Abstract 4512
Background
R/M SCCHN is associated with poor prognosis and low survival rate. Further, there is a lack of evidence of how the disease impacts patients’ quality of life (QoL) and ability to perform activities of daily living (ADL). This study examines patients’ experience of living with R/M SCCHN.
Methods
A cross-sectional study was conducted in the EU5 from Jan to May 2019. Medical oncologists recruited patients to complete a survey, including the Functional Assessment of Cancer Therapy – Head and Neck Cancer (FACT-H&N), a 39-item instrument evaluating patients’ QoL (score range 0-148; higher scores indicating better QoL), the European Quality of Life – 5 Dimension Questionnaire (EQ-5D-3L; utility scores range -0.59-1, VAS scores 0-100; with higher scores indicating better health status) and questions on daily life impact using a 7-point scale (7= extremely high impact). Physicians also completed a case report form (CRF) for each patient. This analysis is based on interim data.
Results
191 patients completed the survey. Median age was 66 years (45% < 65, 55% ≥ 65), 77% were male, the majority (82%) had an ECOG score 0-1 and 39% required caregiver support for daily needs (mean 32.7 hours per week). At data capture, 9% of patients were in paid work, 21% on sick leave and 48% retired. Most patients (93%) received at least one therapy line following R/M. Patients reported diminished health status, with a mean EQ-5D utility score of 0.62 and a mean VAS score of 58. Mean FACT-H&N score was low at 74.0. Almost half of patients reported high impact (score 5-7) on ADL and family/social life (43% and 46%, respectively). For patients with a lower FACT-H&N score (lowest score quartile [26–60.2]), 75% reported high impact on ADL, versus 15% patients in the highest FACT-H&N score quartile (87.5–120). 81% patients in the lowest FACT-H&N quartile reported high family/social life impact, versus 15% patients in the highest quartile.
Conclusions
In addition to considerable impact on health status and QoL, patients report high impact on ability to perform ADL, with a high caregiving burden. There is a clear relationship between reduced QoL and restricted ADL and social life, highlighting the need to consider novel approaches to improve QoL in R/M SCCHN.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Bristol-Myers Squibb.
Funding
Bristol-Myers Squibb.
Disclosure
P. Singh: Full / Part-time employment: Bristol-Myers Squibb. B. Bennett: Full / Part-time employment: Bristol-Myers Squibb. M.C. Contente: Full / Part-time employment: Bristol-Myers Squibb. All other authors have declared no conflicts of interest.
Resources from the same session
3252 - Genes involved in DNA replication, chromatin remodeling and cell cycle as potential biomarkers for therapy outcome to immune therapy in patients with metastatic cutaneous malignant melanoma
Presenter: Fernanda Costa Svedman
Session: Poster Display session 3
Resources:
Abstract
5545 - Phase Ib/II Study (SENSITIZE) assessing safety, pharmacokinetics (PK), pharmacodynamics (PD), and clinical outcome of domatinostat in combination with pembrolizumab in patients with advanced melanoma refractory/non-responding to prior checkpoint inhibitor therapy
Presenter: Jessica Hassel
Session: Poster Display session 3
Resources:
Abstract
5213 - Genomic landscape of primary malignant melanoma of esophagus
Presenter: Jie Dai
Session: Poster Display session 3
Resources:
Abstract
2716 - A phase III, randomised, double-blind study of adjuvant cemiplimab versus placebo post-surgery and radiation in patients with high-risk cutaneous squamous cell carcinoma (CSCC)
Presenter: Danny Rischin
Session: Poster Display session 3
Resources:
Abstract
3550 - ILLUMINATE 301: A randomized phase 3 study of tilsotolimod in combination with ipilimumab compared with ipilimumab alone in patients with advanced melanoma following progression on or after anti-PD-1 therapy
Presenter: Marcus Butler
Session: Poster Display session 3
Resources:
Abstract
1645 - PRIME002 - Early phase II study of Azacitidine and Carboplatin priming for Avelumab in patients with advanced melanoma who are resistant to immunotherapy
Presenter: Andre Van Der Westhuizen
Session: Poster Display session 3
Resources:
Abstract
4440 - Pembrolizumab (pembro) Plus Lenvatinib (len) for First-Line Treatment of patients (pts) With Advanced Melanoma: Phase 3 LEAP-003 Study
Presenter: Alexander Eggermont
Session: Poster Display session 3
Resources:
Abstract
3454 - Proof of concept study with the histone deacetylase inhibitor vorinostat in patients with resistant BRAFV600 mutated advanced melanoma
Presenter: Sanne Huijberts
Session: Poster Display session 3
Resources:
Abstract
1832 - A phase Ia/Ib clinical study to evaluate the safety, pharmacokinetics (PK) and preliminary anti-tumor activity of FCN-159 in patients with advanced melanoma harboring NRAS-aberrant (Ia) and NRAS-mutation (Ib).
Presenter: Lu Si
Session: Poster Display session 3
Resources:
Abstract
3996 - A Phase I Clinical Trial Investigating the Therapeutic Cancer Vaccine UV1 in Combination with Pembrolizumab as First-Line Treatment of Patients with Malignant Melanoma
Presenter: Sanjiv Agarwala
Session: Poster Display session 3
Resources:
Abstract