Evidence map›Paper›PMID 27604993›Full record

Trial reportCancer immunology, immunotherapy : CII2016

Complete response to nivolumab monotherapy in a treatment-naive, BRAF wild-type patient with advanced mucosal melanoma and elevated lactate dehydrogenase: a case report from a phase III trial.

Paolo A Ascierto, Vito Vanella, Antonio Maria Grimaldi, Festino Lucia, Marco Palla, Ester Simeone, Nicola Mozzillo

Abstract readCase ReportsClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Cancer immunology, immunotherapy : CII, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing 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

12 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Multimodal treatment and immune checkpoint inhibition in sinonasal mucosal melanoma: real-world data of a retrospective, single-center study.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2023
    Article
  5. Review
  6. The miRNAs Role in Melanoma and in Its Resistance to Therapy.International journal of molecular sciences · 2020
    Review
  7. Review
  8. Article
  9. Article
  10. Article
  11. Mucosal Melanoma: a Literature Review.Current oncology reports · 2018
    Review
  12. Review
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

7 authors.

Paolo A AsciertoIstituto Nazionale Tumori Fondazione "G. Pascale", Via Mariano Semmola, 80131, Naples, Italy. paolo.ascierto@gmail.com.
Vito VanellaIstituto Nazionale Tumori Fondazione "G. Pascale", Via Mariano Semmola, 80131, Naples, Italy.
Antonio Maria GrimaldiIstituto Nazionale Tumori Fondazione "G. Pascale", Via Mariano Semmola, 80131, Naples, Italy.
Festino LuciaIstituto Nazionale Tumori Fondazione "G. Pascale", Via Mariano Semmola, 80131, Naples, Italy.
Marco PallaIstituto Nazionale Tumori Fondazione "G. Pascale", Via Mariano Semmola, 80131, Naples, Italy.
Ester SimeoneIstituto Nazionale Tumori Fondazione "G. Pascale", Via Mariano Semmola, 80131, Naples, Italy.
Nicola MozzilloIstituto Nazionale Tumori Fondazione "G. Pascale", Via Mariano Semmola, 80131, Naples, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The anti-PD-1 agent, nivolumab, has been approved both as monotherapy and in combination with ipilimumab for the treatment of unresectable or metastatic melanoma in the USA and European Union. Here we present the case of a patient with treatment-naive, metastatic mucosal melanoma and baseline LDH approximately seven times the upper limit of normal. The patient was enrolled in a clinical trial (CheckMate 066) and achieved a partial response, followed by a durable complete response with nivolumab treatment. The patient's LDH levels were documented in each cycle and dropped markedly within 2 months, when partial response to treatment was already evident. LDH levels remained low for the rest of follow-up, consistent with the ongoing complete response to treatment. The patient experienced only mild immune-related adverse events (grade 1-2), which included vitiligo and rash. This exceptional response suggests that patients with high LDH levels at baseline should be considered for nivolumab treatment. LDH levels, however, should not serve as a predictive marker of response to nivolumab. Moreover, this case suggests the need to identify patients who will achieve the greatest benefit from nivolumab monotherapy.

Indexed as

AgedAntibodies, MonoclonalBiomarkers, PharmacologicalEpistaxisFemaleHumansImmunotherapyL-Lactate DehydrogenaseMelanomaNasal MucosaNeoplasm MetastasisNeoplasm StagingNivolumabNose NeoplasmsProgrammed Cell Death 1 ReceptorProto-Oncogene Proteins B-rafAntibodies, MonoclonalBiomarkers, PharmacologicalBRAF protein, humanL-Lactate DehydrogenaseNivolumabPDCD1 protein, humanProgrammed Cell Death 1 ReceptorProto-Oncogene Proteins B-rafCheckMate-066Lactate dehydrogenaseMelanomaNivolumabPD-1

Identifiers

PMID27604993
PMCPMC11028877

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.