Background The mFOLFIRINOX regimen(oxaliplatin,irinotecan,leucovorin and 5-fluorouracil)and GX regimen(gemcitabine combined with capecitabine)are standard adjuvant chemotherapies for resected pancreatic ductal adenocarcinoma(PDAC),but mFOLFIRINOX exhibits significant toxicities.SOXIRI regimen(S-1 combined with oxaliplatin and irinotecan)and GS regimen(gemcitabine plus S-1)are used as modified on the basis of mFOLFIRINOX and GX regimen.The comparison of GS and SOXIRI has not been reported.Objective To compare the efficacy and safety of adjuvant GS with SOXIRI for PDAC retrospectively.Methods This study analyzed 41 patients with PDAC who underwent postoperative adjuvant chemotherapy at the Oncology Center of Nanjing Drum Tower Hospital,Affiliated Hospital of Nanjing University Medical School,from March 2018 to June 2023(21 in the GS group and 20 in the SOXIRI group).The enrolled patients were followed up via review of electronic medical records and telephone calls.The follow-up period continued until August 31,2024.The primary endpoint was disease-free survival(DFS).Secondary endpoints included the 2-year overall survival(OS)rate and adverse events(AEs).Survival curves were plotted using the Kaplan-Meier method and compared with the Log-rank test.Univariate and multivariate Cox proportional hazards models were used to identify factors associated with DFS and OS.Results The median disease-free survival(mDFS)was 18.65 months in the GS group and 13.03 months in the SOXIRI group,with the 2-year overall survival(OS)rates being 84.7%and 66.0%,respectively.No statistically significant differences were observed in mDFS and 2-year OS rates between the two groups(χ2=0.646,P=0.421;χ2=3.269,P=0.071).Multivariate Cox proportional hazards regression analysis revealed that postoperative CA19-9 level(HR=3.66,95%CI=1.26-10.64)and surgical margin status(HR=2.64,95%CI=1.05-6.61)were independent influence factors for DFS(P<0.05),whereas advanced age(HR=3.42,95%CI=1.13-10.36)and TNM stage(HR=5.68,95%CI=1.40-22.97)were independent influnce factors for OS(P<0.05).Subgroup analysis showed no statistically significant difference in therapeutic efficacy between the GS and SOXIRI regimens(P>0.05).The incidences of overall diarrhea(χ2=7.796,P=0.005)and peripheral neurotoxicity(χ2=7.552,P=0.006)were significantly higher in the SOXIRI group than in the GS group.Conclusion For postoperative adjuvant therapy in PDAC,the GS demonstrated noninferiority to the SOXIRI regimen in efficacy and better safety with lower diarrhea/peripheral nerve toxicity incidence.
(8.0+极速模式)