ArticleCureus2025
Inequalities in Drug Access for Advanced Melanoma: The Prognostic Impact Resulting From the Approval Delay of the Combined Ipilimumab/Nivolumab Treatment in Portugal.
Article in Cureus, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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.
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.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Introduction A combination of ipilimumab/nivolumab has demonstrated a median overall survival (mOS) of 71.9 months in advanced melanoma, establishing it as the standard first-line (1L) therapy. However, the approval of this combination by the Portuguese Regulatory Authority occurred 76 months after its approval by the European Authority, leaving tyrosine kinase inhibitors as the only 1L option available for the BRAF-mutated melanoma population. Our study aims to evaluate real-world data from patients with advanced melanoma and assess the potential prognostic impact of the delayed availability of ipilimumab/nivolumab combination therapy on this population. Methods This was an observational, retrospective cohort study conducted at a Portuguese Comprehensive Cancer Center. The study included adult patients with melanoma who received innovative therapies in the 1L between May 2016 and December 2021 and who would meet the criteria for treatment with ipilimumab/nivolumab. The primary outcome measure was mOS; secondary outcome measures included median progression-free survival (mPFS), objective response rate (ORR), and safety data. Results Our study included 172 patients, of which 50% were male, and 32.6% (n = 56) had BRAF-mutated melanoma. In 1L setting, 70.9% received anti-programmed cell death protein 1 (anti-PD-1) monotherapy, while the rest were treated with targeted therapies. The median follow-up time was 57 months. Patients treated with anti-PD-1 had ORR of 36.0%, mPFS of seven months (95% CI 2.9-11.1), and mOS of 19 months (95% CI 7.5-30.4). Among patients treated with targeted therapies, the ORR was 56.0%, mPFS seven months (95% CI 5.1-8.9), and mOS 14 months (95% CI 5.9-22.1). In our population, 10% presented grade 3 or higher adverse events, with no drug-related deaths reported. Conclusion These findings underscore significant disparities in access to innovative therapies in Portugal, which may have adversely impacted patients' outcomes. The delay raises ethical concerns regarding equity in healthcare access and highlights the need for policy measures to expedite the approval and availability of life-extending treatments.
Indexed as
Identifiers
What OpenQuestion holds
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.