---
title: "PD-L1 expression and survival in unresectable or recurrent gastric cancer treated with first-line"
id: "british-journal-of-cancer-0-pd-l1-expression-and-survival-in-unresectable-recurrent-gastric-cancer-treated"
canonical_url: "https://medichelpline.com/clinical-feed/british-journal-of-cancer-0-pd-l1-expression-and-survival-in-unresectable-recurrent-gastric-cancer-treated"
content_type: "clinical_feed_article"
specialty: "Oncology"
source_name: "British Journal of Cancer"
source_url: "https://www.nature.com/articles/s41416-026-03607-7"
published_at: "2026-09-04T12:00:00.000Z"
evidence_level: "Journal Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# PD-L1 expression and survival in unresectable or recurrent gastric cancer treated with first-line
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/british-journal-of-cancer-0-pd-l1-expression-and-survival-in-unresectable-recurrent-gastric-cancer-treated
- **Specialty:** [Oncology](https://medichelpline.com/clinical-feed/oncology.md)
- **Primary Source:** British Journal of Cancer
- **Source URL:** [Original Journal Publication](https://www.nature.com/articles/s41416-026-03607-7)
- **Published At:** 2026-09-04T12:00:00.000Z
- **Evidence Rating:** Journal Feed
## Executive GIST (TL;DR)
- This ancillary analysis of the phase III trial **JCOG1013** assessed the prognostic value of **PD-L1** expression in patients with chemotherapy‑naive unresectable or recurrent gastric cancer treated with first‑line chemotherapy without immune checkpoint inhibitors (ICIs). - PD-L1 was measured on pretreatment tumor specimens using the Dako 28-8 pharmDx assay. Two scoring systems were calculated: the **combined positive score (CPS)** and the **tumor proportion score (TPS)**. - PD-L1 positivity was prespecified as CPS ≥ 5 or TPS ≥ 1% for analysis. - From 741 patients enrolled in JCOG1013, 540 patients had available PD-L1 assessment and were included in this ancillary analysis. - In univariable analyses, neither CPS ≥ 5 nor TPS ≥ 1% showed a statistically significant association with overall survival (OS) or progression‑free survival (PFS). - In multivariable models adjusted for covariates, CPS ≥ 5 was not significantly associated with OS or PFS (OS: HR 0.86, 95% CI 0.71–1.04, p = 0.127; PFS: HR 0.92, 95% CI 0.77–1.11, p = 0.392). - By contrast, **TPS ≥ 1%** was independently associated with improved survival: OS hazard ratio (HR) 0.78 (95% CI 0.62–0.97, p = 0.028) and PFS HR 0.76 (95% CI 0.62–0.94, p = 0.012). - The authors conclude that **TPS ≥ 1%** is an independent favorable prognostic factor for patients with unresectable/recurrent gastric cancer receiving chemotherapy alone. - The source article places these findings in the context of evolving first-line therapy where ICIs plus chemotherapy have shown benefit and PD-L1 CPS is used as a complementary selection marker for ICI therapy; however, chemotherapy alone remains an option, particularly for patients with low CPS. - Details of some methods and full patient characteristics, statistical covariates included in multivariable models, and subsequent sections of the methods and results were not reported in the provided source excerpt and therefore are not summarized here.
## Clinical Analysis & Structured Key Points
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[nature](https://www.nature.com/) 2. [british journal of cancer](https://www.nature.com/bjc) 3. [articles](https://www.nature.com/bjc/articles?type=article) 4. article PD-L1 expression and survival in unresectable/recurrent gastric cancer treated by 1st-line treatment without immune checkpoint inhibitors: JCOG1013A1 [ Download PDF ](https://www.nature.com/articles/s41416-026-03607-7.pdf) [ Download PDF ](https://www.nature.com/articles/s41416-026-03607-7.pdf) * Article * [Open access](https://www.springernature.com/gp/open-science/about/the-fundamentals-of-open-access-and-open-research) * Published: 04 September 2026 Clinical Study # PD-L1 expression and survival in unresectable/recurrent gastric cancer treated by 1st-line treatment without immune checkpoint inhibitors: JCOG1013A1 * [Hidekazu Hirano](https://www.nature.com/articles/s41416-026-03607-7#auth-Hidekazu-Hirano-Aff1)[1](https://www.nature.com/articles/s41416-026-03607-7#Aff1), * [Yasuhide Yamada](https://www.nature.com/articles/s41416-026-03607-7#auth-Yasuhide-Yamada-Aff2) [ORCID: orcid.org/0000-0003-0692-8419](https://orcid.org/0000-0003-0692-8419)[2](https://www.nature.com/articles/s41416-026-03607-7#Aff2), * [Kengo Nagashima](https://www.nature.com/articles/s41416-026-03607-7#auth-Kengo-Nagashima-Aff3) [ORCID: orcid.org/0000-0003-4529-9045](https://orcid.org/0000-0003-4529-9045)[3](https://www.nature.com/articles/s41416-026-03607-7#Aff3), * [Nobuyoshi Hiraoka](https://www.nature.com/articles/s41416-026-03607-7#auth-Nobuyoshi-Hiraoka-Aff4) [ORCID: orcid.org/0000-0003-4215-4385](https://orcid.org/0000-0003-4215-4385)[4](https://www.nature.com/articles/s41416-026-03607-7#Aff4), * [Shigeki Sekine](https://www.nature.com/articles/s41416-026-03607-7#auth-Shigeki-Sekine-Aff4) [ORCID: orcid.org/0000-0003-0884-8981](https://orcid.org/0000-0003-0884-8981)[4](https://www.nature.com/articles/s41416-026-03607-7#Aff4), * [Naoki Takahashi](https://www.nature.com/articles/s41416-026-03607-7#auth-Naoki-Takahashi-Aff5)[5](https://www.nature.com/articles/s41416-026-03607-7#Aff5), * [Mizutomo Azuma](https://www.nature.com/articles/s41416-026-03607-7#auth-Mizutomo-Azuma-Aff6)[6](https://www.nature.com/articles/s41416-026-03607-7#Aff6), * [Satoru Iwasa](https://www.nature.com/articles/s41416-026-03607-7#auth-Satoru-Iwasa-Aff1)[1](https://www.nature.com/articles/s41416-026-03607-7#Aff1), * [Keisuke Kanato](https://www.nature.com/articles/s41416-026-03607-7#auth-Keisuke-Kanato-Aff7)[7](https://www.nature.com/articles/s41416-026-03607-7#Aff7), * [Nozomu Machida](https://www.nature.com/articles/s41416-026-03607-7#auth-Nozomu-Machida-Aff8)[8](https://www.nature.com/articles/s41416-026-03607-7#Aff8), * [Takahiro Kinoshita](https://www.nature.com/articles/s41416-026-03607-7#auth-Takahiro-Kinoshita-Aff9)[9](https://www.nature.com/articles/s41416-026-03607-7#Aff9), * [Hiroaki Hata](https://www.nature.com/articles/s41416-026-03607-7#auth-Hiroaki-Hata-Aff10)[10](https://www.nature.com/articles/s41416-026-03607-7#Aff10), * [Hisato Kawakami](https://www.nature.com/articles/s41416-026-03607-7#auth-Hisato-Kawakami-Aff11-Aff12) [ORCID: orcid.org/0000-0002-3280-4850](https://orcid.org/0000-0002-3280-4850)[11](https://www.nature.com/articles/s41416-026-03607-7#Aff11),[12](https://www.nature.com/articles/s41416-026-03607-7#Aff12), * [Daisuke Takahari](https://www.nature.com/articles/s41416-026-03607-7#auth-Daisuke-Takahari-Aff13)[13](https://www.nature.com/articles/s41416-026-03607-7#Aff13), * [Toshiyasu Ojima](https://www.nature.com/articles/s41416-026-03607-7#auth-Toshiyasu-Ojima-Aff14)[14](https://www.nature.com/articles/s41416-026-03607-7#Aff14), * [Shigenori Kadowaki](https://www.nature.com/articles/s41416-026-03607-7#auth-Shigenori-Kadowaki-Aff15) [ORCID: orcid.org/0000-0001-9923-5309](https://orcid.org/0000-0001-9923-5309)[15](https://www.nature.com/articles/s41416-026-03607-7#Aff15), * [Narikazu Boku](https://www.nature.com/articles/s41416-026-03607-7#auth-Narikazu-Boku-Aff1-Aff16) [ORCID: orcid.org/0000-0002-1438-707X](https://orcid.org/0000-0002-1438-707X)[1](https://www.nature.com/articles/s41416-026-03607-7#Aff1),[16](https://www.nature.com/articles/s41416-026-03607-7#Aff16), * [Yukinori Kurokawa](https://www.nature.com/articles/s41416-026-03607-7#auth-Yukinori-Kurokawa-Aff17) [ORCID: orcid.org/0000-0002-2883-0132](https://orcid.org/0000-0002-2883-0132)[17](https://www.nature.com/articles/s41416-026-03607-7#Aff17), * [Masanori Terashima](https://www.nature.com/articles/s41416-026-03607-7#auth-Masanori-Terashima-Aff18)[18](https://www.nature.com/articles/s41416-026-03607-7#Aff18) & * … * [Takaki Yoshikawa](https://www.nature.com/articles/s41416-026-03607-7#auth-Takaki-Yoshikawa-Aff19)[19](https://www.nature.com/articles/s41416-026-03607-7#Aff19) Show authors [_British Journal of Cancer_](https://www.nature.com/bjc) (2026) [Cite this article](https://www.nature.com/articles/s41416-026-03607-7#citeas) [ Save article ](https://www.nature.com/articles/s41416-026-03607-7/save-research?_csrf=eNryEIiTIbnz4CTos4gr8sfMGY70hthl) [ View saved research ](https://www.nature.com/saved-research) ## Abstract ### Background The prognostic significance of PD-L1 expression in unresectable/recurrent gastric cancer treated by first-line chemotherapy without an immune checkpoint inhibitor (ICI) remains unclear. The phase III trial JCOG1013 demonstrated no overall survival (OS) or progression-free survival (PFS) benefit of docetaxel/cisplatin/S-1 over cisplatin/S-1. This ancillary analysis of JCOG 1013 evaluated the prognostic value of PD-L1 expression. ### Methods PD-L1 expression was assessed in pretreatment tumor specimens using the Dako 28-8 pharmDx assay. Combined positive score (CPS) and tumor proportion score (TPS) were calculated. PD-L1 positivity was defined as CPS ≥ 5 or TPS ≥ 1%. Univariable and multivariable analyses were performed for OS and PFS. ### Results Among 741 patients enrolled in JCOG1013, 540 patients were included. In univariable analyses, neither CPS ≥ 5 nor TPS ≥ 1% was significantly associated with OS or PFS. In multivariable analyses, CPS ≥ 5 was not significantly associated with OS (HR 0.86, 95% CI 0.71–1.04; _p_ = 0.127) or PFS (HR 0.92, 95% CI 0.77–1.11; _p_ = 0.392); however, TPS ≥ 1% was significantly associated with longer OS (HR 0.78, 95% CI 0.62–0.97; _p_ = 0.028) and PFS (HR 0.76, 95% CI 0.62–0.94; _p_ = 0.012). ### Conclusions TPS ≥ 1% is an independent favorable prognostic factor for survival in patients with unresectable/recurrent gastric cancer receiving chemotherapy alone. ### Clinical trial registration UMIN000007652 ### Explore related subjects Discover the latest articles and news in related subjects. * [Gastric cancer](https://www.nature.com/subjects/gastric-cancer) * [Prognostic markers](https://www.nature.com/subjects/prognostic-markers) ## Background Gastric cancer is a major cause of cancer-related death, particularly in East Asia, despite a decreasing trend in prevalence [[1](https://www.nature.com/articles/s41416-026-03607-7#ref-CR1 "Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022;72:7–33."), [2](https://www.nature.com/articles/s41416-026-03607-7#ref-CR2 "Yamada Y. Present status and perspective of chemotherapy for patients with unresectable advanced or metastatic gastric cancer in Japan. Glob Health Med. 2020;2:156–63.")]. Doublet chemotherapy with platinum and a fluoropyrimidine has been the standard first-line chemotherapy backbone for patients with unresectable or recurrent HER2-negative gastric cancer [[3](https://www.nature.com/articles/s41416-026-03607-7#ref-CR3 "Lordick F, Carneiro F, Cascinu S, Fleitas T, Haustermans K, Piessen G, et al. Gastric cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2022;33:1005–20.")]. In a phase III randomized trial (JCOG1013), we demonstrated that the addition of docetaxel to cisplatin/S-1 as first-line chemotherapy had no overall survival (OS) or progression-free survival (PFS) benefit in this population [[4](https://www.nature.com/articles/s41416-026-03607-7#ref-CR4 "Yamada Y, Boku N, Mizusawa J, Iwasa S, Kadowaki S, Nakayama N, et al. Docetaxel plus cisplatin and S-1 versus cisplatin and S-1 in patients with advanced gastric cancer \(JCOG1013\): an open-label, phase 3, randomised controlled trial. Lancet Gastroenterol Hepatol. 2019;4:501–10.")]. Recently, immune checkpoint inhibitors (ICIs) targeting the programmed cell death protein 1/programmed cell death-ligand 1 (PD-1/PD-L1) axis in combination with doublet chemotherapy have shown a survival benefit, reshaping the landscape of the first-line treatment for unresectable or recurrent HER2-negative gastric cancer [[5](https://www.nature.com/articles/s41416-026-03607-7#ref-CR5 "Rha SY, Oh D-Y, Yañez P, Bai Y, Ryu M-H, Lee J, et al. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer \(KEYNOTE-859\): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2023;24:1181–95."),[6](https://www.nature.com/articles/s41416-026-03607-7#ref-CR6 "Janjigian YY, Shitara K, Moehler M, Garrido M, Salman P, Shen L, et al. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma \(CheckMate 649\): a randomised, open-label, phase 3 trial. Lancet. 2021;398:27–40."),[7](https://www.nature.com/articles/s41416-026-03607-7#ref-CR7 "Kang YK, Chen LT, Ryu MH, Oh DY, Oh SC, Chung HC, et al. Nivolumab plus chemotherapy versus placebo plus chemotherapy in patients with HER2-negative, untreated, unresectable advanced or recurrent gastric or gastro-oesophageal junction cancer \(ATTRACTION-4\): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2022;23:234–47."),[8](https://www.nature.com/articles/s41416-026-03607-7#ref-CR8 "Qiu MZ, Oh DY, Kato K, Arkenau T, Tabernero J, Correa MC, et al. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first line treatment for advanced gastric or gastro-oesophageal junction adenocarcinoma: RATIONALE-305 randomised, double blind, phase 3 trial. BMJ. 2024;385:e078876.")]. PD-L1 expression status was evaluated as the PD-L1 combined positive score (CPS) or tumor proportion score (TPS) in pivotal studies and is recognized as a predictive marker for the efficacy of PD-1 inhibitors [[5](https://www.nature.com/articles/s41416-026-03607-7#ref-CR5 "Rha SY, Oh D-Y, Yañez P, Bai Y, Ryu M-H, Lee J, et al. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer \(KEYNOTE-859\): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2023;24:1181–95."),[6](https://www.nature.com/articles/s41416-026-03607-7#ref-CR6 "Janjigian YY, Shitara K, Moehler M, Garrido M, Salman P, Shen L, et al. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma \(CheckMate 649\): a randomised, open-label, phase 3 trial. Lancet. 2021;398:27–40."),[7](https://www.nature.com/articles/s41416-026-03607-7#ref-CR7 "Kang YK, Chen LT, Ryu MH, Oh DY, Oh SC, Chung HC, et al. Nivolumab plus chemotherapy versus placebo plus chemotherapy in patients with HER2-negative, untreated, unresectable advanced or recurrent gastric or gastro-oesophageal junction cancer \(ATTRACTION-4\): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2022;23:234–47.")]. Currently, the PD-L1 CPS has a complementary role in clinical practice for selecting patients with unresectable or recurrent gastric cancer who are suitable for ICI therapy [[9](https://www.nature.com/articles/s41416-026-03607-7#ref-CR9 "Ajani JA, D’Amico TA, Bentrem DJ, Corvera CU, Das P, Enzinger PC, et al. Gastric Cancer, Version 2.2025, NCCN Clinical Practice Guidelines In Oncology. J Natl Compr Canc Netw. 2025;23:169–91.")]. A meta-analysis of phase III trials that have used ICI therapy in the first-line setting suggested that PD-L1 CPS ≥ 5 could represent an acceptable cut-off value that optimizes the risk–benefit balance of ICI therapy; nevertheless, chemotherapy alone remains an important treatment option for patients with PD-L1 CPS < 5, particularly those with CPS < 1 [[10](https://www.nature.com/articles/s41416-026-03607-7#ref-CR10 "Formica V, Morelli C, Fornaro L, Riondino S, Rofei M, Fontana E, et al. PD-L1 thresholds predict efficacy of immune checkpoint inhibition in first-line treatment of advanced gastroesophageal adenocarcinoma. A systematic review and meta-analysis of seven phase III randomized trials. ESMO Open. 2024;9:103967.")]. While several studies have found an association between PD-L1 expression and favorable prognosis in patients with lung cancer [[11](https://www.nature.com/articles/s41416-026-03607-7#ref-CR11 "Ishii H, Azuma K, Kawahara A, Yamada K, Imamura Y, Tokito T, et al. Significance of programmed cell death-ligand 1 expression and its association with survival in patients with small cell lung cancer. J Thorac Oncol. 2015;10:426–30."), [12](https://www.nature.com/articles/s41416-026-03607-7#ref-CR12 "Woodford R, Zhou D, Lord SJ, Marschner I, Cooper WA, Lewis CR, et al. PD-L1 expression as a prognostic marker in patients treated with chemotherapy for metastatic non-small-cell lung cancer. Future Oncol. 2022;18:1793–9.")], the prognostic impact of PD-L1 expression in gastric cancer has not been consistently reported, owing to heterogeneity in study populations (e.g., the inclusion of patients with stage I–III disease) and differences in PD-L1 assessment methods, including the antibody clone, scoring system, and corresponding cut-off values, as well as inter-observer variability among pathologists [[13](https://www.nature.com/articles/s41416-026-03607-7#ref-CR13 "Akimoto E, Kuwata T, Shitara K, Kawazoe A, Sakamoto N, Ishii G, et al. Impact of programmed death-ligand 1 expression on mismatch repair deficiency and Epstein–Barr virus status on survival outcomes in patients with stage II/III gastric cancer after surgery. Ann Surg Oncol. 2023;30:5227–36."),[14](https://www.nature.com/articles/s41416-026-03607-7#ref-CR14 "Kawazoe A, Kuwata T, Kuboki Y, Shitara K, Nagatsuma AK, Aizawa M, et al. Clinicopathological features of programmed death ligand 1 expression with tumor-infiltrating lymphocyte, mismatch repair, and Epstein-Barr virus status in a large cohort of gastric cancer patients. Gastric Cancer. 2017;20:407–15."),[15](https://www.nature.com/articles/s41416-026-03607-7#ref-CR15 "Böger C, Behrens HM, Mathiak M, Krüger S, Kalthoff H, Röcken C. PD-L1 is an independent prognostic predictor in gastric cancer of Western patients. Oncotarget. 2016;7:24269–83."),[16](https://www.nature.com/articles/s41416-026-03607-7#ref-CR16 "Gu L, Chen M, Guo D, Zhu H, Zhang W, Pan J, et al. PD-L1 and gastric cancer prognosis: a systematic review and meta-analysis. PLoS ONE. 2017;12:e0182692."),[17](https://www.nature.com/articles/s41416-026-03607-7#ref-CR17 "Park Y, Koh J, Na HY, Kwak Y, Lee KW, Ahn SH, et al. PD-L1 testing in gastric cancer by the combined positive score of the 22C3 PharmDx and SP263 assay with clinically relevant cut-offs. Cancer Res Treat. 2020;52:661–70.")]. Furthermore, there is a scarcity of studies that have explicitly examined the association between PD-L1 expression status and outcomes in patients with unresectable or recurrent gastric cancer receiving first-line chemotherapy without an ICI. Therefore, we performed this ancillary study of JCOG1013 to clarify the prognostic impact of PD-L1 expression status in patients with unresectable or recurrent gastric cancer receiving first-line chemotherapy without an ICI. ## Methods ### Study population In JCOG1013, 741 patients across 56 hospitals who had chemotherapy-naive unresectable or recurrent gastric cancer with HER2-negative or unknown HER2 status and were aged 20–75 years were randomly assigned to a docetaxel/cisp
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