What question did this study set out to answer?

Evaluate trilaciclib's myeloprotective efficacy and immunomodulatory effects in advanced gastric cancer.

May 29, 2026Journal of Clinical Oncology0 citations

Trilaciclib for myeloprotection in adjuvant and first-line chemotherapy for advanced gastric/gastroesophageal junction adenocarcinoma: A multicohort study.

Puntos clave

Evaluate trilaciclib's myeloprotective efficacy and immunomodulatory effects in advanced gastric cancer.
Prospective multicohort study with two cohorts: resectable and first-line metastatic gastric adenocarcinoma.
Trilaciclib was administered pre-chemotherapy in 240 mg/m² doses over a period of 6-8 cycles.
Primary endpoints included the incidence of grade ≥3 neutropenia and febrile neutropenia, along with exploratory immune biomarker analyses.
Grade ≥3 CIM incidence was 4.46% in Cohort 1 and 2.96% in Cohort 2.
Prophylaxis showed superior myeloprotection with lower CIM rates in primary prophylaxis: 3.35% compared to 4.56% in secondary.
The total number of T cells increased post-treatment, especially CD4+ T cells, while CD8+ T cells showed a decline after 3 cycles.

Resumen

12152 Background: Chemotherapy-induced myelosuppression (CIM) has become one of the important limiting factors in the treatment of gastric cancer, which significantly impairs patients' prognosis.Trilaciclib, a highly selective reversible CDK4/6 inhibitor, reduces chemotherapy-induced hematopoietic stem/progenitor cell (HSPC) damage via transient G1 arrest when administered intravenously pre-chemotherapy, while its transient T-cell suppression may modulate the tumor immune microenvironment.This study evaluates trilaciclib’s myeloprotective efficacy in adjuvant and first-line metastatic gastric/gastroesophageal junction adenocarcinoma (GA/GEJA) and explores immunomodulatory effects. Methods: This prospective multicohort study (ChiCTR2500097520) enrolled Cohort 1 (resectable GA/GEJA, T1-4bN0-3M0 post-D2/R0 resection; n = 75) and Cohort 2 (first-line metastatic GA/GEJA, including recurrence > 6 months post-adjuvant; n = 40). Regimens included SOX/XELOX/FOLFOX ± immune checkpoint inhibitors (ICIs) ± trastuzumab. Trilaciclib (240 mg/m²) was given on days 1 and 3 every 21 days for 6–8 cycles. Primary endpoints: incidence of grade ≥3 neutropenia and febrile neutropenia (FN); exploratory analyses included immune biomarkers and antitumor efficacy. Results: As of January 2026, 204 patients were enrolled (male: 158 ; female: 46; median age: 63 years range: 31–82). Cohort 1: 118 patients (primary prophylaxis PP: 98 ; secondary prophylaxis SP: 20 ). Cohort 2: 86 patients (PP: 48 ; SP: 38 ). Grade ≥3 CIM incidence: Cohort 1 vs. Cohort 2: 4.46% vs. 2.96%; grade ≥3 neutropenia: 3.24% vs. 1.73%; thrombocytopenia: 1.54% vs. 0.74%; anemia: 0.77% vs. 1.97%. Prophylaxis-stratified analysis showed superior myeloprotection with PP: overall grade ≥3 CIM (PP:3.35% vs. SP: 4.56%), neutropenia (PP: 2.75% vs. SP:1.83%), thrombocytopenia (PP: 0.6% vs. SP: 2.29%), and anemia (PP: 1.32% vs. SP: 0.91%). Furthermore, the collection and detection of immune cells from 97 patients before and after treatment revealed that: the total number of T cells in patients showed an increasing trend after prophylactic medication. The number of CD4+ T cells showed an increasing trend; the number of CD8+ T cells began to decline after more than 3 cycles of chemotherapy; the number of Treg T cells increased and returned to the pre-chemotherapy level after more than 4 cycles. Conclusions: Trilaciclib demonstrated effective myeloprotection and immunoregulation in GA/GEJA, with PP showing a favorable trend. Grade ≥3 CIM rates were ≤5.88% (adjuvant) and ≤3.49% (metastatic), with no new safety signals. The studies will continue to analyze the correlation between immune-related indicators and anti-tumor efficacy. Clinical trial information: ChiCTR2500097520.

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