A safety run-in and randomized phase 2 study of cilengitide combined with chemoradiation for newly diagnosed glioblastoma
Nabors LB et al. – Cilengitide was well tolerated when combined with standard chemoradiation and may improve survival for patients newly diagnosed with glioblastoma multiforme regardless of MGMT methylation status. The authors concluded that, from an efficacy and safety standpoint, future trials of this agent in this population should use the 2000mg dose.Methods
- In total, 112 patients were accrued.
- Eighteen patients received standard radiation and temozolomide with cilengitide in a safety run-in phase followed by a randomized phase 2 trial with 94 patients assigned to either a 500mg dose group or 2000mg dose group.
- The trial was designed to estimate overall survival benefit compared with a New Approaches to Brain Tumor Therapy (NABTT) Consortium internal historic control and data from the published European Organization for Research and Treatment of Cancer (EORTC) trial EORTC 26981.
- Cilengitide at all doses studied was well tolerated with radiation and temozolomide.
- The median survival was 19.7months for all patients, 17.4months for the patients in the 500mg dose group, 20.8months for patients in the 2000mg dose group, 30months for patients who had methylated O6-methylguanine-DNA methyltransferase (MGMT) status, and 17.4months for patients who had unmethylated MGMT status.
- For patients aged ≤70years, the median survival and survival at 24months was superior to what was observed in the EORTC trial (20.7months vs 14.6months and 41% vs 27%, respectively; P=.008).