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Gastric Cancer Management and Outcomes / Multiple and Secondary Primary Cancers · Journal article
BMC Cancer · September 12, 2026
Encouraging direction, but not yet definitive.
This retrospective single-centre study of 49 patients with advanced gastric cancer on ICI therapy found that irAE occurrence (42.9%) was independently associated with improved OS (HR 0.37, 95% CI 0.14–0.95; P=0.039) and PFS in landmark analyses, and correlated with greater early tumour shrinkage. The findings are consistent with emerging evidence that irAEs may reflect enhanced antitumour immunity but require prospective validation in larger, multicentre cohorts.
Retrospective single-centre cohort study with predefined landmark analyses. Consecutive patients with advanced or recurrent gastric cancer treated with ICI-containing therapy (nivolumab or pembrolizumab) at a single institution.. Intervention: Nivolumab- or pembrolizumab-containing therapy. Compared with: irAE occurrence (presence vs absence). n = 49. Single institution (not specified).
irAEs occurred in 21 of 49 patients (42.9%), including 6 with grade ≥3 events At 12-week landmark analysis, irAE+ patients had significantly improved OS (HR 0.37, 95% CI 0.14–0.95; P=0.039) versus irAE− patients irAE occurrence remained independent favourable prognostic factor for OS (P=0.022) and PFS (P=0.004) in multivariable analyses
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The association between irAEs and improved survival outcomes suggests clinicians should not reflexively manage irAEs aggressively, but prospective validation is needed before using irAE status as a prognostic or therapeutic decision-making tool in gastric cancer ICI therapy. The findings warrant investigation of whether irAE presence indicates optimal immune activation and tumour control.
A retrospective single-centre cohort of 49 patients with a clear association between irAEs and improved OS and PFS, but limited by small sample size, single-institution design, and lack of a randomized comparator, requiring confirmation in prospective or larger studies.
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The association between irAEs and improved survival outcomes suggests clinicians should not reflexively manage irAEs aggressively, but prospective validation is needed before using irAE status as a prognostic or therapeutic decision-making tool in gastric cancer ICI therapy. The findings warrant investigation of whether irAE presence indicates optimal immune activation and tumour control.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Abstract Background Immune-related adverse events (irAEs) have been associated with favorable outcomes in patients receiving immune checkpoint inhibitors (ICIs). However, evidence in gastric cancer remains limited, and the relationship between irAEs and quantitative measures of tumor response dynamics, including early tumor shrinkage (ETS) and depth of response (DpR), has not been elucidated. We investigated the association of irAEs with survival outcomes and tumor response dynamics in patients with advanced or recurrent gastric cancer treated with ICI-containing therapy. Methods We retrospectively analyzed 49 consecutive patients with advanced or recurrent gastric cancer who received nivolumab- or pembrolizumab-containing therapy at a single institution. To minimize immortal time bias, predefined landmark analyses were performed at 8 and 12 weeks after treatment initiation, with the 12-week landmark analysis designated as the primary analysis. Overall survival (OS), progression-free survival (PFS), ETS, and DpR were evaluated according to irAE occurrence. Multivariable Cox proportional hazards models were used to identify independent prognostic factors. Results irAEs occurred in 21 patients (42.9%), including six patients with grade ≥ 3 events. In the 12-week landmark analysis, patients with irAEs demonstrated significantly improved OS (hazard ratio [HR], 0.37; 95% confidence interval [CI], 0.14–0.95; P = 0.039) and PFS compared with those without irAEs. irAE occurrence remained an independent favorable prognostic factor for OS ( P = 0.022) and PFS ( P = 0.004) in multivariable analyses. Among patients with measurable lesions, exploratory analyses showed that ETS ≤ − 20% was associated with longer OS (HR, 0.19; 95% CI, 0.04–0.96; P = 0.046) and PFS (HR, 0.37; 95% CI, 0.15–0.93; P = 0.035). Furthermore, patients who developed irAEs showed greater early tumor shrinkage than those without (median − 27.6% versus − 10.7%; P = 0.013), with a corresponding difference in depth of response. Conclusions In patients with advanced or recurrent gastric cancer receiving ICI-containing therapy, irAE occurrence was independently associated with favorable survival outcomes. Exploratory analyses also demonstrated associations between irAE occurrence and greater ETS and DpR. These findings suggest that irAEs may be clinically observable indicators of enhanced antitumor immune activity during ICI-containing therapy.
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