SOX plus sintilimab

backgroundGastric cancer (GC) remains a major global health burden, particularly in East Asia, due to its high incidence, aggressive progression, and poor prognosis in advanced stages. Although surgery is the mainstay of curative treatment, outcomes for locally advanced cases remain unsatisfactory despite perioperative chemotherapy. In recent years, immune checkpoint inhibitors, especially anti-PD-1 antibodies like sintilimab, have shown promise in improving survival when combined with chemotherapy. However, the comparative efficacy and safety of SOX plus sintilimab

aimTo compare the efficacy and safety of three neoadjuvant chemotherapy regimens-SOX combined with sintilimab (SOX + PD-1), albumin-bound paclitaxel plus oxaliplatin and S-1 (P-SOX), and SOX-in patients with advanced GC.

methodsA retrospective analysis was conducted on 299 patients with advanced GC who received both neoadjuvant and adjuvant chemotherapy along with standard D2 radical gastrectomy. Among them, 81 patients received SOX plus sintilimab, 118 received the P-SOX regimen, and 100 received the SOX regimen. All patients were randomly assigned to training (70%) or validation (30%) cohorts using the R software sample function. Short-term efficacy, long-term survival outcomes, and adverse events were assessed across the three groups. Additionally, clinical factors associated with progression-free survival (PFS) were further investigated.

resultsIn terms of short-term efficacy, the SOX + sintilimab group had higher objective response rates [91.4% and 70.4% according to the tumor regression grade (TRG) and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, respectively] than did the P-SOX (88.1% and 59.3%) and SOX groups (84.0% and 55.0%), although the intergroup differences were not statistically significant (

conclusionCompared with the SOX and P-SOX regimens, the SOX plus sintilimab combination demonstrated significantly improved short- and long-term efficacy with favorable safety, with superior advantages in terms of 2- and 3-year OS and early PFS, suggesting that this combination is a more promising therapeutic option for patients with advanced GC. Patients who achieved good perioperative chemotherapy responses (meeting the TRG and RECIST 1.1 criteria) and had tumor diameters ≤ 2 cm, well-differentiated histology, earlier cTNM stages, and no lymph node metastasis had a better prognosis.