NYMC Faculty Publications

Efficacy and Safety of Apatinib for Radiation-Induced Brain Injury Among Patients With Head and Neck Cancer: An Open-Label, Single-Arm, Phase 2 Study

Authors

Lei He, Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
Yaxuan Pi, Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
Yi Li, Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
Ying Wu, Department of Biostatistics, Southern Medical University, Guangzhou, China; Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
Jingru Jiang, Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
Xiaoming Rong, Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
Jinhua Cai, Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
Zongwei Yue, Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
Jinping Cheng, Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
Honghong Li, Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
Melvin Lee Chua, Division of Radiation Oncology and Medical Sciences, National Cancer Center Singapore, Singapore; Oncology Academic Programme, Duke-National University Singapore Medical School, Singapore.
Charles B. Simone, Department of Radiation Oncology, New York Proton Center and Memorial Sloan Kettering Cancer Center, New York, New York.
Wilbert S. Aronow, New York Medical College/Westchester Medical Center, Valhalla, New York.Follow
Simona Lattanzi, Neurological Clinic, Department of Experimental and Clinical Medicine, Marche Polytechnic University, Ancona, Italy.
Joshua D. Palmer, Departments of Radiation Oncology and Neurosurgery, James Cancer Center, The Ohio State University, Columbus, Ohio.
Jan Gaertner, Palliative Care Center Hildegard, Basel, Switzerland.
Jon Glass, Departments of Neurology and Neurological Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania.
Pingyan Chen, Department of Biostatistics, Southern Medical University, Guangzhou, China.
Yamei Tang, Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China; Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China; Guangdong Province Key Laboratory of Brain Function and Disease, Zhongshan School of Medicine, Sun Yat-sen University, Guangzhou, China. Electronic address: tangym@mail.sysu.edu.cn.

Author Type(s)

Faculty

DOI

10.1016/j.ijrobp.2022.03.027

Journal Title

International Journal of Radiation Oncology, Biology, Physics

First Page

796

Last Page

804

Document Type

Article

Publication Date

7-15-2022

Department

Medicine

Abstract

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.

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