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Published on: April 22, 2019
From trials to practice: Immune checkpoint inhibitor therapy for melanoma patients in Norway
Denise Reis Costa1, Anna K Winge-Main2, Anna Skog3
1Department of Research, The Cancer Registry of Norway, Norwegian Institute of Public Health, Oslo, Norway; Norwegian Research Centre for Women's Health, Oslo University Hospital, Oslo, Norway.
Background And Purpose:
Norway has one of the highest rates of cutaneous melanoma (CM) incidence and mortality globally. Immune checkpoint inhibitor (ICI) therapy for CM was introduced between 2014 and 2017 to improve treatment and patient prognosis, but knowledge about its clinical usage is limited. This study investigates patient's characteristics and treatment patterns in real-world practice compared to clinical trial results.
Material And Methods:
All adult (≥18) CM patients treated with ICI therapy in Norway from 2014 to 2021 were included, utilizing high-coverage data from multiple national registries to describe patients' health, socioeconomic factors, and treatment management, stratified by first ICI therapy. We compared patient and tumour characteristics with findings from five randomized controlled trials (RCTs).
Results:
Among 2,083 patients receiving ICI therapy, 975 (47%) received nivolumab as their first treatment in the metastatic setting. Patients on combination therapy were younger and had higher education and income levels compared to those on monotherapy. Overall, real-world patients were older and had a higher incidence of brain metastases than those in RCTs. Approximately, 1 in 5 patients would have been excluded from RCTs due to pre-existing autoimmune diseases. Targeted therapy was the most common secondary systemic treatment after first-line PD-1 inhibitors.
Interpretation:
This study details ICI therapy in Norway, highlighting differences between real-world ICI users and clinical trial participants, raising questions about the effectiveness of this treatment for patients not eligible for trials.
Insights
Real-world use of immune checkpoint inhibitors (ICI) for cutaneous melanoma in Norway shows differences from clinical trials. Many patients excluded from trials due to comorbidities received ICI therapy.
Area of Science:
- Oncology
- Dermatology
- Immunotherapy
Background:
- Norway has high rates of cutaneous melanoma (CM) incidence and mortality.
- Immune checkpoint inhibitor (ICI) therapy for CM was introduced to improve outcomes.
- Limited data exists on real-world ICI usage for CM.
Purpose of the Study:
- Investigate patient characteristics and treatment patterns of ICI therapy for CM in Norway.
- Compare real-world data with findings from clinical trials.
- Assess the generalizability of clinical trial results to a broader patient population.
Main Methods:
- Retrospective analysis of 2,083 adult CM patients treated with ICI from 2014-2021 in Norway.
- Utilized national registry data for patient health, socioeconomic factors, and treatment management.
- Compared real-world patient and tumor characteristics with five randomized controlled trials (RCTs).
Main Results:
- Nivolumab was the first treatment for 47% of patients in the metastatic setting.
- Patients receiving combination therapy were younger with higher socioeconomic status.
- Real-world patients were older, had more brain metastases, and 1 in 5 would be excluded from RCTs due to autoimmune diseases.
- Targeted therapy was the most common second-line treatment after PD-1 inhibitors.
Conclusions:
- Significant differences exist between real-world ICI users and clinical trial participants in Norway.
- Treatment patterns and patient profiles in real-world practice diverge from controlled trial settings.
- Effectiveness of ICI therapy for patients ineligible for trials warrants further investigation.
