British journal of cancer · 2026
PD-L1 expression and survival in unresectable/recurrent gastric cancer treated by 1st-line treatment without immune checkpoint inhibitors: JCOG1013A1.
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Hirano Hidekazu, Yamada Yasuhide, Nagashima Kengo, Hiraoka Nobuyoshi, Sekine Shigeki, Takahashi Naoki, Azuma Mizutomo, Iwasa Satoru, Kanato Keisuke, Machida Nozomu, Kinoshita Takahiro, Hata Hiroaki, Kawakami Hisato, Takahari Daisuke, Ojima Toshiyasu, Kadowaki Shigenori, Boku Narikazu, Kurokawa Yukinori, Terashima Masanori, Yoshikawa Takaki
Аннотация
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.
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.