This article is more than 5 years old. Information may no longer be current.
Temozolomide appears effective, safe in advanced colorectal cancer
Temozolomide demonstrated activity and appeared well tolerated in patients with advanced and heavily pretreated colorectal cancer with MGMT promoter methylation, according to results of a phase 2 study.
Researchers included 32 patients with advanced, chemorefractory colorectal cancer who demonstrated MGMT promoter methylation.
All patients received 150 mg/m2 temozolomide (Temodar, Schering-Plough) daily for 5 days in 4-week cycles for up to six cycles.
The 12% objective response rate reached the predetermined level indicating promising activity.
No patients achieved a complete response, according to researchers.
Median PFS was 1.8 months, and median OS was 8.4 months.
Results from additional biomarkers analyses indicated patients with KRAS, BRAF and NRAS wild-type tumors demonstrated significantly higher rates of response (44%) than patients with RAS- or BRAF-mutated tumors (0%; P=.004).
Researchers reported one incidence of grade 4 thrombocytopenia, but no other grade ≥3 toxicities were observed.
“Temozolomide is tolerable and active in heavily pre-treated patients with advanced [colorectal cancer] and MGMT promoter methylation,” the researchers wrote. “Further studies in biomolecularly enriched populations or in a randomized setting are necessary to demonstrate the efficacy of temozolomide after failure of standard treatments.”
Disclosure: See the study for a list of the researchers’ relevant financial disclosures.