14th International Gastrointestinal Cancers Conference (IGICC2024)), İstanbul, Türkiye, 28 Kasım - 01 Aralık 2024, ss.6, (Tam Metin Bildiri)
Background: The exact role of ICIs, particularly nivolumab, in the perioperative management of locally advanced gastric/gastroesophageal junction (GEJ) adenocarcinoma remains uncertain.
Materials-Methods: Clinical and pathological data were retrospectively collected for previously untreated, clinical stage T3-4bN0-3M0 (stage II-III) gastric/GEJ adenocarcinoma patients who received perioperative nivolumab, either in combination with chemotherapy or ipilimumab, between January 2021 and August 2024. Results: A total of 12 eligible patients (10 males/2 females) were included. Five patients (41.7%) were classified as MSI-H/ dMMR, and nine patients (75%) had a PD-L1 CPS of >=5. The median numbers of immunotherapy and chemotherapy cycles prior to surgery were 6 (range, 3-8) and 8 (range, 1-8), respectively. Only one patient with MSI-H/dMMR gastric adenocarcinoma received dual immunotherapy with nivolumab and ipilimumab, while other patients received perioperative nivolumab combined with neoadjuvant chemotherapy. Overall response rate (ORR) and disease control rate (DCR) were 66.7% and 100%, respectively. All patients underwent surgical resection, with an R0 resection rate of 91.6%. In pathological examination, the pathological complete response (pCR) and major pathological response (MPR) rates in the entire cohort were 50% and 58.3%, respectively. The pCR rate was 80% in the MSI-H/dMMR subgroup and 28.6% in patients with a PD-L1 CPS of >=5. The median follow-up time was 12.3 months (range, 7.7 – 42.2). During this period, three patiens experienced tumor recurrence and two patients died, while all other patients remained in remission. The 1-year disease-free survival (DFS) and overall survival (OS) were 69.3% and 87.5%, respectively. All patients experienced at least one treatment-related adverse event (TRAE) during neoadjuvant treatment. The most common TRAEs (>10%) were anemia (91.7%), thrombocytopenia (75%), neutropenia (75%), fatigue (75%), alanine aminotransferase increase (66.7%), aspartate aminotransferase increase (66.7%), peripheral neuropathy (50%), nausea or vomiting (25%), fever (16.7%), and diarrhea (16.7%). Conclusion: In the treatment of locally advanced gastric/GEJ adenocarcinoma, perioperative nivolumab combined with total neoadjuvant chemotherapy appears to be an effective approach for both MSI-H/dMMR patients and MSS/pMMR patients with a PD-L1 CPS of >=5, with an acceptable safety profile. Keywords: nivolumab, perioperative treatment, gastric cancer