Abstract
Introduction
Aim of the study was to investigate real-life phase IV efficacy of the PD-1 inhibitor nivolumab among an unselected and unbiased national cohort of recurrent/metastatic Head and Neck Squamous Cell Carcinoma (rmHNSCC) patients.
Materials & Methods
Inclusion criteria was histologically confirmed rmHNSCC and nivolumab as second-line palliative treatment. Data was collected from patient files at the five Danish head and neck cancer centers and from the DAHANCA database. iRECIST was used for treatment evaluation.
Endpoints were response rate (RR), overall survival (OS) and progression-free survival (PFS), calculated from start of treatment to date of event/censoring by the KM-method. Descriptive statistics were used to describe patients and treatment. Analyses were two-sided, and pResults
146 patients were identified in the period 2017-2020 with a RR of 14%, median OS 10.2 months [95% CI: 8.2-12.2] and median PFS 3.1 months [95% CI: 2.3-4.2]. Patient age (70≥ years) or comorbidity did not significantly affect outcome. WHO performance status (PS)=1 was associated with an increased risk of death (HR: 2.1 [95% CI: 1.2-4.0], p=0.02) and progression (HR: 1.9 [95% CI: 1.2-3.2], p=0.01), being even higher for patients of WHO PS≥2 (risk of death: HR: 6.5 [95% CI: 2.9-14.6], pConclusion
In this unselected national cohort, outcome of second-line treatment reflects data from the registration studies. Furthermore, the results suggest that immunotherapy should be used with great care in treatment of rmHNSCC in patients with poor performance.
Aim of the study was to investigate real-life phase IV efficacy of the PD-1 inhibitor nivolumab among an unselected and unbiased national cohort of recurrent/metastatic Head and Neck Squamous Cell Carcinoma (rmHNSCC) patients.
Materials & Methods
Inclusion criteria was histologically confirmed rmHNSCC and nivolumab as second-line palliative treatment. Data was collected from patient files at the five Danish head and neck cancer centers and from the DAHANCA database. iRECIST was used for treatment evaluation.
Endpoints were response rate (RR), overall survival (OS) and progression-free survival (PFS), calculated from start of treatment to date of event/censoring by the KM-method. Descriptive statistics were used to describe patients and treatment. Analyses were two-sided, and pResults
146 patients were identified in the period 2017-2020 with a RR of 14%, median OS 10.2 months [95% CI: 8.2-12.2] and median PFS 3.1 months [95% CI: 2.3-4.2]. Patient age (70≥ years) or comorbidity did not significantly affect outcome. WHO performance status (PS)=1 was associated with an increased risk of death (HR: 2.1 [95% CI: 1.2-4.0], p=0.02) and progression (HR: 1.9 [95% CI: 1.2-3.2], p=0.01), being even higher for patients of WHO PS≥2 (risk of death: HR: 6.5 [95% CI: 2.9-14.6], pConclusion
In this unselected national cohort, outcome of second-line treatment reflects data from the registration studies. Furthermore, the results suggest that immunotherapy should be used with great care in treatment of rmHNSCC in patients with poor performance.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Acta Oncologica |
| Vol/bind | 61 |
| Nummer | 8 |
| Sider (fra-til) | 972-978 |
| Antal sider | 7 |
| ISSN | 0284-186X |
| DOI | |
| Status | Udgivet - aug. 2022 |