Abstract
This study aimed to prospectively evaluate, on a long-term basis, corneal side effects secondary to compassionate administration of epidermal growth factor receptor (EGFR) inhibitor depatuxizumab mafodotin (ABT-414) in patients affected by EGFR-amplified recurrent glioblastoma. Fifteen patients with a median follow-up of 4.3 months after treatment discontinuation were enrolled. Each patient underwent full ophthalmologic examination including in vivo corneal confocal microscopy (CCM). No CTCAE grade 4 toxicity and four (27%) grade 3 toxicities were documented during treatment. Ocular symptoms (blurred vision, eye pain, photophobia) were experienced by all patients, reaching maximal severity after the second ABT-414 infusion, with persistence until treatment discontinuation. During treatment, CCM documented specific changes in the corneal epithelium and in the sub-basal nerve plexus layer fibers of all eyes. The median time of symptoms resolution after treatment discontinuation ranged from 38 days (eye pain) to 53 days (photophobia). The median time of signs resolution ranges from 14 days (corneal ulcer) to 38 days (superficial punctate epitheliopathy, corneal stroma edema and intraepithelial cysts). ABT-414 corneal side effects are detectable in all treated patients. Related symptoms are gradually experienced by all patients during treatment and although reversible, they are characterized by a relative prolonged persistence after treatment discontinuation.
Highlights
Glioblastoma (GBM) is the most common primary malignant tumor of the central nervous system in adults, accounting for almost 50% of all malignant primary tumors of the brain, with a 5-years overall survival of 5% [1]
The aim of the present study is to further evaluate corneal side effects secondary to compassionate administration of epidermal growth factor receptor (EGFR) inhibitor ABT-414 using confocal microscopy (CCM) in a larger number of patients with a longer follow-up, and to obtain a mean time to resolution of these side effects
Fifteen patients affected by EGFR-amplified recurrent GBM were consecutively enrolled from January 2019 to May 2019 at Veneto Institute of Oncology-IRCCS, Padua, Italy
Summary
Glioblastoma (GBM) is the most common primary malignant tumor of the central nervous system in adults, accounting for almost 50% of all malignant primary tumors of the brain, with a 5-years overall survival of 5% [1]. Ocular Side Effects of ABT-414 system tumors [2,3,4,5,6] These drugs have been proved to improve the prognosis of patients affected these tumors, suggesting a possible use in patients affected by EGFR amplified GBM [1,2,3,4,5,6]. Antibody-drug conjugates (ADC), a class of anticancer drugs, are composed by monoclonal antibodies with specific targeting properties and cytotoxic agents characterized by anti-tumor effects. The recent phase-II controlled study on ABT-414 in the treatment of EGFR amplified recurrent GBM (NTELLANCE 2; NCT02343406) has suggested a possible role of this agent (in combination with temozolomide) in the treatment of this tumor. The ocular toxicity related to the attached toxin has interfered with ABT-414 dose intensity, probably affecting the treatment outcome of the clinical trial [3]
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