A phase 2 study of temozolomide in pretreated metastatic colorectal cancer with MGMT promoter methylation.

ABSTRACT:

Background

Presently, few options are available for refractory colorectal cancer (CRC). O6-methyl-guanine-DNA-methyltransferase (MGMT) promoter methylation is a frequent and early event in CRC tumourigenesis. This epigenetic silencing is a predictor of response to the alkylating drug temozolomide in glioblastoma. Preclinical evidences and some case reports showed temozolomide activity in CRC with MGMT silencing, but the available data from clinical trials are inconsistent.

Methods

This was a multicentre, phase 2 trial, planned according to a two-stage Simon's optimal design to investigate activity and safety of temozolomide in refractory CRC harbouring MGMT promoter methylation. The primary end point was overall response rate (ORR). Patients who failed two or more prior trea

SUBMITTER: Calegari MA 

PROVIDER: S-EPMC5482728 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature