About 30% of Head and Neck Cancer (HNC) cases are diagnosed in patients aged 70 years and older. Due to their location, HNC and the toxicity of associated treatments may have consequences on quality of life. The aim of this study was to assess the effectiveness of Geriatric Assessment (GA)-driven interventions on quality of life for 2 years in older patients with HNC.
The EGeSOR study was a two parallel group, multicenter, randomized, controlled and open-label trial, including HNC patients aged 65 years and over between 2013 and 2018. Patients were randomized 1 :1 to receive either a pre-therapeutic GA, a standardized geriatric intervention and follow-up (intervention group) or standard of care (control group). The main outcome was quality of life measures through the European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30/100) and HNC questionnaire (QLQ-HN35/100) at 6, 12 and 24 months. Linear mixed models were performed.
Among the 475 patients included (238 in the intervention group and 237 in the control group), the median age was 75.3 years, 31% were women, 44% with oral cancer and 21% metastasis. At baseline, the median score of global health status was 66.7 [50-83.3]. There were no statistically significant differences in evolution between the two groups in either the QLQ-C30 (15 dimensions) or HN35 scores (18 dimensions) over the 24-month period. The evolution of global health status followed a J-shape between M0 and M24 (median gain : 8 points). In the intervention group, 74% of patients did not receive the complete intervention as planned. Statistical analyses regarding age, tumor site and metastasis status are ongoing.
Baseline GA did not improve quality of life for 2 years in older patients with HNC. Difficulties in implementation of complete interventions may have contributed to this result. Alternative models to implement GA-driven interventions could be explored.
Clinical trial identification
Legal entity responsible for the study
Assistance Publique des Hôpitaux de Paris - APHP.
The EGeSOR study was supported by grants from the French National Cancer Institute [INCa] [RAFC1202] and the platform for clinical research in older cancer patients (PACAN, Ligue Nationale contre le Cancer).
E. Paillaud: Financial Interests, Invited Speaker, Honoraria for presentation during an educational Symposium: Amgen, Servier; Financial Interests, Advisory Board: Pfizer, BMS; Financial Interests, Other, Supports for participation to congress, travel and inscription from Nutricia. P. Caillet: Non-Financial Interests, Other, Contract as expert in geriatric oncology for an observational prospective cohort (phase IV). No fees: Pfizer; Financial Interests, Invited Speaker, Honoraria for presentation during an educational Symposium: Amgen; Financial Interests, Advisory Board: Pfizer. A. Raynaud-Simon: Financial Interests, Other: Nestlé, Nutricia, Lactalis, Fresenius, Entreprises de la Nutrition Clinique. A. Anota: Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, Sandoz, Amgen, Ipsen; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Other, Travel fees: BMS, AstraZeneca, Novartis; Financial Interests, Personal, Invited Speaker, Travel fees: AstraZeneca. All other authors have declared no conflicts of interest.