Evidence map›Paper›PMID 22194030›Full record

Trial reportStrahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al]2012

Prospective phase II trial of cetuximab plus VMAT-SIB in locally advanced head and neck squamous cell carcinoma. Feasibility and tolerability in elderly and chemotherapy-ineligible patients.

F Alongi, M Bignardi, I Garassino, S Pentimalli, R Cavina, P Mancosu, G Reggiori, A Poletti, D Ferrari, P Foa and 8 more

Abstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al], 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
–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

17 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Carboplatin/Paclitaxel can be an effective alternative for cisplatin-ineligible patients with locally advanced HNSCC.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2026
    Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. IMRT/VMAT for malignancies in the head-and-neck region : Outcome in patients aged 80.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2016
    Article
  9. Unilateral and bilateral neck SIB for head and neck cancer patients : Intensity-modulated proton therapy, tomotherapy, and RapidArc.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2016
    Article
  10. Article
  11. Article
  12. Significance of p16 expression in head and neck cancer patients treated with radiotherapy and cetuximab.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2014
    Article
  13. Article
  14. Article
  15. Cellular and molecular properties of (90)Y-labeled cetuximab in combination with radiotherapy on human tumor cells in vitro.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2012
    Article
  16. Squamous cell carcinoma of the head and neck in the elderly.Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2012
    Review
  17. Article
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

18 authors.

F AlongiRadiotherapy and Radiosurgery, Humanitas Cancer Center, Istituto Clinico Humanitas, Via Manzoni 56, 20098, Rozzano (Milan), Italy. filippo.alongi@humanitas.it
M Bignardi
I Garassino
S Pentimalli
R Cavina
P Mancosu
G Reggiori
A Poletti
D Ferrari
P Foa
A Bigoni
A Dragonetti
P Salvatori
O Spahiu
A Fogliata
L Cozzi
A Santoro
M Scorsetti

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCetuximab plus radiotherapy (RT) may be an effective alternative to chemoradiation in locally advanced head and neck squamous cell carcinoma (LASCCHN) patients. We analyzed a group of patients treated at our institute with cetuximab plus volumetric modulation arc therapy (VMAT) with the RapidArc technique in a simultaneous integrated boost (SIB) regime. The primary end point was the assessment of acute toxicity and the feasibility of the combined approach. MATERIALS AND

methodsBetween December 2008 and March 2010, 22 patients were submitted to IMRT-SIB plus cetuximab for radical intent in case of LASCCHN. None of the patients was suitable for chemotherapy because of important comorbidities (the majority suffered of heart chronic diseases). All patients underwent planning CT (additional image modalities were acquired for contouring purposes in the same treatment position: MRI in 12 and FDG-PET in 4 out of 22 patients). VMAT, by means of RapidArc, and SIB with two dose levels of 54.45 Gy and 69.96 Gy in 33 fractions were adopted. All patients included in the analysis were concomitantly treated with cetuximab: administration of the drug was initiated 1 week before RT at a loading dose of 400 mg/m(2) body surface area over a period of 120 min, follow by a weekly 60 min infusion of 250 mg/m(2) for the duration of RT. Patients were assessed for toxicities according to the Radiation Therapy Oncology Group (RTOG) criteria.

resultsAll but 2 patients completed treatment and achieved the minimum follow-up of 12 months after the end of the treatment. Of the 22 patients, 18% (4 patients) showed grade 1, 36% (8 patients) grade 2, and 36% (8 patients) showed grade 3 dermatitis, while 9% (2 patients) had grade 1, 36% (8 patients) grade 2, and 45% (10 patients) had grade 3 mucositis/stomatitis. No grade 4 toxicities were recorded. Considering blood parameters, 3 cases of grade 1 anemia and 1 case of grade 2 thrombocytopenia were observed. Nobody required feeding tube placement during treatment.

conclusionThe here reported toxicity data are promising and encouraging in regard to the adoption of moderate hypofractionation with VMAT-SIB techniques, when cetuximab is concomitantly administered.

Indexed as

AgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsCarcinoma, Squamous CellCetuximabChemoradiotherapyDose Fractionation, RadiationFeasibility StudiesFemaleHumansMaleMiddle AgedNeoplasm InvasivenessNeoplasm StagingAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsCetuximab

Identifiers

What OpenQuestion holds

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Registered trials

None linked

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.