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Real-world data on PD-1 inhibitor therapy in metastatic melanoma
Anna Arheden1, Joanna Skalenius2, Sara Bjursten1,3
1a Department of Oncology , Sahlgrenska University Hospital , Gothenburg , Sweden.
Abstract:
Introduction: Phase III studies of PD-1 inhibitors have demonstrated remarkable improvements in the survival of patients with metastatic melanoma (MM). If these results are generalizable to an unselected patient population treated in clinical routine is unknown. This study aimed to investigate and describe clinical efficacy and safety of PD-1 inhibitors in patients with MM treated in routine clinical practice. Material and methods: A retrospective descriptive study of patients with metastatic or inoperable cutaneous melanoma treated with PD-1 inhibitors at a single institution (Department of Oncology, Sahlgrenska University Hospital) from 1 September 2015 to 31 August 2017. Data were obtained from medical records. Results: A total of 116 patients were included in the analyses. The overall survival (OS) at 12-month follow-up was 70.2% and the median OS was 27.9 months. Patients with BRAF mutated tumors had increased OS, whereas ECOG PS ≥2, LDH > ULN and presence or history of brain metastases (stage M1d) were associated with impaired survival. Immune-related AEs of any grade occurred in 64 (55.2%) patients and 15 (12.9%) patients experienced immune-related AEs of grades 3 and 4. Notably, rheumatic adverse events occurred at a higher rate (15.5%) than previously reported. The occurrence of immune-related AEs was associated with a benefit in OS, while the severity of immune-related AEs did not affect survival, nor did the use of systemic corticosteroids. Conclusions: The efficacy and safety of PD1 inhibitors in routine clinical practice appear comparable to that described in clinical trials.
Insights
Programmed cell death protein 1 (PD-1) inhibitors show comparable efficacy and safety in routine metastatic melanoma care as in clinical trials. Immune-related adverse events were common but associated with improved overall survival.
Area of Science:
- Oncology
- Immunotherapy
- Melanoma Research
Background:
- Phase III trials show PD-1 inhibitors improve survival in metastatic melanoma (MM).
- Generalizability of trial results to routine clinical practice remains uncertain.
- Need to evaluate real-world effectiveness and safety of PD-1 inhibitors in MM.
Purpose of the Study:
- To investigate and describe the clinical efficacy of PD-1 inhibitors in MM patients treated in routine practice.
- To assess the safety profile, including immune-related adverse events (irAEs), of PD-1 inhibitors in a real-world MM cohort.
- To identify factors associated with survival outcomes in MM patients receiving PD-1 inhibitors.
Main Methods:
- Retrospective descriptive study of 116 MM patients treated with PD-1 inhibitors.
- Data collected from medical records at a single institution between September 2015 and August 2017.
- Analysis of overall survival (OS), immune-related adverse events (irAEs), and prognostic factors.
Main Results:
- 12-month OS was 70.2%, with a median OS of 27.9 months.
- BRAF mutation correlated with increased OS; ECOG PS ≥2, elevated LDH, and brain metastases were associated with poorer survival.
- irAEs occurred in 55.2% of patients; grade 3-4 irAEs in 12.9%. Rheumatic irAEs were notably higher (15.5%).
- Occurrence of irAEs was linked to improved OS, irrespective of severity or corticosteroid use.
Conclusions:
- PD-1 inhibitors demonstrate comparable efficacy and safety in routine MM care to clinical trial findings.
- Real-world data supports the benefit of PD-1 inhibitors in metastatic melanoma.
- Understanding irAEs and prognostic factors is crucial for optimizing treatment in clinical practice.
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