Evidence map›Paper›PMID 31955148›Full record

Observational studyRadiology and oncology2020

Retrospective analysis of treatment-naive Slovenian patients with metastatic melanoma treated with pembrolizumab - real-world experience.

Nezka Hribernik, Marko Boc, Janja Ocvirk, Jasna Knez-Arbeiter, Tanja Mesti, Marija Ignjatovic, Martina Rebersek

Abstract readObservational Study
In one paragraph

Observational study in Radiology and oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
–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

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  6. Early-time-pointRadiology and oncology · 2025
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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

7 authors.

Nezka HribernikDepartment of Medical Oncology, Institute of Oncology Ljubljana, Ljubljana, Slovenia.
Marko BocDepartment of Medical Oncology, Institute of Oncology Ljubljana, Ljubljana, Slovenia.
Janja OcvirkDepartment of Medical Oncology, Institute of Oncology Ljubljana, Ljubljana, Slovenia.
Jasna Knez-ArbeiterUniversity Medical Centre Maribor, Maribor, Slovenia.
Tanja MestiDepartment of Medical Oncology, Institute of Oncology Ljubljana, Ljubljana, Slovenia.
Marija IgnjatovicDepartment of Medical Oncology, Institute of Oncology Ljubljana, Ljubljana, Slovenia.
Martina RebersekDepartment of Medical Oncology, Institute of Oncology Ljubljana, Ljubljana, Slovenia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background Based on recent data from clinical trials, the immune checkpoint inhibitor pembrolizumab prolongs survival and has a good toxicity profile in patients with advanced or metastatic melanoma. However, the question remains whether these results are transmitted into daily clinical practice. The aim of this study was to assess the efficacy and toxicity of pembrolizumab in treatment-naive patients with metastatic melanoma in everyday clinical practice in Slovenia and compare it to the results from clinical trials. Patients and methods This observational retrospective cohort study included 138 consecutive metastatic treatment-naive melanoma patients treated with pembrolizumab at the Institute of Oncology Ljubljana in Slovenia, from January 2016 to December 2018. Patient and treatment characteristics were retrospectively collected from hospital data base. Statistical data was obtained using the SPSS software version 22. Survival rate was calculated with the Kaplan-Meier method. Observation period took place between January 2016 and the end of June 2019. Results The estimated median overall survival (OS) was 25.1 months (95% CI, 14.6-35.6) and the median progression-free survival (PFS) was 10.7 months (95% CI, 5.9-15.4). Among all patients, 29 (21.0%) achieved complete response, 31 (22.5%) partial response and 23 (16.7%) reached stable disease. The number of organs with metastatic involvement and the level of baseline lactate dehydrogenase (LDH) concentration had significant influence on survival rates. Immune-related adverse events (irAE) were reported in 88 (63%) patients, while grade 3-4 irAE occurred in 12 (8.7%). Due to toxicity, 16 (11.6%) patients discontinued the treatment. Conclusions Our real-world data from single centre retrospective analysis of treatment-naive metastatic melanoma patients treated with pembrolizumab showed inferior median OS and similar median PFS, compared to the results from clinical trials. However, patients with normal serum levels of LDH and a small number of organs with metastatic involvement had comparable survival outcomes. Toxicity rates of pembrolizumab were quite similar. These results further support the use of pembrolizumab for metastatic treatment-naive melanoma patients.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalFemaleHumansKaplan-Meier EstimateL-Lactate DehydrogenaseMaleMelanomaMiddle AgedProgression-Free SurvivalRetrospective StudiesSkin NeoplasmsSloveniaAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalL-Lactate Dehydrogenasepembrolizumabimmunotherapymetastatic melanomapembrolizumabtreatment-naive

Identifiers

PMID31955148
PMCPMC7087416

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Registered trials

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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.