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. 2024 Dec 31;20(1):2423479.
doi: 10.1080/21645515.2024.2423479. Epub 2024 Nov 4.

Efficacy of rechallenge after first-line immunotherapy for advanced gastric cancer: A retrospective real-world study

Mengya Guo  1 , Wenhui Zhao  1 , Yue Chen  1 , Dan Zou  1 , Weiwei Peng, Huanhuan Sha, Guoren Zhou  1 , Ying Fang, Bo Shen
Affiliations

Efficacy of rechallenge after first-line immunotherapy for advanced gastric cancer: A retrospective real-world study

Mengya Guo et al. Hum Vaccin Immunother. .

Abstract

We aimed to explore the efficacy of rechallenge after first-line immunotherapy in advanced gastric cancer (AGC) and to analyze the factors affecting prognosis based on clinical characteristics. Eighty-five AGC patients who underwent rechallenged after the failure of first-line treatment with immune checkpoint inhibitors (ICIs) were retrospectively collected from July 2019 to December 2022 in Jiangsu Cancer Hospital. Potential factors affecting prognosis were analyzed by univariate and multivariate Cox analysis. Survival analysis was performed by Kaplan-Meier method and Log rank test. Stratified factors included human epidermal growth factor receptor 2 (HER-2) and programmed cell death-ligand 1 combined positive score (PD-L1 CPS). The objective response rate (ORR) was 15.3%, and the disease control rate (DCR) was 74.1%. The median progression-free survival (PFS) was 4.8 months. Results showed that patients in the I + C group had the best response. The ORR was 20.0% VS 8.7% in the I + C group and I + C + AAD group. The DCR was 78.0% VS 65.2%, and the median PFS was 6.7 VS 4.7 months [hazard ratio (HR): 0.55, 95% confidence interval (CI): 0.30-1.00, p = .022]. The ORR was 20.0% VS 8.3% in the I + C group and I + C + ADC group. The DCR was 78.0% VS 75.0%, and the median PFS was 6.7 VS 4.4 months (HR: 0.59, 95%CI: 0.26-1.30, p = .112). The median PFS was 4.7 VS 4.4 months in the I + C + AAD group and I + C + ADC group (HR: 1.21, 95%CI: 0.60-2.47, p = .580). Adverse events (AEs) were found in 34 patients, mainly including leukopenia 9 (10.6%), and neutropenia 8 (9.4%). The incidence of grade 3-4 AEs was 8.2%. There were no drug-related deaths and all AEs were manageable. Rechallenge after first-line immunotherapy showed good survival benefit and acceptable safety in the therapy of AGC. Especially for patients with HER-2-positive and PD-L1 CPS ≥ 1%, rechallenge may be an effective treatment modality.

Keywords: Advanced gastric cancer; efficacy; immune checkpoint inhibitors; rechallenge; safety.

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Conflict of interest statement

No potential conflict of interest was reported by the author(s).

Figures

Figure 1.
Figure 1.
Immune checkpoint inhibitors (ICIs) used in second-line therapy (a) and efficacy response in three groups (b). A immune checkpoint inhibitors (ICIs) used in second-line therapy. B the efficacy response of rechallenge in three groups.
Figure 2.
Figure 2.
Kaplan-Meier curve of progression-free survival (PFS) in all patients (a) and different treatment groups (b–d). A Kaplan-Meier curve of progression-free survival (PFS) in all patients. B Kaplan-Meier curve of progression-free survival (PFS) in the I + C and I + C + AAD groups. C Kaplan-Meier curve of progression-free survival (PFS) in the I + C and I + C + ADC groups. D Kaplan-Meier curve of progression-free survival (PFS) in the I + C + AAD and I + C + ADC groups.
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This work was supported by 2021 Key Projects of Jiangsu Provincial Healthcare Commission Scientific Research Programs [ZD2021019] and 2023 Jiangsu Provincial Healthcare Commission Scientific Research Programs [H2023123].