Short-term efficacy and safety evaluation of PD-1 inhibitor combined with chemotherapy as a first-line neoadjuvant therapy for locally advanced gastric adenocarcinoma

doi:10.19803/j.1672-8629.20220594

Abstract

Abstract: Objective To evaluate the short-term efficacy and safety of programmed death receptor-1 (PD-1) inhibitor combined with oxaliplatin plus S-1 (SOX) regimen in neoadjuvant therapy of locally advanced gastric adenocarcinoma. Methods The clinical data on 114 patients with locally advanced gastric adenocarcinoma admitted to the First Hospital of Lanzhou University between 2020 and 2022 was analyzed retrospectively. According to treatment regimens, these patients were divided into the PD-1 inhibitor combined with SOX group (35 cases) and SOX group (79 cases). The short-term efficacy and adverse reactions in the two groups were assessed after treatment. Results In terms of short-term efficacy, the percentages of patients evaluated as CR, MPR and pCR after treatment in the combined group and chemotherapy group were 17.14% vs 3.79% (χ²=4.247, P=0.039), 28.57% vs 12.66% (χ²=4.246, P=0.039) and 20.00% vs 6.33%(χ²=4.813,P=0.028) respectively, so the difference was statistically significant. The ORR between the two groups was 71.43% and 50.63% respectively, suggesting that the difference was of statistical significance (χ²=4.280, P=0.039). The DCR was 100% and 97.47% respectively, with no statistically significant difference. The descending rate of N stage was 91.43% and 56.96% respectively in the two groups, and the difference was also statistically significant (χ²=13.143, P<0.001). In terms of adverse reactions, there was no significant difference between the two groups. As for 1~2 grade adverse reactions, the incidence of transaminase elevation in the combination group was higher, and the difference was statistically significant. No grade 4 adverse reactions or treatment related deaths were observed in either group. Conclusion PD-1 inhibitor combined with SOX regimen showed significant efficacy and good safety in neoadjuvant therapy of locally advanced gastric adenocarcinoma, which can be used as a first-line treatment option.

Key words: programmed death receptor-1 inhibitor(PP-1), sintilimab, oxaliplatin, S-1(SOX), gastric cancer, neoadjuvant chemotherapy, immunotherapy, drug adverse reactions

CLC Number:

R994.1
R735

JIAO Fuzhi, CHEN Yarui, JI Wei, HAO Jianpeng, GUAN Quanlin. Short-term efficacy and safety evaluation of PD-1 inhibitor combined with chemotherapy as a first-line neoadjuvant therapy for locally advanced gastric adenocarcinoma[J]. Chinese Journal of Pharmacovigilance, 2023, 20(3): 301-305.

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