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Article type: Research Article
Authors: Yang, Dong-Yia | Cheng, Xueb | Bu, Xing-Yaoa; * | Yan, Zhao-Yuea | Qu, Ming-Qia | Zhao, Yue-Wuc | Kong, Ling-Feic | Wang, Yao-Weid | Luo, Jian-Chaod
Affiliations: [a] The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan, China | [b] Rehabilitation Medical College, Henan University of Traditional Chinese Medicine, Zhengzhou, Henan, China | [c] Department of Pathology, Zhengzhou University People’s Hospital, Zhengzhou, Henan, China | [d] Department of Radiotherapy, Zhengzhou University People’s Hospital, Zhengzhou, Henan, China
Correspondence: [*] Corresponding author: Xing-Yao Bu, Department of Neurosurgery, Zhengzhou University People’s Hospital, No. 7 Weft Five Street, Jinshui District, Zhengzhou, Henan 450003, China. E-mail: [email protected].
Abstract: BACKGROUND: Glioblastoma is the most common and most aggressive type of primary brain tumor. OBJECTIVE: The aim of this study was to investigate the efficacy and safety of intranasal granulocyte-macrophage colony stimulating factor (GM-CSF) administration combined with chemoradiotherapy in patients with glioblastoma who underwent surgery. METHODS: Ninety-two patients were randomly divided into two groups: a control group (n= 46), who received radiotherapy with adjuvant local delivery of nimustine hydrochloride (ACNU) and systemic administration of temozolomide, and an intervention group (n= 46), who received intranasal GM-CSF prior to each cycle of adjuvant chemotherapy in addition to the treatment of the control group. Karnofsky performance status (KPS) scores, progression-free survival (PFS), overall survival (OS), and adverse effects were calculated and compared between the two groups. RESULTS: Compared with the control group, the intervention group had longer PFS (7.8 vs. 6.9 months, P= 0.016) and OS (19.2 vs. 17.1 months, P= 0.045, without adjustment for interim analyses). The KPS scores were also higher in the intervention group than in the control group after 6 months (84.35 ± 8.86 vs. 80.65 ± 7.72; t= 4.552, P= 0.036). Furthermore, the patients in the intervention group had lower incidence of neutropenia and thrombocytopenia (8.7% vs. 29.5%, P= 0.012; 8.7% vs. 18.2%, P= 0.186). Other adverse events were similar in both groups, and most adverse events were grade I/II and resolved spontaneously. CONCLUSION: Intranasal GM-CSF enhances the efficacy of the local ACNU administration combined with oral temozolomide chemotherapy. The survival and performance status were significantly improved in patients with glioblastoma after surgery. Additionally, the GM-CSF therapy was able to reduce the occurrence of chemotherapy-related neutropenia and thrombocytopenia.
Keywords: Glioblastoma, GM-CSF, intranasal, rendezvous chemoradiotherapy, survival
DOI: 10.3233/THC-220194
Journal: Technology and Health Care, vol. 31, no. 2, pp. 635-645, 2023
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