A phase 1b multicenter study of TAS-102 in combination with irinotecan in patients with advanced recurrent or unresectable gastric and gastroesophageal adenocarcinoma after at least one line of treatment with a fluoropyrimidine and platinum-containing regimen.

ABSTRACT: TAS-102 is approved for treatment of refractory metastatic gastroesophageal carcinoma (mGEC). This study sought to determine whether the combination of TAS-102 with irinotecan (TASIRI) was safe and effective in previously treated mGEC. This was a single-arm phase 1b study for patients (pts) with mGEC previously treated with at least one line of fluoropyrimidine and platinum-containing regimen. TAS-102 was given at 25 mg/m² twice daily on days 1 to 5 with irinotecan 180 mg/m² on day 1 of a 14-day cycle. The primary endpoint was progression-free survival at 6 months ≥ 35% (PFS-6). 20 Pts were enrolled. The study met its primary endpoint. PFS-6 is 40% (95% CI 19.3-60.0). Median PFS and overall survival are 5.3 months and not reached, respectively. 17 of 20 pts had measur

SUBMITTER: Dayyani F 

PROVIDER: S-EPMC9769492 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature