A retrospective multicenter study on the efficacy and safety of disitamab vedotin monotherapy versus combination with anti-PD-1 immunotherapy in advanced gastric cancer
Abstract Novel therapeutic agents including disitamab vedotin (RC48, an antibody-drug conjugate) and immune-checkpoint inhibitors (e.g., PD-1 inhibitors) have provided new hope as an advanced gastric-cancer (GC) treatment. This multicenter retrospective study studied RC48 monotherapy (MT)’s efficacy...
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Nature Portfolio
2025-01-01
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| Online Access: | https://doi.org/10.1038/s41598-025-86504-y |
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| author | Shuailei Dong Chen Wei Xueting Wang Xinyi Yang Wei Shen Shuyi Li Jiye Xu Yijie Ma Liangyu Bie Wenyue Yu Ning Li |
| author_facet | Shuailei Dong Chen Wei Xueting Wang Xinyi Yang Wei Shen Shuyi Li Jiye Xu Yijie Ma Liangyu Bie Wenyue Yu Ning Li |
| author_sort | Shuailei Dong |
| collection | DOAJ |
| description | Abstract Novel therapeutic agents including disitamab vedotin (RC48, an antibody-drug conjugate) and immune-checkpoint inhibitors (e.g., PD-1 inhibitors) have provided new hope as an advanced gastric-cancer (GC) treatment. This multicenter retrospective study studied RC48 monotherapy (MT)’s efficacy and safety against its combination with anti-PD-1 immunotherapy (IT) in advanced GC. Patients treated with RC48 MT or RC48 combined with anti-PD-1 IT from July 2021 to April 2023 were recruited for the study. The progression-free survival (PFS), overall survival (OS), objective-response rate (ORR), disease-control rate (DCR), and safety were studied. After propensity score matching (PSM) (1:1), this study included 34 in the RC48 plus anti-PD-1 IT group and 34 in the RC48 MT group. The median PFS was significantly longer in the combination-therapy (CT) group than in the MT group (5.3 versus 3.8 months, HR: 0.51, 95% CI: 0.31–0.85, p = 0.010), and the median OS was also notably increased (10.0 versus 6.8 months, HR: 0.45, 95% CI: 0.27–0.77, p = 0.003). The ORR and DCR were higher in the combination group (41.18% versus 14.71%, p = 0.031; 61.76% versus 35.30%, p = 0.052). Moreover, subgroup analyses further revealed that those in the CT group experienced a longer PFS and OS, particularly those with high HER2 expression or a PD-L1 CPS score of 1 or higher. The combination therapy (CT) achieved acceptable tolerability and manageable adverse events. Furthermore, the most common grade 3–5 treatment-related adverse events (TRAEs) included decreased white-blood-cell (WBC) count, decreased neutrophil count, and anemia. No new safety risks were observed. In sum, the RC48 and anti-PD-1 IT combination showed good efficacy and a manageable safety profile, indicating its strong potential as an advanced GC therapeutic option. |
| format | Article |
| id | doaj-art-ff2e912702b74e759b23a47d98173c41 |
| institution | Kabale University |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Nature Portfolio |
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| series | Scientific Reports |
| spelling | doaj-art-ff2e912702b74e759b23a47d98173c412025-01-19T12:24:31ZengNature PortfolioScientific Reports2045-23222025-01-0115111110.1038/s41598-025-86504-yA retrospective multicenter study on the efficacy and safety of disitamab vedotin monotherapy versus combination with anti-PD-1 immunotherapy in advanced gastric cancerShuailei Dong0Chen Wei1Xueting Wang2Xinyi Yang3Wei Shen4Shuyi Li5Jiye Xu6Yijie Ma7Liangyu Bie8Wenyue Yu9Ning Li10Department of Gastrointestinal Oncology, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer HospitalDepartment of Gastrointestinal Oncology, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer HospitalDepartment of Internal Medicine, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer HospitalPhase I Clinical Research Center, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer HospitalDepartment of Oncology, The First Affiliated Hospital of Xinxiang Medical UniversityDepartment of Medical Oncology, Anyang Tumor Hospital & The Affiliated Anyang Tumor Hospital of Henan University of Science and TechnologyDepartment of Oncology, Zhoukou Central HospitalDepartment of Gastrointestinal Oncology, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer HospitalDepartment of Gastrointestinal Oncology, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer HospitalDepartment of Gastrointestinal Oncology, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer HospitalDepartment of Gastrointestinal Oncology, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer HospitalAbstract Novel therapeutic agents including disitamab vedotin (RC48, an antibody-drug conjugate) and immune-checkpoint inhibitors (e.g., PD-1 inhibitors) have provided new hope as an advanced gastric-cancer (GC) treatment. This multicenter retrospective study studied RC48 monotherapy (MT)’s efficacy and safety against its combination with anti-PD-1 immunotherapy (IT) in advanced GC. Patients treated with RC48 MT or RC48 combined with anti-PD-1 IT from July 2021 to April 2023 were recruited for the study. The progression-free survival (PFS), overall survival (OS), objective-response rate (ORR), disease-control rate (DCR), and safety were studied. After propensity score matching (PSM) (1:1), this study included 34 in the RC48 plus anti-PD-1 IT group and 34 in the RC48 MT group. The median PFS was significantly longer in the combination-therapy (CT) group than in the MT group (5.3 versus 3.8 months, HR: 0.51, 95% CI: 0.31–0.85, p = 0.010), and the median OS was also notably increased (10.0 versus 6.8 months, HR: 0.45, 95% CI: 0.27–0.77, p = 0.003). The ORR and DCR were higher in the combination group (41.18% versus 14.71%, p = 0.031; 61.76% versus 35.30%, p = 0.052). Moreover, subgroup analyses further revealed that those in the CT group experienced a longer PFS and OS, particularly those with high HER2 expression or a PD-L1 CPS score of 1 or higher. The combination therapy (CT) achieved acceptable tolerability and manageable adverse events. Furthermore, the most common grade 3–5 treatment-related adverse events (TRAEs) included decreased white-blood-cell (WBC) count, decreased neutrophil count, and anemia. No new safety risks were observed. In sum, the RC48 and anti-PD-1 IT combination showed good efficacy and a manageable safety profile, indicating its strong potential as an advanced GC therapeutic option.https://doi.org/10.1038/s41598-025-86504-yGastric cancerDisitamab vedotinAntibody-drug conjugateRC48anti-PD-1 immunotherapy |
| spellingShingle | Shuailei Dong Chen Wei Xueting Wang Xinyi Yang Wei Shen Shuyi Li Jiye Xu Yijie Ma Liangyu Bie Wenyue Yu Ning Li A retrospective multicenter study on the efficacy and safety of disitamab vedotin monotherapy versus combination with anti-PD-1 immunotherapy in advanced gastric cancer Scientific Reports Gastric cancer Disitamab vedotin Antibody-drug conjugate RC48 anti-PD-1 immunotherapy |
| title | A retrospective multicenter study on the efficacy and safety of disitamab vedotin monotherapy versus combination with anti-PD-1 immunotherapy in advanced gastric cancer |
| title_full | A retrospective multicenter study on the efficacy and safety of disitamab vedotin monotherapy versus combination with anti-PD-1 immunotherapy in advanced gastric cancer |
| title_fullStr | A retrospective multicenter study on the efficacy and safety of disitamab vedotin monotherapy versus combination with anti-PD-1 immunotherapy in advanced gastric cancer |
| title_full_unstemmed | A retrospective multicenter study on the efficacy and safety of disitamab vedotin monotherapy versus combination with anti-PD-1 immunotherapy in advanced gastric cancer |
| title_short | A retrospective multicenter study on the efficacy and safety of disitamab vedotin monotherapy versus combination with anti-PD-1 immunotherapy in advanced gastric cancer |
| title_sort | retrospective multicenter study on the efficacy and safety of disitamab vedotin monotherapy versus combination with anti pd 1 immunotherapy in advanced gastric cancer |
| topic | Gastric cancer Disitamab vedotin Antibody-drug conjugate RC48 anti-PD-1 immunotherapy |
| url | https://doi.org/10.1038/s41598-025-86504-y |
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