Evidence map›Paper›PMID 28911070›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2017

Induction TPF followed by concomitant treatment versus concomitant treatment alone in locally advanced head and neck cancer. A phase II-III trial.

M G Ghi, A Paccagnella, D Ferrari, P Foa, D Alterio, C Codecà, F Nolè, E Verri, R Orecchia, F Morelli and 28 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2017. 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 90 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
90citing papers in PubMed, 5 pooled it
17.8field-weighted citation impact, top 1% 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.

NCT01086826 phase3completednot on this map

Neoadjuvant Docetaxel+Cisplatin and 5-fluorouracil (TPF) Followed by Radiotherapy+Concomitant Chemo or Cetuximab Versus Radiotherapy+Concomitant Chemo or Cetuximab in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck. A Randomized Phase III Factorial Study.

TypeinterventionalSponsorAssociazione Volontari Pazienti OncologiciRan2008 to 2014Enrolled320ConditionsHead and Neck Squamous Cell CarcinomaArmsRT+CDDP/5-FU, RT+CETUXIMAB, INDUCTION CTx(TPF)+(RT+CDDP/5-FU), INDUCTION CTx(TPF)+(RT+CETUXIMAB)
NCT05527782 phase2active not recruitingnot on this mapstarted 2019, after this paper: background citation

A Phase II Study of Efficacy and Safety of Induction Modified TPF (mTPF) Followed by Concurrent Chemoradiotherapy (CCRT) in Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LASCCHN)

TypeinterventionalSponsorHospital Universitario Doctor PesetRan2019 to 2025Enrolled40ConditionsLocally Advanced Head and Neck Squamous Cell CarcinomaArmsmodified TPF, Quality of life assessment (QoL)
3 · Its place in the literature

Who cites it

90 citing papers in PubMed, 5 syntheses or guidelines pooled it, 201 citations in OpenAlex.

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  4. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): An update on 107 randomized trials and 19,805 patients, on behalf of MACH-NC Group.Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2021
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30 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

38 authors at 16 institutions in 1 country.

M G GhiMedical Oncology Department, Ospedale dell'Angelo, Venezia.
A PaccagnellaMedical Oncology Department, Ospedale dell'Angelo, Venezia.
D FerrariMedical Oncology Unit, Ospedale San Paolo, Milano.
P FoaMedical Oncology Unit, Ospedale San Paolo, Milano.
D AlterioAdvanced Radiotherapy Center.
C CodecàMedical Oncology Unit, Ospedale San Paolo, Milano.
F NolèUnit of Urogenital and Head and Neck Oncology, Istituto Europeo di Oncologia, Milano.
E VerriUnit of Urogenital and Head and Neck Oncology, Istituto Europeo di Oncologia, Milano.
R OrecchiaAdvanced Radiotherapy Center.
F MorelliU.O.C. Medical Oncology.
S ParisiU.O.C. Radiation Oncology, IRCCS Casa Sollievo della Sofferenza, San Giovanni, Rotondo.
C MastromauroMedical Oncology Department, Ospedale dell'Angelo, Venezia.
C A MioneRadiotherapy Department, Ospedale SS Giovanni e Paolo, Venezia.
C RossettoMedical Oncology Department.
M PolsinelliS.O.C. Radiation Oncology, Azienda Ospedaliero-Universitaria S.Maria della Misericordia, Udine.
H KoussisMedical Oncology Department 2, Istituto Oncologico Veneto- IRCCS, Padova.
L LoreggianRadiotherapy Department, Istituto Oncologico Veneto - IRCCS, Padova.
A BonettiMedical Oncology Department, Ospedale Mater Salutis, Legnago.
F CampostriniRadiotherapy Department, Ospedale Mater Salutis, Legnago.
G AzzarelloOncology Unit, Department of Internal Medical Sciences, Mirano.
C D'AmbrosioMedical Oncology Department.
F BertoniRadiotherapy Department, Azienda Ospedaliero Universitaria, Modena.
C CasanovaMedical Oncology Department.
E EmilianiRadiotherapy Department, Azienda USL, Ravenna.
M GuaraldiMedical Oncology Department, Policlinico Sant'Orsola-Malpighi, Bologna.
F BunkheilaRadiotherapy Department, Policlinico Sant'Orsola-Malpighi, Bologna.
P BidoliMedical Oncology Department, Ospedale San Gerardo, Monza.
R M NiespoloRadiotherapy Department, Ospedale San Gerardo, Monza, Ospedale San Gerardo, Monza.
A GavaRadiotherapy Department, Ospedale Ca' Foncello, Treviso.
E MassaDepartment of Medical Science, Università degli Studi di Cagliari, Cagliari.
A FrattegianiRadiation Oncology Department, Ospedale S. Maria della Misericordia, Perugia.
F ValdugaMedical Oncology Department, Ospedale S. Chiara, Trento.
G PieriMedical Oncology Department, AO Triestina, Trieste.
T CipaniNiguarda Cancer Center, Ospedale Niguarda Cà Granda, Milano.
D Da CorteOncology Department, Ospedale S. Martino, Belluno.
F ChiappaLaboratory of Clinical Research, Istituto di Ricerche Farmacologiche "Mario Negri," Milano, Italy.
E RulliLaboratory of Clinical Research, Istituto di Ricerche Farmacologiche "Mario Negri," Milano, Italy.
GSTTC (Gruppo di Studio Tumori della Testa e del Collo) Italian Study Group
Ospedale dell' Angelo · ITAzienda Ospedaliera San Gerardo · ITEuropean Institute of Oncology · ITIRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola · ITIstituto Oncologico Veneto · ITMario Negri Institute for Pharmacological Research · ITAzienda Sanitaria Universitaria Integrata di Trieste · ITAzienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda · ITCa' Foncello Hospital · ITCasa Sollievo della Sofferenza · ITOspedale Civile di Venezia · ITOspedale Martini · ITOspedale Santa Chiara · ITOspedale Santa Maria · ITOspedale Santa Maria della Misericordia di Udine · ITUniversity of Cagliari · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPlatinum-based chemoradiation (CCRT) is the standard treatment for Locally Advanced Head and Neck Squamous-Cell Carcinoma (LAHNSCC). Cetuximab/RT (CET/RT) is an alternative treatment option to CCRT. The efficacy of induction chemotherapy (IC) followed by chemoradiation compared to chemoradiation alone has not been demonstrated in randomized clinical trials. The goals of this phase II-III trial were to assess: (i) the overall survival (OS) of IC versus no-induction (no-IC) and (ii) the Grade 3-4 in-field mucosal toxicity of CCRT versus CET/RT. The present paper focuses on the analysis of efficacy. MATERIALS AND

methodsPatients with LAHNSCC were randomized to receive concomitant treatment alone [CCRT (Arm A1) or CET/RT (Arm A2)], or three cycles of induction docetaxel/cisplatin/5 fluorouracil (TPF) followed by CCRT (Arm B1) or followed by CET/RT (Arm B2). The superiority hypothesis of OS comparison of IC versus no-IC (Arms B1 + B2 versus A1 + A2) required 204 deaths to detect an absolute 3-year OS difference of 12% (HR 0.675, with 80% power at two-sided 5% significance level).

results414 out of 421 patients were finally analyzed: 206 in the IC and 208 in the no-IC arm. Six patients were excluded because of major violation and one because of metastatic disease at diagnosis. With a median follow-up of 44.8 months, OS was significantly higher in the IC arm (HR 0.74; 95% CI 0.56-0.97; P = 0.031). Complete Responses (P = 0.0028), Progression Free Survival (P = 0.013) and the Loco-regional Control (P = 0.036) were also significantly higher in the IC arm. Compliance to concomitant treatments was not affected by induction TPF.

conclusionsIC followed by concomitant treatment improved the outcome of patients with LAHNSCC without compromising compliance to the concomitant treatments. The degree of the benefit of IC could be different according to the type of the subsequent concomitant strategy. CLINICAL TRIAL NUMBER: NCT01086826, www.clinicaltrials.gov.

Indexed as

Induction ChemotherapyAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellChemoradiotherapyCisplatinFemaleFluorouracilHead and Neck NeoplasmsHumansMaleMiddle AgedSquamous Cell Carcinoma of Head and NeckSurvival AnalysisCisplatinFluorouracilTaxoidsconcomitant chemoradiotherapyhead and neck cancerinduction chemotherapy

Identifiers

PMID28911070
OpenAlexW2734196292

What OpenQuestion holds

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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.