Evidence map›Paper›PMID 25897826›Full record

Trial reportScientific reports2015

Recombinant mutated human TNF in combination with chemotherapy for stage IIIB/IV non-small cell lung cancer: a randomized, phase III study.

Xiaowen Ma, Yang Song, Kuo Zhang, Lei Shang, Yuan Gao, Wei Zhang, Xiaochang Xue, Huimin Jia, Jian Geng, Wei Zhou and 6 more

Erratum issuedOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Scientific reports, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.0field-weighted citation impact, top 22% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 10 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 6 institutions in 1 country.

Xiaowen MaState Key Laboratory of Cancer Biology, Biotechnology Center, School of Pharmacy, The Fourth Military Medical University, Xi'an, China.
Yang SongDepartment of Oncology, Tangdu Hospital, The Fourth Military Medical University, Xi'an, China.
Kuo ZhangState Key Laboratory of Cancer Biology, Biotechnology Center, School of Pharmacy, The Fourth Military Medical University, Xi'an, China.
Lei ShangDepartment of Health Statistics, School of Public Health, The Fourth Military Medical University, Xi'an, China.
Yuan GaoState Key Laboratory of Cancer Biology, Biotechnology Center, School of Pharmacy, The Fourth Military Medical University, Xi'an, China.
Wei ZhangState Key Laboratory of Cancer Biology, Biotechnology Center, School of Pharmacy, The Fourth Military Medical University, Xi'an, China.
Xiaochang XueState Key Laboratory of Cancer Biology, Biotechnology Center, School of Pharmacy, The Fourth Military Medical University, Xi'an, China.
Huimin JiaThe Affiliated Cancer Hospital of Xinjiang Medical University, Urumqi, China.
Jian GengDepartment of Medical Oncology, General Hospital of Nanjing Military Command, Medical School of Nanjing University, Nanjing, China.
Wei ZhouGeneral Hospital of Ningxia Medical University, Yinchuan, China.
Yazheng DangCancer Center, The 323 Hospital of People's Liberation Army, Xi'an, China.
Enxiao LiDepartment of Medical Oncology, First Affiliated Hospital of Medical College, Xi'an Jiaotong University, Xi'an, China.
Xinyu TiDepartment of Respiratory Medicine, Xijing Hospital, The Fourth Military Medical University, Xi'an, China.
Fulin FanNew Taihe Biopharmaceutical Co., Ltd., Guangzhou, China.
Yingqi ZhangState Key Laboratory of Cancer Biology, Biotechnology Center, School of Pharmacy, The Fourth Military Medical University, Xi'an, China.
Meng LiDepartment of Pharmacogenomics, School of Pharmacy, The Fourth Military Medical University, Xi'an, China.
Air Force Medical University · CNFirst Affiliated Hospital of Xi'an Jiaotong University · CNNanjing University · CNNingxia Medical University · CNXijing Hospital · CNXinjiang Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Tumor necrosis factor (TNF), an anti-angiogenic agent in cancer treatment, is limited to isolated limb perfusion due to systemic toxicities. We previously prepared a TNF mutant (rmhTNF) that significantly improved responses in lung cancer patients and exhibited a promising safety profile in phase I and II studies. To further investigate whether rmhTNF with standard chemotherapy provides a survival benefit, 529 patients with stage IIIB/IV non-small cell lung cancer (NSCLC) were randomly assigned to receive docetaxel plus carboplatin/cisplatin with rmhTNF (265) or chemotherapy alone (264). After four cycles of treatment, the median overall survival was 13.7 months in the chemotherapy plus rmhTNF group compared with 10.3 months in the chemotherapy group (hazard ratio (HR) 0.75, P = 0.001). The median progression-free survival in the chemotherapy plus rmhTNF group and the chemotherapy group was 8.6 and 4.5 months (HR 0.76, P = 0.001), respectively, with corresponding response rates of 38.5% and 27.7% (P = 0.008). Increased hyperpyrexia and pulmonary hemorrhage were associated with rmhTNF, but most effects were well tolerated. The results indicated that rmhTNF effectively potentiated chemotherapy in patients with advanced NSCLC and was comparable with bevacizumab, an angiogenesis inhibitor approved by the Food and Drug Administration (FDA) for NSCLC.

Indexed as

AdultAgedAngiogenesis InhibitorsAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Non-Small-Cell LungCisplatinDocetaxelDrug Administration ScheduleFemaleHumansLung NeoplasmsMaleMiddle AgedMutationNeoplasm StagingAngiogenesis InhibitorsCarboplatinCisplatinDocetaxelRecombinant ProteinsTaxoidsTNF protein, humanTumor Necrosis Factor-alpha

Identifiers

PMID25897826
PMCPMC4404801
OpenAlexW2047588463

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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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.