Safety and activity of trifluridine/tipiracil and ramucirumab in previously treated advanced gastric cancer: An open-label, single-arm, phase 2 trial
The Lancet: Gastroenterology & Hepatology Jan 29, 2021
Kawazoe A, Ando T, Hosaka H, et al. - In this open-label, single-arm, two-cohort, phase 2 study, researchers examined the safety as well as the activity of trifluridine/tipiracil and ramucirumab for previously treated advanced gastric cancer. Patients suffering from unresectable advanced gastric cancer or gastro-oesophageal junction adenocarcinoma were enrolled; patients previously managed with one line of chemotherapy without ramucirumab were assigned to cohort A (N = 33), and patients previously managed with two to four lines of chemotherapy, including ramucirumab, were included in cohort B (N = 31). Patients were administered trifluridine/tipiracil (35 mg/m2) orally twice daily on days 1–5 and days 8–12 of each 28-day treatment cycle, plus intravenous ramucirumab (8 mg/kg) on days 1 and 15. The disease control rate in cohort A and in cohort B was 85% and 77%, respectively. Serious treatment-related adverse events were recorded in three patients in cohort A, while zero patients in cohort B had a serious treatment-related adverse event; no treatment-related deaths were reported in either cohort. Overall, the safety profile and clinical activity shown by trifluridine/tipiracil and ramucirumab in these patients with previously treated advanced gastric cancer irrespective of previous ramucirumab exposure was considered acceptable.
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