Cetuximab, bevacizumab, and irinotecan for patients with primary glioblastoma and progression after radiation therapy and temozolomide: a phase II trial

• DOI: 10.1093/neuonc/nop063
• Publication Date: 2017-02-02T00:11:40Z
• Authors: Benedikte Hasselb...; Ulrik Lassen; Steinbjørn Hansen; Mats Holmberg; Morten Mau‐Sørensen; Michael Kosteljanetz; Helle Broholm; Marie‐Thérése Sto...; Hans Skovgaard Po...
• Keywords: Temozolomide; Interim analysis

The aim of this clinical trial was to investigate safety and efficacy when combining cetuximab with bevacizumab irinotecan in patients recurrent primary glioblastoma multiforme (GBM). Patients were included GBM progression within 6 months ending standard treatment (radiotherapy temozolomide). Bevacizumab administered IV every 2 weeks. first 10 received 5 mg/kg, but increased mg/kg after interim analysis. Irinotecan dose based on whether taking enzyme-inducing antiepileptic drugs or not: 340 125 mg/m2, respectively. Cetuximab 400 mg/m2 as loading followed by 250 weekly IV. Forty-three enrolled the trial, which 32 available for response. Radiographic responses noted 34%, had complete 9 partial responses. 6-month progression-free survival probability 30% median overall 29 weeks (95% CI: 23–37 weeks). One patient lacunar infarction, 1 multiple pulmonary embolisms, 3 grade skin toxicity, needed plastic surgery. excluded due suspicion interstitial lung disease. Three deep-vein thrombosis; all continued study adequate treatment. combination is well tolerated except an encouraging response rate. However, data do not seem be superior compared results alone.