Evidence map›Paper›PMID 32939054›Full record

Trial reportBritish journal of cancer2020

Prognostic and predictive significance of nuclear HIF1α expression in locally advanced HNSCC patients treated with chemoradiation with or without nimotuzumab.

Usha Patel, Manish Pandey, Sadhana Kannan, Tanuja A Samant, Poonam Gera, Neha Mittal, Swapnil Rane, Asawari Patil, Vanita Noronha, Amit Joshi and 3 more

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in British journal of cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.2field-weighted citation impact, top 23% 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, 20 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

13 authors at 2 institutions in 1 country.

Usha PatelMahimkar Lab, Cancer Research Institute, Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre, Navi Mumbai, Maharashtra, India.
Manish PandeyMahimkar Lab, Cancer Research Institute, Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre, Navi Mumbai, Maharashtra, India.
Sadhana KannanHomi Bhabha National Institute, Training School Complex, Anushakti Nagar, Mumbai, Maharashtra, India.
Tanuja A SamantMahimkar Lab, Cancer Research Institute, Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre, Navi Mumbai, Maharashtra, India.
Poonam GeraHomi Bhabha National Institute, Training School Complex, Anushakti Nagar, Mumbai, Maharashtra, India.
Neha MittalHomi Bhabha National Institute, Training School Complex, Anushakti Nagar, Mumbai, Maharashtra, India.
Swapnil RaneHomi Bhabha National Institute, Training School Complex, Anushakti Nagar, Mumbai, Maharashtra, India.
Asawari PatilHomi Bhabha National Institute, Training School Complex, Anushakti Nagar, Mumbai, Maharashtra, India.
Vanita NoronhaHomi Bhabha National Institute, Training School Complex, Anushakti Nagar, Mumbai, Maharashtra, India.
Amit JoshiHomi Bhabha National Institute, Training School Complex, Anushakti Nagar, Mumbai, Maharashtra, India.
Vijay M PatilHomi Bhabha National Institute, Training School Complex, Anushakti Nagar, Mumbai, Maharashtra, India.
Kumar PrabhashHomi Bhabha National Institute, Training School Complex, Anushakti Nagar, Mumbai, Maharashtra, India.
Manoj B MahimkarMahimkar Lab, Cancer Research Institute, Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre, Navi Mumbai, Maharashtra, India. mmahimkar@actrec.gov.in.ORCID http://orcid.org/0000-0003-4098-0157
Homi Bhabha National Institute · INTata Memorial Hospital · IN

Funding

Council of Scientific and Industrial Research (CSIR) 09/513(0099)/2014-EMR-IDAE | TMC | Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre (Advanced Centre for Treatment, Research and Education in Cancer) TMC/SIA/2696DST | Science and Engineering Research Board (SERB) EMR/2015/001591
6 · The paper itself

Abstract

backgroundAnti-EGFR-based therapies have limited success in HNSCC patients. Predictive biomarkers are greatly needed to identify the patients likely to be benefited from these targeted therapies. Here, we present the prognostic and predictive association of biomarkers in HPV-negative locally advanced (LA) HNSCC patients.

methodsTreatment-naive tumour tissue samples of 404 patients, a subset of randomised Phase 3 trial comparing cisplatin radiation (CRT) versus nimotuzumab plus cisplatin radiation (NCRT) were analysed to evaluate the expression of HIF1α, EGFR and pEGFR by immunohistochemistry and EGFR gene copy change by FISH. Progression-free survival (PFS), locoregional control (LRC) and overall survival (OS) were estimated by Kaplan-Meier method. Hazard ratios were estimated by Cox proportional hazard models.

resultsBaseline characteristics of the patients were balanced between two treatment groups (CRT vs NCRT) and were representative of the trial cohort. The median follow-up was of 39.13 months. Low HIF1α was associated with better PFS [HR (95% CI) = 0.62 (0.42-0.93)], LRC [HR (95% CI) = 0.56 (0.37-0.86)] and OS [HR (95% CI) = 0.63 (0.43-0.93)] in the CRT group. Multivariable analysis revealed HIF1α as an independent negative prognostic biomarker. For patients with high HIF1α, NCRT significantly improved the outcomes [PFS:HR (95% CI) = 0.55 (0.37-0.82), LRC:HR (95% CI) = 0.55 (0.36-0.85) and OS:HR (95% CI) = 0.54 (0.36-0.81)] compared to CRT. While in patients with low HIF1α, no difference in the clinical outcomes was observed between treatments. Interaction test suggested a predictive value of HIF1α for OS (P = 0.008).

conclusionsHigh HIF1α expression is a predictor of poor clinical response to CRT in HPV-negative LA-HNSCC patients. These patients with high HIF1α significantly benefited with the addition of nimotuzumab to CRT. CLINICAL

trial registrationRegistered with the Clinical Trial Registry of India (Trial registration identifier-CTRI/2014/09/004980).

Indexed as

AdultAgedAlphapapillomavirusAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalBiomarkers, TumorCell NucleusChemoradiotherapyCisplatinErbB ReceptorsFemaleGene DosageHead and Neck NeoplasmsHumansHypoxia-Inducible Factor 1, alpha SubunitKaplan-Meier EstimateAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalBiomarkers, TumorCisplatinErbB ReceptorsHIF1A protein, humanHypoxia-Inducible Factor 1, alpha SubunitnimotuzumabRadiation-Sensitizing Agents

Identifiers

PMID32939054
PMCPMC7722894
OpenAlexW3087184775

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.