Effectiveness of Geriatric Assessment-Driven Interventions on Survival and Functional and Nutritional Status in Older Patients with Head and Neck Cancer: A Randomized Controlled Trial (EGeSOR)

Abstract

This study assesses the efficacy of Geriatric Assessment (GA)-driven interventions and follow-up on six-month mortality, functional, and nutritional status in older patients with head and neck cancer (HNC). HNC patients aged 65 years or over were included between November 2013 and September 2018 by 15 Ear, Nose, and Throat (ENT) and maxillofacial surgery departments at 13 centers in France. The study was of an open-label, multicenter, randomized, controlled, and parallel-group design, with independent outcome assessments. The patients were randomized 1:1 to benefit from GA-driven interventions and follow-up versus standard of care. The interventions consisted in a pre-therapeutic GA, a standardized geriatric intervention, and follow-up, tailored to the cancer-treatment plan for 24 months. The primary outcome was a composite criterion including six-month mortality, functional impairment (fall in the Activities of Daily Living (ADL) score ≥2), and weight loss ≥10%. Among the patients included (n = 499), 475 were randomized to the experimental (n = 238) or control arm (n = 237). The median age was 75.3 years [70.4–81.9]; 69.5% were men, and the principal tumor site was oral cavity (43.9%). There were no statistically significant differences regarding the primary endpoint (n = 98 events; 41.0% in the experimental arm versus 90 (38.0%); p = 0.53), or for each criterion (i.e., death (31 (13%) versus 27 (11.4%); p = 0.48), weight loss of ≥10% (69 (29%) versus 65 (27.4%); p = 0.73) and fall in ADL score ≥2 (9 (3.8%) versus 13 (5.5%); p = 0.35)). In older patients with HNC, GA-driven interventions and follow-up failed to improve six-month overall survival, functional, and nutritional status.

Evaluation of Concomitant Systemic Treatment in Older Adults With Head and Neck Squamous Cell Carcinoma Undergoing Definitive Radiotherapy

“…In the future, prospective trials in which the value of geriatric assessment and prognostic scores also can be examined are required to increase the scientific evidence regarding optimal treatment for older adults with HNSCC. 49 , 50 , 51 Several studies, including phase 3 trials (novel agents such as NBTRX3 [ NCT04892173 ] or hypofractionation with split-course [ NCT01864850 ]) and prospective pilot studies (eg, hypofractionation [ NCT04284540 ] or omitting coverage of elective sites of disease [ NCT04832555 ]) are currently being conducted to improve nonsurgical treatment of older adults with HNSCC.…”

Practical Assessment and Management of Vulnerabilities in Older Patients Receiving Systemic Cancer Therapy: ASCO Guideline Update

“…A total of 15 publications met eligibility criteria and form the evidentiary basis for the guideline recommendation pertaining to Clinical Question 1. 3,4,[14][15][16][17][18][19][20][21][22][23][24] The identified publications include the respective primary reports of nine RCTs evaluating GAM 3,4,[14][15][16][17][18][19][20] ; four reports of secondary analyses of data from the primary RCTs [23][24][25][26] ; one systematic review of GA studies 22 ; and one systematic review of GA studies with meta-analysis. 21 The identified RCTs were published between 2020 and 2022.…”

“…The RCTs evaluated comparable GA with management interventions. For the clinical question concerning the role of GA in older adults with cancer to suggest specific interventions to improve clinical outcomes, the primary outcomes of the nine RCTs included completion of planned chemotherapy (n 5 2) 14,19 ; the proportion of patients with grade 3-5 toxicity (n 5 2) 3,4 ; quality of life (n 5 2) 16,17 ; overall survival (n 5 1) 20 ; a composite criterion of 6-month mortality, functional impairment (fall in the Activities of Daily Living [ADL] score ≥2), and weight loss (≥10%; n 5 1) 18 ; and patient satisfaction with communication about agingrelated concerns (n 5 1). 15 A total of 11 publications were identified by the systematic review and form the evidentiary basis for the Clinical Question 2 guideline recommendations concerning which GA tools should be used to predict outcomes, 5,6,12,[27][28][29][30][31][32][33][34] and help inform the development of the PGA.…”

“…There were also no differences between the groups observed in daily life activities, 90 days physical performance, or hospital admissions (55% of controls v 47% of intervention group patients; risk rate, 0.86 [95% CI, 0.69 to 1.07]; P 5 .19). In 96% (68/71) of cases, patients in the intervention group received the GA after treatment initiation (median time to CGA was 14.5 days [IQR,[6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21] after the start of treatment). Participants in the usual care group did not receive the study-specific GA but could be referred to a geriatrician by their clinician.…”

Advances in Geriatric Oncology: Exploring Practical Ways to Optimize Treatment in Older Patients with Cancer

“…However, data regarding the effects of GA-driven interventions on clinical outcomes such as survival rate or quality of life among older patients with cancer are very sparse [ 12 ]. A recent randomized study assessed the efficacy of GA-driven interventions and follow-up on six-month mortality, functional, and nutritional status in older patients with head and neck cancer (HNC) and failed to improve these outcomes [ 13 ].…”