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. 2021 Oct;9(20):1568.
doi: 10.21037/atm-21-4747.

Analysis of the efficacy and prognostic factors of PD-1 inhibitors in advanced gallbladder cancer

Qitong Zheng #  1 , Chen Wu #  1 , Huangshu Ye  2 , Zhenggang Xu  1 , Yang Ji  1 , Jianhua Rao  1 , Ling Lu  1 , Yaqing Zhu #  3 , Feng Cheng #  1
Affiliations

Analysis of the efficacy and prognostic factors of PD-1 inhibitors in advanced gallbladder cancer

Qitong Zheng et al. Ann Transl Med. 2021 Oct.

Abstract

Background: Gallbladder cancer (GBC) is highly malignant, its early diagnosis is difficult, and the 5-year survival rate is less than 5%. For patients with advanced GBC (GBCa), combined chemotherapy, radiotherapy, targeted therapy, and immunotherapy are needed to improve the overall survival (OS) rate of patients.

Methods: Data were collected from 53 patients with GBCa who had volunteered to receive programmed death protein-1 (PD-1)-based treatment at the First Affiliated Hospital of Nanjing Medical University from February 2018 to February 2021. Statistical analysis of the collected data, including Kaplan-Meier method, log-rank test, Cox proportional hazard regression model and other methods.

Results: The objective response rates (ORRs) and disease control rates (DCRs) of 53 participants 3 months after receiving immunotherapy were 30.2% and 79.2%, respectively. The ORRs and DCRs of the combined treatment group were higher than those of the camrelizumab group (CG) (P<0.05). The DCRs of the camrelizumab plus apatinib group (CAG) at 3 and 6 months were 90.9% and 45.5% (P=0.003), respectively, while the DCRs at 3 and 6 months of the camrelizumab plus chemotherapy group (CCG) were 85.7% and 71.4% (P=0.450), respectively. After treatment, there were statistically significant differences before and after CA199 for each group (P<0.05). The median progression-free survival (mPFS) of the 53 participants was 7 months, and the median overall survival (mOS) was 12 months. The mPFS and mOS of the CAG and the CCG were greater than those in the CG (6 vs. 3 months, P<0.001, 12 vs. 8 months, P=0.019; 9 vs. 3 months, P<0.001, 13 vs. 8 months, P<0.001, respectively). A total of 16 cases had grade 1 or 2 adverse events, and 3 cases had grade 3 and higher adverse events.

Conclusions: For GBCa patients, PD-1 combined with targeted therapy or chemotherapy is more effective than immunotherapy alone. The targeted therapy group has more obvious early effects on the disease control rate, and combined chemotherapy can achieve sustained effects, providing new ideas for the future GBCa application of immune, targeted, and chemotherapy sequential therapy.

Keywords: Gallbladder cancer (GBC); chemotherapy; immune checkpoint inhibitors (ICIs); immunotherapy; targeted therapy.

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Conflict of interest statement

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://dx.doi.org/10.21037/atm-21-4747). All authors reported that the project was supported by the National Natural Science Foundation of China (81871259 and 820706752), and the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences (2019-I2M-5-035). Dr. LL serves as an unpaid Associate Editors-in-Chief of Annals of Translational Medicine from Jun 2019 to May 2024. The authors have no other conflicts of interest to declare.

Figures

Figure 1
Figure 1
Changes of DCR and CA199 before and after treatment in the 3 groups. (A) Disease control rates of 3 groups of patients when the curative effect was evaluated at 3 months; (B) disease control rates of the 3 groups of patients at 6 months of curative effect evaluation; (C) comparison of disease control rates between 3 months and 6 months in the combined group; (D) changes before and after CA199 in the camrelizumab group at 3 months; (E) changes in CA199 before and after 3 months in the camrelizumab plus apatinib group; (F) changes in CA199 before and after 3 months in the camrelizumab plus chemotherapy group; (G) changes in CA199 before and after 6 months in the camrelizumab plus apatinib group; (H) changes in CA199 before and after 6 months in the camrelizumab plus chemotherapy group. DCR, disease control rate.
Figure 2
Figure 2
The progression-free survival curves of the three groups of patients.
Figure 3
Figure 3
The overall survival curve of the 3 groups of patients.
See this image and copyright information in PMC

References

    1. Hundal R, Shaffer EA. Gallbladder cancer: epidemiology and outcome. Clin Epidemiol 2014;6:99-109. - PMC - PubMed
    1. Goetze TO. Gallbladder carcinoma: Prognostic factors and therapeutic options. World J Gastroenterol 2015;21:12211-7. 10.3748/wjg.v21.i43.12211 - DOI - PMC - PubMed
    1. Shen H, He M, Lin R, et al. PLEKpromotes gallbladder cancer invasion and metastasis through EGFR/CCL2 pathway. J Exp Clin Cancer Res 2019;38:247. 10.1186/s13046-019-1250-8 - DOI - PMC - PubMed
    1. Christofi T, Baritaki S, Falzone L, et al. Current Perspectives in Cancer Immunotherapy. Cancers (Basel) 2019;11:1472. 10.3390/cancers11101472 - DOI - PMC - PubMed
    1. Seymour L, Bogaerts J, Perrone A, et al. iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics. Lancet Oncol 2017;18:e143-52. 10.1016/S1470-2045(17)30074-8 - DOI - PMC - PubMed