A pilot clinical study of apatinib plus irinotecan in patients with recurrent high-grade glioma: Clinical Trial/Experimental Study.

Medicine (Baltimore)

Department of Radiation Oncology, The Affiliated Lianyungang Hospital of Xuzhou Medical University, Lianyungang City Department of Radiation Oncology, Suzhou Kowloon Hospital Shanghai Jiao Tong University School of Medicine, Suzhou Department of Oncology, Sihong Fenjinting Hospital, Suqian City, China.

Published: December 2017

AI Article Synopsis

  • Malignant glioma is a highly vascular brain tumor, and this study investigates the combination of apatinib, a tyrosine kinase inhibitor, with irinotecan for patients with recurrent cases after temozolomide treatment.
  • Ten patients were enrolled, receiving the combination treatment for six cycles, followed by apatinib alone as maintenance, with only a few needing dosage adjustments.
  • The results showed a 55% objective response rate and 78% disease control rate, with the average progression-free survival being 8.3 months; however, the treatment also had common side effects like gastrointestinal issues, hypertension, and myelosuppression.

Article Abstract

Background: Malignant glioma is the most common primary malignant brain tumor that displays high vascularity, making vascular endothelial growth factor receptors become promising targets. This study was conducted to evaluate the efficacy and safety of apatinib, a new potent oral small-molecule tyrosine kinase inhibitor targeted vascular endothelial growth factor receptor 2, combined with irinotecan, in patients with recurrent malignant glioma.

Methods: Ten patients with recurrent malignant glioma who were experiencing relapse after treatment of temozolomide were enrolled in this study. They received oral apatinib (500 mg qd) in conjunction with irinotecan (340 mg/m or 125 mg/m depending on use of enzyme-inducing antiepileptic drugs) for 6 cycles. After that the patients continued to take apatinib as maintenance. Dosage adjustment occurred in only 3 (30.0%) patients.

Results: Among the 10 patients, 9 were available for the efficacy evaluation. There were 5 with partial response, 2 with stable disease and 2 with progressive disease. The objective response rate and the disease control rate (DCR) were 55% (5/9) and 78% (7/9), respectively. The median progress free survival time was 8.3 months. As for safety analysis, the most 3 common adverse events were gastrointestinal reaction (31.8%), hypertension (22.7%), and myelosuppression (18.0%).

Conclusion: Apatinib combined with irinotecan seems to be a promising therapeutic option for recurrent malignant glioma patients. Perspective clinical studies with adequate sample size are required to validate our results.

Trial Registration: NCT02848794 /Ahead-BG306.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5728925PMC
http://dx.doi.org/10.1097/MD.0000000000009053DOI Listing

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