Regorafenib combined with irinotecan as second-line treatment in metastatic gastro-oesophageal adenocarcinomas: results of PRODIGE 58-UCGI35-REGIRI Unicancer randomised phase II study.

ABSTRACT:

Background

Several options have been evaluated in metastatic gastro-oesophageal adenocarcinomas (mGA) after failure of first-line fluoropyrimidine and platinum-based chemotherapy. Regorafenib (REGO), a receptor tyrosine kinase inhibitor, has shown promising activity as second- and third-line treatment of mGA.

Patients and methods

PRODIGE58-UCGI35-REGIRI was a comparative, prospective, phase II, open-label study evaluating the safety and efficacy of REGO [160 mg/day on day 2 (D2)-D8/D16-D22] plus irinotecan (IRI: 180 mg/m² intravenously on D1/D15 every 28 days) versus IRI alone in patients with mGA (gastric or gastro-oesophageal junction/tumour Siewert II and III) after failure of first-line fluoropyrimidine and platinum-based chemotherapy. Primary endpoint was ove

SUBMITTER: Samalin E 

PROVIDER: S-EPMC12141891 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature