Previous studies demonstrated that the combination of chemotherapy with ramucirumab allows to improve the treatment results in advanced gastric cancer (GC). The one of the available options for the second line chemotherapy is combination of irinotecan with fluoropyrimidines. As angiogenesis inhibitors can enhance the efficacy of chemotherapy, we investigated the combination of irinotecan and fluoropyrimidines with ramucirumab in metastatic GC.
Eligible patients had advancedmorphologicallyverifiedGC and disease progression during or within 4 months following first-line therapy. They received FOLFIRI plus ramucirumab(8 mg/kg on day 1) or XELIRI in combination with ramucirumab(8 mg/kg on days 1 and 8). The primary end point was progression-free survival (PFS). Secondary end-points were overall survival (OS), disease control rate (DCR) and safety.
Between September 2015 and October 2018, 23 patients were enrolled. Median number of cycles was 9 (2-20). Six patients achieved a partial response (PR) for an objective response rate of 26.1%. A total of 15 (65.2%) patients had stable disease (SD) for a DCR of 91.3%. With a median follow up 8,2 months, median PFS was 7.6 months (95% CI 5.9-9.2) and the median OS was 9.5 months (95% Cl 6.74 – 12.3). Median duration of PR response was 4,5 months (2,7-5,2 +) and median duration of SD was 4,2 months (2,1-10,1+ ).The main treatment-related grade 3 or 4 adverse events were decreased neutrophil count (1/23; 4.3%), anemia (1/23; 4.3%) and diarrhea (1/23; 4.3).The most frequent adverse events of special interest (AESIs) any grade were hypertension (10/23; 43.4%), bleeding/hemorrhage (5/23; 21.7%), proteinuria (5/23; 21.7%) and venous thromboembolic events (6/23; 26%). Gastrointestinal perforationdeveloped in two patients (2/23; 8.7%). No treatment-related deaths occurred.
In our research ramucirumab with irinotecan and fluoropyrimidinesdemonstrate the high activity and a manageable safety profile in patients with pre-treated metastatic GC.
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All authors have declared no conflicts of interest.