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Nimotuzumab Combined With Chemoradiation Therapy in Newly Diagnosed Pediatric Diffuse Intrinsic Pontine Glioma

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机构： [1]Department of Radiation Oncology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China. [2]Department of Oncology, Xiangya Hospital Central South University, Changsha, China. [3]Department of Radiation Oncology, The Third People's Hospital Of Zhengzhou, Zhengzhou, China. [4]Department of Surgery, Shandong Cancer Hospital Institute, Jinan, China. [5]Department of Radiation Oncology, Xuan Wu Hospital Capital Medical University, Beijing, China. [6]Department of Radiation Oncology, Xinhua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine, Shanghai, China. [7]Department of Neurosurgery, Xuan Wu Hospital Capital Medical University, Beijing, China. [8]Department of Neurosurgery, West China School of Medicine/West China Hospital of Sichuan University, Chengdu, China. [9]Department of Neurosurgery, Peking Union Medical College Hospital, Beijing, China. [10]Department of Radiation Oncology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China [11]Department of Radiation Oncology, Xinhua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine, Shanghai, China

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Diffuse intrinsic pontine glioma (DIPG) is a rare and fatal pediatric malignancy of the brainstem with a lack of effective therapeutic options. This study assesses the efficacy and safety of adding nimotuzumab to temozolomide (TMZ) chemoradiation therapy for newly diagnosed pediatric DIPG.We conducted an open-label, single-arm, prospective, multicenter study involving children aged 3-15 years with histologically or radiographically confirmed DIPG from April 3, 2021 to April 13, 2023. Nimotuzumab (150 mg/m2/wk) was administered concurrently with local radiation therapy (54 Gy/30 f) and TMZ (75 mg/m2/d) for 6 weeks, followed by adjuvant TMZ (150-200 mg/m2 for 5 consecutive days of a 28-day cycle for 6 cycles) and nimotuzumab (150 mg/m2 biweekly until to disease progression). The primary endpoint was objective response rate (ORR). The secondary endpoints were overall survival (OS), progression-free survival (PFS), and safety. Adverse events were summarized using descriptive statistics.Of 48 enrolled patients, with a median age of 7 years (4-14), 28 (58.3%) were histologically confirmed, and 25 (89.3%) had H3K27M mutations. With a median follow-up of 26.5 months (95% CI, 14.6-not applicable), the ORR was 37.5%; the median OS and PFS were 10.5 (8.3-11.2) and 7.8 (5.1-8.4) months; and 1-year OS and PFS rates were 33.3% and 26.9%, respectively. Multivariate analysis showed that a partial response and no steroid use were associated with favorable OS. Distant metastasis was observed in 7 patients (14.6%). The most common grade ≥ 3 treatment-related adverse events were leukopenia (27.1%), lymphopenia (27.1%), and neutropenia (25.0%).Adding nimotuzumab to chemoradiation therapy is feasible, with ORR and survival rates favorably comparable with previous data in pediatric DIPG, despite not meeting the prespecified statistical significance for improved ORR compared with historical data. The overall safety profile was manageable, with no new safety concerns.Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.

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出版当年[2025]版：

大类 | 1 区

医学

小类 | 2 区肿瘤学 2 区核医学

最新[2025]版：

大类 | 1 区

医学

小类 | 2 区肿瘤学 2 区核医学

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出版当年[2023]版：

Q1 ONCOLOGY Q1 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING

最新[2024]版：

Q1 ONCOLOGY Q1 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING

影响因子： 6.5 最新[2024版] 6.5 最新五年平均 6.4 出版当年[2023版] 6.1 出版当年五年平均 7 出版前一年[2022版] 6.5 出版后一年[2024版]

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第一作者机构： [1]Department of Radiation Oncology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.

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