Elderly Head and Neck Cancer (ELAN) study: Personalized treatment according to geriatric assessment in patients age 70 or older: First prospective trials in patients with squamous cell cancer of the head and neck (SCCHN) unsuitable for surgery.

Authors

Joel Guigay

Joel Guigay

Gustave Roussy, Villejuif at present Centre Antoine-Lacassagne, IUFC, Nice, France

Joel Guigay , Herve Le Caer , Cecile Mertens , Cecile Ortholan , Emmanuel Blot , Yungan Tao , Frederic Peyrade , Yoann Pointreau , Pierre Guillet , Cedrik Lafond , Karen Benezery , Sophie Renard-Oldrini , Julia Villa , Georges Garnier , Marc Alfonsi , Naima Lezghed , Nadejda Vintonenko , Dominique Schwob , Perrine Capolino , Anne Auperin

Organizations

Gustave Roussy, Villejuif at present Centre Antoine-Lacassagne, IUFC, Nice, France, CH de Draguignan, Draguignan, France, Medical Oncology, Institut Bergonié, Bordeaux, France, Princess Grace Hospital, Monaco, Monaco, C.H.B. Vannes, Vannes, France, Institut Gustave Roussy, Villejuif, France, Anticancer Center, Centre Antoine-Lacassagne, IUFC, Nice, France, Clinique Victor Hugo, Le Mans, France, Centre hospitalier Intercommunal de Toulon - La Seyne sur Mer, Toulon, France, Department of Radiation Oncology, Centre Antoine-Lacassagne, Nice, France, Institut de Cancérologie de Lorraine (ICL), Vandoeuvre-lès-Nancy, France, Hôpital A. Michallon, CHU de Grenoble, Grenoble, France, Hôpital Princesse Grace, Monaco, Monaco, Institut Sainte Catherine, Avignon, France, Institut Gustave Roussy (IGR), Villejuif, France, GORTEC, Villejuif, France, Gustave Roussy, Villejuif, France

Research Funding

Other

Background: 30% of SCCHN occur in patients (pts) >= 70y and the main challenges in these pts are to cope with the treatment benefit/risk ratio and the tumor related symptoms. However, these pts are usually not included in trials. We developed a large prospective clinical program planed to enroll 448 pts in 3 distinct trials to improve the multidisciplinary management of elderly SCCHN pts. The main objectives of this study are to demonstrate that a geriatric evaluation is feasible in daily practice for SCCHN pts and to set new standards of care in this population. Methods: To be included in one of the three trials, SCCHN pts aged 70 or over, not suitable for surgery, must first be enrolled in ELAN-ONCOVAL study where they are classified as fit or unfit, using a geriatric evaluation applicable to the daily practice. Comprehensive Geriatric Assessment is optional. In curative situation, unfit pts are proposed to be enrolled in the randomized non-inferiority ELAN-RT trial, comparing standard radiotherapy (RT, 70Gy, 35 fractions, 7 weeks) and hypofractionated split course schedule (30 Gy in 10 fractions, 2 weeks stop, 25 Gy in 10 fractions, total 6 weeks). Main endpoint is the rate of patients alive with local control 6 months after end of RT. 202 pts are planned to be randomized. In first line treatment of recurrent and/or metastatic (R/M) pts: - Fit pts are proposed to be enrolled in the 2-stage phase II ELAN-FIT trial, which evaluates the cetuximab-carboplatin-5FU (EXTREME) combination in terms of efficacy (objective response at 12 weeks) and safety assessed by lack of grade>=3 toxicity and lack of loss of independence. Enrollment of 82 pts is planned. - Unfit pts are proposed to be enrolled in the efficacy randomized phase III ELAN-UNFIT trial, that compares two monotherapies (cetuximab 500 mg/m² every 2 weeks versus weekly methotrexate 40 mg/m²) in terms of failure free survival (failures are progression, treatment stop, loss >= 2 points in Activities in Daily Living scale or death). 164 pts are planned to be randomized. Inclusions started on June 2013. At now 23 centers are opened. Grants: INCa PAIR Clinical trial information: NCT01884623; NCT01864850; NCT01864772.

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Abstract Details

Meeting

2014 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Head and Neck Cancer

Track

Head and Neck Cancer

Sub Track

Head and Neck Cancer

Clinical Trial Registration Number

NCT01884623; NCT01864850; NCT01864772

Citation

J Clin Oncol 32:5s, 2014 (suppl; abstr TPS6099)

DOI

10.1200/jco.2014.32.15_suppl.tps6099

Abstract #

TPS6099

Poster Bd #

133A

Abstract Disclosures