Evidence map›Paper›PMID 36188432›Full record

ArticleEClinicalMedicine2022

S-1/temozolomide versus S-1/temozolomide plus thalidomide in advanced pancreatic and non-pancreatic neuroendocrine tumours (STEM): A randomised, open-label, multicentre phase 2 trial.

Yihebali Chi, Lijie Song, Weili Liu, Yuhong Zhou, Yadong Miao, Weijia Fang, Huangying Tan, Susheng Shi, Hai Jiang, Jianming Xu and 15 more

2 registry-linked trialsAbstract read
In one paragraph

Article in EClinicalMedicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT03204019 phase2unknown statusnot on this map

A Phase II Randomized,Controlled,Open Label,Multicentre Study of Tegafur Combined With Temozolomide Versus Tegafur Combined With Temozolomide and Thalidomide in Subjects With Advanced Pancreatic Neuroendocrine Tumor

TypeinterventionalSponsorChinese Academy of Medical SciencesRan2016 to 2018Enrolled60ConditionsPancreatic Neuroendocrine TumorArmsTegafur and Temozolomide, Tegafur and Temozolomide combined with Thalidomide
NCT03204032 phase2unknown statusnot on this map

A Phase II Randomized,Controlled,Open Label,Multicentre Study of Tegafur Combined With Temozolomide Versus Tegafur Combined With Temozolomide and Thalidomide in Subjects With Advanced Extrapancreatic Neuroendocrine Tumor

TypeinterventionalSponsorChinese Academy of Medical SciencesRan2016 to 2018Enrolled60ConditionsExtrapancreatic Neuroendocrine TumorArmsTegafur, Temozolomide, Thalidomide
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Review
  6. Review
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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

25 authors.

Yihebali ChiDepartment of Medical Oncology, National Cancer Centre/National Clinical Research Centre for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Lijie SongDepartment of Oncology, The First Affiliated Hospital of Zhengzhou University, China.
Weili LiuDepartment of Medical Oncology, National Cancer Centre/National Clinical Research Centre for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Yuhong ZhouDepartment of Medical Oncology, Zhongshan Hospital, Fudan University, China.
Yadong MiaoChia Tai Tianqing Pharmarceutical Group Co., Ltd, China.
Weijia FangDepartment of Medical Oncology, The First Affiliated Hospital, Zhejiang University School of Medicine, & Key Laboratory of Cancer Prevention and Intervention, Ministry of Education, Hangzhou, China.
Huangying TanDepartment of Integrative Oncology, China-Japan Friendship Hospital, China.
Susheng ShiDepartment of Pathology, National Cancer Centre/National Clinical Research Centre for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Hai JiangXuanZhu (Beijing) Biopharmaceutical Co., Ltd, China.
Jianming XuSenior Department of Oncology, the Fifth Medical Centre of PLA General Hospital, China.
Ru JiaSenior Department of Oncology, the Fifth Medical Centre of PLA General Hospital, China.
Bo ZhengDepartment of Pathology, National Cancer Centre/National Clinical Research Centre for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Liming JiangDepartment of Radiology, National Cancer Centre/National Clinical Research Centre for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Jiuda ZhaoBreast Disease Diagnosis and Treatment Centre of Affiliated Hospital of Qinghai University & Affiliated Cancer Hospital of Qinghai University, China.
Rui ZhangDepartment of Colorectal Cancer, Liaoning Cancer Hospital & Institute, China.
Huijing TanDepartment of Medical Oncology, National Cancer Centre/National Clinical Research Centre for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Yuehua WangDepartment of Medical Oncology, National Cancer Centre/National Clinical Research Centre for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Qichen ChenDepartment of Hepatobiliary Surgery, State Key Laboratory of Molecular Oncology, National Cancer Centre/National Clinical Research Centre for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Minjie YangDepartment of Oncology, The First Affiliated Hospital of Zhengzhou University, China.
Xi GuoDepartment of Medical Oncology, Zhongshan Hospital, Fudan University, China.
Zhou TongDepartment of Medical Oncology, The First Affiliated Hospital, Zhejiang University School of Medicine, & Key Laboratory of Cancer Prevention and Intervention, Ministry of Education, Hangzhou, China.
Zhirong QiDepartment of Integrative Oncology, China-Japan Friendship Hospital, China.
Fuxing ZhaoBreast Disease Diagnosis and Treatment Centre of Affiliated Hospital of Qinghai University & Affiliated Cancer Hospital of Qinghai University, China.
Xiaofei YanDepartment of Colorectal Cancer, Liaoning Cancer Hospital & Institute, China.
Hong ZhaoDepartment of Hepatobiliary Surgery, State Key Laboratory of Molecular Oncology, National Cancer Centre/National Clinical Research Centre for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: There are currently limited systemic treatment options for patients with advanced neuroendocrine tumours (NETS) and the efficacy of existing treatments is sub-optimal. We evaluated the efficacy and safety of Tegafur/gimeracil/oteracil/potassium capsules (S-1)/Temozolomide with or without thalidomide for the treatment of NETS (STEM trial). Methods: A randomised, controlled, open-label, phase 2 trial conducted at eight hospitals in China. Adults (≥18 years) with unresectable/metastatic, pancreatic or non-pancreatic NETS, with an Eastern Cooperative Oncology Group (ECOG) PS of 0-1, and progression on ≤2 previous therapies were randomised (1:1, using hierarchical block randomization with block length 4, stratified by pancreatic/non-pancreatic disease to receive S-1 40-60 mg orally twice daily on days 1-14 plus temozolomide 200 mg orally daily on days 10-14 in a 21-day cycle OR S-1 and temozolomide plus thalidomide orally nightly (100 mg on days 1-7, 200 mg on days 8-14, and 300 mg from day 15), until disease progression, death, intolerable toxicity, withdrawal of informed consent or at the investigator's discretion. The primary endpoint was objective response rate (ORR) by RECIST 1.1 in an intention-to-treat population. Safety was assessed in all patients who received treatment. The study was registered at ClinicalTrials.gov: NCT03204019 (pancreatic group) and NCT03204032 (non-pancreatic group). Findings: Between March 23, 2017 and November 16, 2020, 187 patients were screened and 140 were randomly assigned to S-1/temozolomide plus thalidomide (n = 69) or S-1/temozolomide ( Interpretation: S-1/temozolomide with or without thalidomide leads to a comparable treatment response in patients with advanced/metastatic NETS. Funding: This work was supported by CAMS Innovation Fund for Medical Sciences (CIFMS,2021-I2M-1-066, 2017-I2M-4-002, 2021-I2M-1-019, 2017-I2M-1-001), the National Natural Science Foundation of China (81972311, 82141127, 31970794,), the State Key Project on Infection Diseases of China (2017ZX10201021-007-003), the Non-profit Central Research Institute Fund of Chinese Academy of Medical Sciences (2019PT310026), Sanming Project of Medicine in Shenzhen (SZSM202011010), and the State Key Laboratory Special fund from the Ministry of Science (2060204).

Indexed as

Neuroendocrine tumoursS-1TemozolomideThalidomide

Identifiers

PMID36188432
PMCPMC9520203

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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.