Abstract
ObjectiveOur aim was to compare the clinical outcomes of patients treated with bevacizumab combined with corticosteroids and those with bevacizumab monotherapy from a radiation-induced brain necrosis (RN) registry cohort (NCT03908502).MethodsWe utilized clinical data from a prospective RN registry cohort (NCT03908502) from July 2017 to June 2020. Patients were considered eligible if they had symptomatic RN after radiotherapy for nasopharyngeal carcinoma (NPC) and received bevacizumab (5 mg/kg, two to four cycles) with a minimum follow-up time of 3 months. The primary outcome was a 2-month response rate determined by MRI and clinical symptoms. Secondary outcomes included quality of life [evaluated by the abbreviated World Health Organization Quality of Life (WHOQOL-BREF) questionnaire] and cognitive function (evaluated by the Montreal Cognitive Assessment scale) at 2 months, RN recurrence during follow-up, and adverse events.ResultsA total of 123 patients (34 in the combined therapy group and 89 in the monotherapy group) were enrolled in our study with a median follow-up time of 0.97 year [interquartile range (IQR) = 0.35–2.60 years]. The clinical efficacy of RN did not differ significantly between patients in these two groups [odds ratio (OR) = 1.642, 95%CI = 0.584–4.614, p = 0.347]. Furthermore, bevacizumab combined with corticosteroids did not reduce recurrence compared with bevacizumab monotherapy [hazard ratio (HR) = 1.329, 95%CI = 0.849–2.079, p = 0.213]. The most common adverse events of bevacizumab were hypertension (17.89%), followed by nosebleed (8.13%) and fatigue (8.13%). There was no difference in grade 2 or more severe adverse events between the two groups (p = 0.811).InterpretationOur results showed that the treatment strategy of combining bevacizumab with corticosteroids did not lead to better clinical outcomes for RN patients with a background of radiotherapy for nasopharyngeal carcinoma.
Highlights
Nasopharyngeal carcinoma (NPC) is characterized by a distinct geographical feature with high incidence rates in southern China and Southeast Asia [1]
Patients were selected from the radiation-induced brain necrosis (RN) cohort study according to the following criteria: 1) patients with NPC, treated with radiotherapy, and confirmed RN without evidence of tumor recurrence by using radiographic imaging
2) Patients who presented with evidence of progressive neurologic signs or symptoms appropriate to the location of RN, such as seizure, hemiparesis, limb numbness, cognitive impairment, and blurred vision, or symptoms that cannot be clearly localized but are clinically attributable to RN, such as headache and dizziness; 3) the interval between radiotherapy and the diagnosis of RN must exceed 6 months in order to exclude acute radiation injury to the brain; 4) patients who received at least two cycles of bevacizumab (5 mg/kg, every 2 weeks); and 5) those with a follow-up duration of more than 3 months
Summary
Nasopharyngeal carcinoma (NPC) is characterized by a distinct geographical feature with high incidence rates in southern China and Southeast Asia [1]. The age-standardized incidence rate of NPC in China is 3.0 per 100,000 people [2]. NPC is highly sensitive to ionizing radiation, and radiotherapy is the mainstay of its treatment strategy. Patients often suffer from a delayed complication called radiation-induced brain necrosis (RN), occurring 6 months to several years after radiotherapy. The typical symptoms of RN include headache, cognitive dysfunction, dysphagia, and mental disorder, which severely affect patients’ quality of life [3]. Efforts to prevent or minimize RN have long been attempted in both laboratory and clinical studies
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