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Efficacy and Safety of Apatinib for Radiation-induced Brain Injury Among Patients With Head and Neck Cancer: An
1Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
Purpose:
The treatment of radiation-induced brain injury (RI) caused by radiation therapy for head and neck cancer is challenging. Antiangiogenic therapy is a promising treatment. Apatinib is an oral tyrosine kinase inhibitor that selectively inhibits vascular endothelial growth factor receptor 2. We aimed to assess the efficacy and safety of apatinib in patients with RI.
Methods And Materials:
In this phase 2, open-label, single-arm, prospective study, we recruited patients aged 35 to 80 years with prior radiation therapy history for head and neck cancer who had newly diagnosed RI at the Sun Yat-sen Memorial Hospital, China. Apatinib was administered at a dosage of 250 mg once daily orally for 4 weeks. A Simon minimax 2-stage design was performed. The primary outcome was the proportion of patients with overall clinical efficacy, defined as a radiographic response of ≥25% reduction in baseline brain edema volume on magnetic resonance fluid attenuated inversion recovery images at week 4. Secondary end points were the overall improvement rate of brain necrosis, neurologic function, and safety.
Results:
We screened 37 patients, 36 of whom were enrolled between October 17, 2019, and August 3, 2020. At the cutoff date, 36 patients were assessed for efficacy and safety (19 were enrolled in stage 1 and 17 in stage 2). Of the 36 patients evaluated for overall clinical efficacy, 22 patients (61.1%; 95% CI, 43.5%-76.9%) achieved the primary end point at week 4. Among the 31 patients with brain necrosis lesions, 19 patients (61.3%; 95% CI, 42.2%-78.2%) showed improvement of brain necrosis. The most common grade 1 to 2 adverse events were hand-foot syndrome, fatigue, and hypertension There were no treatment-related grade 4 to 5 toxic effects.
Conclusions:
Oral apatinib shows promising efficacy and is well-tolerated in patients with RI. Further randomized controlled studies are warranted.
Insights
Apatinib, an antiangiogenic drug, demonstrated significant efficacy in treating radiation-induced brain injury (RI) in head and neck cancer patients. This oral treatment showed promising results and was well-tolerated, suggesting its potential as a therapeutic option for RI.
Area of Science:
- Oncology
- Radiotherapy
- Pharmacology
Background:
- Radiation-induced brain injury (RI) presents a significant clinical challenge following head and neck cancer radiation therapy.
- Antiangiogenic therapies offer a promising avenue for managing RI.
- Apatinib, a selective VEGFR2 inhibitor, is being investigated for its therapeutic potential.
Purpose of the Study:
- To evaluate the efficacy and safety of apatinib in patients suffering from radiation-induced brain injury (RI).
- To determine the radiographic response rate and improvement in neurological function.
- To assess the tolerability and adverse events associated with apatinib treatment in this patient population.
Main Methods:
- A phase 2, open-label, single-arm, prospective study was conducted.
- 36 patients with newly diagnosed RI after head and neck cancer radiation therapy were enrolled.
- Apatinib was administered orally at 250 mg daily for 4 weeks, with efficacy assessed by reduction in brain edema volume and improvement in brain necrosis and neurological function.
Main Results:
- 61.1% of patients achieved the primary endpoint of ≥25% reduction in brain edema volume at week 4.
- 61.3% of patients with brain necrosis lesions showed improvement.
- Common adverse events included hand-foot syndrome, fatigue, and hypertension; no grade 4-5 toxic effects were reported.
Conclusions:
- Oral apatinib demonstrates promising efficacy in treating radiation-induced brain injury (RI).
- The drug is well-tolerated by patients, with manageable side effects.
- Further investigation through randomized controlled trials is recommended to confirm these findings.
