Dataset Information

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.

SUBMITTER: Paillaud E

PROVIDER: S-EPMC9265581 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature

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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).

Paillaud Elena E Brugel Lydia L Bertolus Chloe C Baron Melany M Bequignon Emilie E Caillet Philippe P Schouman Thomas T Lacau Saint Guily Jean J Périé Sophie S Bouvard Eric E Laurent Marie M Salvan Didier D Chaumette Laurence L de Decker Laure L Piot Benoit B Barry Beatrix B Raynaud-Simon Agathe A Sauvaget Elisabeth E Bach Christine C Bizard Antoine A Bounar Abderrahmane A Minard Aurelien A Aziz Bechara B Chevalier Eric E Chevalier Dominique D Gaxatte Cedric C Malard Olivier O Liuu Evelyne E Lacour Sandrine S Gregoire Laetitia L Lafont Charlotte C Canouï-Poitrine Florence F

Cancers 20220705 13

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 indep ...[more]

PMID: 35805060

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Project description:Survival is poorer in elderly patients with head and neck squamous cell carcinomas [HNSCCs] than in younger patients. Possible explanations include a contribution of co-morbidities to mortality, frequent refusal of standard therapy, and the use of suboptimal treatments due to concern about toxicities. The Comprehensive Geriatric Assessment [CGA] is a multidimensional assessment of general health that can help to customise treatment and follow-up plans. The CGA has been proven effective in several health settings but has not been evaluated in randomised studies of patients with cancer. Our aim here was to assess the impact of the CGA on overall survival, function, and nutritional status of elderly patients with HNSCC.EGeSOR is an open-label, multicentre, randomised, controlled, parallel-group trial in patients aged 70 years or older and receiving standard care for HNSCC. The intervention includes four components: the CGA conducted by a geriatrician before cancer treatment, participation of the same geriatrician in cancer treatment selection, a standardised geriatric therapeutic intervention designed by the same geriatrician; and geriatric follow-up for 24 months. The primary endpoint, assessed after 6 months, is a composite criterion including death, functional impairment [Activities of Daily Living score decrease ? 2], and weight loss ? 10%. Secondary endpoints include progression-free survival, unscheduled admissions, quality of life, treatment toxicities, costs, and completion of the planned cancer treatment. A centralised online system is used to perform 1:1 randomisation with a minimisation algorithm for centre, age, T and N stages, and tumour site [oral, oropharyngeal, hypopharyngeal, or laryngeal]. The estimated sample size is 704 patients, who are being recruited by 14 centres in 9 French cities.EGeSOR is the first randomised trial of the CGA in elderly cancer patients. We expect the CGA to have direct clinical benefits on the management of elderly patients with HNSCC. If this expectation is fulfilled, the trial may lead to modifications of the management model for elderly patients with cancer.Trial registration: NCT02025062.

Project description:Cancer treatments for older patients must account for heterogeneity in health and functional status. Guidelines advocate the use of geriatric assessments (GAs), but comprehensive assessments are laborious and the utility of specific GA domains remains unclear. The identification of specific domains as prognostic factors may support survival predictions and treatment decisions. We aimed to evaluate the associations between several GA domains and overall survival in older cancer patients. We linked cancer registry data and administrative claims data from cancer patients residing in Osaka Prefecture, Japan. The subjects were patients aged ≥70 years who received a diagnosis of gastric, colorectal, or lung cancer between 2010 and 2014 at 36 designated cancer care hospitals. The following three GA domains were assessed at cancer diagnosis: functional status through activities of daily living (ADL), comorbidities, and nutritional status through body mass index. Cox proportional hazards models were constructed for the three cancer types to estimate each domain's prognostic effect while adjusting for gender, age, and cancer stage. Adjusted hazard ratios (HRs) for all-cause mortality were calculated. We identified 5,559, 4,746, and 4,837 patients with gastric, colorectal, and lung cancer respectively. ADL impairment (HRs: 1.39-3.34, 1.64-2.86, and 1.24-3.21 for gastric, colorectal, and lung cancer, respectively), comorbidities (1.32-1.58, 1.33-1.97, and 1.19-1.29 for gastric, colorectal, and lung cancer, respectively), and underweight (1.36, 1.51, and 1.54 for gastric, colorectal, and lung cancer, respectively) were significantly associated with poorer overall survival. In contrast, overweight was significantly associated with improved overall survival (HRs: 0.82 and 0.89 for gastric and lung cancer respectively). The addition of the three domains increased the models' C-statistics (0.816 to 0.836, 0.764 to 0.787, and 0.759 to 0.783 for gastric, colorectal, and lung cancer respectively). Incorporating these factors into initial patient evaluations during diagnosis may aid prognostic predictions and treatment strategies in geriatric oncology.

Project description:ObjectiveThere is limited evidence regarding the economic effects of nutrition support in cancer patients. This study aims at investigating the cost-effectiveness profile of systematic oral nutritional supplementation (ONS) in head and neck cancer (HNC) patients undergoing radiotherapy (RT) and receiving nutritional counseling.MethodsA cost-effectiveness analysis based on a RCT was performed to estimate direct medical costs, life years gained (LYG) and Quality-Adjusted Life Years (QALY) for nutritional counseling with or without ONS at 5-month and 6-year follow up time. Value of information analysis was performed to value the expected gain from reducing uncertainty through further data collection.ResultsONS with nutritional counseling produced higher QALY than nutritional counseling alone (0.291 ± 0.087 vs 0.288 ± 0.087), however the difference was not significant (0.0027, P = 0.84). Mean costs were €987.60 vs €996.09, respectively in the treatment and control group (-€8.96, P = 0.98). The Incremental Cost Effectiveness Ratio (ICER) was -€3,277/QALY, with 55.4% probabilities of being cost-effective at a cost-effectiveness threshold of €30,000/QALY. The Expected Incremental Benefit was €95.16 and the Population Expected Value of Perfect Information was €8.6 million, implying that additional research is likely to be worthwhile. At a median 6-year follow up, the treatment group had a significantly better survival rate when adjusting for late effect (P = 0.039).ConclusionOur findings provide the first evidence to inform decisions about funding and reimbursement of ONS in combination with nutritional counseling in HNC patients undergoing RT. ONS may improve quality of cancer care at no additional costs, however further research on the cost-effectiveness of nutritional supplementation is recommended.Trial registrationClinicalTrials.gov: NCT02055833. Registered 5th February 2014 https://clinicaltrials.gov/ct2/show/NCT02055833.

Dataset Information

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).

Publications

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).

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