Effect of Tissue Sample Type on The Evaluation of PD‐L1 (SP142) Expression in Breast Cancer

Usui, Takeshi; Shimoda, Masafumi; Abe, Kaori; Masunaga, Nanae; Tsukabe, Masami; Yoshinami, Tetsuhiro; Sota, Yoshiaki; Miyake, Tomohiro; Tanei, Tomonori; Shimazu, Kenzo

doi:https://doi.org/10.21873/anticanres.17893

Effect of Tissue Sample Type on The Evaluation of PD‐L1 (SP142) Expression in Breast Cancer

Usui, Takeshi; Shimoda, Masafumi; Abe, Kaori et al.

Anticancer Research, 2025, 45(12), 5587-5594

Number of Access:87（2026-02-04 02:46 Counts）

Identifier to cite or link to this item: https://hdl.handle.net/11094/103650

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Title	Effect of Tissue Sample Type on The Evaluation of PD‐L1 (SP142) Expression in Breast Cancer
Creator	ORCID 0009-0009-0510-6756 0009-0009-0510-6756 Scopus Author ID 59402076900 59402076900 CreatorName Usui, Takeshi
	NRID 1000030644455 1000030644455 ORCID 0000-0002-0832-9877 0000-0002-0832-9877 researchmap permalink shimodam shimodam Scopus Author ID 55796822600 55796822600 CreatorName Shimoda, Masafumi
	NRID 1000080587593 1000080587593 CreatorName Abe, Kaori
	NRID 1000060961620 1000060961620 Scopus Author ID 57195636812 57195636812 ORCID 0000-0002-6164-5107 0000-0002-6164-5107 researchmap permalink nnnnnanae nnnnnanae CreatorName Masunaga, Nanae
	researchmap permalink masami-tsukabe masami-tsukabe ORCID 0009-0009-3284-0833 0009-0009-3284-0833 Scopus Author ID 55908971300 55908971300 CreatorName Tsukabe, Masami
	NRID 1000030894240 1000030894240 researchmap permalink osaka-yoshi osaka-yoshi Scopus Author ID 36009656500 36009656500 CreatorName Yoshinami, Tetsuhiro
	ORCID 0000-0001-5963-652X 0000-0001-5963-652X researchmap permalink y_sota123 y_sota123 Scopus Author ID 56308090600 56308090600 NRID 1000080943779 1000080943779 CreatorName Sota, Yoshiaki
	NRID 1000000636110 1000000636110 ORCID 0000-0002-9362-9822 0000-0002-9362-9822 researchmap permalink tomohiromiyake tomohiromiyake Scopus Author ID 55165894400 55165894400 CreatorName Miyake, Tomohiro
	NRID 1000080771518 1000080771518 ORCID 0000-0003-2183-8681 0000-0003-2183-8681 researchmap permalink tanei tanei Scopus Author ID 6506192669 6506192669 CreatorName Tanei, Tomonori
	NRID 1000030448039 1000030448039 researchmap permalink _-23f _-23f Scopus Author ID 7005224756 7005224756 ORCID 0000-0002-0837-2357 0000-0002-0837-2357 CreatorName Shimazu, Kenzo
Subject	breast cancer
	neoadjuvant chemotherapy
	PD‑L1
	primary tumor
	SP142
Description	Usui T., Shimoda M., Abe K., et al. Effect of Tissue Sample Type on The Evaluation of PD‐L1 (SP142) Expression in Breast Cancer. Anticancer Research 45, 5587 (2025); https://doi.org/10.21873/anticanres.17893.
Abstract	Background/Aim: PD‑L1 expression is a key biomarker for immune checkpoint inhibitor therapy in breast cancer treatment. However, many factors affect PD‑L1 assessment. This study evaluated how specimen‑related factors affect PD‑L1 expression in breast cancer and provides a guide for optimal specimen selection. Patients and Methods: We retrospectively analyzed 30 consecutive breast cancer specimens submitted for PD‑L1 testing at the Osaka University Hospital between November 2019 and November 2021. PD‑L1 expression was evaluated using the VENTANA SP142 immunohistochemistry assay. Expression in tumor‑infiltrating immune cells (IC) was quantified as the percentage of PD‑L1‑positive IC within the tumor area, and positivity was defined as IC ≥1%. Results: The overall PD‑L1 positivity rate was 47%. PD‑L1 expression was significantly higher in surgical specimens compared with biopsy samples (65% vs. 23%, p=0.032) and in primary tumors compared with metastatic/recurrent sites (58% vs. 0%, p=0.018). All specimens from patients with Stage IV or recurrent disease were PD‑L1‑negative, compared with 74% positivity at earlier stages (p<0.001). Although not statistically significant, specimens from patients who had received chemotherapy within 40 days showed lower PD‑L1 positivity than chemotherapy‑naïve specimens (14% vs. 57%, p=0.086). In advanced disease (Stage IV/recurrent), 82% of specimens were from biopsies and 55% from metastatic sites, potentially explaining the lower PD‑L1 positivity. Conclusion: For optimal PD‑L1 assessment in breast cancer, surgical specimens from primary tumors without prior therapy are preferable due to larger evaluable tumor areas. For patients requiring neoadjuvant chemotherapy or with de novo Stage IV disease, multiple biopsies of primary tumors using thick needles before treatment, with attention being paid to sampling tumor margins to account for potential immune‑excluded phenotypes, are recommended.
Publisher	International Institute of Anticancer Research
Source Title	Anticancer Research
Volume (Issue)	45(12)
Page	5587-5594
Date of Issued	2025-11-29
Language	English
Handle URL	https://hdl.handle.net/11094/103650
PISSN	02507005
eISSN	17917530
Relation.isIdenticalTo	DOI (Publisher Version) https://doi.org/10.21873/anticanres.17893
Access Rights	embargoed access
CopyRight	The full-text file will be made open to the public on 29 May 2026 in accordance with the publisher's policy.
oaire:version	Version of Record
Category	学術雑誌論文 Journal Article

Resource Type	journal article
Local Type	Journal Article
DCMI Type	Text
DCTERMS.bibliographicCitation	Anticancer Research. 2025, 45(12), p. 5587-5594
DC.title	Effect of Tissue Sample Type on The Evaluation of PD‐L1 (SP142) Expression in Breast Cancer
DC.creator	Usui, Takeshi
	Shimoda, Masafumi
	Abe, Kaori
	Masunaga, Nanae
	Tsukabe, Masami
	Yoshinami, Tetsuhiro
	Sota, Yoshiaki
	Miyake, Tomohiro
	Tanei, Tomonori
	Shimazu, Kenzo
DC.publisher	International Institute of Anticancer Research
DC.language' scheme='DCTERMS.RFC1766	English
DC.type' scheme='DCTERMS.DCMIType	Text
DCTERMS.issued' scheme='DCTERMS.W3CDTF	2025-11-29
DC.identifier	https://doi.org/10.21873/anticanres.17893
DC.subject	breast cancer
	neoadjuvant chemotherapy
	PD‑L1
	primary tumor
	SP142
DC.description	Usui T., Shimoda M., Abe K., et al. Effect of Tissue Sample Type on The Evaluation of PD‐L1 (SP142) Expression in Breast Cancer. Anticancer Research 45, 5587 (2025); https://doi.org/10.21873/anticanres.17893.
DCTERMS.abstract	Background/Aim: PD‑L1 expression is a key biomarker for immune checkpoint inhibitor therapy in breast cancer treatment. However, many factors affect PD‑L1 assessment. This study evaluated how specimen‑related factors affect PD‑L1 expression in breast cancer and provides a guide for optimal specimen selection. Patients and Methods: We retrospectively analyzed 30 consecutive breast cancer specimens submitted for PD‑L1 testing at the Osaka University Hospital between November 2019 and November 2021. PD‑L1 expression was evaluated using the VENTANA SP142 immunohistochemistry assay. Expression in tumor‑infiltrating immune cells (IC) was quantified as the percentage of PD‑L1‑positive IC within the tumor area, and positivity was defined as IC ≥1%. Results: The overall PD‑L1 positivity rate was 47%. PD‑L1 expression was significantly higher in surgical specimens compared with biopsy samples (65% vs. 23%, p=0.032) and in primary tumors compared with metastatic/recurrent sites (58% vs. 0%, p=0.018). All specimens from patients with Stage IV or recurrent disease were PD‑L1‑negative, compared with 74% positivity at earlier stages (p<0.001). Although not statistically significant, specimens from patients who had received chemotherapy within 40 days showed lower PD‑L1 positivity than chemotherapy‑naïve specimens (14% vs. 57%, p=0.086). In advanced disease (Stage IV/recurrent), 82% of specimens were from biopsies and 55% from metastatic sites, potentially explaining the lower PD‑L1 positivity. Conclusion: For optimal PD‑L1 assessment in breast cancer, surgical specimens from primary tumors without prior therapy are preferable due to larger evaluable tumor areas. For patients requiring neoadjuvant chemotherapy or with de novo Stage IV disease, multiple biopsies of primary tumors using thick needles before treatment, with attention being paid to sampling tumor margins to account for potential immune‑excluded phenotypes, are recommended.
DC.rights	The full-text file will be made open to the public on 29 May 2026 in accordance with the publisher's policy.
DC.format	103650
citation_title	Effect of Tissue Sample Type on The Evaluation of PD‐L1 (SP142) Expression in Breast Cancer
citation_author	Usui, Takeshi
	Shimoda, Masafumi
	Abe, Kaori
	Masunaga, Nanae
	Tsukabe, Masami
	Yoshinami, Tetsuhiro
	Sota, Yoshiaki
	Miyake, Tomohiro
	Tanei, Tomonori
	Shimazu, Kenzo
citation_publisher	International Institute of Anticancer Research
citation_language	English
citation_date	2025-11-29
citation_journal_title	Anticancer Research
citation_volume	45
citation_issue	12
citation_firstpage	5587
citation_lastpage	5594
citation_doi	https://doi.org/10.21873/anticanres.17893
citation_public_url	https://hdl.handle.net/11094/103650

Effect of Tissue Sample Type on The Evaluation of PD‐L1 (SP142) Expression in Breast Cancer

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