Impact of comprehensive geriatric assessment on survival, function, and nutritional status in elderly patients with head and neck cancer: protocol for a multicentre randomised controlled trial (EGeSOR)

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, 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

Background: 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.

Methods/design: 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.

Discussion: 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: Trial registration: NCT02025062.

Figures

Figure 1
Figure 1
EGeSOR flow chart.
Figure 2
Figure 2
Follow-up over the first 6 months (M) for patients treated with surgery alone in the EGeSOR study.

References

    1. Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010;127(12):2893–2917.
    1. Grenman R, Chevalier D, Gregoire V, Myers E, Rogers S. Treatment of head and neck cancer in the elderly: European Consensus (panel 6) at the EUFOS Congress in Vienna 2007. Eur Arch Otorhinolaryngol. 2010;267(10):1619–1621.
    1. Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011;61(2):69–90.
    1. Bourhis J, Overgaard J, Audry H, Ang KK, Saunders M, Bernier J, Horiot JC, Le Maitre A, Pajak TF, Poulsen MG, O'Sullivan B, Dobrowsky W, Hliniak A, Skladowski K, Hay JH, Pinto LH, Fallai C, Fu KK, Sylvester R, Pignon JP. Meta-Analysis of Radiotherapy in Carcinomas of Head and neck (MARCH) Collaborative Group. Hyperfractionated or accelerated radiotherapy in head and neck cancer: a meta-analysis. Lancet. 2006;368(9538):843–854.
    1. Cojocariu OM, Huguet F, Lefevre M, Perie S. Prognosis and predictive factors in head-and-neck cancers. Bull Cancer. 2009;96(4):369–378.
    1. Michiels S, Le Maitre A, Buyse M, Burzykowski T, Maillard E, Bogaerts J, Vermorken JB, Budach W, Pajak TF, Ang KK, Bourhis J, Pignon JP. MARCH and MACH-NC Collaborative Groups. Surrogate endpoints for overall survival in locally advanced head and neck cancer: meta-analyses of individual patient data. Lancet Oncol. 2009;10(4):341–350.
    1. Homma A, Sakashita T, Oridate N, Suzuki F, Suzuki S, Hatakeyama H, Mizumachi T, Taki S, Fukuda S. Importance of comorbidity in hypopharyngeal cancer. Head Neck. 2010;32(2):148–153.
    1. van der Schroeff MP, Derks W, Hordijk GJ, de Leeuw RJ. The effect of age on survival and quality of life in elderly head and neck cancer patients: a long-term prospective study. Eur Arch Otorhinolaryngol. 2007;264(4):415–422.
    1. Paleri V, Wight RG, Silver CE, Haigentz M Jr, Takes RP, Bradley PJ, Rinaldo A, Sanabria A, Bien S, Ferlito A. Comorbidity in head and neck cancer: a critical appraisal and recommendations for practice. Oral Oncol. 2010;46(10):712–719.
    1. Peters TT, Langendijk JA, Plaat BE, Wedman J, Roodenburg JL, van Dijk BA, Sluiter WJ, van der Laan BF, Halmos GB. Co-morbidity and treatment outcomes of elderly pharyngeal cancer patients: a matched control study. Oral Oncol. 2011;47(12):1159–1164.
    1. Blackwell KE, Azizzadeh B, Ayala C, Rawnsley JD. Octogenarian free flap reconstruction: complications and cost of therapy. Otolaryngol Head Neck Surg. 2002;126(3):301–306.
    1. Datema FR, Ferrier MB, van der Schroeff MP, de Jong RJ B. Impact of comorbidity on short-term mortality and overall survival of head and neck cancer patients. Head Neck. 2010;32(6):728–736.
    1. Reid BC, Alberg AJ, Klassen AC, Samet JM, Rozier RG, Garcia I, Winn DM. Comorbidity and survival of elderly head and neck carcinoma patients. Cancer. 2001;92(8):2109–2116.
    1. Milisavljevic D, Stankovic M, Zivic M, Stankovic P. Head and neck cancer surgery in elderly: complications and survival rate. Coll Antropol. 2012;36(Suppl 2):13–17.
    1. Sarini J, Fournier C, Lefebvre JL, Bonafos G, Van JT, Coche-Dequeant B. Head and neck squamous cell carcinoma in elderly patients: a long-term retrospective review of 273 cases. Arch Otolaryngol Head Neck Surg. 2001;127(9):1089–1092.
    1. Bernardi D, Barzan L, Franchin G, Cinelli R, Balestreri L, Tirelli U, Vaccher E. Treatment of head and neck cancer in elderly patients: state of the art and guidelines. Crit Rev Oncol Hematol. 2005;53(1):71–80.
    1. Genden EM, Rinaldo A, Shaha AR, Clayman GL, Werner JA, Suarez C, Ferlito A. Treatment considerations for head and neck cancer in the elderly. J Laryngol Otol. 2005;119(3):169–174.
    1. Peters TT, van der Laan BF, Plaat BE, Wedman J, Langendijk JA, Halmos GB. The impact of comorbidity on treatment-related side effects in older patients with laryngeal cancer. Oral Oncol. 2011;47(1):56–61.
    1. Rubenstein LZ, Stuck AE, Siu AL, Wieland D. Impacts of geriatric evaluation and management programs on defined outcomes: overview of the evidence. J Am Geriatr Soc. 1991;39(9 Pt 2):8S–16S. discussion 17S-18S.
    1. Ellis G, Whitehead MA, O'Neill D, Langhorne P, Robinson D. Comprehensive geriatric assessment for older adults admitted to hospital. Cochrane Database Syst Rev. 2011;7 CD006211.
    1. Extermann M, Aapro M, Bernabei R, Cohen HJ, Droz JP, Lichtman S, Mor V, Monfardini S, Repetto L, Sorbye L, Topinkova E. Task Force on CGA of the International Society of Geriatric Oncology. Use of comprehensive geriatric assessment in older cancer patients: recommendations from the task force on CGA of the International Society of Geriatric Oncology (SIOG) Crit Rev Oncol Hematol. 2005;55(3):241–252.
    1. Balducci L, Extermann M. Management of cancer in the older person: a practical approach. Oncologist. 2000;5(3):224–237.
    1. Caillet P, Canoui-Poitrine F, Vouriot J, Berle M, Reinald N, Krypciak S, Bastuji-Garin S, Culine S, Paillaud E. Comprehensive geriatric assessment in the decision-making process in elderly patients with cancer: ELCAPA study. J Clin Oncol. 2011;29(27):3636–3642.
    1. Terret C, Zulian GB, Naiem A, Albrand G. Multidisciplinary approach to the geriatric oncology patient. J Clin Oncol. 2007;25(14):1876–1881.
    1. Paillaud E, Liuu E, Laurent M, Le Thuaut A, Vincent H, Raynaud-Simon A, Bastuji-Garin S, Tournigand C, Caillet P, Canoui-Poitrine F. Geriatric syndromes increased the nutritional risk in elderly cancer patients independently from tumoursite and metastatic status. The ELCAPA-05 cohort study. Clin Nutr. 2014;33(2):330–335.
    1. Legrain S, Tubach F, Bonnet-Zamponi D, Lemaire A, Aquino JP, Paillaud E, Taillandier-Heriche E, Thomas C, Verny M, Pasquet B, Moutet AL, Lieberherr D, Lacaille S. A new multimodal geriatric discharge-planning intervention to prevent emergency visits and rehospitalizations of older adults: the optimization of medication in AGEd multicenter randomized controlled trial. J Am Geriatr Soc. 2011;59(11):2017–2028.
    1. Katz S, Ford AB, Moskowitz RW, Jackson BA, Jaffe MW. Studies of illness in the aged. The index of Adl: a standardized measure of biological and psychosocial function. JAMA. 1963;185:914–919.
    1. Morice V. RandoWeb, an online randomization tool for clinical trials. Comput Methods Programs Biomed. 2012;107(2):308–314.
    1. Altman DG, Bland JM. Treatment allocation by minimisation. BMJ. 2005;330(7495):843.
    1. Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med. 2008;5(1):e20.
    1. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, Kaasa S, Klee M, Osoba D, Razavi D, Rofe PB, Schraub S, Sneeuw K, Sullivan M, Takeda F. The European organization for research and treatment of cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85(5):365–376.
    1. Fayers PM. Interpreting quality of life data: population-based reference data for the EORTC QLQ-C30. Eur J Cancer. 2001;37(11):1331–1334.
    1. Chaibi P, Magne N, Breton S, Chebib A, Watson S, Duron JJ, Hannoun L, Lefranc JP, Piette F, Menegaux F, Spano JP. Influence of geriatric consultation with comprehensive geriatric assessment on final therapeutic decision in elderly cancer patients. Crit Rev Oncol Hematol. 2011;79(3):302–307.
    1. Marenco D, Marinello R, Berruti A, Gaspari F, Stasi MF, Rosato R, Bertetto O, Molaschi M, Ciccone G. Multidimensional geriatric assessment in treatment decision in elderly cancer patients: 6-year experience in an outpatient geriatric oncology service. Crit Rev Oncol Hematol. 2008;68(2):157–164.
    1. Girre V, Falcou MC, Gisselbrecht M, Gridel G, Mosseri V, Bouleuc C, Poinsot R, Vedrine L, Ollivier L, Garabige V, Pierga JY, Diéras V, Mignot L. Does a geriatric oncology consultation modify the cancer treatment plan for elderly patients? J Gerontol A Biol Sci Med Sci. 2008;63(7):724–730.

Source: PubMed

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

3
Abonneren