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Peer-reviewedCC BY 4.0Frontiers in Pharmacology

Association of trilaciclib use with hematologic outcomes during perioperative immunochemotherapy in resectable esophageal squamous cell carcinoma: a prospective observational cohort study

  • Chaoquan He1,2
  • Xirui Lin1,2
  • Haijie Xu1,2
  • Jiong Lin1,2
  • Peishen Li2
  • Weisen Wang1,2
  • Bo Chen1
  • Ruijun Lin1,2
  • Shaobo Zhang1,2
  • Haitao Li1,2
  • Xiaoyu Zhang1,2
  • Yu Li1,2
9 more authors
  • Zexin Huang1,2
  • Ruen Xie2,3
  • Zefeng Chen2,3
  • Jiaying Wu1,2
  • Chenshu Huang1,2
  • Rui Guo1,2
  • Hongling Gao1
  • Zefeng Xie1,2
  • Hansheng Wu1,2
  1. 1Department of Thoracic Surgery, The First Affiliated Hospital of Shantou University Medical College
  2. 2Shantou University Medical College
  3. 3Department of Thoracic Surgery, Cancer Hospital of Shantou University Medical College
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Abstract

Background: Perioperative immunochemotherapy is a key treatment strategy for resectable esophageal squamous cell carcinoma (ESCC), but chemotherapy-induced myelosuppression (CIM) may compromise treatment delivery. Trilaciclib, a transiently acting, reversible cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, has shown myeloprotective effects in advanced solid tumors; however, evidence in perioperative ESCC is limited. This study investigated the association between trilaciclib use and hematologic outcomes during perioperative immunochemotherapy.

Methods: In this single-center, prospective observational cohort study, 93 patients (control group, n = 65; trilaciclib group, n = 28) enrolled between October 2023 and March 2026 were analyzed. Stabilized inverse probability of treatment weighting (IPTW) was used to balance baseline characteristics. Binary, longitudinal, and survival outcomes were analyzed using IPTW-weighted Firth-penalized logistic regression, weighted generalized estimating equations, and weighted Cox models, respectively, with false discovery rate (FDR) adjustment for multiple comparisons.

Results: After weighting, baseline characteristics were well balanced (all standardized mean differences <0.10). Compared with control, the trilaciclib group had lower weighted incidences of grade 3–4 CIM (3.0% vs. 31.2%; odds ratio [OR] 0.11, 95% confidence interval [CI]: 0.01–0.48; FDR-adjusted P = 0.007), grade 3–4 neutropenia (3.0% vs. 28.3%; OR 0.12, 95% CI: 0.01–0.55; FDR-adjusted P = 0.010), and grade 3–4 anemia (0.0% vs. 17.3%; OR 0.08, 95% CI: <0.01–0.67; FDR-adjusted P = 0.030). Grade 3–4 thrombocytopenia, severe neutropenia, and febrile neutropenia did not differ significantly. Granulocyte colony-stimulating factor (G-CSF) and erythropoiesis-stimulating agent (ESA) use was also lower in the trilaciclib group (34.4% vs. 79.7% and 3.7% vs. 29.6%; FDR-adjusted P < 0.001 and P = 0.010, respectively). Overall survival, disease-free survival, and pathologic outcomes did not differ significantly. These findings should not be interpreted as evidence of equivalence or noninferiority.

Conclusion: In this small, single-center cohort, trilaciclib use was associated with lower grade 3–4 myelosuppression and less hematopoietic supportive care. No statistically significant unfavorable differences in pathologic or survival outcomes were observed; however, equivalence cannot be inferred. These results are hypothesis-generating and require validation in randomized trials.

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Cite

BibTeXRIS
BibTeX
@article{he2026association,
  title = {{Association of trilaciclib use with hematologic outcomes during perioperative immunochemotherapy in resectable esophageal squamous cell carcinoma: a prospective observational cohort study}},
  author = {Chaoquan He and Xirui Lin and Haijie Xu and Jiong Lin and Peishen Li and Weisen Wang and Bo Chen and Ruijun Lin and Shaobo Zhang and Haitao Li and Xiaoyu Zhang and Yu Li and Zexin Huang and Ruen Xie and Zefeng Chen and Jiaying Wu and Chenshu Huang and Rui Guo and Hongling Gao and Zefeng Xie and Hansheng Wu},
  journal = {Frontiers in Pharmacology},
  year = {2026},
  month = oct,
  doi = {10.3389/fphar.2026.1933364},
  url = {https://www.frontiersin.org/articles/10.3389/fphar.2026.1933364/full},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Association of trilaciclib use with hematologic outcomes during perioperative immunochemotherapy in resectable esophageal squamous cell carcinoma: a prospective observational cohort study
AU  - Chaoquan He
AU  - Xirui Lin
AU  - Haijie Xu
AU  - Jiong Lin
AU  - Peishen Li
AU  - Weisen Wang
AU  - Bo Chen
AU  - Ruijun Lin
AU  - Shaobo Zhang
AU  - Haitao Li
AU  - Xiaoyu Zhang
AU  - Yu Li
AU  - Zexin Huang
AU  - Ruen Xie
AU  - Zefeng Chen
AU  - Jiaying Wu
AU  - Chenshu Huang
AU  - Rui Guo
AU  - Hongling Gao
AU  - Zefeng Xie
AU  - Hansheng Wu
PY  - 2026
DA  - 2026/10/28
JO  - Frontiers in Pharmacology
DO  - 10.3389/fphar.2026.1933364
UR  - https://www.frontiersin.org/articles/10.3389/fphar.2026.1933364/full
AB  - Background: Perioperative immunochemotherapy is a key treatment strategy for resectable esophageal squamous cell carcinoma (ESCC), but chemotherapy-induced myelosuppression (CIM) may compromise treatment delivery. Trilaciclib, a transiently acting, reversible cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, has shown myeloprotective effects in advanced solid tumors; however, evidence in perioperative ESCC is limited. This study investigated the association between trilaciclib use and hematologic outcomes during perioperative immunochemotherapy.  Methods: In this single-center, prospective observational cohort study, 93 patients (control group, n = 65; trilaciclib group, n = 28) enrolled between October 2023 and March 2026 were analyzed. Stabilized inverse probability of treatment weighting (IPTW) was used to balance baseline characteristics. Binary, longitudinal, and survival outcomes were analyzed using IPTW-weighted Firth-penalized logistic regression, weighted generalized estimating equations, and weighted Cox models, respectively, with false discovery rate (FDR) adjustment for multiple comparisons.  Results: After weighting, baseline characteristics were well balanced (all standardized mean differences <0.10). Compared with control, the trilaciclib group had lower weighted incidences of grade 3–4 CIM (3.0% vs. 31.2%; odds ratio [OR] 0.11, 95% confidence interval [CI]: 0.01–0.48; FDR-adjusted P = 0.007), grade 3–4 neutropenia (3.0% vs. 28.3%; OR 0.12, 95% CI: 0.01–0.55; FDR-adjusted P = 0.010), and grade 3–4 anemia (0.0% vs. 17.3%; OR 0.08, 95% CI: <0.01–0.67; FDR-adjusted P = 0.030). Grade 3–4 thrombocytopenia, severe neutropenia, and febrile neutropenia did not differ significantly. Granulocyte colony-stimulating factor (G-CSF) and erythropoiesis-stimulating agent (ESA) use was also lower in the trilaciclib group (34.4% vs. 79.7% and 3.7% vs. 29.6%; FDR-adjusted P < 0.001 and P = 0.010, respectively). Overall survival, disease-free survival, and pathologic outcomes did not differ significantly. These findings should not be interpreted as evidence of equivalence or noninferiority.  Conclusion: In this small, single-center cohort, trilaciclib use was associated with lower grade 3–4 myelosuppression and less hematopoietic supportive care. No statistically significant unfavorable differences in pathologic or survival outcomes were observed; however, equivalence cannot be inferred. These results are hypothesis-generating and require validation in randomized trials.
SN  - 1663-9812
ER  -