Akademik Veri Yönetim Sistemi
14th International Gastrointestinal Cancers Conference (IGICC2024)), İstanbul, Türkiye, 28 Kasım - 01 Aralık 2024, ss.7-8, (Tam Metin Bildiri)
Background: The combination of ramucirumab(RAM) and paclitaxel(PTX) is the preferred second-line treatment regimen for patients with metastatic gastric cancer. However, the contribution of adding immunotherapy to this combination is unknown. In this study, we aimed to analyze the real-life data of the combination of RAM and PTX and to investigate the contribution of adding immunotherapy to this combination. Materials-Methods: From January 2018 to September 2024, clinical and pathological data from 46 patients with advanced gastric cancer treated with RAM plus PTX, with or without immune checkpoint inhibitor(ICI), in second-line or beyond were analyzed retrospectively. Results: Median age of the entire cohort was 50(range, 24- 85) and 46.7% of them were female. A majority of the patients’ tumors were characterized by diffuse histology(67.4%). HER2 status was negative in 93.5% of the patients. Mismatch repair deficiency (dMMR) was observed in only one patient(2.2%), while 30.4% of patients had a PD-L1 CPS of >=1%. The percentages of the patients with synchronous and metachronous metastases were 73.9% and 26.1%, respectively. Patients with an ECOG performance score of 0 and 1 accounted for 63.0% and 29.3% of the entire cohort, respectively. The median number of RAM and PTX cycles was 4 (range, 1-12) for both agents. There were no significant differences in response rates and survival outcomes between patients who received RAM plus PTX(n=27) and those who received RAM plus PTX plus nivolumab(n=10) as second-line treatment (ORR 18.5% vs. 30%, p=0.57; DCR 55.6% vs. 80%, p=0.17; median PFS 4.3 vs. 3.1 months, p=0.85; median OS 7.8 vs. 9.6 months, p=0.64). In the third-line treatment(n=9), seven patients received RAM plus PTX, while only two patients received RAM plus PTX plus ICI(One patient received nivolumab, and the other received pembrolizumab). ORR and DCR were 33.3% and 66.7%, respectively. The median PFS was 4.3 months (95% CI 3.4-5.1 months) and the median OS was 7.4 months (95% CI 2.0-12.7 months). Multivariate analysis revealed that age>=50 years (OR 2.1 [95% CI 0.9-4.4], p=0.04) and the presence of ascites (OR 2.5 [95% CI 1.2-5.5],p=0.01) were associated with poorer overall survival. The most commonly (>10%) experienced grade>=3 treatment-related adverse events (TRAEs) while receiving RAM plus PTX (± ICI) were anemia (39.1%), neutropenia (32.6%), infections (19.6%), thrombocytopenia (13.0%), and alanine aminotransferase and/ or aspartate aminotransferase increase (10.9%). Four patients (10.8%) in second-line treatment and two patients (22.2%) in third-line treatment discontinued therapy due to TRAEs. Conclusion: Although the efficacy of RAM plus PTX as second-line treatment or beyond was comparable to previous studies, the incidence of grade>=3 TRAEs was notably higher than in clinical trials. In the second-line treatment, the addition of nivolumab to RAM plus PTX did not result in significantly improved response rates and survival outcomes. Keywords: Ramucirumab, paclitaxel, immunotherapy