurrent or Metastatic Head and Neck Cancers Treated With Anti‐PD‐1 Antibody Monotherapy |
| title_full_unstemmed | Relationship Between Short‐Term Outcomes and PD‐L1 Expression Based on Combined Positive Score and Tumor Proportion Score in Recurrent or Metastatic Head and Neck Cancers Treated With Anti‐PD‐1 Antibody Monotherapy |
| title_short | Relationship Between Short‐Term Outcomes and PD‐L1 Expression Based on Combined Positive Score and Tumor Proportion Score in Recurrent or Metastatic Head and Neck Cancers Treated With Anti‐PD‐1 Antibody Monotherapy |
| title_sort | relationship between short term outcomes and pd l1 expression based on combined positive score and tumor proportion score in recurrent or metastatic head and neck cancers treated with anti pd 1 antibody monotherapy |
| topic | biomarkers chemotherapy head and neck cancer prognostic factor |
| url | https://doi.org/10.1002/cnr2.70125 |
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