Evidence map›Paper›PMID 28054320›Full record

ArticleClinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico2017

Pembrolizumab for advanced melanoma: experience from the Spanish Expanded Access Program.

M González-Cao, A Arance, J M Piulats, I Marquez-Rodas, J L Manzano, A Berrocal, G Crespo, D Rodriguez, E Perez-Ruiz, M Berciano and 15 more

Abstract read
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In one paragraph

Article in Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Anti-PD-1/anti-CTLA-4 efficacy in melanoma brain metastases depends on extracranial disease and augmentation of CD8Proceedings of the National Academy of Sciences of the United States of America · 2018
    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

25 authors.

M González-CaoTranslational Cancer Research Unit, Dr. Rosell Oncology Institute, Quiron Dexeus University Hospital, 08028, Barcelona, Spain. mgonzalezcao@oncorosell.com.
A AranceHospital Clinic I Provincial, Barcelona, Spain.
J M PiulatsCatalan Institute of Oncology, Barcelona, Spain.
I Marquez-RodasGregorio Marañón Institute of Health Research, Madrid, Spain.
J L ManzanoGermans Trias I Pujol University Hospital, Barcelona, Spain.
A BerrocalGeneral University Hospital, Valencia, Spain.
G CrespoBurgos University Hospital, Burgos, Spain.
D RodriguezInsular University Hospital of Gran Canaria, Canary Islands, Spain.
E Perez-RuizCosta del Sol Hospital, Marbella, Malaga, Spain.
M BercianoRegional University Hospital of Malaga, Malaga, Spain.
A SoriaRamony Cajal Hospital, Madrid, Spain.
A G CastanoMarqués de Valdecilla University Hospital, Santander, Spain.
E EspinosaLa Paz University Hospital, Madrid, Spain.
C MontagutDel Mar University Hospital, Barcelona, Spain.
L AlonsoVirgen de la Victoria Hospital, Malaga, Spain.
T PuertolasMiguel Servet University Hospital, Zaragoza, Spain.
C AguadoSan Carlos Hospital, Madrid, Spain.
M A RoyoDr. Peset Hospital, Valencia, Spain.
R BlancoConsorci Sanitari de Terrassa, Barcelona, Spain.
J F RodríguezClara Campal Hospital, Madrid, Spain.
E MuñozValld'Hebron University Hospital, Barcelona, Spain.
P MutSon Llatzer University Hospital, Mallorca, Spain.
F BarronNational Cancer Institute, Mexico City, Mexico.
S Martin-AlgarraNavarra University Clinic, Pamplona, Spain.
Spanish Melanoma Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe programmed death (PD-1) inhibitor pembrolizumab has been recently approved for the treatment of advanced melanoma. We evaluated the clinical activity of pembrolizumab in melanoma patients treated under the Spanish Expanded Access Program.

methodsAdvanced melanoma patients who failed to previous treatment lines were treated with pembrolizumab 2 mg/kg every three weeks. Patients with brain metastases were not excluded if they were asymptomatic. Data were retrospectively collected from 21 centers in the Spanish Melanoma Group.

resultsSixty-seven advanced melanoma patients were analyzed. Most patients were stage M1c (73.1%), had high LDH levels (55.2%) and had ECOG PS 1 or higher (59.7%). For cutaneous melanoma patients, median overall survival was 14.0 months; the 18-month overall survival rate was 47.1%. Overall response rate was 27%, including three patients with complete responses (6.5%). Median response duration was not reached, with 83.3% of responses ongoing (3.5 m+ to 20.4 m+). From ten patients included with brain metastases, four (40%) had an objective response, two (20%) of them achieved a complete response. Significant prognostic factors for overall survival were LDH level, ECOG PS and objective response. There were no serious adverse events.

conclusionAlthough this was a heavily pretreated cohort, pembrolizumab activity at the approved dose and schedule was confirmed in the clinical setting with long-term responders, also including patients with brain metastases.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic AgentsDisease-Free SurvivalFemaleHumansKaplan-Meier EstimateMaleMelanomaMiddle AgedProportional Hazards ModelsRetrospective StudiesSalvage TherapySpainAntibodies, Monoclonal, HumanizedAntineoplastic AgentspembrolizumabCNS metastasesExpanded access programMelanomaPembrolizumabSurvival

Identifiers

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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.