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Published on: April 22, 2019
Nivolumab for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: A Retrospective Tertiary Centre's
Yue Jennifer Du1,2, Rui Fu2, Justin T Levinsky2
1Temerty School of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada.
Abstract:
Nivolumab, a PD-1 checkpoint inhibitor, was approved in Canada in 2017 for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) based on the phase 3 trial CHECKMATE-141. We aimed to examine the demographics and efficacy of nivolumab in a Canadian, real-world setting. A retrospective chart review was performed on patients who received nivolumab for R/M HNSCC from 2017 to 2020 at a high-volume cancer centre. Data were abstracted from 34 patients, based on physician notes and imaging reports. The median patient age at nivolumab initiation was 61, 24% were female, and 62% were current or former smokers. Prior to nivolumab, 44% of patients underwent surgery, 97% radiation, and 100% chemotherapy. Most (97%) therapies were for primary disease. Overall survival at 6 and 12 months following drug initiation was 38% and 23%, respectively. Progression-free survival at 6 and 12 months was 33% and 22%, respectively. Eighteen percent of patients experienced an immune-related adverse event, the most common of which was pneumonitis (3/8) and endocrine events (3/8). Seven out of eight of the immune adverse events were grade 1-2; 1/8 was grade 3. Nivolumab appears to have decreased survival rates in our single-centre Canadian population compared to CHECKMATE-141 and presented a manageable adverse event profile for R/M HNSCC.
Insights
Nivolumab treatment for recurrent or metastatic head and neck squamous cell carcinoma in Canada showed lower survival rates than clinical trials but had a manageable safety profile, with immune-related adverse events typically being mild.
Area of Science:
- Oncology
- Immunotherapy
- Head and Neck Cancer
Background:
- Nivolumab, a PD-1 inhibitor, is approved for recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).
- Real-world data is crucial for understanding treatment effectiveness and safety in diverse patient populations.
- The CHECKMATE-141 trial established nivolumab's efficacy in R/M HNSCC.
Purpose of the Study:
- To evaluate the real-world demographics and efficacy of nivolumab in Canadian patients with R/M HNSCC.
- To assess the safety and adverse event profile of nivolumab in this patient cohort.
- To compare real-world outcomes with those reported in the pivotal CHECKMATE-141 trial.
Main Methods:
- Retrospective chart review of 34 patients treated with nivolumab for R/M HNSCC from 2017 to 2020.
- Data abstraction included patient demographics, prior treatments, overall survival (OS), progression-free survival (PFS), and immune-related adverse events (irAEs).
- Analysis focused on a single, high-volume Canadian cancer center.
Main Results:
- The median patient age was 61; 24% were female, and 62% were current/former smokers. Most patients had received prior surgery, radiation, and chemotherapy.
- Six-month OS was 38% and 12-month OS was 23%. Six-month PFS was 33% and 12-month PFS was 22%.
- Eighteen percent of patients experienced irAEs, predominantly pneumonitis and endocrine events, mostly grade 1-2.
Conclusions:
- Nivolumab demonstrated a manageable adverse event profile in this Canadian real-world R/M HNSCC cohort.
- Observed survival rates were lower compared to the CHECKMATE-141 trial.
- Further investigation is warranted to understand factors contributing to survival differences in real-world settings.
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