Capecitabine plus temozolomide in patients with grade 3 unresectable or metastatic gastroenteropancreatic neuroendocrine neoplasms with Ki-67 index <55%: single-arm phase II study.

ABSTRACT:

Background

Grade 3 neuroendocrine neoplasms (NENs) of gastroenteropancreatic (GEP) origin with Ki-67 indices <55% do not respond well to platinum-based chemotherapy. The combination of capecitabine and temozolomide (CAPTEM) has shown favorable responses in grade 1-2 NENs, but has rarely been studied in patients with grade 3 NENs.

Patients and methods

This open-label, single-arm phase II trial included patients with unresectable or metastatic grade 3 NENs of GEP origin with Ki-67 indices <55% enrolled between June 2017 and July 2020. Patients received oral capecitabine 750 mg/m² twice daily on days 1 to 14 and oral temozolomide 200 mg/m² once daily on days 10 to 14 every 4 weeks. Histologic findings were centrally reviewed after the completion of enrollm

SUBMITTER: Jeong H 

PROVIDER: S-EPMC8099746 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature