Short-term efficacy and safety analysis of PD-1 inhibitor combined with SOX neoadjuvant therapy for locally advanced gastric adenocarcinoma / 肿瘤

ABSTRACT

Objective:To explore the short-term efficacy and safety for the new adjuvant therapy of programmed cell protein-1(PD-1)inhibitor combined with Oxaliplatin+Tegafur(SOX)in locally advanced gastric adenocarcinoma. Methods:Retrospective collection of clinical data from 72 locally advanced(stage Ⅲ)gastric adenocarcinoma patients admitted to our gastrointestinal surgery department from January 2020 to July 2020,according to different treatment plans,patients were divided into a control group(n=36)and an observation group(n=36).The control group received SOX chemotherapy regimen,while the observation group received PD-1 inhibitor combined with SOX regimen.Both groups of patients underwent chemotherapy for 3 cycles,and were re-evaluated after resting for 3-4 weeks.Patients with no disease progression and tolerable surgery underwent D2 gastric cancer radical surgery.The overall survival(OS),pathological complete response(pCR)rate,progression free survival period(PFS),RO resection rate,objective response rate(ORR),disease control rate(DCR)and adverse drug reaction were compared between the two groups. Results:The pCR rate,ORR and DCR of the observation group were significantly higher than those of the control group[pCR rate:25％(9/36)vs 5.6％(2/36),x2=5.258,P=0.022;ORR:58.33％(21/36)vs 25.00％(9/36),x2=8.229,P=0.004;DCR:88.89％(32/36)vs 69.44％(25/36),x2=4.1 26,P=0.042].The incidence of adverse reactions such as elevated ALT,elevated AST,and hand foot syndrome during neoadjuvant chemotherapy in the observation group was significantly higher than those in the control group(P＜0.05).The incidence of other adverse reactions was not significantly difference between the two groups of patients(P＞0.05),and there were no neoadjuvant chemotherapy related death events in both groups.The R0 resection rates of the two groups were 97.22％and 91.67％,respectively(x2=1.059,P=0.303).The median OS and median PFS of 72 patients were 36 and 1 3 months,respectively.The 2-year OS rate of the two groups were 82.2％and 71.5％,respectively.Kaplan Meier survival curve analysis showed that the OS rate of the observation group was significantly higher than that of the control group(x2=4.240,P=0.039);the median PFS of the observation group was higher than that of the control group at 14 and 1 1 months,respectively(x2=4.173,P=0.041);COX univariate regression analysis did not identify any factors affecting survival of locally advanced gastric adenocarcinoma. Conclusion:The neoadjuvant treatment of locally advanced gastric adenocarcinoma with PD-1 inhibitor combined with SOX regimen is safe and effective,and the adverse reactions are controllable.