Evidence map›Paper›PMID 40715648›Full record

Observational studyClinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico2026

Retreatment and rechallenge with BRAF/MEK inhibitors in patients with metastatic melanoma: results from the real-world Spanish Melanoma Registry (GEM-1801).

Pablo Ayala-de Miguel, Eva Muñoz-Couselo, Lourdes Gutiérrez-Sanz, Luis Antonio Fernández, Víctor Navarro-Pérez, Miguel Ángel Berciano-Guerrero, Francisco García-Arroyo, Carlos Aguado-de la Rosa, Pablo Cerezuela-Fuentes, Margarita Majem and 6 more

Registry-linked trialAbstract readObservational StudyMulticenter Study
PubMed Publisher
In one paragraph

Observational study in Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03605771 (Descriptive Observational Study on the Characteristics of Advanced and Metastatic Melanoma in Spain), which is not on this 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.

NCT03605771 recruitingnot on this map

Descriptive Observational Study on the Characteristics of Advanced and Metastatic Melanoma in Spain

Typeobservational_patient_registrySponsorGrupo Español Multidisciplinar de MelanomaRan2018 to 2025Enrolled400ConditionsMelanoma Stage Iv, Melanoma Stage Iii, Advanced CancerArmsDaily Clinical Practice
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Longitudinal Genomic Analysis to Fine-tune Targeted Therapy: Results of the Phase II LOGIC 2 Trial in Patients with BRAFV600-Mutant Metastatic Melanoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Trial
  2. Review
  3. Article
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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

16 authors.

Pablo Ayala-de MiguelMedical Oncology Department, Hospital Universitario San Pedro de Alcántara, Pablo Naranjo Porras Avenue s/n, 10003, Cáceres, Spain. pabloayala2003@gmail.com.ORCID http://orcid.org/0000-0002-9557-5880
Eva Muñoz-CouseloMedical Oncology Department, Hospital Universitari Vall d'Hebron y Vall Hebrón Institute of Oncology (VHIO), Barcelona, Spain.
Lourdes Gutiérrez-SanzMedical Oncology Department, Hospital Universitario Puerta de Hierro, Madrid, Spain.
Luis Antonio FernándezMedical Oncology Department, Parc Taulí Sabadell Hospital Universitari, Sabadell, Spain.
Víctor Navarro-PérezMedical Oncology Department, Hospital Universitario Costa del Sol, Marbella, Spain.
Miguel Ángel Berciano-GuerreroInstituto de Investigaciones Biomédicas de Málaga (IBIMA), Hospital Regional Universitario de Málaga (HRU), Málaga, Spain.
Francisco García-ArroyoMedical Oncology Department, Complejo Hospitalario Universitario de Pontevedra, Pontevedra, Spain.
Carlos Aguado-de la RosaMedical Oncology Department, Hospital Universitario Clínico San Carlos, Madrid, Spain.
Pablo Cerezuela-FuentesMedical Oncology Department, Instituto Murciano de Investigación Biosanitaria (IMIB), Hospital Clínico Universitario Virgen de La Arrixaca, Ciudad de Murcia, Spain.
Margarita MajemMedical Oncology Department, Hospital de La Santa Creu I Sant Pau, Barcelona, Spain.
Begoña Campos-BaleaMedical Oncology Department, Hospital Universitario Lucus Augusti, Lugo, Spain.
Ainara SoriaMedical Oncology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain.
Berta Hernández-MarínMedical Oncology Department, Hospital Universitario La Princesa, Madrid, Spain.
Almudena García-CastañoMedical Oncology Department, Hospital Universitario Marqués de Valdecilla, Valladolid, Spain.
Salvador Martín-AlgarraMedical Oncology Department, Clínica Universidad de Navarra, Pamplona, Spain.
Iván Márquez-RodasMedical Oncology Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.ORCID http://orcid.org/0000-0002-2476-668X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeMost patients with BRAF-mutant melanoma eventually develop resistance to BRAF/MEK inhibitors (BRAF/MEKi) and immune-checkpoint blockade. Emerging evidence from retrospective cohorts indicates promising activity from re-exposure to BRAF/MEKi after a treatment-free interval of targeted therapy (TT), probably due to tumor regression and proliferation of sensitive clones. However, there is limited prospective evidence on this approach. METHODS/PATIENTS: GEM1801 is a prospective observational study by the Spanish Melanoma Group (GEM), including 1123 patients treated at 37 centers. We conducted a descriptive analysis of baseline characteristics, objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) for the 24 patients who received a second course of BRAF/MEKi, either as retreatment (after relapse following prior adjuvant TT) or rechallenge (following prior progression on TT in the metastatic setting).

resultsFive patients underwent retreatment, and 19 received rechallenge. The BRAF/MEKi median free interval for retreatment was 20.9 months (range 12.4-57.3), with an ORR of 20%, and median PFS and OS of 5.5 and 8.4 months, respectively. The median free interval of TT for rechallenge was 6.8 months, with an ORR of 31.6%, and median PFS and OS of 5.7 and 7.6 months. Patients with ECOG ≤ 1 experienced longer survival with rechallenge (8.2 vs 4.3 months; HR 9.07 [95% CI 1.37-59.8]; p = 0.022).

conclusionRetreatment or rechallenge with BRAF/MEKi in the metastatic setting has shown clinical activity in patients with metastatic melanoma who lack therapeutic alternatives to prolong survival. Therefore, in our experience, it may represent a valid therapeutic strategy for selected patients. CLINICALTRIALS: GOV: NCT03605771 (REGISTRATION DATE: 20-07-2018): NCT03605771.

Indexed as

MelanomaProtein Kinase InhibitorsProto-Oncogene Proteins B-rafSkin NeoplasmsAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedProgression-Free SurvivalProspective StudiesRegistriesRetreatmentSpainBRAF protein, humanProtein Kinase InhibitorsProto-Oncogene Proteins B-rafMetastatic melanomaReal-worldRechallengeRetreatmentTargeted therapy

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Registered trials

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.