Evidence map›Paper›PMID 31888551›Full record

Trial reportBMC cancer2019

Administration of nimotuzumab combined with cisplatin plus 5-fluorouracil as induction therapy improves treatment response and tolerance in patients with locally advanced nasopharyngeal carcinoma receiving concurrent radiochemotherapy: a multicenter randomized controlled study.

Ying Lu, Dagui Chen, Jinhui Liang, Jianquan Gao, Zhanxiong Luo, Rensheng Wang, Wenqi Liu, Changjie Huang, Xuejian Ning, Meilian Liu and 1 more

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 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.

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

21 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  7. Efficacy of concurrent chemoradiotherapy combined with nimotuzumab in the treatment of nasopharyngeal carcinoma with cervical lymph node metastasis.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2023
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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

11 authors.

Ying LuDepartment of Oncology, the Fourth Affiliated Hospital of Guangxi Medical University, Liuzhou, China.
Dagui ChenDepartment of Oncology, the Fourth Affiliated Hospital of Guangxi Medical University, Liuzhou, China.
Jinhui LiangDepartment of Radiotherapy, Wuzhou Red Cross Hospital, Wuzhou, China.
Jianquan GaoDepartment of Radiotherapy, Wuzhou Red Cross Hospital, Wuzhou, China.
Zhanxiong LuoDepartment of Radiotherapy, Liuzhou People's Hospital, Liuzhou, China.
Rensheng WangDepartment of Radiotherapy, the First Affiliated Hospital of Guangxi Medical University, Nanning, China.
Wenqi LiuDepartment of Radiotherapy, the Second Affiliated Hospital of Guangxi Medical University, Nanning, China.
Changjie HuangDepartment of Oncology, the Second People's Hospital of Nanning, Nanning, China.
Xuejian NingDepartment of Oncology, Liuzhou Traditional Chinese Medical Hospital, Liuzhou, China.
Meilian LiuDepartment of Radiotherapy, the Affiliated Hospital of Guilin Medical College, Guilin, China.
Haixin HuangDepartment of Oncology, the Fourth Affiliated Hospital of Guangxi Medical University, Liuzhou, China. 13507726193@163.com.

Funding

Department of Health of Guangxi Zhuang Autonomous Region Self-raised Funds Project Z20170895Liuzhou City Science and technology research projects 2015J030512
6 · The paper itself

Abstract

backgroundNimotuzumab (NTZ) is an anti-EGFR monoclonal antibody. However,the effect of targeted drugs combined with induction therapy in locally advanced nasopharyngeal carcinoma remains unclear. The aim of this study is to investigate the safety and efficacy of NTZ combined with cisplatin plus 5-fluorouracil (PF) as induction regimen in locally advanced nasopharyngeal carcinoma (NPC) patients receiving concurrent radiochemotherapy.

methodsThis was a multicenter randomized controlled study performed in eight Guangxi hospitals in 2015-2017. Eligible patients with NPC were randomized into nimotuzumab/PF (NPF group) and docetaxel/PF (DPF group) regimens, respectively, as induction therapy. After 2 cycles of induction therapy, all patients received cisplatin and concurrent intensity modulated radiation therapy (IMRT). Then, the two groups were compared for safety and efficacy.

resultsA total of 118 patients with stage III-IVa NPC were assessed, with 58 and 60 in the NPF and DPF groups, respectively. Compared with DPF treatment, NPF induction therapy showed a more pronounced effect on cervical lymph nodes (P = 0.036), with higher response rate (RR) (81% vs 60%). Compared with the DPF group, the NPF group showed significantly reduced leukopenia, neutropenia and gastrointestinal reactions (all P < 0.05); rash only appeared in the NPF group, but all cases were grade 1. During concurrent treatment with radiotherapy and chemotherapy, the NPF group showed better tolerance to radiotherapy and chemotherapy; neutropenia, anemia, gastrointestinal reactions, oral mucositis and radiation dermatitis in the NPF group were significantly reduced (P < 0.05). The expression rate of EGFR was 94.9% (112/118). Compared with the DPF group, patients with EGFR expression in the NPF group showed better response (77.8% vs 63.0%, P = 0.033).

conclusionFor locally advanced NPC patients receiving follow-up cisplatin and IMRT, nimotuzumab/PF for induction therapy has better lymph node response rate and milder adverse reactions than the DPF regimen. In addition, the patients have better tolerance in subsequent concurrent radiotherapy and chemotherapy; however, long-term efficacy needs further follow-up evaluation.

trial registrationThe registration number of the clinical trial is ChiCTR-OIC-16008201 and retrospectively registered on March 31, 2016.

Indexed as

AdolescentAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsChemoradiotherapyCisplatinDocetaxelDrug ToleranceFemaleFluorouracilHumansInduction ChemotherapyLymphatic MetastasisMaleMiddle AgedAntibodies, Monoclonal, HumanizedCisplatinDocetaxelFluorouracilnimotuzumabAdverse reactionCurative effectEGFR monoclonal antibodyInduction therapyLocally advanced nasopharyngeal carcinoma

Identifiers

PMID31888551
PMCPMC6937916

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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.