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Safety and efficacy of immunotherapy plus chemotherapy as neoadjuvant treatment for patients with locally advanced gastric cancer: a retrospective cohort study

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Abstract

Background: The combined use of programmed death receptor-1 (PD-1) inhibitors and chemotherapy has reshaped the treatment landscape of advanced or metastatic gastric cancer (GC). This study aimed to assess the efficacy and safety of PD-1 inhibitors combined with chemotherapy in a neoadjuvant setting for locally advanced GC (LAGC). Methods: Patients diagnosed with clinical stage II-III GC undergoing neoadjuvant PD-1 inhibitors plus chemotherapy were enrolled from December 2019 to July 2022. Clinicopathological characteristics, pathological information, and survival data were recorded and analyzed. Results: A total of 42 eligible patients were enrolled, of whom 37 (88.1%) had clinical stage III disease. All the patients underwent surgery, and the R0 resection rate was 90.5%. Major pathological response (MPR) and pathological complete response (pCR) rates were 42.9% and 26.2%, respectively. The overall TNM downstaging rate was 76.2%. A total of 36 (85.7%) patients received adjuvant chemotherapy. With a median follow-up of 23.1 months, four patients died after tumor recurrence, and three were alive with recurrence. The 1-year overall survival (OS) and disease-free survival (DFS) rates were 94.4% and 89.5%, respectively, and the median OS and DFS were not reached. Neoadjuvant treatment was well tolerated with no grade 4–5 treatment-related adverse events (TRAEs) observed. The most common grade 3 TRAEs were anemia and alanine aminotransferase increase (n = 2 each, 9.6%). Conclusions: PD-1 inhibitors plus chemotherapy demonstrated promising efficacy, with encouraging pCR and survival outcomes in a neoadjuvant setting for patients with LAGC. The combined therapy also showed a good safety profile.

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Data Availability

All data generated or analyzed during this study are available upon reasonable request from correspondence author.

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Authors and Affiliations

  1. Department of General Surgery, Chengdu Fifth People’s Hospital, No. 33 Mashi Street, Chengdu, 611130, Sichuan Province, P.R. China

    Xue Wang, Jinxiang Huang, He Huang, Yang Liu, Chao Ji & Jian Liu

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  1. Xue Wang
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  2. Jinxiang Huang
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  3. He Huang
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  4. Yang Liu
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  5. Chao Ji
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  6. Jian Liu
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Contributions

WX and LJ were in charge of the study concepts and design. HJ, HH, LY and JC performed data acquisition, analysis or interpretation. WX, HJ and LJ drafted the manuscript and made the figures. Critical revision of the manuscript for important intellectual content: HH, LY and JC revised the manuscript. All authors contributed to the article and approved the submitted version.

Corresponding author

Correspondence to Jian Liu.

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The study was approved by institutional review board of Chengdu Fifth People’s Hospital and carried out in accordance with the Helsinki Declaration (as revised in 2013). Written informed consent was obtained from all patients.

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No conflict of interests was declared in the study.

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No potential conflict of interests was declared in the study.

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Informed consent was obtained all patients.

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Wang, X., Huang, J., Huang, H. et al. Safety and efficacy of immunotherapy plus chemotherapy as neoadjuvant treatment for patients with locally advanced gastric cancer: a retrospective cohort study. Invest New Drugs 41, 579–586 (2023). https://doi.org/10.1007/s10637-023-01379-y

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