Evidence map›Paper›PMID 32873270›Full record

Trial reportBMC cancer2020

Dose-dense TPF induction chemotherapy for locally advanced head and neck cancer: a phase II study.

Ching-Yun Hsieh, Ming-Yuh Lein, Shih-Neng Yang, Yao-Ching Wang, Yin-Jun Lin, Chen-Yuan Lin, Chun-Hung Hua, Ming-Hsul Tsai, Ching-Chan Lin

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04397341 (A Phase II Study of Biweekly Induction Regimen With Docetaxel, Cisplatin and Fluorouracil for Patients With Locally Advanced Squamous Cell Carcinoma of Head and Neck), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 10% 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.

NCT04397341 phase2completednot on this map

A Phase II Study of Biweekly Induction Regimen With Docetaxel, Cisplatin and Fluorouracil for Patients With Locally Advanced Squamous Cell Carcinoma of Head and Neck

TypeinterventionalSponsorChina Medical University HospitalRan2014 to 2019Enrolled58ConditionsLocally Advanced Head and Neck CarcinomaArmsdocetaxel, cisplatin, fluorouracil
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

  1. Pooled it
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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

9 authors at 1 institution in 1 country.

Ching-Yun HsiehDivision of Hematology and Oncology, Department of internal medicine, China Medical University Hospital, China Medical University, 2 Yude Rd, North District, Taichung, 404, Taiwan.
Ming-Yuh LeinDivision of Hematology and Oncology, Department of internal medicine, China Medical University Hospital, China Medical University, 2 Yude Rd, North District, Taichung, 404, Taiwan.
Shih-Neng YangDivision of Radiation Oncology, China Medical University Hospital, China Medical University, Taichung, 404, Taiwan.
Yao-Ching WangDivision of Radiation Oncology, China Medical University Hospital, China Medical University, Taichung, 404, Taiwan.
Yin-Jun LinDivision of Radiation Oncology, China Medical University Hospital, China Medical University, Taichung, 404, Taiwan.
Chen-Yuan LinDivision of Hematology and Oncology, Department of internal medicine, China Medical University Hospital, China Medical University, 2 Yude Rd, North District, Taichung, 404, Taiwan.
Chun-Hung HuaDepartment of Otorhinolaryngology, China Medical University Hospital, China Medical University, Taichung, 404, Taiwan.
Ming-Hsul TsaiDepartment of Otorhinolaryngology, China Medical University Hospital, China Medical University, Taichung, 404, Taiwan.
Ching-Chan LinDivision of Hematology and Oncology, Department of internal medicine, China Medical University Hospital, China Medical University, 2 Yude Rd, North District, Taichung, 404, Taiwan. linchin13256@gmail.com.ORCID http://orcid.org/0000-0002-2712-6389
China Medical University · TW

Funding

China Medical University DMR-108-BC-6National Health Research Institutes NHRI-180A1- CACO-13191902
6 · The paper itself

Abstract

backgroundPhase 3 studies suggest that induction chemotherapy (ICT) of cisplatin and 5-fluorouracil plus docetaxel (TPF) is effective but toxic for patients with squamous-cell carcinoma of the head and neck (SCCHN). Dose-dense chemotherapy may yield favorable outcomes compared with standard-dose chemotherapy, yet the optimal induction regimen remains undefined. We assessed the efficacy and tolerability of biweekly dose-dense TPF ICT in patients with SCCHN.

methodsIn this prospective phase II study, We enrolled patients with stage III/IV (AJCC 7th edition) unresectable squamous cell carcinoma of head and neck cancer. Patients received dose-dense TPF (ddTPF) with cisplatin and docetaxel 50 mg/m2 on day 1, leucovorin 250 mg/m2 on day1, followed by 48-h continuous infusion of 2500 mg/m2 of 5-fluorouracil on day 1 and 2, every 2 weeks for 6 cycles followed by radiotherapy. The primary endpoint was the response rate (RR) after ICT.

resultsFifty-eight patients were enrolled from June 2014 to September 2015. Overall RR after ICT was 89.6% [complete response (CR), 31%; partial response (PR), 58.6%]. Grade 3/4 neutropenia, mucositis, and diarrhea incidences were 25.9, 1.7, and 1.7%, respectively. 94.8% of patients completed all treatment courses of ICT without dose reduction. The 3-year overall survival (OS) was 54.3% (95%CI: 39.7 to 66.8%) and progression-free survival (PFS) was 34.3% (95%CI: 22.0 to 46.9%). Multivariate analysis showed that CR after ICT is an independent prognostic factor for OS and PFS.

conclusionsSix cycles of ddTPF is an active, well-tolerated induction regimen for patients with SCCHN. The presence of CR after ICT predicted long-term survival.

trial registrationClinicalTrials.gov Identifier: NCT04397341 , May 21, 2020, retrospectively registered.

Indexed as

AdultAgedAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsCisplatinCombined Modality TherapyDocetaxelFemaleFluorouracilHead and Neck NeoplasmsHumansInduction ChemotherapyLeucovorinMaleMiddle AgedProgression-Free SurvivalAntimetabolites, AntineoplasticCisplatinDocetaxelFluorouracilLeucovorinCisplatinDocetaxelDose-dense chemotherapyFluorouracilHead and neck cancerInduction chemotherapy

Identifiers

PMID32873270
PMCPMC7465725
OpenAlexW3082694009

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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.