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
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.
Disclaimer
This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org
Abstract Disclosures
2023 ASCO Annual Meeting
First Author: Summera Qiheng Zhou
2019 ASCO Annual Meeting
First Author: Cécile Mertens
2023 ASCO Annual Meeting
First Author: Cindy Kenis
2024 ASCO Annual Meeting
First Author: Dandan Zheng