Evidence map›Paper›PMID 32559817›Full record

Trial reportInternational journal of cancer2020

Real-world outcomes of advanced melanoma patients not represented in phase III trials.

Michiel C T van Zeijl, Rawa K Ismail, Liesbeth C de Wreede, Alfonsus J M van den Eertwegh, Anthonius de Boer, Maaike van Dartel, Doranne L Hilarius, Maureen J B Aarts, Franchette W P J van den Berkmortel, Marye J Boers-Sonderen and 11 more

Open access · bronzeAbstract readPragmatic Clinical Trial
In one paragraph

Trial report in International journal of cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
2.4field-weighted citation impact, top 9% 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

20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 36 citations in OpenAlex.

  1. Pooled it
  2. Neoadjuvant treatment for stage III and IV cutaneous melanoma.The Cochrane database of systematic reviews · 2023
    Pooled it
  3. Trial
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  13. Article
  14. Anti-PD-1: When to Stop Treatment.Current oncology reports · 2022
    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

21 authors at 17 institutions in 2 countries.

Michiel C T van ZeijlScientific department, Dutch Institute for Clinical Auditing, Leiden, The Netherlands.
Rawa K IsmailScientific department, Dutch Institute for Clinical Auditing, Leiden, The Netherlands.ORCID 0000-0002-0838-0349
Liesbeth C de WreedeDepartment of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands.
Alfonsus J M van den EertweghDepartment of Medical Oncology, Amsterdam University Medical Centers, Amsterdam, The Netherlands.
Anthonius de BoerDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht, The Netherlands.
Maaike van DartelMedicines Evaluation Board, Utrecht, The Netherlands.
Doranne L HilariusDepartment of Pharmacy, Red Cross Hospital, Beverwijk, The Netherlands.
Maureen J B AartsDepartment of Medical Oncology, Maastricht University Medical Center+, Maastricht, The Netherlands.
Franchette W P J van den BerkmortelDepartment of Medical Oncology, Zuyderland Medical Center, Sittard-Geleen, The Netherlands.
Marye J Boers-SonderenDepartment of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.
Jan-Willem B de GrootIsala Oncology Center, Isala, Zwolle, The Netherlands.
Geke A P HospersDepartment of Medical Oncology, University Medical Centre Groningen, Groningen, The Netherlands.
Ellen KapiteijnDepartment of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands.
Djura PiersmaDepartment of Internal Medicine, Medisch Spectrum Twente, Enschede, The Netherlands.
Rozemarijn S van RijnDepartment of Internal Medicine, Medical Center Leeuwarden, Leeuwarden, The Netherlands.
Karijn P M SuijkerbuijkDepartment of Medical Oncology, University Medical Center Utrecht, Utrecht, The Netherlands.
Albert J Ten TijeDepartment of Internal Medicine, Amphia Hospital, Breda, The Netherlands.
Astrid A M van der VeldtDepartments of Medical Oncology and Radiology & Nuclear Medicine, Erasmus Medical Centre, Rotterdam, The Netherlands.
Gerard VreugdenhilDepartment of Internal Medicine, Maxima Medical Center, Eindhoven, The Netherlands.
John B A G HaanenDepartment of Medical Oncology and Immunology, Netherlands Cancer Institute, Amsterdam, The Netherlands.
Michel W J M WoutersScientific department, Dutch Institute for Clinical Auditing, Leiden, The Netherlands.
Leiden University Medical Center · NLRadboud University Nijmegen · NLThe Netherlands Cancer Institute · NLAmphia Ziekenhuis · NLAmsterdam University Medical Centers · NLDutch Institute for Clinical Auditing · NLErasmus MC · NLIsala · NLMaastricht University Medical Centre · NLMedicines Evaluation Board · NLMedisch Centrum Leeuwarden · NLMedisch Spectrum Twente · NLPharmo Institute · NLRed Cross Hospital · GRUniversity Medical Center Groningen · NLUniversity Medical Center Utrecht · NLZuyderland Medisch Centrum · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The aim was to provide evidence on systemically treated patients with advanced melanoma not represented in phase III trials to support clinical decision-making. Analysis were performed on advanced melanoma patients diagnosed between 2014 and 2017 in the Netherlands, treated with immune- or targeted therapy, who met ≥1 trial exclusion criteria. These criteria were derived from the KEYNOTE-006 and CHECKMATE-067/-066 phase III trials. Prognostic importance of factors associated with overall survival (OS) was assessed with the Kaplan-Meier method, Cox models, predicted OS probabilities of prognostic subgroups and a conditional inference survival tree (CIST). A nationwide population-based registry was used as data source. Of 2536 systemically treated patients with advanced melanoma, 1004 (40%) patients were ineligible for phase IIII trials. Ineligible patients had a poorer median OS (mOS) compared to eligible patients (8.8 vs 23 months). Eligibility criteria strongly associated with OS in systemically treated ineligible patients were Eastern Cooperative Oncology Group Performance Score (ECOG PS) ≥2, brain metastases (BM) and lactate dehydrogenase (LDH) of >500 U/L. Patients with ECOG PS of ≥2 with or without symptomatic BM had a predicted mOS of 6.5 and 11.3 months and a 3-year survival probability of 9.3% and 23.6%, respectively. The CIST showed the strongest prognostic covariate for survival was LDH, followed by ECOG PS. The prognosis of patients with LDH of >500 U/L is poor, but long-term survival is possible. The prognosis of ineligible patients with advanced melanoma in real-world was very heterogeneous and highly dependent on LDH value, ECOG PS and symptomatic BM.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Agents, ImmunologicalClinical Decision-MakingClinical Trials, Phase III as TopicFemaleHumansMaleMelanomaMiddle AgedMolecular Targeted TherapyNeoplasm StagingNetherlandsPatient SelectionPrognosisAntineoplastic Agents, Immunologicaladvanced melanomadecision treeineligibilityreal-world outcomessurvival

Identifiers

PMID32559817
PMCPMC7689762
OpenAlexW3036011106

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.