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).

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.

Prehabilitation Program in Elderly Patients: A Prospective Cohort Study of Patients Followed Up Postoperatively for Up to 6 Months.

The preoperative period may be an opportune period to optimize patients' physical condition with a multimodal preoperative program. The impact of a "prehabilitation" program on elderly patients is discussed. This mono-center observational cohort study included consecutively 139 patients planned for major abdominal and thoracic surgery, with 44 in the control group (age < 65) and 95 in the elderly group (age > 65). All patients followed a "prehabilitation" program including exercise training, nutritional optimization, psychological support, and behavioral change. Seventeen patients in the control group and 45 in the elderly group completed the study at six months. The 6-minute walk test (6 MWT) increased in both groups from the initial evaluation to the last (median value of 80 m (interquartile range 51) for those under 65 years; 59 m (34) for the elderly group; p = 0.114). The 6 MWT was also similar after one month of prehabilitation for both populations. The rate of postoperative complications was similar in the two groups. Prehabilitation showed equivalence in patients over 65 years of age compared to younger patients in terms of increase in functional capabilities and of postoperative evolution. This multimodal program represents a bundle of care that can benefit a frailer population.

Frailty Related to Anesthesia guided by the Index "bispectraL" (FRAIL) study: study protocol for a randomized controlled trial.

BACKGROUND: Currently, patients older than 60 years of age represent 25% of the population and are at an increased risk during surgery. Therefore, reducing postoperative morbidity and mortality is a major concern in medical research and practice. Dependence on caregivers and cognitive impairment represent two major risk factors in the elderly, especially in frail patients after surgery under general anesthesia. In this context, continuous monitoring of the depth of anesthesia using a bispectral index (BIS) sensor may reduce the occurrence of impairments by gaining better control of the anesthetic depth. The first aim of this study is to compare manual versus automated administration of intravenous anesthetics with regard to 6-month functional decline in persons aged 70 years and older. The secondary objective includes an evaluation of the influence of the frail phenotype on self-sufficiency in elderly patients after general anesthesia. METHODS/DESIGN: After receiving ethical committee approval and written consent, a complete preoperative assessment of physiological reserve and self-sufficiency will be performed on patients more than 70 years old who are scheduled for surgery under general anesthesia. This evaluation will determine the patient's frailty status in three categories: robust, pre-frail, and frail. Then, patients will be randomized into two groups: manual administration of anesthetics guided by BIS sensor (manual group) or automated administration (automated group) with recording of the anesthesia. A second examination will be scheduled after 6 months to assess changes in functional abilities, cognitive functions, and frailty status. A priori calculation of sample size gives a population of 430 patients to be included in this multicenter trial. DISCUSSION: This clinical study is designed to detect any postoperative complications and deaths related to the performance of the general anesthesia guided by the BIS sensor and the preoperative functional status of the elderly: robust, pre-frail, or frail. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02524327 . Registered on 10 August 2015.

[Aging and HIV infection: 4 years follow-up of 149 HIV infected patients older than 60 years in West Paris agglomeration (COREVIH Île-de-France Ouest)]. / Vieillissement et infection par le VIH: suivi de 149 patients âgés de plus de 60ans infectés par le VIH (COREVIH Île-de-France Ouest).

UNLABELLED: In France, patients over 50 years represent more than 23.6% of all registered cases in the French Hospital Database for HIV (FHDH), and 18% of newly HIV-diagnosed patients. OBJECTIVE: To describe the long-term evolution after 4 years of a cohort of HIV infected patients older than 60 years recruited in COREVIH Île-de-France Ouest. RESULTS: One hundred and forty-nine participants, 115 men (77%) and 34 women (23%), were included in the cohort analysis in 2004, and baseline characteristics were: median age 65.4 years (60.3-86.3), CDC stage C: 36%, HBV and HCV co-infections: four (2.7%) and eight (5.4%) patients, median time from first HIV infection diagnosis: 8.5 years (0.25-19.5), ongoing HAART regimen: 88%, median duration of ARV treatment: 7.5 years (0.2-15.5), baseline CD4 cells count: 372/mm(3) (18-1860), HIV viral load less than 200 c/ml: 104 (70%). After a 4-year follow-up, 111 patients were alive, all but one treated with HAART, 17/149 (11.5%) were lost for follow-up, and 21/149 were deceased (14%). Causes of death were acute cardiovascular disease (4/21), neoplasia (11/21), neurological disease 1/21, end stage liver disease 3/21, unknown 2/21. The prevalence of co-morbidities after 4 years of follow-up were: arterial hypertension 40/111 (36%), hypercholesterolemia 48/111 (43%), diabetes 23/111 (21%), kidney disease with renal insufficiency (creatinine clairance<60 ml/min): 36/111 (32%). At the end of follow-up, median CD4 cells count was 494/mm(3), and viral load was undetectable less than 200 c/ml in 107/111 patients (96%). No new opportunistic infection occurred during the 4-year follow-up, but 24 patients had a new diagnosis of neoplasia (incidence 40/1000 person-year). Cancer was the cause of death in 11/24. CONCLUSION: Clinical and immunological improvement was continuous under HAART in these aged HIV infected patients, but co-morbidities are frequently observed in this population, with high incidence of cardiovascular disease and neoplasia, and related mortality. A multidisciplinary approach, with preventive consultations, oncology and cardiovascular screening, as done in geriatrics, is warranted in the aging HIV population.