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Published on: April 20, 2018
Real-world Outcomes in Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck With Nivolumab: Galician Study
Leticia Iglesias1, Rocío Vílchez2, Santiago Aguín3
1Department of Medical Oncology, Complejo Hospitalario Universitario de Ourense (CHUO), Ourense, Spain; leticia.iglesias.rey@sergas.es.
Background/Aim:
Real-world evidence regarding the use of nivolumab in metastatic squamous cell carcinoma of head and neck (R/M SCCHN) is limited. This study aimed to describe the clinical characteristics, outcomes, and safety of nivolumab in R/M SCCHN patients treated in routine clinical practice.
Patients And Methods:
This retrospective, observational study evaluated the efficacy/safety of nivolumab in 116 patients with R/M SCCHN treated at nine centers within the Galician Group of Head and Neck Cancer health network between 2017 and 2019.
Results:
Basal characteristics of patients included a median age of 60 years, ECOG performance status -2 (14%) and -3 (1%) and a first diagnosis of stage IV a/b/c (74%). Nivolumab was used as first line, second line, and third line therapy in 17%, 66%, and 17% of patients, respectively. After a median follow-up of 14 months (range=1-69 months), the median progression-free survival was 2.30 months (95%CI=1.45-3.14) and the median overall survival was 8.1 months (95%CI=5.93-10.23). Outcomes were better when nivolumab was administered earlier in treatment course. Grade 3/4 adverse events were observed in 21.27% of patients.
Conclusion:
These findings support the efficacy and safety of nivolumab in the real-world treatment of R/M SCCHN.
Insights
This study shows nivolumab is effective and safe for head and neck squamous cell carcinoma (SCCHN) in real-world settings. Early use of nivolumab in metastatic SCCHN improved patient outcomes.
Area of Science:
- Oncology
- Immunotherapy
- Head and Neck Cancer Research
Background:
- Limited real-world data exists for nivolumab in metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).
- Understanding nivolumab's effectiveness and safety in routine clinical practice is crucial for treatment optimization.
Purpose of the Study:
- To describe the clinical characteristics of R/M SCCHN patients treated with nivolumab.
- To evaluate the outcomes and safety profile of nivolumab in a real-world R/M SCCHN patient cohort.
- To assess the impact of treatment line on nivolumab efficacy in R/M SCCHN.
Main Methods:
- Retrospective, observational study design.
- Inclusion of 116 R/M SCCHN patients from nine healthcare network centers.
- Data collection on patient characteristics, treatment lines, progression-free survival, overall survival, and adverse events between 2017 and 2019.
Main Results:
- Median progression-free survival was 2.30 months and median overall survival was 8.1 months.
- Nivolumab administered earlier in the treatment course (first or second line) correlated with better outcomes.
- Grade 3/4 adverse events occurred in 21.27% of patients, indicating a manageable safety profile.
Conclusions:
- Nivolumab demonstrates efficacy and a favorable safety profile in the real-world treatment of R/M SCCHN.
- Early-line nivolumab administration may enhance survival outcomes in R/M SCCHN patients.
- This study provides valuable real-world evidence supporting nivolumab's role in R/M SCCHN management.
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