Evidence map›Paper›PMID 28592616›Full record

Trial reportThe oncologist2017

Multicenter Phase II Study of Panitumumab in Platinum Pretreated, Advanced Head and Neck Squamous Cell Cancer.

Marco Siano, Francesca Molinari, Vittoria Martin, Nicolas Mach, Martin Früh, Stefania Freguia, Irene Corradino, Michele Ghielmini, Milo Frattini, Vittoria Espeli

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in The oncologist, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
3.5field-weighted citation impact, top 7% 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

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Review
  6. Review
  7. Review
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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

10 authors at 5 institutions in 1 country.

Marco SianoDepartment of Medical Oncology and Hematology, Cantonal Hospital St. Gallen, St. Gallen, Switzerland marco.siano@kssg.ch.
Francesca MolinariInstitute of Pathology, Laboratory of Molecular Pathology, Locarno, Switzerland.
Vittoria MartinInstitute of Pathology, Laboratory of Molecular Pathology, Locarno, Switzerland.
Nicolas MachClinical Research Unit of the Dr. Henri Dubois-Ferrière, University Hospital, Geneva, Switzerland.
Martin FrühDepartment of Medical Oncology and Hematology, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.
Stefania FreguiaInstitute of Pathology, Laboratory of Molecular Pathology, Locarno, Switzerland.
Irene CorradinoClinical Trial Unit, Ente Ospedaliero Cantonale, Bellinzona, Switzerland.
Michele GhielminiOncology Institute of Southern Switzerland, San Giovanni Hospital, Bellinzona, Switzerland.
Milo FrattiniInstitute of Pathology, Laboratory of Molecular Pathology, Locarno, Switzerland.
Vittoria EspeliOncology Institute of Southern Switzerland, San Giovanni Hospital, Bellinzona, Switzerland.
Istituto Cantonale di Patologia · CHOspedale San Giovanni Bellinzona · CHUniversity of St.Gallen · CHEnte Ospedaliero Cantonale · CHUniversity Hospital of Geneva · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

lessons learnedPanitumumab shows activity in terms of disease control rate and preventing disease progression but not for tumor shrinkage in head and neck squamous cell cancer for second-line treatment. Epidermal growth factor receptor (EGFR) copy number gain, a property of tumor cells that theoretically could identify patients more likely to experience disease response, was common among patients having disease control.Our trial, given the lower toxicity with an every-2-week schedule, provides guidance for future trials, for example, in combinations of immune therapies and anti-EGFR-antibodies.

backgroundThe objective of this study was to investigate the efficacy and safety of panitumumab (anti-epidermal growth factor receptor [EGFR] antibody) given as a single agent in platinum-pretreated head and neck squamous cell cancer (HNSCC).

methodsPatients with advanced HNSCC previously treated with platinum-containing therapy were included. Panitumumab was administered intravenously every 2 weeks at a dose of 6 mg/kg. Primary endpoint was overall response rate (ORR) according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1; secondary endpoints were progression-free survival (PFS) and safety. A Simon's two-step design was chosen; 4 partial remissions (PR) in the first 32 patients were required for continuing to step two. An exploratory biomarker analysis was performed.

resultsThirty-three patients were enrolled. Two patients obtained a PR for an ORR of 6%, and 15 (45%) showed stable disease (SD) for at least 2 months, resulting in a 51% disease control rate. Median PFS was 2.6 months (95% confidence interval [CI]: 1.7-3.7), while median OS was 9.7 months (95% CI: 6.3-17.2). The most frequent adverse drug reactions were cutaneous rash (64%) and hypomagnesemia (55%). Overall, 30% of patients experienced grade 3/4 adverse events. No infusion-related reactions occurred. EGFR copy number gain (CNG) was more frequent in patients who benefitted from panitumumab. Two uncommon

conclusionPanitumumab monotherapy in pretreated HNSCC patients was well tolerated but moderately active. We observed a considerable disease control rate. Future strategies with this agent comprise right patient selection through the identification of reliable biomarkers and gene signatures predicting response and, considering good tolerability and convenience, combination strategies with novel agents and immune therapeutic agents.

Indexed as

Administration, IntravenousAdultAgedAged, 80 and overAntibodies, MonoclonalAntineoplastic AgentsErbB ReceptorsFemaleHead and Neck NeoplasmsHumansMaleMiddle AgedMutationNeoplasms, Squamous CellPanitumumabPlatinum CompoundsAntibodies, MonoclonalAntineoplastic AgentsEGFR protein, humanErbB ReceptorsKRAS protein, humanPanitumumabPlatinum CompoundsProto-Oncogene Proteins p21(ras)

Identifiers

PMID28592616
PMCPMC5507653
OpenAlexW2623774984

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.