Efficacy and safety of sintilimab combined with nab-paclitaxel plus S-1 for neoadjuvant treatment of locally advanced gastric cancer.

BACKGROUND

Gastric cancer is a leading global cause of cancer mortality, with poor survival in locally advanced stages. While immune checkpoint inhibitors (ICIs) like sintilimab have improved outcomes in advanced disease, their role as neoadjuvant therapy remains understudied. This study investigates sintilimab combined with nab-paclitaxel/S-1 as preoperative treatment for locally advanced gastric cancer (LAGC), addressing an unmet need for effective neoadjuvant strategies.

AIM

To explore the efficacy and safety of combination treatment with sintilimab and nab-paclitaxel plus S-1 as neoadjuvant therapy for LAGC.

METHODS

Clinical data from 82 patients diagnosed with LAGC, who underwent preoperative treatment and surgery between April 2020 and December 2022, were included. Patients were divided into 2 groups according to treatment regimen: ICI (sintilimab + nab-paclitaxel + S-1; and non-ICI (nab-paclitaxel + S-1). Imaging and pathological efficacy, intra- and postoperative conditions, molecular subtypes, short-term survival outcomes, and safety were compared between the 2 groups.

RESULTS

Imaging evaluation of therapeutic efficacy revealed that the inclusion of ICI yielded a significantly higher complete response rate (13.2% 0.0%; = 0.048), and objective response rate (69.8% 31.0%, = 0.001) compared with non-ICI treatment. Pathological evaluation revealed that the ICI group exhibited a significantly higher pathological complete response rate (13.2% 0.0%; = 0.048) and major pathological response rate (35.8% 13.8%; = 0.041) than those in the non-ICI group. The two-year disease-free survival rate in the ICI group was greater than that in the non-ICI group (83.0% 55.2%; = 0.043). The use of ICI did not increase the incidence of adverse reactions (47.2% 41.4%; = 0.614) or perioperative adverse events (18.9% 13.8%; = 0.761).

CONCLUSION

The combination of sintilimab with nab-paclitaxel + S-1 for neoadjuvant treatment of LAGC improved efficacy in patients without increasing adverse drug reactions and perioperative adverse events, suggesting that this treatment regimen is safe and feasible.