Evidence map›Paper›PMID 36705923›Full record

Trial reportJAMA network open2023

Adjuvant Temozolomide Chemotherapy With or Without Interferon Alfa Among Patients With Newly Diagnosed High-grade Gliomas: A Randomized Clinical Trial.

Chengcheng Guo, Qunying Yang, Pengfei Xu, Meiling Deng, Taipeng Jiang, Linbo Cai, Jibin Li, Ke Sai, Shaoyan Xi, Hui Ouyang and 34 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in JAMA network open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01765088 (A Phase III Trial on Adjuvant Standard Temozolomide Chemotherapy With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas), which is not on this map. Cited by 29 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 4 pooled it
8.3field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01765088 phase3unknown statusnot on this map

A Phase III Trial on Adjuvant Standard Temozolomide Chemotherapy With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas

TypeinterventionalSponsorSun Yat-sen UniversityRan2012 to 2019Enrolled300ConditionsAnaplastic Oligoastrocytoma, Anaplastic Astrocytoma, GlioblastomaArmsTemozolomide, α-IFN
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 4 syntheses or guidelines pooled it, 29 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

44 authors at 16 institutions in 1 country.

Chengcheng GuoDepartment of Neurosurgery and Neuro-oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
Qunying YangDepartment of Neurosurgery and Neuro-oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
Pengfei XuDepartment of Neurosurgery and Neuro-oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
Meiling DengDepartment of Radiation, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
Taipeng JiangDepartment of Neurosurgery, The First Affiliated Hospital of Shenzhen University, Shenzhen Second People's Hospital, Shenzhen, China.
Linbo CaiDepartment of Neuro-oncology, Guangdong Sanjiu Brain Hospital, Guangzhou, China.
Jibin LiDepartment of Clinical Research, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
Ke SaiDepartment of Neurosurgery and Neuro-oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
Shaoyan XiDepartment of Pathology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
Hui OuyangDepartment of Neurosurgery, Guangdong Sanjiu Brain Hospital, Guangzhou, China.
Mingfa LiuDepartment of Neurosurgery, Shantou Central Hospital, Shantou, China.
Xianming LiDepartment of Radiation Oncology, Shenzhen People's Hospital, The Second Clinical Medical College, Jinan University, Shenzhen, Guangdong, China.
Zihuang LiDepartment of Radiation Oncology, Shenzhen People's Hospital, The Second Clinical Medical College, Jinan University, Shenzhen, Guangdong, China.
Xiangrong NiDepartment of Neurosurgery and Neuro-oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
Xi CaoDepartment of Neurosurgery and Neuro-oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
Cong LiDepartment of Neurosurgery, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
Shaoxiong WuDepartment of Radiation, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
Xiaojing DuDepartment of Radiation, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
Jun SuDepartment of Neurosurgery, Tumor Hospital of Harbin Medical University, Harbin, China.
Xiaoying XueDepartment of Radiotherapy, The Second Hospital of Hebei Medical University, Shijiazhuang, China.
Yiming WangDepartment of Medical Oncology, The First Affiliated Hospital, Jinan University, Guangzhou, China.
Gang LiDepartment of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.
Zhiyong QinDepartment of Neurosurgery, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China.
Hui YangDepartment of Neurosurgery, Xinqiao Hospital, Third Military Medical University, Chongqing, China.
Tao ZhouDepartment of Oncology, Guangdong Armed Police Corps Hospital, Guangzhou, China.
Jinquan LiuDepartment of Radiation Oncology, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, China.
Xuefeng HuDepartment of Radiation Oncology, First People's Hospital of Fo Shan Affiliated with Sun Yat-Sen University, Foshan, China.
Jian WangDepartment of Neurosurgery and Neuro-oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
Xiaobing JiangDepartment of Neurosurgery and Neuro-oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
Fuhua LinDepartment of Neurosurgery and Neuro-oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
Xiangheng ZhangDepartment of Neurosurgery and Neuro-oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
Chao KeDepartment of Neurosurgery and Neuro-oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
Xiaofei LvDepartment of Medical Imaging, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
Yanchun LvDepartment of Medical Imaging, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
Wanming HuDepartment of Pathology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
Jing ZengDepartment of Pathology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
Zhenghe ChenDepartment of Neurosurgery and Neuro-oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
Sheng ZhongDepartment of Neurosurgery and Neuro-oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
Hairong WangDepartment of Neurosurgery and Neuro-oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
Yinsheng ChenDepartment of Neurosurgery and Neuro-oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
Ji ZhangDepartment of Neurosurgery and Neuro-oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
Depei LiDepartment of Neurosurgery and Neuro-oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
Yonggao MouDepartment of Neurosurgery and Neuro-oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
Zhongping ChenDepartment of Neurosurgery and Neuro-oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
Sun Yat-sen University · CNSun Yat-sen University Cancer Center · CNState Key Laboratory of Oncology in South ChinaGuangdong 999 Brain Hospital · CNShenzhen Second People's Hospital · CNAir Force Medical University · CNFirst Affiliated Hospital of Jinan University · CNFirst People's Hospital of Foshan · CNGuangzhou Medical University · CNGuangzhou University of Chinese Medicine · CNHebei Medical University · CNHuashan Hospital · CNShantou Central Hospital · CNSouthern University of Science and Technology · CNThird Affiliated Hospital of Harbin Medical University · CNXinqiao Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Importance: High-grade gliomas (HGGs) constitute the most common and aggressive primary brain tumor, with 5-year survival rates of 30.9% for grade 3 gliomas and 6.6% for grade 4 gliomas. The add-on efficacy of interferon alfa is unclear for the treatment of HGG. Objectives: To compare the therapeutic efficacy and toxic effects of the combination of temozolomide and interferon alfa and temozolomide alone in patients with newly diagnosed HGG. Design, Setting, and Participants: This multicenter, randomized, phase 3 clinical trial enrolled 199 patients with newly diagnosed HGG from May 1, 2012, to March 30, 2016, at 15 Chinese medical centers. Follow-up was completed July 31, 2021, and data were analyzed from September 13 to November 24, 2021. Eligible patients were aged 18 to 75 years with newly diagnosed and histologically confirmed HGG and had received no prior chemotherapy, radiotherapy, or immunotherapy for their HGG. Interventions: All patients received standard radiotherapy concurrent with temozolomide. After a 4-week break, patients in the temozolomide with interferon alfa group received standard temozolomide combined with interferon alfa every 28 days. Patients in the temozolomide group received standard temozolomide. Main Outcomes and Measures: The primary end point was 2-year overall survival (OS). Secondary end points were 2-year progression-free survival (PFS) and treatment tolerability. Results: A total of 199 patients with HGG were enrolled, with a median follow-up time of 66.0 (95% CI, 59.1-72.9) months. Seventy-nine patients (39.7%) were women and 120 (60.3%) were men, with ages ranging from 18 to 75 years and a median age of 46.9 (95% CI, 45.3-48.7) years. The median OS of patients in the temozolomide plus interferon alfa group (26.7 [95% CI, 21.6-31.7] months) was significantly longer than that in the standard group (18.8 [95% CI, 16.9-20.7] months; hazard ratio [HR], 0.64 [95% CI, 0.47-0.88]; P = .005). Temozolomide plus interferon alfa also significantly improved median OS in patients with O6-methylguanine-DNA methyltransferase (MGMT) unmethylation (24.7 [95% CI, 20.5-28.8] months) compared with temozolomide (17.4 [95% CI, 14.1-20.7] months; HR, 0.57 [95% CI, 0.37-0.87]; P = .008). Seizure and influenzalike symptoms were more common in the temozolomide plus interferon alfa group, with 2 of 100 (2.0%) and 5 of 100 (5.0%) patients with grades 1 and 2 toxic effects, respectively (P = .02). Finally, results suggested that methylation level at the IFNAR1/2 promoter was a marker of sensitivity to temozolomide plus interferon alfa. Conclusions and Relevance: Compared with the standard regimen, temozolomide plus interferon alfa treatment could prolong the survival time of patients with HGG, especially the MGMT promoter unmethylation variant, and the toxic effects remained tolerable. Trial Registration: ClinicalTrials.gov Identifier: NCT01765088.

Indexed as

Brain NeoplasmsGliomaAdolescentAdultAgedAntineoplastic Agents, AlkylatingDacarbazineFemaleHumansInterferon-alphaMaleMiddle AgedTemozolomideYoung AdultAntineoplastic Agents, AlkylatingDacarbazineInterferon-alphaTemozolomide

Identifiers

PMID36705923
PMCPMC11839150
OpenAlexW4318264012

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.