Impact of comprehensive geriatric assessment on survival, function, and nutritional status in elderly patients with head and neck cancer: protocol ... View Full Text


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Article Info

DATE

2014-06-13

AUTHORS

Lydia Brugel, Marie Laurent, Philippe Caillet, Anne Radenne, Isabelle Durand-Zaleski, Michel Martin, Melany Baron, Héloïse de Kermadec, Sylvie Bastuji-Garin, Florence Canouï-Poitrine, Elena Paillaud

ABSTRACT

BackgroundSurvival 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.Methods/designEGeSOR 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.DiscussionEGeSOR 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 registrationTrial registration: NCT02025062 More... »

PAGES

427

References to SciGraph publications

  • 2006-11-11. The effect of age on survival and quality of life in elderly head and neck cancer patients: a long-term prospective study in EUROPEAN ARCHIVES OF OTO-RHINO-LARYNGOLOGY
  • 2010-05-09. Treatment of head and neck cancer in the elderly in EUROPEAN ARCHIVES OF OTO-RHINO-LARYNGOLOGY
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1186/1471-2407-14-427

    DOI

    http://dx.doi.org/10.1186/1471-2407-14-427

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1034541105

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/24923533


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    18 schema:description BackgroundSurvival 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.Methods/designEGeSOR 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.DiscussionEGeSOR 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 registrationTrial registration: NCT02025062
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    25 French cities
    26 HNSCC
    27 N stage
    28 admission
    29 age
    30 aim
    31 algorithm
    32 assessment
    33 benefits
    34 cancer
    35 cancer patients
    36 cancer treatment
    37 cancer treatment selection
    38 carcinoma
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    41 center
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    58 explanation
    59 frequent refusal
    60 function
    61 functional impairment
    62 general health
    63 geriatric assessment
    64 geriatricians
    65 head
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    67 health settings
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    69 impairment
    70 intervention
    71 life
    72 loss
    73 management
    74 management model
    75 minimisation algorithm
    76 model
    77 modification
    78 months
    79 mortality
    80 multicentre
    81 multidimensional assessment
    82 neck cancer
    83 neck squamous cell carcinoma
    84 nutritional status
    85 online system
    86 overall survival
    87 parallel-group trial
    88 participation
    89 patients
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    92 primary endpoint
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    94 quality
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