Work

Efficacy and safety of nimotuzumab in addition to radiotherapy and temozolomide for cerebral glioblastoma: a phase II multicenter clinical trial

Year: 2019

Type: article

Abstract: Background: Nimotuzumab is a humanized anti-epidermal growth factor receptor (EGFR) antibody that has shown preclinical and clinical anticancer activity in cerebral glioblastoma multiforme (GBM).We conducted a phase II, single-arm, multicenter clinical trial to evaluate the benefit of adding nimotuzumab to current standard chemo-radiotherapy for patients with GBM with positive EGFR expression.Methods: Newly diagnosed patients with histologically proven single supratentorial GBM and epidermal growth factor receptor (EGFR) positive expressions were recruited.All patients were treated with nimotuzumab, administered once a week intravenously for 6 weeks in addition to radiotherapy with concomitant and adjuvant temozolomide after surgery.The primary endpoints were overall survival (OS) and progression-free survival (PFS).Secondary objectives included objective response rate (ORR) and toxicity.Results: A total of 39 patients were enrolled and 36 patients were evaluated for efficacy.The ORR at the end of RT was 72.2%.Median OS and PFS were 24.5 and 11.9 months.The 1-year OS and PFS rates were 83.3% and 49.3%.The 2-year OS and PFS rates were 51.1% and 29.0%.O (6)-methylquanine DNA methyl-tranferase (MGMT) expression is known to affect the efficacy of chemotherapy and status of its expression is examined.No significant correlation between treatment outcomes and MGMT status was found.Most frequent treatment-related toxicities were mild to moderate and included constipation, anorexia, fatigue, nausea, vomiting, and leucopenia.Conclusions: Our study show that nimotuzumab in addition to standard treatment is well tolerable and has increased survival in newly diagnosed GBM patients with EGFR positive expression.

Source: Journal of Cancer

DOI: 10.7150/jca.30123